Recon: MHRA staff fret over planned budget cuts; FDA rejects Sesen Bio's bladder cancer drug
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Merck's Welireg scores FDA nod in cancers spurred by rare disease—and its label is broader than expected (Fierce) (BioPharmaDive)
- Zombie biotech Sesen Bio's resurrection plans limping again as FDA rejects bladder cancer drug (Fierce)
- FDA lifts clinical hold on Rocket gene therapy trial, creating launchpad for start of pediatric dosing (Fierce) (BioPharmaDive)
- Mylan Urges Justices to Eye PTAB Rule That Has Caused ‘Chaos’ (Bloomberg)
- As Biden signals interest in linking drug prices with R&D costs, new study finds costs per NME are increasing (Endpoints)
- Merck joins its peers with plan to cut access to discounted drugs for contract pharmacies (Endpoints)
- Pfizer, US Army nab a new approval for a decades-old vaccine (Endpoints)
- GSK and CureVac’s second vaccine yields stronger response (FT) (Reuters)
- Staff at UK medicines regulator express alarm at plan for budget cuts (FT)
- Covid Vaccines Produced in Africa Are Being Exported to Europe (NYTimes)
- EU evaluates Roche arthritis drug as COVID-19 treatment (Reuters) (EMA)
- ACT-Accelerator launches urgent US$ 7.7 billion appeal to stem surge of dangerous variants and save lives everywhere (WHO)
- The prospect of booster shots is igniting a global health debate. (NYTimes)
- Vaccine patents battle intensifies as poor nations struggle in war on coronavirus (FT)
- Indian pharma cos’ US revenues still sliding (ET)
- Health Canada accepts rolling submission for Merck’s experimental COVID therapy (Pharmafile)
Florida Gov. DeSantis Expands Monoclonal Antibody Treatments Amid COVID-19 Spike (NPR) - UK review finds COVID-19 shots do not raise risk of miscarriage (Reuters)
- The fine print: Understanding the new policy authorizing extra Covid vaccine doses for the immunocompromised (STAT)
- Eli Lilly’s lebrikizumab significantly improves atopic dermatitis in Phase III trial (Pharmafile)
- US FDA Lowers FY '22 PDUFA Fees Due to Hiring, Attrition Concerns (Pink Sheet)
- Pfizer expands recall of anti-smoking drug over carcinogen presence (Reuters)
- The 7-year itch? Boehringer culls $600M cancer pact with CureVac, heaping more woe to the biotech (Fierce)
- Organon shares jump as Merck's new women's health spinoff posts strong start for biosims, infertility drugs (Fierce)
- As US review of Eli Lilly-partnered PD-1 gets underway, Innovent touts another frontline win in China (Endpoints)
- ‘Stuck in a cul-de-sac’: Researchers are finally breaking away from the central dogma of depression (STAT)
- Recro Pharma takes manufacturing business ‘bi-coastal’ with $50M deal for CDMO Irisys (Fierce)
- Pazdur To Oncology Drug Developers: Step Back, Slow Down – And Find The Right Dose (Pink Sheet)
- Several months after rebranding, an old Martin Skhreli company touts promising pivotal data in a rare kidney disorder (Endpoints)
- Combined paracetamol and ibuprofen medicine approved for general sale (MHRA)
- Are Robotic Surgeries Really Better? (NYTimes)
- Medtech Sector Keeps Lobbying European Commission As Remote Auditing Becomes More Urgent (MedtechInsight)
- Memic inks SPAC merger, lining up $360M to challenge Intuitive for robotic surgery market (MedtechDive)
- Abbott nets US approval for its Amplatzer Amulet heart implant to help cut down AFib stroke risks (Fierce)
- Thermo Fisher’s COVID tests snare FDA green light for detecting Delta and other variants (Fierce)
- BrainQ reels in $40M to trial AI-powered electromagnetic field therapy device for stroke recovery (Fierce)
- Post-market review of ventilators, CPAP and BiPAP devices (TGA)
- The 6-Year Saga Finally Ends: FDA Issues Final Rule Modifying The Intended Use Regulation (FDA Law Blog)
- Sacklers' Ch. 11 Releases Are Fair, Supporting States Say (Law360)
- Boston Scientific Beats FCA Suit Over Defective Defibrillators (Law360)
- Drug Benefit Managers Call Feds' Price Disclosure Rule Faulty (Law360)
- 'Flanax' Trademark Fight Heading To High Court Again (Law360)
- Prosecutors secure guilty plea in $110M biotech scam at Vermont ski resort (Endpoints)
- Bayer takes legal battle over glyphosate cancer claims to U.S. supreme court (Reuters)
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