Food and Drug Administration (FDA)
NEWS
This week had three important target action dates, known as Prescription Drug User Fee Act (PDUFA) dates, for the U.S. Food and Drug Administration (FDA). The agency got ahead of its schedule and approved all of these drugs ahead of schedule. Let’s take a look.
Shares of Pompano Beach, Fla.-based BioStem Technologies are down more than 6 percent this morning following the company’s announcement it has launched a new life sciences subsidiary, the Amnion Division of BioStem Life Sciences focused on the development of amniotic tissue-based therapies.
Emergent BioSolutions, headquartered in Gaithersburg, Maryland, inked a deal to buy PaxVax, based in Redwood City, California, for $270 million in cash.
The U.S. Food and Drug Administration (FDA) rejected Englewood, Colorado-based Ampio Pharmaceuticals’ Biologics License Application (BLA) for its drug for osteoarthritis of the knee, Ampion.
GW Pharmaceuticals has finally revealed the price of its cannabis-based epilepsy drug Epidiolex.
Shares of Paratek Pharmaceuticals are climbing in pre-market trading after the company announced a U.S. Food and Drug Administration advisory committee voted overwhelmingly in favor of the company’s intravenous and oral treatments for acute bacterial skin and skin structure infections (ABSSSI).
Last week, Teva Pharmaceutical released what tried to be an optimistic second-quarter financial report, despite revenues that had decreased by 18 percent and softening sales of its biggest product, Copaxone.
Cambridge, Mass.-based Sarepta Therapeutics expanded its gene therapy pipeline up to 11 in an equity deal with Lacerta Therapeutics. Investing $30 million into Alachua, Florida-based Lacerta Therapeutics, Sarepta gained access to the company’s AAV-based CNS-targeted gene therapies.
The U.S. Food and Drug Administration approved a new generic potassium chloride oral solution under a novel term called the Competitive Generic Therapy designation.
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