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FDA Approves Baxter’s HYQVIA for Treatment of Adults with Primary Immunodeficiency

September 15, 2014 8:31 am | News | Comments

Baxter International and Halozyme Therapeutics announced that the FDA approved Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI), HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase].

Gilead to License Generic Version of Sovaldi

September 15, 2014 8:07 am | by The Associated Press | News | Comments

Gilead Sciences says it has reached a deal with several generic drugmakers to produce cheaper...

Feds Say Bayer Colon Supplement Makes Bogus Claims

September 12, 2014 3:23 pm | News | Comments

The Department of Justice filed a court motion against the German conglomerate over its...

Merck KGaA Discontinues Clinical Development Program of Tecemotide for Stage III Non-Small Cell Lung Cancer

September 12, 2014 3:18 pm | News | Comments

Merck KGaA announced that its biopharmaceutical division will discontinue the clinical...

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Lilly Says CYRAMZA Phase III Second-Line Colorectal Cancer Trial Meets Primary Endpoint of Overall Survival

September 12, 2014 8:56 am | News | Comments

Eli Lilly and Company today announced that the RAISE trial, a Phase III study of ramucirumab (CYRAMZA) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival.   

Center for Advanced Cellular Therapeutics to Rise on Penn Medicine Campus

September 12, 2014 8:09 am | News | Comments

The University of Pennsylvania today reached an important milestone in its alliance with Novartis as it unveiled plans for the construction of a first-of-its-kind Center for Advanced Cellular Therapeutics (CACT) on the Penn Medicine campus in Philadelphia.

FDA Backs Novo Nordisk Injection for Obesity

September 11, 2014 5:47 pm | by The Associated Press | News | Comments

Federal health experts say a diabetes drug from Novo Nordisk should be approved for a new use in treating obesity. The panel of Food and Drug Administration advisers voted 14-1 that the injectable drug's benefits outweigh it risks for patients who are obese or dangerously overweight.

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Abbott Approves $3B Share Buyback

September 11, 2014 3:16 pm | News | Comments

Abbott Laboratories said Thursday that its board approved spending up to $3 billion to buy back the health conglomerate's stock.                     

Roche Ranked Most Sustainable Healthcare Company in the Dow Jones Sustainability Indices

September 11, 2014 11:25 am | News | Comments

For the sixth consecutive year, Roche has been recognized by the Dow Jones Sustainability Indices (DJSI) as the Group Leader in sustainability within the pharmaceuticals, biotechnology and life sciences industry. This places Roche amongst the top 10 percent of companies across all surveyed industries.

Baxter Announces Baxalta as the Name of New Global Biopharmaceutical Company

September 11, 2014 8:37 am | News | Comments

Baxter International has announced that Baxalta Incorporated will be the name of the new, publicly traded biopharmaceutical company that is expected to launch in mid-2015.             

FDA Approves New Indication for the Use of XTANDI Capsules

September 11, 2014 8:29 am | News | Comments

Astellas Pharma and Medivation announced today that the FDA approved a new indication for the use of XTANDI (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC).          

Lilly Receives European Marketing OK for Insulin

September 10, 2014 10:58 am | News | Comments

European regulators have approved a long-lasting insulin from Eli Lilly and Co. and German drugmaker Boehringer Ingelheim that is the subject of patent infringement litigation with French rival Sanofi.        

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Mylan to Pay $300M for U.S. Rights to Arixtra Injection

September 10, 2014 7:59 am | News | Comments

Mylan has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra® (fondaparinux sodium) Injection and the authorized generic (AG) of Arixtra from Aspen Global Incorporated.

Valeant Pharmaceuticals Expands Bausch + Lomb Manufacturing Facility, Adding 120 New Jobs in Rochester, NY

September 9, 2014 8:39 am | News | Comments

Valeant Pharmaceuticals hosted a ribbon cutting ceremony for the new Bausch + Lomb ULTRA contact lens manufacturing lines and solar array assembly at the company's Optics Center in Rochester, NY. The ceremony recognized the expansion and installation of the new manufacturing lines, which will produce the company's silicone hydrogel contact lens, Bausch + Lomb ULTRA.

Shortage of Bladder Cancer Drug Could be Tragic for Patients, Doctor Says

September 9, 2014 8:32 am | by Sheryl Ubelacker, The Canadian Press | News | Comments

The shortage of the medication — called bacillus Calmette-Guerin, or BCG — has been caused by manufacturing problems at plants operated by two different pharmaceutical companies — Merck and Sanofi Pasteur.        

Merus Labs Acquire Sintrom from Novartis

September 8, 2014 8:49 am | News | Comments

Merus Labs International has acquired from Novartis AG, in certain European countries, the rights to manufacture, market, and sell the branded prescription medicine product Sintrom® (acenocoumarol).          

Monkey Study: Ebola Vaccine Works, Needs Booster

September 8, 2014 8:13 am | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

New monkey studies show that one shot of an experimental Ebola vaccine can trigger fast protection, but the effect waned unless the animals got a booster shot made a different way.            

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Ophthotech Achieves $50M Milestone under Ex-US Licensing and Commercial Agreement with Novartis for Fovista®

September 8, 2014 8:07 am | News | Comments

Ophthotech Corporation today announced that it has achieved a $50 million enrollment milestone payment from Novartis Pharma AG as part of the ex-US licensing and commercialization agreement between the two companies focused on the treatment of wet age-related macular degeneration (AMD).

FDA Approves Keytruda for Advanced Melanoma

September 4, 2014 3:49 pm | News | Comments

The U.S. Food and Drug Administration has granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.       

Lilly Says Insulin Fares Well in Late-Stage Tests

September 4, 2014 11:51 am | News | Comments

Lilly said peglispro produced statistically significant lower blood sugar levels in patients when compared to people who took the Sanofi insulin Lantus in two late-stage studies of people with type 1 diabetes.       

Court Orders Takeda to Pay $6B Over Actos Diabetes Drug

September 4, 2014 10:51 am | News | Comments

Takeda Pharmaceutical has been ordered by a U.S. district court to pay $6 billion in punitive damages over a lawsuit filed by a man who claimed his bladder cancer was caused by Takeda's diabetes medicine Actos.       

Johnson & Johnson to Accelerate Ebola Vaccine Program

September 4, 2014 8:43 am | News | Comments

Johnson & Johnson will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate with its partners in global health to deliver immediate relief aid to address the current Ebola outbreak.

FDA: Little Evidence to Support Testosterone Drugs

September 3, 2014 3:30 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks.  

AstraZeneca and Redx Pharma to Collaborate on Targeting Genetic Drivers of Tumor Growth

September 3, 2014 8:54 am | News | Comments

AstraZeneca has entered into a research collaboration with Redx Pharma Limited to discover and develop new molecules targeting a genetic driver of tumor growth and survival. The research will complement AstraZeneca’s strategic approach focused on genetic drivers of cancer and mechanisms of resistance to established and novel cancer therapies.

UK High Court Gives Positive Judgment in Teva's Patent Case Against AstraZeneca

September 3, 2014 8:33 am | News | Comments

Teva Pharmaceutical announced that a positive judgment has been given by the UK High Court in support of Teva's case against AstraZeneca relating to the validity of EP 1,085,877 covering the SMART ( S ingle inhaler M aintenance A nd R eliever T herapy) indication for AstraZeneca's fixed dose formoterol/budesonide combination product, Symbicort®.

Eisai Sells U.S. Rights to Zonegran Capsules to Concordia Pharmaceuticals

September 3, 2014 8:11 am | News | Comments

Eisai today announced it has entered into an agreement with Concordia Pharmaceuticals Inc., a subsidiary of Concordia Healthcare Corp., to purchase Eisai's U.S. and Puerto Rican commercialization and distribution rights to Zonegran.   

EMD Serono Appoints New Senior Vice President, Neurology and Immunology

September 2, 2014 9:09 am | News | Comments

EMD Serono announced today that Drew Young has joined the company as Senior Vice President, Neurology and Immunology. In this capacity, he will be responsible for leading the strategic direction of the U.S. Neurology and Immunology franchise, including future products.

Pfizer and Protalix BioTherapeutics Announce FDA Approval of Pediatric Indication for ELELYSO™

August 28, 2014 1:41 pm | News | Comments

Pfizer and Protalix BioTherapeutics announced that the FDA approved ELELYSO™ for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.

Novo Nordisk Buys Production Plant in New Hampshire

August 28, 2014 11:47 am | News | Comments

The facility was established in 1989, expanded in 2003-2006 and acquired by Olympus Biotech in 2011. It has been used primarily for mammalian cell manufacturing until production was phased out earlier this year.       

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