Mar 4, 2021 11:10am
Biogen plans to bring on 90 new employees to staff its planned gene therapy manufacturing facility. (Biogen)
As Biogen awaits an FDA decision on its controversial Alzheimer s disease hopeful aducanumab, the company is setting the stage for an entry into the hot gene therapy field.
Biogen has drawn up plans for a new gene therapy manufacturing facility at its Research Triangle Park campus in North Carolina. The 175,000-square-foot facility will be designed to scale up the manufacturing of the products that are in Biogen s growing gene therapy pipeline. Biogen expects the facility to be up and running by 2023.
The company will invest some $200 million in the new site, with plans to add about 90 new jobs to its current Research Triangle Park workforce of 1,900. The company currently has 20 clinical programs across its North Carolina operations and performs commercial manufacturing at Research Triangle Park for drugs such as Tysabri, Avonex and Plegridy,
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Merck's "wartime" coronavirus tie-up with Johnson & Johnson puts the vaccine giant on deck to support drug substance, formulation and vial-filling work in the U.S. And the government is chipping in with $269 million to equip two Merck manufacturing plants for the work.
Mar 3, 2021 10:50am
The FDA has sent a last-minute notification of an advisory committee review of FibroGen and AstraZeneca s first-in-class anemia candidate roxadustat, threatening another decision delay. (FDA)
FibroGen and AstraZeneca already endured a delay in the U.S. review of their anemia candidate roxadustat. Just as the pair was expecting to snag its first-in-class approval, as the revised date draws near, a capricious FDA has stunned the companies with a second blow.
The FDA will convene an advisory committee to review roxadustat’s application for treating anemia caused by chronic kidney disease, both in patients who require dialysis and those who don’t, the two companies said Monday.
Gilead Sciences plans to cut more than 170 jobs in California, as it builds a new business services center in North Carolina. The Foster City-based pharma will transfer about half of the jobs to the consolidated services hub now under construction in the Research Triangle Park area.