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Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
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March 5, 2015
06:58 EDTBMYBristol-Myers price target raised to $75 from $70 at JPMorgan
JPMorgan raised its price target for shares of Bristol-Myers to $75 after the company received FDA approval of Opdivo in lung cancer earlier than expected. The firm sees "rapid adoption" of the drug and notes Bristol has a number of pipeline catalysts remaining in 2015. It reiterates an Overweight rating on the stock.
05:59 EDTJNJJ&J says 'looking forward' to continuing collaboration with AbbVie
Johnson & Johnson (JNJ) issued a statement after AbbVie (ABBV) reached an agreement to acquire Pharmacyclics (PCYC) saying its "looking forward" to continuing its Imbruvica collaboration with AbbVie (ABBV), Bloomberg and Reuters reported. Pharmacyclics co-markets Imbruvica with Johnson & Johnson, and media reports as late as last night said J&J was close to buying its partner. AbbVie late last night announced it would acquire Pharmacyclics for $19.9B or $261.25 per share.
March 4, 2015
18:37 EDTJNJOn The Fly: After Hours Movers
UP AFTER EARNINGS: Roundy's (RNDY), up 12.7%... Pacific Ethanol (PEIX), up 11.5%... Miller Industries (MLR), 6.9%. ALSO HIGHER: Pharmacyclics (PCYC), up 2.8% after speculation of acquisition by Johnson & Johnson (JNJ). Johnson & Johnson is up marginally. DOWN AFTER EARNINGS: Semtech (SMTC), down 5.3%... Callon Petroleum (CPE), down 1.3%. ALSO LOWER: Vanda Pharmaceuticals (VNDA), down 7% following results from tradipitant Phase II study... Encana (ECA), down 4.2% after announcing C$1.25B bought deal offering... Apollo Commercial (ARI), down 2.9% after filing to sell 10M shares of common stock... Neustar (NSR), down 2.7% after making statement on LNPA vendor selection.
18:34 EDTMRKMerck, Eisai enter clinical trial collaboration to test safety of KEYTRUDA
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17:22 EDTJNJPharmacyclics up 2% after speculation of acquisition by Johnson & Johnson
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17:11 EDTJNJPharmacyclics said to agree to be bought by J&J, Bloomberg says
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17:11 EDTBMYOn The Fly: Closing Wrap
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16:35 EDTJNJJohnson & Johnson close to deal to buy Pharmacyclics, FT reports
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16:17 EDTBMYBristol-Myers reports FDA approval of Opdivo
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16:02 EDTBMYOptions Update; March 4, 2015
iPath S&P 500 VIX Short-Term Futures down 6c to 27.22. Option volume leaders: AAPL TSLA TWTR AA PBR NFLX MNKD FB BMY C according to Track Data.
14:28 EDTBMYBristol-Myers announces FDA approval of added Opdivo indication
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13:58 EDTBMYBristol-Myers jumps 4% to $64.23 after FDA approves Opdivo for lung cancer
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13:40 EDTBMYFDA expands use of Opdivo to treat lung cancer
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12:11 EDTCELGCelgene reaffirms long-term financial targets
Celgene in conference presentation slides reaffirmed its 2017 product sales target of $13B-$14B and 2020 target of over $20B. The company also reaffirmed its 2017 earnings per share target of $7.50 and 2020 target of greater than $12.50. Celgene said it is on track to meet or exceed its 2017 targets. It expects "strong growth" to 2020 by on label expansions and new products.
11:09 EDTNVS, SNY, SHPGSanofi, Novartis, Shire may be weighing Genfit acquisition, Bloomberg says
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09:36 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AA AMZN CELG MCD SINA TSLA V TWTR PBR
07:53 EDTNVSDiplomat Pharmacy to dispense Novartis Psoriasis drug Cosentyx
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05:25 EDTBMYBristol-Myers signs exclusive agreement with Bavarian Nordic for Prostvac
Bavarian Nordic and Bristol-Myers Squibb announced an agreement that provides Bristol-Myers Squibb an exclusive option to license and commercialize Prostvac, Bavarian Nordic’s investigational Phase 3 prostate-specific antigen, or PSA,-targeting cancer immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer, or mCRPC. Under terms of the agreement, Bavarian Nordic will receive an upfront payment of $60M. Bristol-Myers Squibb can exercise the option in its sole discretion within a designated time after data is available from the ongoing Phase 3 trial. Bavarian Nordic would be entitled to a payment of $80M upon exercise of the option plus additional incremental payments starting at $50M, but with a potential to exceed $230M should the median overall survival benefit of Prostvac exceed the efficacy seen in Phase 2 results. Furthermore, Bavarian Nordic could receive regulatory milestone payments of $110M, up to $495M in sales milestones as well as tiered double-digit royalties on future sales of Prostvac. The parties have also agreed to enter into a supply contract, under which Bavarian Nordic will undertake the future commercial manufacturing of Prostvac. An investigator sponsored Phase 2 study is currently in the planning stages to investigate the combination of Bristol-Myers Squibb’s Yervoy and Prostvac. The companies have also entered into an agreement by which they may conduct one or more exploratory combination studies of Prostvac and agents from Bristol-Myers Squibb’s immuno-oncology portfolio.
March 3, 2015
16:01 EDTJNJOptions Update; March 3, 2015
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14:17 EDTGSKGlaxoSmithKline looking for buyers for Nicotinell business, AFR reports
GlaxoSmithKline is looking for a buyer for its Australian nicotine chewing gum business Nicotinell, according to the Australian Financial Review. Reference Link
12:06 EDTPFEPfizer receives orphan status for lung cancer drug
The FDA granted Pfizer orphan status for its treatment of non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations, dacomitinib.
11:46 EDTCELG, BMY, NVS, JNJ, SNYLeerink biotech analyst holds an analyst/industry conference call
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08:37 EDTPFEPfizer says EC approves expanded indication for Prevenar 13
Pfizer announced that the European Commission approved an expanded indication for the use of Prevenar 13 -- pneumococcal polysaccharide conjugate vaccine 13-valent, adsorbed -- for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults, which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia, including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease in adults aged 65 and older.
07:16 EDTBMYCowen to hold a conference
35th Annual Health Care Conference is being held in Boston on March 2-4 with webcasted company presentations to begin on March 3 at 8 am; not all company presentations may be webcasted. Webcast Link
06:02 EDTBMYBristol-Myers reports hepatitis C cure rate of 97% in study
A combination of two once-daily medications for chronic hepatitis C infection has been shown in newly released study results to cure almost all the patients who participated, despite the patients also being co-infected with HIV. This patient population historically has been challenging to treat for hepatitis C, in large part due to potential drug-drug interactions between the antiviral therapy regimens used to treat each infection. Results of ALLY-2, a Phase 3 clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of chronic hepatitis C in patients co-infected with HIV were announced last week and showed that those treated for 12 weeks, 97% achieved cure. The ALLY-2 study met the primary endpoint, with 96% of treatment-naïve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase. In ALLY-2, high SVR rates occurred among all patients treated for 12 weeks, regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen, or race. ALLY-2 also included an 8-week arm; 38 of 50 treatment-naïve patients with HCV achieved SVR12. However, study investigators concluded that further studies are needed to assess the potential of shorter-duration, all-oral treatment regimens.
March 2, 2015
16:31 EDTPFEPfizer files automatic mixed securities shelf
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16:26 EDTJNJOn The Fly: Closing Wrap
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12:13 EDTJNJOn The Fly: Midday Wrap
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11:52 EDTJNJJohnson & Johnson EPS dilution from Cordis deal seems modest, says Wells Fargo
Wells Fargo estimates that Johnson & Johnson's (JNJ) planned sale of Cordis to Cardinal Health (CAH) should dilute J&J yearly EPS by about 3c-4c, assuming all is else equal, and the firm expects the company to be able to absorb at least some of this dilution and possibly offset the rest via share repurchases. Wells maintains its Outperform rating on J&J shares.
09:46 EDTCELGCelgene announces EC approved Abraxane
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09:34 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL MNTA CELG TSLA MCD ARUN GILD KO TWTR NFLX
09:28 EDTBMYBristol-Myers says FDA accepts Yervoy sBLA for review
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09:02 EDTPFEAstraZeneca mulls linking bonuses to Pfizer defense pledges, Sunday Times says
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08:53 EDTSNYNon-profit gives lukewarm review to MannKind inhaled insulin, TheStreet says
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08:07 EDTNVSArray BioPharma announces completion of binimetinib and encorafenib transactions
Array BioPharma (ARRY) announced the completion of both the binimetinib and encorafenib definitive agreements with Novartis. Along with global ownership of both assets, Array will receive an upfront payment of $85M from Novartis (NVS). Effective March 2, 2015, Novartis' global, exclusive license to binimetinib terminated with all rights reverting to Array, and Array received global rights to encorafenib. Array will receive an $85M upfront payment from Novartis and reimbursement for certain transaction-related expenses. Novartis will provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array patent and other intellectual property rights it owns to the extent they relate to binimetinib and encorafenib. Other than a de minimis payment to Novartis from Array, there are no milestone payments or royalties payable between the parties under the encorafenib agreement. As part of the transactions, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Array entered into a third party agreement necessary to complete the transactions. Net consideration Array agreed to pay amounts to $25M. This payment is consistent with the earnings guidance provided on the quarterly conference call held on February 3, 2015. Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs associated with MILO, which Array will continue to conduct. For NEMO and all other ongoing and planned clinical trials for binimetinib (other than COLUMBUS, as described above), Novartis will conduct and solely fund each trial, until a mutually agreed-upon transition date to Array. Following this transition, Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs required to complete these studies. Novartis will remain responsible for conducting and funding development of the NRAS melanoma companion diagnostic until Premarket Approval is received from the U.S. Food and Drug Administration. Following approval, Novartis will transfer the product and Premarket Approval to a diagnostic vendor of Array's designation. Novartis also retains binimetinib and encorafenib supply obligations for all clinical and commercial needs for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of binimetinib and encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib and binimetinib.
08:01 EDTJNJCardinal Health offers to buy Cordis from Johnson & Johnson in $1.99B deal
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07:53 EDTJNJCardinal Health to host conference call
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07:35 EDTJNJCardinal Health to buy Cordis from Johnson & Johnson in $1.99B deal
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07:35 EDTJNJCardinal Health to acquire Cordis for $1.94B in cash
Cardinal Health (CAH) announced plans to acquire Johnson & Johnson's (JNJ) Cordis business, a global manufacturer of cardiology and endovascular devices, for $1.94B in cash, or approximately $1.59B, net of the present value of tax benefits. The acquisition is expected to be financed with a combination of $1B in new senior unsecured notes and the remainder with existing cash. The transaction is expected to close in the United States and key non-U.S. countries towards the end of calendar 2015. Assuming this timing, Cardinal Health expects fiscal 2017 accretion in non-GAAP diluted earnings per share from continuing operations of greater than 20c per share, which includes the cost of an incremental 7c-8c per share of interest expense associated with financing the transaction. The company expects the acquisition to be increasingly accretive thereafter and assumes that synergies will exceed $100M annually by the end of fiscal 2018. Cordis had annual sales in 2014 of approximately $780M, split almost evenly between cardiology and endovascular products. Upon completion of that process, Cardinal Health expects to enter into a definitive purchase and sale agreement in respect of the proposed acquisition. The proposed transaction will also be subject to customary closing conditions, including regulatory approvals, and is expected to close in the approximately 20 principal countries towards the end of calendar year 2015 and in the remaining countries on a rolling basis afterward.
07:31 EDTNVSIncyte appoints Steven Stein as Chief Medical Officer
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07:20 EDTSHPG, BMYCowen to hold a conference
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07:17 EDTSHPGShire submits application to FDA for approval of lifitegrast
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07:04 EDTGSKIsis Pharmaceuticals earns $15M from GlaxoSmithKline for advancing ISIS-TTR Rx
Isis Pharmaceuticals (ISIS) announced that it has earned a $15M milestone payment from GSK (GSK) related to advancing the Phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy. ISIS-TTRRx is an antisense drug Isis is developing with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Including this milestone payment, Isis has generated $60 million in upfront and milestone payments for advancing ISIS-TTRRx. In addition, if GSK elects to exercise its option to exclusively license ISIS-TTRRx, Isis is eligible to receive a license fee, regulatory and sales milestone payments and double-digit royalties on sales of ISIS-TTRRx.
February 27, 2015
16:22 EDTSHPGStocks have another winning week after Greek deal, Yellen reassurance
Stocks ended higher this week after the euro zone sealed its deal to extend Greece's bailout and Fed chair Janet Yellen reiterated that the central bank would take a patient approach to raising interest rates. MACRO NEWS: Last Friday afternoon, Greece reached a framework deal with its euro zone partners to extend its bailout by four months, contingent on a reform proposal being accepted. The proposals were accepted by the EU early this week... In testimony before Congress, Janet Yellen reiterated that the Federal Reserve can remain patient in deciding when to hike interest rates... U.S. economic data was mixed, as the Q4 GDP growth revision, durable goods orders for January, and an index of consumer sentiment beat expectations, but weekly jobless claims and existing home sales for January missed expectations... Somewhat positive economic data came out of China, as the flash HSBC/Markit Purchasing Managers' Index was 50.1, representing a four month high. However, China's export orders declined at the fastest rate in 20 months. COMPANY NEWS: Drug maker Valeant (VRX) agreed to buy Salix (SLXP), which develops gastrointestinal products, for $158 per share. In another development on the M&A front, Bloomberg reported that HP (HPQ) is in talks to make its biggest acquisition in several years by potentially acquiring Aruba Networks (ARUN), which provides Wi-Fi products. Additionally, PTC Therapeutics (PTCT) rose after Reuters said the company is working with financial advisers to explore a potential sale after receiving takeover interest from several companies including Shire (SHPG) and BioMarin (BMRN)... Solar energy company SunPower (SPWR) was one of this week's big winners after its quarterly results topped expectations, and the company announced that it's in advanced talks to form a joint YieldCo vehicle with peer First Solar (FSLR). First Solar also rallied after the news... Among the noteworthy losers this week was Lumber Liquidators (LL), after the company reported Q4 earnings per share and revenue that missed consensus expectations. The flooring retailer also warned on its associated call that an upcoming "60 Minutes" piece may cast the company in an unfavorable light and disclosed in its annual report that the Department of Justice indicated in recent communications that it is contemplating seeking criminal charges under the Lacey Act... Companies that rose after reporting their quarterly results included Home Depot (HD) and Gap (GPS), while HP, TASER (TASR), and J.C. Penney (JCP) dropped after reporting their results. INDEXES: For the week, the Dow was down 0.04% to 18,132.70, the Nasdaq was up 0.15% to 4,963.53, and the S&P 500 was down 0.27% to 2,104.50.
14:34 EDTJNJPharmacyclics says Imbruvica combination enhances anti-tumor activity
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13:35 EDTBMYBristol-Myers reports FDA accepts BLA for Opdivo
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12:35 EDTABTMylan completes acquisition of assets from Abbott
Mylan N.V. and Mylan (MYL) announced the successful completion of the acquisition of Abbott Laboratories' (ABT) non-U.S. developed markets specialty and branded generics business. Under the previously announced terms of the transaction agreement, Abbott received 110M shares of Mylan N.V., resulting in former Mylan shareholders now owning approximately 78% of Mylan N.V. and Abbott now owning approximately 22% of Mylan N.V. Mylan Inc. and Abbott's non-U.S. developed markets specialty and branded generics business have been reorganized under Mylan N.V., a new public company organized in the Netherlands. Mylan N.V. will be led by the former Mylan Inc. executive team. The company will trade on Nasdaq under the ticker symbol MYL.
11:33 EDTNVSNovartis says phase II data highlights benefits of Alcon RTH258 in wet AMD
Novartis reports Alcon presented positive results from its second Phase II clinical study of RTH258 during the 38th Annual Macula Society Meeting. This study evaluated the efficacy and safety of the compound versus aflibercept in patients with neovascular age-related macular degeneration, or wet AMD. The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept, with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH258-treated patients. Patients treated every three months with RTH258 also experienced a prolonged duration-of-action, potentially leading to a reduced treatment burden. A total of 90 patients diagnosed with wet AMD participated in the prospective, randomized, double-masked multicenter, two-arm study. The primary objective was to compare the efficacy of RTH258 6mg versus aflibercept 2mg with the primary endpoint being the mean change in best corrected visual acuity, from Baseline to Week 12. Secondary endpoints included the change assessment in BCVA and central subfield foveal thickness as measured by spectral domain optical coherence tomography. Both RTH258 and aflibercept were well tolerated and no new safety signal was reported during the study.
08:29 EDTBMYBristol-Myers price target raised to $78 from $70 at Argus
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08:15 EDTJNJJohnson & Johnson would benefit from Pharmacyclics deal, says Wells Fargo
After Bloomberg and The Financial Times reported that Johnson & Johnson (JNJ) and Novartis (NVS) are interested in buying Pharmacyclics (PCYC), Wells Fargo thinks the deal would cause a slight acceleration of Johnson & Johnson's revenue growth. The firm believes that the deal could be slightly dilutive to Johnson & Johnson's EPS in the first full year and 1%-4% accretive thereafter. Wells keeps an Outperform rating on Johnson & Johnson.
07:50 EDTNVSNovartis holders approve dividend increase to CHF 2.60
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07:37 EDTCELGCelgene removed from the short-term buy list at Deutsche Bank
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07:25 EDTNVSNovartis lung cancer drug Zykadia recommended for EU approval
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07:22 EDTSNYSanofi reports positive opinion from CHMP for Toujeo
Sanofi announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has issued a positive opinion recommending the approval of Toujeo, a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus with low within-individual, within-day blood sugar variability. The European Commission is expected to make a final decision on granting marketing authorization for Toujeo in the EU in the coming months. Toujeo was approved by the FDA and is under review by other regulatory authorities around the world. Once approved, Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 insulin units, and it has a maximum single injection dose of 80 IU.
07:16 EDTNVSZykadia recommended by EMA for approval in advanced NSCLC
The European Medicines Agency has recommended granting a conditional marketing authorization for Zykadia. Zykadia is recommended for the treatment of adult patients with a type of lung cancer called anaplastic lymphoma kinase positive non-small cell lung cancer, or NSCLC, when the disease is advanced and has already been treated with crizotinib. The applicant for Zykadia is Novartis Europharm.
February 26, 2015
15:23 EDTBMYBristol-Myers reports ALLY trial demonstrates 97% hepatitis C cure rates
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15:20 EDTMRKMerck says GARDASIL 9 recommended by CDC advisory committee
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12:31 EDTPFEPfizer says CDC recommends serogroup B meningococcal vaccine for those at risk
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09:41 EDTMRK, JNJHospira launches generic Remicade, WSJ says
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09:05 EDTNVSFDA grants Sandoz tentative approval of Fusilev generic
The FDA posted on its website that it granted Novartis's Sandoz tentative approval for levoleucovorin calcium, a generic of Spectrum's (SPPI) colon cancer drug Fusilev. Reference Link
08:35 EDTBMYBristol-Myers says BMS-966176 Phase IIa study met primary endpoint
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08:03 EDTJNJJohnson & Johnson forms new health and wellness platform
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06:52 EDTJNJPharmacyclics downgraded to Hold from Buy at WallachBeth
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05:32 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
Sanofi announced that the FDA approved Toujeo, a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2. The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations.
February 25, 2015
20:05 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
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14:47 EDTJNJPharmacyclics could fetch as much as $19B in sale, FT says
Pharmacyclics (PCYC) is considering a sale that could fetch as much as $19B, reported Financial Times, citing people familiar with the matter who said Johnson & Johnson (JNJ) is exploring a potential deal for the company. The Fly notes that Bloomberg had a similar report, but its report said Pharmacyclics could fetch $17B-$18B in a sale. Reference Link
14:10 EDTNVS, JNJPharmacyclics downgraded to Hold on lack of upside at Deutsche Bank
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13:44 EDTCELGCelgene price target raised to $155 from $130 at Argus
Argus increased its price target on Celgene as the firm thinks the company is "well on its way" to meeting its growth targets. The firm thinks the company reported strong Q4 results and keeps a Buy rating on the shares.
12:54 EDTNVS, JNJPharmacyclics exploring options including sale, Bloomberg reports
According to sources, Pharmacyclics (PCYC), which develops cancer treatments, is currently exploring options, Bloomberg reports. One option may include a sale of the company, and the sources say Johnson & Johnson (JNJ) and Novartis (NVS) have expressed interest in the company. Pharmacyclics could fetch $17B-$18B in a sale, the sources add. Reference Link
12:53 EDTNVS, JNJPharmacyclics weighing sale to U.S. drugmaker, Bloomberg reports
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12:13 EDTNVS, GSKGlaxoSmithKline sees Novartis transaction closing next week
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11:24 EDTGSKGlaxoSmithKline announces return of alli to retail stores
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08:36 EDTBMYBristol-Myers announces data from Phase IIb BMS-663068 trial
Bristol-Myers Squibb Company announced data from a Phase IIb trial of investigational compound BMS-663068, designed as an HIV-1 attachment inhibitor, in treatment-experienced HIV-1 patients. In the study, which compared BMS-663068 to a pharmacoenhanced protease inhibitor, virologic response rates and immunologic reconstitution were similar across the BMS-663068 and Reyataz/ritonavir arms of the trial through 48 weeks. Specifically, 61-82% of BMS-663068 patients had HIV-1 RNA levels <50 c/mL, compared to 71% of Reyataz/ritonavir patients at week 48. HIV-1 RNA levels <50 c/mL typically indicate virus replication is undetectable. Treatment with BMS-663068 resulted in no dose response safety signals, no treatment discontinuations related to adverse events, and no treatment-related serious adverse events over the course of the trial. The most common AEs were headache and abdominal pain. Due to the positive results seen thus far, a Phase III clinical trial of the attachment inhibitor among heavily treatment-experienced patients began on Monday, February 23, 2015. For the purposes of the Phase III trial, heavily treatment-experienced patients are defined as individuals who can no longer formulate a viable regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications. The Phase IIb study results, presented yesterday at the 22nd Conference on Retroviruses and Opportunistic Infections, highlight the novel mechanism of action of the investigational prodrug BMS-663068, which when converted into its active moiety BMS-626529, is designed to bind directly to the HIV gp120 protein, and prevents initial viral attachment to the host CD4+ T cell and entry into the host immune cell.
08:08 EDTMRKMerck to present new data from IMPROVE-IT, TRA 2ºP studies
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08:07 EDTNVSNovartis' Farydak myeloma drug approved by FDA, to be distributed by Diplomat
Novartis' (NVS) drug Farydak for the treatment of patients with multiple myeloma Diplomat Pharmacy has been approved by the FDA. The drug is now a treatment option for patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. Farydak will be distributed by Diplomat Pharmacy (DPLO).
06:14 EDTSHPGPTC Therapeutics takeout price likely tops $100/share, said Credit Suisse
Credit Suisse yesterday raised its price target for PTC Therapeutics (PTCT) shares to $100 from $66 after Reuters reported the drug market is starting a sale process with Shire (SHPG) and Biomarin (BMRN) as possible suitors. The firm believes a takeout is a likely outcome before or after data the Phase III data expected to be announced in October. PTC has Translarna Phase III trials ongoing in Duchenne muscular dystrophy and cystic fibrosis to support full approval in the U.S. Credit Suisse said yesterday in a note to investors that a takeout value for the company likely exceeds $100 per share. It believes PTC would be a good fit for Vertex (VRTX), Biogen (BIIB), Roche (RHHBY) and others. The firm kept an Outperform rating on the stock. PTC Therapeutics shares closed yesterday up $6.20 to $71.16.
February 24, 2015
16:19 EDTNVSAratana Therapeutics to pay Elanco up to $3M to regains rights to AT-004
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08:07 EDTPFEPfizer announces Trumenba studies met primary objectives
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08:04 EDTCELGCelgene reports Abraxane now reimbursed in Italy as first-line treatment
Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, announced that Italian authorities have issued a positive decision for NHS reimbursement of ABRAXANE -- paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel -- in combination with gemcitabine, for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, or pancreatic cancer. The reimbursement decision has been published in the Italian Official Gazette no. 30, dated February 6, 2015.
07:46 EDTBMYJacobs Engineering awarded contract from Bristol-Myers
Jacobs Engineering Group (JEC) announced that it received a contract from Bristol-Myers Squibb Company (BMY) to provide architectural and engineering services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. The facility is being designed to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
07:31 EDTCELGRBC Capital to hold a conference
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07:05 EDTSHPGShire acquires Meritage Pharma
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05:17 EDTMRKMerck collaborates with Medicines Patent Pool to expand Raltegravir access
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February 23, 2015
16:27 EDTSHPGOn The Fly: Closing Wrap
Stocks on Wall Street began the session in negative territory and remained there for most of the session, with the Nasdaq the lone index to post a small gain. The Dow was weighed down by shares of Boeing (BA), which slid after the stock received a downgrade. There was little in the way of positive economic news, as the most notable report showed existing homes were lower than expected due to a shortage of inventory. The averages drifted for most of the session, as investors may be waiting on the sidelines ahead of tomorrow’s banking panel testimony by Fed Chair Janet Yellen. ECONOMIC EVENTS: In the U.S., the Chicago Fed national activity index rebounded to 0.13 in January, which was nearly in-line with expectations. Existing home sales dropped 4.9% to a 4.82M rate in January, which was much worse than the expected 1.8% drop to a 4.95M unit rate. In Europe, the Ifo Institute’s measure of German business confidence rose to 106.8 in February, which was up a tenth of a percentage point from the previous month but below the 107.7 consensus forecast. Also, the Bank of Israel became the latest central bank to cut rates this year, lowering its main interest rate to 0.1% from 0.25%. COMPANY NEWS: The shares of a number of health insurers rose after the Centers for Medicare and Medicaid Services, or CMS, issued preliminary 2016 Medicare Advantage rates. According to Credit Suisse, the rates were favorable for the insurers. Following the CMS announcement made late Friday, Humana (HUM) climbed $8.40, or 5.38%, to $164.52, UnitedHealth (UNH) rose $3.78, or 3.36%, to $116.40, and WellCare (WCG) gained $4.68, or 5.53%, to $89.30. MAJOR MOVERS: Among the notable gainers was PTC Therapeutics (PTCT), which jumped $9.77, or 17.7%, to $64.96 after Reuters said the company is working with financial advisers to explore a potential sale after receiving takeover interest from several companies including Shire (SHPG) and BioMarin (BMRN). Also higher was Valeant (VRX), which rose $25.49, or 14.71%, to $198.75 after the company agreed to buy Salix (SLXP) for $158 per share and also reported better-than-forecast earnings. Salix shares, however, fell $2.09, or 1.32%, to $155.76, as a report Friday from CNBC's David Faber telegraphed the deal and suggested Valeant could value Salix around $160 per share. Among the noteworthy losers was Spectrum Pharmaceuticals (SPPI), which dropped $1.18, or 15.82%, to $6.28 after a judge ruled that a drug which could compete with the company's Fusilev treatment does not infringe on the company's intellectual property. Also lower were shares of Boeing, which fell $3.57, or 2.26%, to $154.74 after the stock was downgraded to Sell from Neutral at Goldman Sachs. INDEXES: The Dow fell 23.60, or 0.13%, to 18,116.84, the Nasdaq gained 5.01, or 0.1%, to 4,960.97, and the S&P 500 slipped 0.64, or 0.03%, to 2,109.66.
15:00 EDTNVSFDA approves Farydak for treatment of multiple myeloma
The FDA approved Farydak for the treatment of patients with multiple myeloma, a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. Farydak is the first HDAC inhibitor approved to treat multiple myeloma. It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication. Farydak is marketed by Novartis.
13:40 EDTNVSAnalysts clash on Spectrum outlook after patent suit setback
Two research firms had divergent views on Spectrum Pharmaceuticals (SPPI) after a judge ruled that a drug which could compete with the company's Fusilev treatment does not infringe on the company's intellectual property. BACKGROUND: Late Friday, a federal judge ruled that Novartis' (NVS) levoleucovorin, a generic version of Spectrum's Fusilev, does not infringe on Spectrum's intellectual property. Fusilev is indicated after high-dose methotrexate therapy in osteosarcoma, a type of cancer that starts in the bones. It is also used to treat patients with advanced metastatic colorectal cancer. BEARISH TAKE: Roth Capital analyst Joseph Pantginis downgraded Spectrum to Neutral from Buy following the ruling, as he believes the risk to the company's revenue has risen. The company is meaningfully less likely to become profitable again, wrote Pantginis, noting that Fusilev accounted for about 50% of the company's product revenue. According to the analyst, Spectrum is becoming increasingly focused on developing its earlier stage drugs, and he expects those drugs to grow slowly. Pantginis slashed his price target on the shares to $7 from $15. BULLISH TAKE: In a note to investors earlier today, Reni Benjamin, an analyst at research firm H.C. Wainwright, wrote that the stock's plunge after the judge's ruling "creates a table-pounding buying opportunity," noting that Fusilev has been granted exclusivity as a colorectal treatment until 2018. Benjamin does not expect the company's revenue from Fusilev to decline at all until 2018, as a citizen's petition submitted by Spectrum to the FDA, along with an appeal the company is mounting to Friday's ruling, and the difficulty that Novartis will have launching its version of the drug while the appeal is ongoing, will help prevent Spectrum's revenue from dropping. Also likely to protect Spectrum's revenue are the strong relationships that the company has developed with hospitals and community doctors, the analyst stated. He kept a $15 price target and Buy rating on the shares. PRICE ACTION: In mid-afternoon trading, Spectrum tumbled $1.44, or 19.3% to $6.02.
13:33 EDTGSKRBS could name Howard Davies as chairman this week, FT reports
Royal Bank of Scotland (RBS) could name Howard Davies as its chairman as early as Thursday, when the bank reports its full-year results, the Financial Times reports. Davies is currently chairman of insurance business Phoenix Group and chairs Morgan Stanley's (MS) risk committee. Current RBS Chairman Philip Hampton is set to become GlaxoSmithKline's (GSK) chairman as early as this summer. Reference Link
12:53 EDTSHPGAnalysts debate potential for competing Salix takeover bid
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12:29 EDTSHPGPTC Therapeutics exploring potential sale, Reuters reports
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12:21 EDTNVS, BMYOn The Fly: Midday Wrap
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11:17 EDTNVS, GSKFTC puts conditions on Novartis's proposed acquisition of GSK oncology drugs
According to the FTC, Global pharmaceutical company Novartis (NVS) has agreed to divest all assets related to its BRAF and MEK inhibitor drugs, currently in development, to Boulder, Colorado-based Array BioPharma (ARRY) to settle charges that Novartis’s $16B acquisition of GlaxoSmithKline’s (GSK) portfolio of cancer-treatment drugs would likely be anticompetitive...If the acquisition goes forward as proposed, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product. For that reason, Novartis’s acquisition of GSK’s portfolio of cancer-treatment drugs would likely cause significant competitive harm in the U.S. markets for both the BRAF and MEK inhibitors, ultimately raising prices for consumers and depriving them of potentially superior products. Under the terms of the proposed consent agreement, Novartis is required to provide transitional services to Array BioPharma to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in BRAF and MEK inhibitor markets is not reduced. Reference Link
08:27 EDTMRKNGM Biopharmaceuticals to hold a teleconference
NGM Biopharm discusses the strategic collaboration with Merck to discover, develop and commercialize novel biologic therapeutics on a teleconference to be held on February 23 at 9:30 am. Webcast Link
08:15 EDTBMYRigel Pharmaceuticals and Bristol-Myers announces R&D collaboration agreement
Rigel Pharmaceuticals (RIGL) and Bristol-Myers (BMY) announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel's extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system's activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb's Opdivo and Yervoy. Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel's TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30M upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309M for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
08:06 EDTBMYBristol-Myers, Rigel enter R&D agreement for TGF beta receptor kinase inhibitors
Rigel Pharmaceuticals (RIGL) and Bristol-Myers Squibb (BMY) announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel’s extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system’s activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb’s Opdivo, or nivolumab, and Yervoy, or ipilimumab. Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel’s TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30M upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309M for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
08:01 EDTBMYBristol-Myers to acquire Flexus, potential total consideration may be $1.25B
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07:55 EDTSHPGJefferies says other bidders may emerge for Salix
Jefferies says it could envision other bidders emerging for Salix (SLXP) and points out recent media reports have suggested Shire (SHPG) and Endo (ENDP) have considered making a bid for the company. It lists AstraZeneca (AZN) and Takeda as others who could have possible interest in Salix. The firm believes Valeant (VRX) could afford to pay more for Salix should other bidders emerge.
07:14 EDTNVSSpectrum says plans to appeal patent suit loss to Novartis unit
Spectrum Pharmaceuticals (SPPI) confirmed in a regulatory filing that on February 20, the U.S. District Court for the District of Nevada ordered that judgment be entered in favor of defendant Sandoz in the matter entitled Spectrum Pharmaceuticals, Inc. et al v. Sandoz Inc. "Spectrum Pharmaceuticals Inc. intends to appeal this decision and the ultimate outcome of this litigation remains uncertain," the company stated. Sandoz is the generic pharmaceuticals division of Novartis (NVS).
07:04 EDTMRKMerck, NGM Biopharmaceuticals announce multi-year collaboration
NGM Biopharmaceuticals and Merck announced they have entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. This agreement will become effective upon the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The collaboration includes multiple drug candidates currently in preclinical development at NGM, including NP201, which is being evaluated for the treatment of diabetes, obesity and nonalcoholic steatohepatitis. NGM will lead the research and development of the existing preclinical candidates and have the autonomy to identify and pursue other discovery stage programs at its discretion. Merck will have the option to license all resulting NGM programs following human proof of concept trials. If Merck exercises this option, Merck will lead global product development and commercialization for the resulting products, if approved. Under the terms of the agreement, Merck will make an upfront payment to NGM of $94M and will purchase a 15 percent equity stake in NGM for $106M at a price per share that represents a 20% premium to NGM’s most recent financing. Merck will commit up to $250M to fund all of NGM’s efforts under the initial five-year term of the collaboration, with the potential for additional funding if certain conditions are met. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. Merck will have the option to extend the research agreement for two additional two-year terms.
February 22, 2015
18:04 EDTSHPGShire completes acquisition of NPS Pharma
Shire (SHPG) announces the successful completion of the tender offer for all of the outstanding shares of NPS Pharmaceuticals (NPSP) and the subsequent acquisition of NPS Pharma.The tender offer expired at 12:00 midnight, New York City time, at the end of Friday, February 20, and was not extended. As of the expiration of the tender offer, a total of approximately 88,869,118 common shares of NPS Pharma had been validly tendered and not withdrawn pursuant to the tender offer, representing approximately 81.7% of the outstanding common shares of NPS Pharma. All shares that were validly tendered and not withdrawn pursuant to the tender offer were accepted for payment. After the acceptance of shares that were validly tendered and not withdrawn pursuant to the tender offer, Shire completed the acquisition of NPS Pharma today through a merger of one of Shire's subsidiaries with and into NPS Pharma. In connection with the merger, all common shares of NPS Pharma that were not accepted for payment in the tender offer (excluding any shares held by NPS Pharma as treasury stock (other than any shares held in an NPS Pharma benefit plan) and any shares with respect to which the holders have properly demanded appraisal rights in accordance with Delaware law) were converted into the right to receive $46.00 per share in cash, without interest and less any applicable withholding taxes, the same price that will be paid for shares accepted for payment in the tender offer. Following completion of the merger, NPS Pharma became a wholly owned subsidiary of Shire and NPS Pharma's shares ceased to be traded on NASDAQ.
15:59 EDTSHPGValeant to buy Salix for $10.1B, FT says
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12:51 EDTJNJJ&J considers Cordis sale with Cardinal the leading suitor, Bloomberg says
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February 20, 2015
17:31 EDTJNJJ&J considering sale of Cordis with Cardinal the leading suitor, Bloomberg says
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16:03 EDTJNJ, CELGOptions Update; February 20, 2015
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10:33 EDTPFEBattleground update: AbbVie named top global pick at Jefferies
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10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
09:38 EDTCELG, JNJActive equity options trading on open
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07:23 EDTBMY, GSK, JNJ, PFEAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:08 EDTSHPG, SNY, ABT, NVS, GSK, MRKAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
05:27 EDTCELGCelgene Revlimid approved by EC
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February 19, 2015
18:25 EDTPFEPiper Jaffray biotech analyst to hold analyst/industry conference call
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16:50 EDTSNYSanofi appoints Olivier Brandicourt CEO
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14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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09:59 EDTSNYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Altisource Residential (RESI) upgraded to Neutral from Sell at Compass Point... Angie's List (ANGI) upgraded to Overweight from Equal-Weight at First Analysis... Barrick Gold (ABX) upgraded to Buy from Hold at TD Securities... British Land (BTLCY) upgraded to Buy from Hold at Societe Generale... Coach (COH) upgraded to Buy from Hold at Topeka... Fiat Chrysler (FCAU) upgraded to Outperform from Neutral at Exane BNP Paribas... Garmin (GRMN) upgraded at BofA/Merrill... Hologic (HOLX) upgraded to Buy from Hold at Canaccord... Iberdrola (IBDRY) upgraded to Neutral from Underweight at HSBC... KPN (KKPNY) upgraded to Neutral from Underperform at Exane BNP Paribas... Monster Worldwide (MWW) upgraded at Evercore ISI... Pharmacyclics (PCYC) upgraded to Buy from Neutral at Nomura... RPC, Inc. (RES) upgraded to Equal Weight from Underweight at Morgan Stanley... Sanofi (SNY) upgraded to Buy from Neutral at BofA/Merrill... Sasol (SSL) upgraded to Neutral from Underweight at HSBC... Tractor Supply (TSCO) upgraded at Oppenheimer... Valero (VLO) upgraded to Buy from Hold at Deutsche Bank... Weingarten Realty (WRI) upgraded to Neutral from Sell at UBS... Werner (WERN) upgraded on improving freight fundamentals at RBC Capital... diaDexus (DDXS) upgraded to Buy from Neutral at Ladenburg,
08:38 EDTMRKNewLink reports clinical development milestone achieved with Merck for rVSV-EBOV
NewLink Genetics (NLNK) announced that it had received notification from Merck (MRK) that the milestone event specified in the license and collaboration agreement between the two companies relating to the further development of the rVSV-EBOV, Ebola, vaccine candidate had been achieved. Under the terms of the agreement, NewLink Genetics will receive a payment of $20M in connection with the achievement of the milestone. The milestone pertains to the initiation of a key clinical trial for the vaccine.
08:23 EDTGSKGlaxoSmithKline weakness creates buying opportunity, says Argus
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07:12 EDTPFE, NVSWharton Health Care Club to hold a conference
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06:21 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
05:31 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
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