Bayer announced last week that it will close its hemophilia manufacturing facility in Wuppertal, Germany, and lay off 350 workers. Its recombinant factor VIII production will take place at its site in Berkeley, California. The cuts in Germany come on top of the announced layoffs in October of more than 225 manufacturing workers in Berkeley.
The FDA has extended the patent for Pfizer’s top selling drug, Lyrica, which was set to expire at the end of this year. The company now has exclusivity until June 30, 2019. With Lyrica sales reaching nearly $3.5 billion in the US in 2017, this extension will allow Pfizer to protect about half of that figure next year.
Pfizer has announced that as of January 2019 it will be raising prices on 41 of its drugs. Thirty-seven will increase by 5%, three by 3% and one by 9%. In total, these drugs represent about 10% of Pfizer’s portfolio. These increases follow similar increases this past summer to about the same number of drugs.
The first of a series of recalls involving blood pressure medication were in August. Months later, tainted drugs continue to be found in the US supply. The FDA and Sandoz have announced the recall of one lot of losartain blood pressure medicine that was manufactured by its Lek Pharmaceuticals unit in Ljubljana, Slovenia, because it contains N-nitrosodiethylamine (NDEA), a suspected carcinogen.
NDEA along with N-Nitrosodimethylamine (NDMA) are two probable human carcinogens that the FDA has discovered can be created during manufacturing under certain conditions.
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The third quarter US sales for Regeneron’s Eylea were listed as $1.02 billion. This is the first time the drug has generated over $1 billion in quarterly US sales. Q2 sales were $992 million. In August, Eylea received an FDA nod in wet age-related macular degeneration as a 12-week dosing formulation, and the agency is scheduled to decide on the drug’s use in diabetic retinopathy by May 13, 2019.
Pfizer and Bain Capital have teamed up to form a new biotech, Cerevel Theracpeutics. The company will focus on development drug candidates to treat disorders of the central nervous system. Prizer is contributing a portfolio of pre-commercial neuroscience assets and Bain Capital is providing #350 million in capital.
Teva has lost its appeal to maintain several patents on its 40 mg version of its multiple sclerosis drug Copaxone.
The drug is a key sales contributor for Teva. Sales of the short-acting version of the drug have plummeted with Mylan and Novartis generics out there. Sales for the 20mg and 40mg versions together amounted to $940 million in North America…
Insmed’s Arikayce has become the first drug approved under a novel FDA pathway designed to speed development of antibiotics.
The active component of antibiotic Arikayce is amikacin, a decade-old antibiotic that’s on the WHO’s essential drug list. But instead of administering it intravenously, Insmed created an…
Regeneron is planning a build out of its second campus in Rensselaer, New York. The plan includes adding manufacturing capacity, laboratory space and warehouse facilities. With the expansion, Regeneron will be 1,500 jobs over the next seven years and receiving $140 million in tax incentives from the state.