Food and Drug Administration (FDA)
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The pharma industry has developed ad campaigns to tout the efficacy of its branded products to consumers, often using celebrities to add his or her personal stamp onto a pharmaceutical product.
On Monday, the U.S. Food and Drug Administration issued a new draft guidance for the development of novel medicines aimed at the treatment of opioid use disorder.
China is the largest supplier of active pharmaceutical ingredients (API) in the world, supplying 40 percent of APIs to global pharma companies. And a recent series of scandals and issues related to drug manufacturing in China has highlighted how many problems this could cause the global drug supply chain.
Akouos, based in Boston, announced a Series A financing worth $50 million. The round was led by seed investors 5AM Ventures and New Enterprise Associates (NEA).
Mark Emalfarb, founder, chairman and chief executive officer of Jupiter, Florida-based Dyadic International, believes he knows how to revolutionize biopharma manufacturing. Emalfarb took time out to talk to BioSpace about his company and its C1 technology platform.
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter—basically a rejection—to Austin, Texas-based Pain Therapeutics for Remoxy ER for pain.
Now that July is over, the U.S. Food and Drug Administration (FDA) appears to be back in full swing with a full docket of drug decisions to make. There are four therapeutics with PDUFA dates this week involving six biopharma companies. Here’s a look.
Almirall, headquartered in Barcelona, Spain, announced it is buying five dermatology products from Allergan. Those include Aczone (dapsone), Tazorac (tazarotene), Azelex (azelaic acid), Cordran Tape (fludroxycortide) and Seysara (sarecycline).
Cellectis announced it had appointed Stefan Scherer to the role of senior vice president Clinical Development and deputy chief medical officer.
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