New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
<< 1 | 2 | 3 | 4 | 5 | 6 | all recent news | >>
December 22, 2014
12:36 EDTMRKHarris & Harris company signs collaborative study agreement with Merck
Subscribe for More Information
11:09 EDTNVSFTC puts conditions on Lilly's proposed acquisition of Novartis Animal Health
Global pharmaceutical company Eli Lilly and Company (LLY) has agreed to divest its Sentinel product line of medications for treating heartworm disease in dogs in order to settle FTC charges that its proposed $5.4B acquisition of Novartis (NVS) Animal Health would likely be anticompetitive. Under the proposed settlement, Eli Lilly will divest its Sentinel product line and associated assets to the French pharmaceutical company, Virbac. Indianapolis-based Eli Lilly, through its Elanco Animal Health division, and Switzerland-based Novartis AG’s Novartis Animal Health business unit both develop and market a wide range of animal health products, including medications to treat diseases and conditions affecting pets and livestock. Reference Link
09:38 EDTCELGActive equity options trading
Subscribe for More Information
09:21 EDTGSKLigand partner Glaxo files sNDA seeking additional indication for Promacta
Subscribe for More Information
08:08 EDTMRKNewLink Genetics, Merck awarded $30M contract for Ebola vaccine candidate
NewLink Genetics (NLNK) and Merck (MRK) announced that the Biomedical Advanced Research and Development Authority, or BARDA, of the United States Department of Health and Human Services, or HHS, has awarded NewLink Genetics' wholly-owned subsidiary, BioProtection Systems, as the prime contractor in a $30 million contract to support the manufacturing and development activities of its investigational rVSV-EBOV vaccine candidate, including clinical development through a new 330-person Phase Ib study. Pending the results of Phase I trials underway, the U.S. National Institutes of Health has announced plans to initiate, in early 2015, a large randomized, controlled Phase II/III study to evaluate the safety and efficacy of this and another investigational Ebola vaccine candidate.
08:01 EDTJNJAASLD publishes new recommendations for treating Hepatitis C
Subscribe for More Information
06:44 EDTPFEPfizer 'unlikely' to make fresh bid for AstraZeneca, Reuters reports
AstraZeneca (AZN) CEO Pascal Soriot told Swedish business daily Dagens Industri that Pfizer (PFE) is "unlikely" to make a fresh bid for the company, Reuters reports. Reference Link
06:34 EDTSNYImmunoGen appoints Richard Gregory as Chief Scientific Officer
ImmunoGen (IMGN) announced the appointment of Richard Gregory as Executive Vice President, Research and Chief Scientific Officer. Gregory will join the company on January 5, 2015, at which time current CSO, John Lambert, will assume the position of Executive Vice President, Distinguished Research Fellow. Gregory most recently served as senior vice president and head of research for the Sanofi (SNY) Genzyme Research & Development Center.
06:33 EDTJNJSevion announces antibody discovery collaboration with Johnson & Johnson
Subscribe for More Information
06:29 EDTJNJGilead drops 4% after Express Scripts picks AbbVie for hepatitis C
Shares of Gilead (GILD) are moving lower in pre-market trading after Express Scripts (ESRX) spokesman Brian Henry told CNBC's Meg Tirrell and other news outlets that the pharmacy benefits manger will exclusively offer AbbVie's (ABBV) recently approved hepatitis C regimen Viekira Pak at a "significant discount" starting Jan. 1. Express Scripts will no longer offer competing drugs from Gilead and Johnson & Johnson (JNJ). Shares of AbbVie are rising 6% to $71.50 in pre-market trading while Gilead is down 4% to $104.15. AbbVie discovered part of the Viekira Pak regimen via its ongoing collaboration with Enanta Pharmaceuticals (ENTA). Shares of Enanta are up 7% to $49.96 in pre-open trading.
06:05 EDTJNJMacroGenics ennters collaboration, license agreement with Janssen
Subscribe for More Information
05:44 EDTJNJExpress Scripts to offer AbbVie hepatitis C drug exclusively, CNBC reports
Express Scripts (ESRX) will offer AbbVie's (ABBV) just approved hepatitis C regimen Viekira Pak at a "significant discount" starting Jan. 1, while excluding competing drugs from Gilead (GILD) and Johnson & Johnson (JNJ), CNBC's Meg Tirrell reports, citing comments from the pharmacy benefits manager's spokesman Brian Henry. Reference Link
December 19, 2014
11:32 EDTPFELigand reports Pfizer receives EU marketing authorization for Duavive
Ligand Pharmaceuticals (LGND) announced that its partner Pfizer (PFE) has received EU marketing authorization for DUAVIVE from the European Commission. In the EU, DUAVIVE is indicated for the treatment of estrogen deficiency symptoms in postmenopausal women with a uterus for whom treatment with progestin-containing therapy is not appropriate. Ligand will be entitled to a milestone payment following Pfizer obtaining pricing of DUAVIVE in a major European market, the company stated.
11:08 EDTJNJJohnson & Johnson receives positive CHMP opinion to extend Velcade indication
Subscribe for More Information
09:37 EDTCELGActive equity options trading
Active equity options trading according to Track Data: AAPL TSLA BBRY AMZN CELG GILD JCP AMAT FB
08:14 EDTCELGCelgene reports positive CHMP opinion to extend REVLIMID indicated use
Subscribe for More Information
08:07 EDTMRKMerck begins tender offer to acquire Cubist
Subscribe for More Information
December 18, 2014
12:55 EDTPFECourt delays Teva's launch of generic Celebrex, Globes reports
Subscribe for More Information
10:58 EDTMRKTetraphase seen as takeover target after antibiotic trial success
Subscribe for More Information
09:21 EDTGSKOn The Fly: Pre-market Movers
Subscribe for More Information
08:03 EDTPFEPfizer reports statistically significant results in Phase 3 pregabalin study
Pfizer announced top-line results from a double-blind Phase 3 study evaluating pregabalin controlled-release formulation in adult patients with postherpetic neuralgia. The results show that pregabalin CR resulted in a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response in pain reduction. PHN is a type of peripheral neuropathic pain caused by nerve damage. Symptoms include continued burning or electric shock-like pain.1 This study is the final of three Phase 3 studies of the pregabalin CR formulation conducted to ascertain the potential use of pregabalin as a once-a-day therapy. The first study in adults with partial onset seizures with epilepsy did not meet its primary endpoint. In the second study in patients with fibromyalgia, pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to LTR in pain reduction. The objective of the Phase 3 double-blind, randomized, placebo-controlled study was to evaluate the safety and efficacy of pregabalin CR compared with placebo in the durability of effect for the treatment of pain associated with PHN among patients who initially respond to single-blind pregabalin.
07:36 EDTMRKMerck acquires OncoEthix, terms include upfront payment of up to $110M
Subscribe for More Information
07:28 EDTPFEPfizer shares poised to perform well in 2015, says Deutsche Bank
Subscribe for More Information
07:15 EDTGSKAgenus reports GSK ZOE-50 Phase 3 study met primary endpoint
Subscribe for More Information
December 17, 2014
15:09 EDTNVSNovartis unit gets FDA approval for swimmer’s ear treatment
Subscribe for More Information
11:28 EDTSHPGNPS Pharmaceuticals calls active on Shire considering bid report
Subscribe for More Information
11:13 EDTSHPGShire considering bid for NPS Pharmaceuticals, Bloomberg reports
Subscribe for More Information
10:49 EDTSHPGNPS Pharmaceuticals jumps 12%, halted after report of potential Shire bid
Shire (SHPG) has NPS Pharmaceuticals (NPSP) on the top of its list of potential takeover targets, but is also said to be considering other targets, according to Bloomberg.
10:47 EDTSHPGNPS Pharmaceuticals said to be on top of Shire takeover list, Bloommberg says
Subscribe for More Information
10:47 EDTSHPGNPS halted for volatility after Bloomberg says Shire considers bid
Subscribe for More Information
10:36 EDTMRKCowen pharmaceuticals analysts hold an analyst/industry conference call
Analyst Research Team discusses the imminent Merck/Cubist Zerbaxa opportunity and the Cempra SOLITAIRE-ORAL Trial readout on an Analyst/Industry conference call to be held on December 17 at 2 pm.
09:04 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
Subscribe for More Information
09:02 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
Subscribe for More Information
08:06 EDTJNJInovio appoints Zane Yang as VP, Clinical Development, Oncology
Subscribe for More Information
08:01 EDTPFEPfizer initiates Phase 2 PF-06252616 study
Subscribe for More Information
07:29 EDTNVSFDA PDUFA Date for Novartis Bexsero is December 17, 2014
Subscribe for More Information
December 16, 2014
08:47 EDTBMY, MRK, NVSHemispherx Ampligen provides anti-tumor activity
Subscribe for More Information
07:20 EDTJNJGeron announces early HSR clearance for collaboration with Janssen
Subscribe for More Information
07:06 EDTNVSBioLineRx and Novartis enter into strategic collaboration agreement
Subscribe for More Information
05:48 EDTNVSNovartis gains FDA approval for Signifor LAR
Subscribe for More Information
December 15, 2014
18:32 EDTPFEPfizer announces Palbociclib PALOMA-1 data published in The Lancet Oncology
Subscribe for More Information
12:09 EDTPFEPfizer increases dividend 8% to 28c per share
Subscribe for More Information
10:40 EDTPFEOPKO Health deal with Pfizer removes financing overhang, says Ladenburg
Ladenburg views the agreement OPKO Health (OPK) signed with Pfizer (PFE) as a significant positive catalyst since the company is partnering with an established leader in short-acting hGH and because the large upfront payment removes near-term financing needs as an overhang on the stock. The firm reiterates its Buy rating and $14.50 price target on OPKO, but said it will re-examine its projections after the deal closes.
10:19 EDTPFEOPKO Health soars after entering hGP-CTP agreement with Pfizer
Subscribe for More Information
09:03 EDTPFEBaxter to divest Vero cell vaccines platform to Nanotherapeutics
Baxter International (BAX) announced that it has entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. Financial details were not disclosed. The agreement with Nanotherapeutics includes all assets related to the platform, including vaccines for H5N1, H1N1 and seasonal influenza. The agreement also includes investigational vaccine programs for Ross River virus, Chikungunya disease and West Nile virus. In recent weeks, the company has also completed the sale of its commercial vaccines business and related manufacturing facilities to Pfizer (PFE).
08:02 EDTPFEPfizer, OPKO Health enter into global agreement for hGH-CTP
Subscribe for More Information
December 12, 2014
16:33 EDTMRKStocks finish week lower amid steep decline in oil prices
Subscribe for More Information
14:01 EDTJNJGenOn Energy to receive $3M milestone payment in Janssen collaboration
Genmab announced it has reached a milestone in its DuoBody technology platform collaboration with Janssen Biotech (JNJ), triggering a $3M payment. The milestone payment is for pre-clinical progress with a DuoBody product candidate targeting cancer. Today's news will not impact Genmab's 2014 financial guidance.
11:19 EDTABTAbbott board increases quarterly dividend to 24c from 22c
The board of Abbott increased the company's quarterly common dividend to 24c per share from 22c per share. The cash dividend is payable Feb. 13, 2015, to shareholders of record at the close of business on Jan. 15, 2015.
08:36 EDTNVSNovartis reports BOLERO-1 trial did not meet primary objective
Subscribe for More Information
08:01 EDTCELGPiper predicts two large-cap biotechs could be acquired in 2015
Subscribe for More Information
05:31 EDTNVSNovartis reports Cosentyx 'superior' in head-to-head psoriasis study
Subscribe for More Information
December 11, 2014
08:57 EDTSHPGLeerink major pharma & biotech analysts hold analyst/industry conference call
Subscribe for More Information
08:27 EDTMRKNewLink Genetics falls after Ebola vaccine trial suspended
Shares of NewLink Genetics (NLNK) are falling in pre-market trading after a clinical trial of the Ebola vaccine being developed by the company and partner Merck (MRK) was temporarily suspended as a precautionary measure after four patients complained of joint pains in their hands and feet, the University of Geneva Hospital said. The trials are scheduled to resume next month in up to 15 volunteers after checks to make sure that the joint pain symptoms were benign and temporary, the hospital added. Shares of NewLink are down 6.5% to $34.50 in early morning trading following the news, while Merck shares are indicated to open fractionally higher.
06:29 EDTSHPGShire CEO sees no immediate need to spend break-up fee, Reuters reports
Subscribe for More Information
05:24 EDTABTAbbott IRIDICA now available in Europe
Subscribe for More Information
December 10, 2014
16:00 EDTMRKOptions Update; December 10, 2014
Subscribe for More Information
13:45 EDTMRKMerck's Gardasil 9 approved by FDA
Subscribe for More Information
08:47 EDTMRKMerck, IBCSG, BIG announce opening of PANACEA study
The International Breast Cancer Study Group, Breast International Group, and Merck announced the opening of the PANACEA study, a global collaborative study exploring a new way to treat HER2+ breast cancer that has become resistant to the current standard of care. The PANACEA study will investigate the use of pembrolizumab in combination with trastuzumab to evaluate whether the addition of an anti-PD-1 therapy can reverse trastuzumab resistance in patients with HER2+ breast cancer whose cancer has spread while on trastuzumab therapy. The trial, “Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2+ Breast Cancer,” is a Phase 1b/2 study in patients with HER2+ breast cancer whose cancer has spread while on treatment with trastuzumab. Primary outcome measures of the study are recommended dose and efficacy and safety profile of pembrolizumab in combination with trastuzumab. Response will be assessed by RECIST 1.1 criteria. Secondary outcome measures include safety and tolerability, disease control, duration of response, time to progression, progression-free survival and overall survival. The study is enrolling adult females with unresectable or metastatic breast adenocarcinoma with confirmed HER2-positivity. There are 10 sites participating in the study across Europe and Australia: Peter MacCallum Cancer Centre and Westmead Hospital in Australia; Medical University of Vienna in Austria; Jules Bordet Institute and CHU Sart Tilman in Belgium; Institut de Cancérologie de l’OUEST, Centre Léon Bérard and Institut Gustave Roussy in France; and Istituto Europeo di Oncologia Milano and Azienda USL4 Prato in Italy.
08:32 EDTMRKMerck announces early findings showing 18.5% overall response rate with Keytruda
Merck announced early study findings demonstrating an overall response rate of 18.5% with KEYTRUDA, the company’s anti-PD-1 therapy, as assessed by RECIST v1.1, central review in PD-L1 positive, advanced triple-negative breast cancer – one of the most aggressive forms of breast cancer. At the time of analysis, the median duration of response had not been reached with three of five responders on therapy for 11 months or more. These early findings, from the ongoing Phase 1b KEYNOTE-012 study, were shared today for the first time as part of the official press program at the 2014 San Antonio Breast Cancer Symposium and will be presented in an oral session at 10:45 a.m. CST by Dr. Rita Nanda, the University of Chicago. Data presented were from a cohort of the ongoing Phase 1b KEYNOTE-012 study which evaluated KEYTRUDA monotherapy at 10 mg/kg every two weeks in patients with advanced TNBC whose tumors were determined to be positive for PD-L1 expression. As measured by Merck’s proprietary PD-L1 immunohistochemistry clinical trial assay, tumors were considered to be PD-L1 positive if staining was present in the stroma or in greater than or equal to one percent of tumor cells. In the study, 58 percent of patients screened had tumors determined to be positive for PD-L1 expression. Most patients enrolled in this study had received two or more prior chemotherapies for metastatic disease and 87.5 percent had received prior neo-adjuvant or adjuvant therapy.
08:31 EDTPFETeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
07:38 EDTPFEMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
06:08 EDTBMYBristol-Myers partners with Ono Pharma and Kyowa Hakko Kirin for oncology trial
Subscribe for More Information
December 9, 2014
16:35 EDTBMYBristol-Myers raises dividend to 37c per share from 36c per share
Subscribe for More Information
16:28 EDTMRKOn The Fly: Closing Wrap
Stocks on Wall Street opened in the red on the heels of a sharp sell-off in China and amid continued concern over tumbling oil prices. The domestic economic calendar offered little in the way of a catalyst and the market moved in a narrow range throughout the morning. However, the averages began to pare their losses once the European markets closed. By mid-afternoon the averages had turned mixed with the Nasdaq higher, the S&P flat, and the Dow the laggard, which is the way the trading day closed. ECONOMIC EVENTS: In the U.S., the National Federation of Independent Business' optimism index rose to 98.1 from a prior reading of 96.1. The JOLTS report showed job openings increased 149K to 4.83M in October, which was above the expectation for 4.795M openings. Wholesale sales increased 0.2% in October and inventories grew 0.4%, both of which were better than expected. In Asia, China's Shanghai composite index plunged 5.4%, making for the stock market's sharpest selloff in years, after the country’s securities clearing house raised the threshold for the type of collateral used for short-term loans and policymakers warned about potentially slower economic growth. In Europe, Greek stocks and bonds also tumbled after a move to bring forward presidential elections, which could potentially derail Greece’s bailout and austerity efforts. COMPANY NEWS: Verizon (VZ) was among the Dow's worst performers, sinking $1.98, or 4.05%, to $46.92 after the company warned that Q4 impacts of its promotional offers, together with the strong customer volumes this quarter, will put short-term pressure on its earnings per share. After last night's commentary from the company, Robert W. Baird downgraded Verizon shares to Neutral from Outperform and lowered its price target on the stock to $50 from $54... Merck (MRK) also weighed on the Dow, as the drugmaker fell $1.87, or 3.02%, to $60.01 after a Delaware court denied Cubist's (CBST) bid to stop Hospira (HSP) from selling a generic version of Cubicin in 2016. Merck announced just yesterday morning that it had agreed to buy Cubist in a transaction with a total value of approximately $9.5B. The news is a "tough start" to Merck's takeover and makes the $9.5B buyout price look $2B to $3B too high, according to analysts at Leerink. Shares of Cubist also fell $xxx, or xxx%, to $xxx following the court ruling. MAJOR MOVERS: Among the notable gainers was bluebird bio (BLUE), which surged $35.39, or 72.39%, to $84.28 after the company announced data from eight subjects treated with its LentiGlobin drug product and Piper Jaffray more than doubled its price target for the shares to $112 from $52. Among the noteworthy losers was Conn's (CONN), which plunged $14.26, or 40.64%, to $20.83 after unexpectedly reporting losses for its third fiscal quarter, withdrawing its FY15 guidance and announcing the departure of its CFO. Also lower was Spirit Airlines (SAVE), which slid $10.70, or 12.67%, to $73.77 after the company said last night that since late October there has been compression in the fare structure for close-in bookings, believed to be driven by the industry’s willingness to trade lower fuel prices for lower fares. Also, this morning, Raymond James downgraded Spirit Airlines to Market Perform from Outperform, citing valuation, European deflation headwinds, and earnings that are still being revised down. INDEXES: The Dow fell 51.28, or 0.29%, to 17,801.20, the Nasdaq rose 25.77, or 0.54%, to 4,766.46, and the S&P 500 slipped 0.49, or 0.02%, to 2,059.82.
14:10 EDTCELGCelgene ISTODAX combination demonstrates complete response in 51% of patients
Subscribe for More Information
13:08 EDTMRKMerck may have paid $2B-$3B too much for Cubist, analyst says
Subscribe for More Information
12:25 EDTMRKOn The Fly: Midday Wrap
Subscribe for More Information
12:22 EDTSHPG, PFEPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
11:19 EDTSNYSanofi reportedly ready to make acquisitions in animal medicine, Bloomberg says
Subscribe for More Information
10:32 EDTPFEPfizer says in talks with FDA on path forward for Mylotarg
Pfizer announced the presentation of encouraging early- and late-stage data from clinical studies across several hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia. Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate MYLOTARG in select adult AML populations. Research was presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, December 6-9. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said “In particular, we are encouraged by the significant clinical evidence emerging from large randomized trials, such as AML-19 and ALFA-0701, demonstrating a positive impact of MYLOTARG when added to standard first-line treatment for patients with acute myeloid leukemia. We are engaging in discussions with the U.S. FDA and other health authorities to determine the best path forward for MYLOTARG. In addition, we plan to initiate an expanded access protocol for the therapy by the end of 2014 in the United States in patients with relapsed or refractory acute myeloid leukemia for whom there are no other treatment options.”
10:23 EDTGSK, SHPGOn The Fly: Analyst Downgrade Summary
Subscribe for More Information
10:10 EDTMRKMerck trades sharply lower, levels to watch
The stock is down over 4.3% to $59.23 at time of writing. At that price next support is at $57.95. Resistance is at $60.25.
09:10 EDTGSKARIAD takeover rumors rekindled, Independent says
Subscribe for More Information
08:34 EDTCELGCelgene price target raised to $130 from $102 at Argus
Argus hiked its price target on Celgene as the firm thinks the company posted solid Q3 results, while it is continuing to make progress in its pipeline. Argus keeps a Buy rating on the shares.
08:28 EDTCELGCelgene price target raised to $130 from $112 at UBS
Subscribe for More Information
08:25 EDTBMY, MRKBristol-Myers data positive, says BMO Capital
Subscribe for More Information
08:23 EDTMRKMerck has 'no way out' of Cubist deal after court decision, says Leerink
Subscribe for More Information
08:12 EDTMRKMerck still sees Cubist acquisition neutral to modestly accretive to 2015 EPS
Merck (MRK) issued the following statement regarding the decision of the U.S. District Court for the District of Delaware. The decision, which upheld the patent for CUBICIN that expires on June 15, 2016 and invalidated four others, is subject to appeal. The company continues to believe the acquisition of Cubist (CBST) will create strong fundamental value for Merck’s shareholders. The combined strength of both companies will provide both incremental and long-term value, and Merck expects the transaction to add more than $1B of revenue to its 2015 base, with strong growth potential thereafter. The court’s decision does not change Merck’s expectation that the transaction will be neutral to modestly accretive to 2015 non-GAAP EPS. The company also continues to expect that the transaction will contribute mid-single digit accretion on a percentage basis to non-GAAP EPS in 2016, and will continue to be accretive thereafter.
08:11 EDTMRKCubist downgraded to Sector Perform from Outperform at RBC Capital
Subscribe for More Information
07:44 EDTPFE, CELG, GSKAmerican Association for Cancer Research to hold a symposium
Subscribe for More Information
05:50 EDTJNJPharmacyclics data demonstrates safety, durability response
New, 27-month IMBRUVICA median follow-up data announced by Pharmacyclics (PCYC) support the use of IMBRUVICA over longer periods of time in patients with relapsed/refractory mantle cell lymphoma, or MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA's efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:46 EDTCELGCelgene presents POMALYST/IMNOVID Phase IIIb study results at ASH meeting
Celgene announced that results from the STRATUS trial, a single-arm phase IIIb study of pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory multiple myeloma were presented at the 56th American Society of Hematology annual meeting. Pomalidomide is marketed as POMALYST in the United States and IMNOVID in the European Union. In the study, 599 patients with refractory, or relapsed and refractory, disease who had previously failed lenalidomide and bortezomib had been enrolled at the time of the data cutoff. The primary endpoint was safety, and key secondary endpoints included pomalidomide exposure, overall response rate, or ORR, duration of response, or DOR, progression-free survival, or PFS, overall survival, or OS, and cytogenetic analyses. Patients had a median five prior therapies. All patients received thromboprophylaxis with low-dose aspirin, low-molecular-weight heparin, or equivalent. At a median follow-up of 6.8 months with a median four cycles received, the median PFS and OS were 4.2 months and 11.9 months, respectively. The ORR was 35%, with 8% of patients achieving at least a very good partial response, or VGPR. The median DOR was 6.8 months. In patients refractory to prior lenalidomide or lenalidomide and bortezomib, similar PFS, OS, and ORR were achieved.
05:43 EDTJNJPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:38 EDTSHPGShire downgraded to Neutral from Buy at BofA/Merrill
Subscribe for More Information
05:37 EDTGSKGlaxoSmithKline downgraded to Underperform from Neutral at BofA/Merrill
BofA/Merrill downgraded GlaxoSmithKline to Underperform citing a lack of pipeline catalysts and its belief the European pharma sector is close to fair value.
05:27 EDTJNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
Subscribe for More Information
05:22 EDTCELGCelgene reports REVLIMID study data suggests improved response rates, PFS, OS
Subscribe for More Information
05:17 EDTCELGCelgene reports Vidaza Phase III study shows doubled overall survival times
Subscribe for More Information
December 8, 2014
19:00 EDTMRKCubist CEO says Cubicin patent ruling will not affect Merck transaction
Subscribe for More Information
18:00 EDTMRKCubist loses bid to stop Hospira's generic Cubicin after 2016, Bloomberg says
Cubist's (CBST) patent for Cubicin that expires in June 2016 upheld by judge, Bloomberg added. Note that this morning Merck (MRK) and Cubist Pharmaceuticals announced that the companies have entered into a definitive agreement under which Merck will acquire Cubist for $102 per share in cash.
17:54 EDTMRKFour Cubist Cubicin patents invalidated as Hospira wins ruling, Bloomberg says
Subscribe for More Information
17:30 EDTMRKMerck acquisition of Cubist could be a 'winner', Barron's says
Subscribe for More Information
17:30 EDTMRKMerck shares lower after reports of judge decision in Cubist/Hospira case
Subscribe for More Information
16:24 EDTMRKOn The Fly: Closing Wrap
Stocks on Wall Street were lower amid another drop in crude oil prices, which tumbled to five-year lows. The market opened slightly lower following weaker than expected data from China and Japan, with nothing of note on the domestic calendar to get buyers involved in the day’s activity. Near noon, the averages gained downside momentum and though the market pared its losses several times, it was never able to gain any steam to pull the indexes back into the green. ECONOMIC EVENTS: In the U.S., no major economic data was released. In Asia, Chinese exports rose 4.7% from a year earlier in November, which missed the consensus estimate for an 8% increase. Chinese imports fell 6.7% from the prior year last month, compared with projections for a 3.8% increase. Additionally, Japan's revised third quarter gross domestic product estimate showed the economy shrank more than initially thought, with growth contracting an annualized 1.9%. COMPANY NEWS: Shares of Cubist Pharmaceuticals (CBST) surged $26.24, or 35.29%, to $100.60 after Merck (MRK) agreed to acquire the maker of next-generation antibiotics for $102 per share in cash, or $8.4B and the assumption of $1.1B in debt. A number of other antibiotic makers also climbed, including Tetraphase (TTPH), which rose $2.45, or 8.82%, to $30.24, and Cempra (CEMP), which advanced $1.64, or 11.37%, to $16.06, while shares of Merck finished fractionally higher, adding 39c, or 0.63%, to $61.88 following the deal announcement. MAJOR MOVERS: Among the notable gainers following their presentations at the American Society of Hematology, or ASH, annual meeting were Calithera Biosciences (CALA), which gained $2.38, or 22.52%, to $12.95, and Acceleron Pharma (XLRN), which jumped $5.11, or 13.6%, to $42.67. Among the noteworthy losers was McDonald's (MCD), which fell $3.70, or 3.84%, to $92.61 after the Dow member reported a 2.2% decline in global same-restaurant sales in November. Additionally, the fast-food giant warned that its fourth quarter results would be hurt by its sales pressures, supplier issues in China and a stronger U.S. dollar. Also lower were shares of Liquidity Services (LQDT), which plunged $2.77, or 27.0%, to $7.49 after the company disclosed that Wal-Mart (WMT) had terminated a deal to provide it with surplus merchandise. INDEXES: The Dow fell 106.31, or 0.59%, to 17,852.48, the Nasdaq dropped 40.06, or 0.84%, to 4,740.69, and the S&P 500 slipped 15.06, or 0.73%, to 2,060.31.
16:24 EDTMRKAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
Subscribe for More Information
14:06 EDTCELGCelgene reports luspatercept, sotatercept increased hemoglobin levels in trials
Subscribe for More Information
13:54 EDTCELGCelgene announces results from phase lll Revlimid study
Subscribe for More Information
13:32 EDTPFE, BMYPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
13:32 EDTGSKEpizyme announces results for PRMT5 inhibitor
Subscribe for More Information
13:12 EDTMRKMerck paid full price but made good deal for Cubist, says UBS
Subscribe for More Information
13:07 EDTNVSNovartis announces data from Jakavi trial
Novartis (NVS) announced data from the largest clinical trial of myelofibrosis patients treated with Jakavi, supporting the safety profile and efficacy benefit as measured in primary and secondary endpoints respectively. In an analysis of 1,144 patients treated with Jakavi to date in this ongoing expanded access study, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis. Findings from the study were presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, California. Novartis research and development efforts, in collaboration with Incyte Corporation (INCY), include early-phase and post-marketing studies in myelofibrosis and other myeloproliferative neoplasms. More than 50 abstracts on ruxolitinib are being presented at ASH, including three oral presentations exploring combinations of ruxolitinib with various investigational compounds, evaluating the possibility of simultaneously targeting multiple cancer pathways that may be involved in the pathogenesis of myelofibrosis. The JUMP study is a Phase IIIb, expanded-access trial for countries with no access to Jakavi outside of a clinical trial. The open-label, multicenter study analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary endpoint is assessment of safety and tolerability of Jakavi. Overall, the safety and efficacy profile of Jakavi was consistent with previous studies.
13:05 EDTNVSNovartis reports six-year results from Phase III ENESTnd study
Subscribe for More Information
12:40 EDTMRKOn The Fly: Midday Wrap
Subscribe for More Information
12:25 EDTMRKAntibiotic makers rise after Merck agrees to buy Cubist
Subscribe for More Information
11:30 EDTNVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
Subscribe for More Information
08:30 EDTMRKMerck says deals with Cubist includes $250M break-up fee clause
Subscribe for More Information
08:21 EDTMRKMerck says looked at all risks, including patent litgation, before Cubist deal
Subscribe for More Information
08:11 EDTMRKCubist volatility elevated into Merck acquiring for $8.4B in cash
Subscribe for More Information
08:08 EDTMRKMerck says about $9.5B of debt to be issued related to Cubist deal
Subscribe for More Information
08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
Subscribe for More Information
07:36 EDTCELGAgios announces Celgene to extend discovery phase of collaboration to April 2016
Agios Pharmaceuticals (AGIO) announced that Celgene (CELG) has elected to extend the period of its exclusivity for an additional year to April 2016 under the global strategic collaboration agreement. The two companies have been working together since April 2010 to discover, develop and commercialize disease-altering therapies in oncology arising from Agios' cancer metabolism research platform. The terms of the collaboration extension are consistent with previously agreed upon financial terms. As a result of the extension, Celgene will maintain its exclusive option to drug candidates that emerge from Agios' cancer metabolism research platform through April 2016. Agios will receive a $20M payment. Following this extension, the discovery portion of the collaboration will expire on April 14, 2016. Under the terms of the original agreement announced in April 2010, Agios leads research, preclinical and early development efforts through Phase 1, while Celgene receives an option to obtain exclusive rights either upon IND acceptance or at the end of Phase 1, to further development and commercialize medicines emerging from Agios' cancer metabolism research. Celgene would lead and fund global development and commercialization of some of these drugs, and Agios would retain development and commercialization rights for certain drugs in the United States. On all programs, Agios is eligible to receive up to $120M in milestone-based payments as well as royalties on any sales.
07:35 EDTMRKAdvaxis reports FDA acceptance of IND application for ADXS-PSA combination trial
Subscribe for More Information
07:17 EDTCELGCelgene price target raised to $131 from $120 at Cantor
Subscribe for More Information
07:13 EDTMRKMerck to host conference call
Subscribe for More Information
07:01 EDTMRKMerck to acquire Cubist for $102 per share in cash, or $9.5B
Subscribe for More Information
07:00 EDTMRKMerck to acquire Cubist for $102 per share in cash
Subscribe for More Information
05:53 EDTBMYStocks with implied volatility movement; BSX BMY
Subscribe for More Information
05:42 EDTNVSSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
05:35 EDTCELGCelgene REVLIMID, low-dose dexamethasone increased PFS
Subscribe for More Information
<< 1 | 2 | 3 | 4 | 5 | 6 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use