Policy
Donald Trump continues to make waves in biopharma; Sage rejects Biogen’s unsolicited takeover offer; the obesity space sees more action with new company launches, IPOs and fresh data; and experts get ready for an important era in the Duchenne muscular dystrophy space.
FEATURED STORIES
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
The recent announcement of RFK Jr.’s termination of mRNA vaccine contracts is the latest effort to undermine this promising technology at the federal level. Pharmaceutical companies and private investors must fill the gap and ensure that research into this critical resource continues.
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public.
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In the latest setback for the pharma industry and its allies, the United States District Court for the Southern District of Ohio dismissed a U.S. Chamber of Commerce lawsuit on the grounds of improper venue.
Lobbying groups and individuals connected with the industry are supporting candidates from both parties, with a particular focus on the future of the 340B discount program and pharmacy benefit managers.
Reiterating his ruling in a prior Inflation Reduction Act case, New Jersey District Court Judge Zahid Quraishi ruled that Novo Nordisk’s participation in the Medicare Drug Price Negotiation Program is of its own free will.
The BIOSECURE Act’s prohibition on doing business with China-based companies may have implications for biotech and biopharma markets on both sides of the Pacific.
With the BIOSECURE Act likely to be voted on in Congress this year, WuXi AppTec’s U.S. revenue dropped 1.2% in the first half of 2024 while the Chinese company increased its lobbying efforts.
The combination therapy is one step closer to becoming a potential new first-line standard of care for patients with unresectable or metastatic urothelial carcinoma in Europe.
Despite their initial kicking and screaming, drugmakers seem confident the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will not greatly impact their bottom lines.
Executives from the three largest pharmacy benefit manager companies testified Tuesday before Congress that rising drug prices in the U.S. are due to pharma companies taking advantage of market exclusivities and excessive charges.
Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws.
The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes.