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News Breaks
May 13, 2014
14:25 EDTARIA, ARIA, ARIA, RXDX, RXDX, RXDX, RHHBY, RHHBY, RHHBY, PFE, PFE, PFE, PBYI, PBYI, PBYI, NVS, NVS, NVS, MRTX, MRTX, MRTX, MRK, MRK, MRK, INCY, INCY, INCY, EXEL, EXEL, EXEL, CLVS, CLVS, CLVS, BMY, BMY, BMY, AZN, AZN, AZN, TSRO, TSRO, TSROLeerink pharma and biotech analysts hold an analyst/industry conference call
Biotech and Pharmaceuticals Analysts provide updates on lung cancer, in conjunction with the upcoming ASCO Annual Meeting, on an Analyst/Industry conference call to be held on May 20 at 3 pm.
News For ARIA;AZN;BMY;CLVS;EXEL;INCY;MRK;MRTX;NVS;PBYI;PFE;RHHBY;RXDX;TSRO From The Last 14 Days
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July 16, 2014
07:59 EDTPFE, AZNTreasury Secretary urges Congress to take action on tax inversions
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07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
06:26 EDTMRK, BMY, RHHBYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
14:35 EDTPBYIPuma Biotechnology volatility elevated
Puma Biotechnology August call option implied volatility is at 138, September is at 113 December is at 95; compared to its 26-week average of 98 according to Track Data, suggesting large near term price movement.
11:13 EDTMRK, BMYPerrigo retreats after analyst sees limited potential buyers
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08:11 EDTMRKMerck looks to revive livestock drug Zilmax, WSJ says
Merck has been preparing to conduct a large-scale study this summer to evaluate the safety of its Zilmax feed additive, which the company pulled from the U.S. market last year over concerns in the beef industry that the drug made it difficult for some animals to walk, reported The Wall Street Journal. Reference Link
07:35 EDTBMY, MRKPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.
05:44 EDTNVSNovartis to license Google 'smart lens' technology
Novartis (NVS) announced that its eye care division Alcon has entered into an agreement with a division of Google (GOOG) to in-license its "smart lens" technology for all ocular medical uses. The agreement with Google[x], a team within Google that is devoted to finding new solutions to big global problems, provides Alcon with the opportunity to develop and commercialize Google's "smart lens" technology with the potential to transform eye care and further enhance Alcon's pipeline and global leadership in contact lenses and intraocular lenses. The transaction remains subject to anti-trust approvals. The agreement between Google and Alcon represents an important step for Novartis, across all of its divisions, to leverage technology to manage human diseases and conditions. Google's key advances in the miniaturization of electronics complement Novartis's deep pharmaceuticals and medical device expertise. Novartis aims to enhance the ways in which diseases are mapped within the body and ultimately prevented.
05:37 EDTRHHBYGenentech Avastin granted priority review by FDA
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05:35 EDTNVSNovartis collaborates with Banner Alzheimer's Institute on study
Novartis announced a collaboration with Banner Alzheimer's Institute, or BAI, on a pioneering clinical study in Alzheimer's disease, or AD, prevention. The study will determine whether two Novartis investigational anti-amyloid treatments can prevent or delay the emergence of symptoms of AD in people identified as being at genetic risk for developing the late-onset form of the disease. Using an innovative trial design, the two treatments will be given in cognitively healthy people at genetic risk of developing the build-up of amyloid protein in the brain that may eventually lead to AD. One treatment is an active immunotherapy, a treatment that stimulates an immune response, and triggers the production of natural antibodies against amyloid. This investigational treatment, given via an injection, is in phase II clinical development. The second treatment, a BACE inhibitor, is an oral medication about to enter phase I trials and is designed to prevent the production of different forms of amyloid.
July 14, 2014
11:20 EDTRHHBY, EXELExelixis seen as potential target for Roche, TheStreet says
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09:16 EDTEXELOn The Fly: Pre-market Movers
HIGHER: Citigroup (C), up 3.6% after reporting better than expected Q2 results, announcing $7B settlement with DOJ and FDIC... Apple (AAPL), up 0.7% after Barclays upgrades stock to Overweight, Morgan Stanley raises Apple estimates above consensus... Shire (SHPG), up 1.6% after receiving revised proposal from AbbVie (ABBV) of GPB 53.20 per share, which it says it would be willing to recommend to Shire shareholders. AbbVie is down 2.8% after the news... Mylan (MYL), up 4% after acquiring Abbott's (ABT) non-U.S. developed markets specialty and branded generics business in all-stock transaction valued at about $5.3B. Abbott up 1.6% after the news... Progenics (PGNX), up 13% after FDA says RELISTOR can be approved on data submitted in sNDA... Exelixis (EXEL), up 13% after announcing coBRIM Phase 3 trial met primary endpoint... URS (URS) up 8% after acquired by AECOM Technology (ACM) for $56.31 per share. AECOM shares alos up 2% after deal announcement... Whiting Petroleum (WLL), up 4.5% after agreeing to acquire Kodiak Oil & Gas (KOG) in a $6B transaction. Kodiak Oil & Gas up 3%... Kandi Technologies (KNDI), up 11% after announcing JV's sale of 4,114 EVs in Q2. LOWER: Riverbed (RVBD), down 4.5% after saying it sees its Q2 adjusted EPS at low end of 26c-28c range... Harmonic (HLIT), down 13% after reporting preliminary Q2 earnings results.. EBay (EBAY), down 0.5% after downgraded at Pacific Crest, confirming partnership plans with Sotheby's (BID).
07:37 EDTARIAARIAD announces continuation of Iclusig review under Article 20 procedure
ARIAD Pharmaceuticals announced that the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has provided the company with a request for limited additional information regarding Iclusig as part of its ongoing review under the Article 20 referral procedure. The PRAC has requested further information regarding proposed dose modifications after achievement of a response and patient monitoring and details concerning a risk management plan. Following ARIAD’s response and input from the agency’s Scientific Advisory Group, the company expects that the PRAC will complete its review and make final recommendations to the Committee for Medicinal Products for Human Use at its meeting in October. As we finalize our recommendations on dose modifications of Iclusig and response monitoring of patients, we will work closely with the European regulatory agency and its expert advisors so that CML patients and their treating physicians have the best guidance available supporting the appropriate use of Iclusig,” said Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. In March ARIAD submitted responses to initial questions outlined by the PRAC as part of the Article 20 process, which was initiated in December of last year, and responses to a second set of questions were submitted to the PRAC in June.
07:23 EDTNVSAlzheimer's Association to hold a conference
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05:19 EDTEXELExelixis announces coBRIM Phase 3 trial met primary endpoint
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July 10, 2014
16:12 EDTMRKMedivation names Dawn Svoronos as Chief Commercial Officer
Medivation (MDVN) announced Dawn Svoronos has been appointed as its chief commercial officer, reporting to David Hung, M.D., founder, CEO and president of Medivation. Svoronos currently is a member of Medivation's Board of Directors and is a former president of Europe and Canada for Merck & Co. (MRK), where she oversaw commercial operations in approximately 30 EU and EU accession countries. Svoronos will lead Medivation's commercial organization on an interim basis and will participate in the company's search for a permanent chief commercial officer. Cheryl Cohen, Medivation's former chief commercial officer, has left the company to pursue other opportunities.
15:43 EDTNVSNovartis siponimod designated as orphan treatment of dermatomyositis
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13:25 EDTARIAARIAD mentioned positively by Stansberry Research
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12:43 EDTBMYBristol-Myers announces plans for Q3 submission of Opdivo BLA
Bristol-Myers Squibb announced earlier that, following discussions with the FDA, the company is planning a Q3 submission of a Biologics Licensing Application for Opdivo for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb. The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor regimen. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.
10:02 EDTRHHBYRoche unit, Merck KGaA to develop companion test for cancer treatment
Ventana Medical Systems, a member of the Roche Group (RHHBY), announced it has entered into an agreement with Merck KGaA (MKGAY), which operates as EMD Serono in the United States and Canada, to collaborate with Merck KGaA's biopharmaceutical division on the development and commercialization of a companion diagnostic for an undisclosed target using Ventana's proprietary diagnostic assays.
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