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BPCIA: Amgen Begins the Patent Dance With AbbVie

2015-12-08 00:56:18| Biotech - Topix.net

On November 25, 2015, Amgen Inc. announced it submitted its first biologics license application to the FDA under the Section 351 biosimilar approval pathway provided in the Biologics Price Competition and Innovation Act . Amgen's BLA seeks approval for its biosimilar of AbbVie's top-selling arthritis drug Humira .

Tags: dance begins patent amgen

 

FDA warns of deadly liver damage with AbbVie hepatitis drugs

2015-10-25 14:37:13| Biotech - Topix.net

Federal health officials are warning doctors and patients that two hepatitis C drugs from AbbVie can cause life-threatening liver injury in patients with advanced forms of the disease. The Food and Drug Administration said Thursday it will require AbbVie to add new warnings to Viekira Pak and Technivie after reported deaths and liver transplants in patients who already had liver damage caused by hepatitis C. The warning could reshape the growing field of high-priced drugs to treat the virus, which also includes Gilead Sciences' blockbuster medications Sovaldi and Harvoni.

Tags: damage drugs liver deadly

 
 

FDA adds liver warning to AbbVie hepatitis C drugs

2015-10-23 01:36:32| Biotech - Topix.net

Federal health officials are warning doctors and patients that two hepatitis C drugs from AbbVie can cause life-threatening liver injury in patients with advanced forms of the disease. The Food and Drug Administration said Thursday it will require AbbVie to add new warnings to Viekira Pak and Technivie about their risks for patients who already have advanced liver damage caused by hepatitis C. The warning could reshape the growing field of high-priced drugs to treat the virus, which also includes Gilead Sciences' blockbuster medications Sovaldi and Harvoni.

Tags: warning drugs adds liver

 

AbbVie, Biogen, Gilead: Smart Money Got Burned Betting on Biotech in Q3

2015-10-20 17:42:28| Biotech - Topix.net

When it rains, it pours, and for big pharma, it certainly poured in the third quarter. With the third quarter over, let's take a closer look at the fundamentals of hedge fund hotels Pfizer Inc. , Gilead Sciences, Inc. , AbbVie Inc , Amgen, Inc. , and Biogen Inc and see how they did in the third quarter .

Tags: money smart biotech burned

 

Allergan may turn sights to Amgen or AbbVie with Teva cash

2015-07-28 18:30:04| Biotech - Topix.net

Allergan Plc says it's “reloaded and ready to move” on further acquisitions after agreeing to sell its generic-drug business for $40.5 billion. The deal with Teva Pharmaceutical Industries Ltd. “gives us a tremendous amount of flexibility to think about transformational M&A as well as continue our pattern of tuck-in acquisitions,” Allergan Chief Executive Officer Brent Saunders said on a conference call today.

Tags: with turn cash sights

 

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