Pharminent · Daily Brief
November 4, 2026
Regulatory & Approvals
FDA accepts uniQure’s BLA for Huntington’s gene therapy
The FDA has accepted uniQure’s biologics license application under the accelerated approval pathway for ifezuntirgene inilparvovec, a gene therapy for Huntington’s disease.
Pharmaceutical Technology →
Dr. Reddy’s wins tentative FDA approval for generic HIV prevention shot
The FDA granted tentative approval to Dr. Reddy’s Laboratories to make a generic version of an HIV prevention medicine.
STAT →
China approves Bio-Thera’s secukinumab biosimilar BAT2306
Bio-Thera Solutions said on October 26, 2026 that China’s National Medical Products Administration approved BAT2306, a biosimilar to Cosentyx (secukinumab), for psoriasis, ankylosing spondylitis and psoriatic arthritis. It will be marketed as YOUZHUOMEI, and according to Bio-Thera is the first secukinumab biosimilar approved in China.
Big Molecule Watch →
FDA’s CBER director urges stronger potency controls in cell and gene therapy manufacturing
The FDA’s CBER director called for stronger potency upkeep in cell and gene therapy manufacturing, saying patients should have assurance that administered products will work as intended.
Pharmaceutical Technology →
FTC sends warning letters to 25 health plan marketers
The FTC sent warning letters to 25 health plan marketers over potentially deceptive marketing practices, following earlier letters to healthcare services companies about price transparency.
MedCity News →
Deals & Partnerships
Lonza to acquire five US CDMO sites from Merck KGaA
Lonza agreed to acquire five US contract development and manufacturing sites from Merck KGaA.
PharmExec →$MKKGY
Theramex sold in private equity deal worth about £2.2B
Theramex, a UK-based specialty pharma company focused on women’s health, is changing hands in a private equity deal said to be worth around £2.2 billion.
Pharmaphorum →
Teva licenses US rights to Samsung Bioepis’ infliximab, etanercept biosimilars
Teva has licensed US rights to Samsung Bioepis’ infliximab and etanercept biosimilars.
PharmExec →
GEBRO and Spektus sign global commercialization deal for ActraFlex
GEBRO Holding and Spektus Pharma agreed a global commercialization partnership for ActraFlex, an extended-release pain management therapy taken twice daily.
Pharmaceutical Technology →
Business & Finance
CVS to split off drugstore business from health insurer
CVS said it will split off its drugstore business, a move that would reverse its $78 billion acquisition of Aetna and dismantle the vertically integrated healthcare conglomerate it created in 2018.
CNBC →
Novo raises outlook as Wegovy pill sales beat estimates
Novo reported quarterly earnings ahead of expectations and raised its outlook, with sales of its Wegovy pill exceeding estimates. Shares rose.
CNBC →$NVO
KFF finds Medicare Part D premiums rising 50% on average
KFF found that Medicare Part D premiums will rise an average of 50 percent next year, and urged seniors to shop carefully during Medicare open enrollment given wide cost variance between plans.
BioPharma Dive →
Vertex executives address IgA nephropathy drug ahead of FDA decision
On a conference call, Vertex executives expressed conviction in the coming launch of its IgA nephropathy medicine povetacicept ahead of an FDA decision.
BioPharma Dive →$VRTX
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