Heidi Overton FDA Vote: One GOP Defection Could Sink the Commissioner Pick
The Senate HELP Committee votes on FDA commissioner nominee Heidi Overton on 18 November. Here is where senators stand, why pharma is watching and what happens if she stalls.
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Windward Bio IPO: $175M Raise Puts Twice-Yearly Asthma Antibody in the Spotlight
Novo-backed Windward Bio raised $175M in its Nasdaq IPO, plus $50M from Sanofi, to fund WIN378, an anti-TSLP antibody aimed at twice-yearly dosing in asthma and COPD.
AstraZeneca Job Cuts: 600 US Sales Roles Go in $1.5B Savings Drive
AstraZeneca is cutting about 600 US respiratory and immunology sales jobs, Bloomberg reports, the first visible step in its $1.5 billion-a-year savings plan.
China NRDL 2026: Pfizer and Innovent GLP-1s Win Coverage as 107 Drugs Join
China’s 2026 reimbursement list adds 107 drugs, including Pfizer’s ecnoglutide and Innovent’s mazdutide for diabetes, from 1 January 2027.
Gazyva Membranous Nephropathy Approval: Roche Wins First FDA Nod in PMN
FDA approves Roche Gazyva as the first drug for primary membranous nephropathy after MAJESTY showed 36% complete remission vs 6% with tacrolimus.
Imfinzi Padcev Bladder Cancer Approval: AstraZeneca Takes On Keytruda in Cisplatin-Free Surgery Setting
The FDA approved perioperative Imfinzi plus Padcev for muscle-invasive bladder cancer patients who cannot take cisplatin. VOLGA cut the risk of death by 42%, and the approval pits AstraZeneca against Merck while Padcev wins either way.
Deramiocel FDA Decision: Capricor Trims Staff as Nov 22 DMD Verdict Nears
Capricor cut about 10% of staff and is preparing a solo launch ahead of the November 22 FDA decision on deramiocel for Duchenne muscular dystrophy.
Etavopivat Filed With FDA and EMA: Novo Nordisk Takes Sickle Cell Pill to Regulators
Novo Nordisk has filed once-daily etavopivat for sickle cell disease with the FDA and EMA after HIBISCUS cut crises by 27%. How it compares with mitapivat.
BioNTech Priority Review Voucher: Why It Is Paying Scholar Rock $205M
BioNTech will pay Scholar Rock $205 million for an FDA priority review voucher, one of the highest prices yet. Here is what it buys and where it may be used.