Policy
Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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The regulator says drug compounders are selling products that falsely claim to contain the same active ingredient, semaglutide, as the blockbuster diabetes and obesity drugs.
The regulator will provide PepGen with a letter within 30 days explaining why a clinical hold was placed on the company’s Phase 1 study of patients with myotonic dystrophy Type 1.
Efforts are underway to fast-track approval for costly gene therapies and make them affordable to a wider patient group via reimbursement through Medicare and Medicaid.
Akebia announced it will submit a new NDA targeting CKD patients on dialysis, which will not involve additional trials.
Known as Relyvrio in the U.S., Amylyx’s AMX0035 may face a longer road to approval in Europe as the company reported that CHMP could reject its marketing authorization application.
The FDA approved Braeburn Pharmaceuticals’ new buprenorphine treatment option with extended-release medication that could pave the way for greater patient compliance.
While the exact settlement details are confidential, the deal will allow Amgen to launch its Stelara biosimilar no later than January 1, 2025.
Ex-FDA Neuroscience Director Billy Dunn was appointed to Prothena’s board of directors last week. Industry representatives and regulatory experts weigh in on the potential ethical implications.
Blueprint Medicines, Indivior PLC and Lexicon Pharmaceuticals are all awaiting FDA decisions this week.
The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023.