Recon: FDA approves Bristol Myers Opdivo for early-stage lung cancer; Pfizer recalls two blood pressure drugs in Canada over carcinogen concerns
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA hands Bristol Myers a landmark approval in early-stage lung cancer after just five days (Endpoints) (Bloomberg) (Reuters)
- White House Sees Covid Treatments Running Out If No New Funding (Bloomberg)
- Biden Administration Finalizes Change In Buy American Rule (Law360) (Inside Health Policy)
- FDA declines pediatric EUA for Ocugen's COVID vaccine Covaxin (Reuters)
- A key study of Gilead’s breast cancer drug meets goal, but withheld data raise doubts (STAT)
- Public health experts sketch a roadmap to get from the Covid pandemic to the ‘next normal’ (STAT) (Washington Post)
- Former Warp Speed chief agrees to pay GSK back $3.9M following sexual harassment (Endpoints)
- ICD Code Breaking: Rare Disease Advocates Want Simpler, Shorter Nomination Process (The Pink Sheet)
- Pfizer Canada recalls BP drug on potential cancer-causing impurity (Reuters) (Endpoints) (Fierce)
- In German-only announcement, Bayer invests $1.5B into native country manufacturing (Endpoints) (Fierce)
- EU Gets Go-Ahead To Negotiate Global Pandemic Treaty (The Pink Sheet)
- Moderna to set up mRNA vaccine manufacturing facility in Kenya (Reuters)
- Charles River expanding plasmid DNA and viral vector development in Europe (BioPharma Reporter)
- IDT Biologika and Exothera collaborate to scale-up viral vaccine manufacturing (BioPharma Reporter)
- In passionate appeal, Enamine CEO asks for pharma industry's help to isolate Russia and slow invasion (Endpoints)
- UK to invest $345M to bolster life science research, manufacturing capabilities (Endpoints)
- ‘We’re all in this together’: As long Covid studies continue, researchers cast a wider net (STAT)
- Almost a third of people report lingering symptom 6-12 months after COVID-19 -study (Reuters)
- Synairgen’s NIH-sponsored COVID-19 trial paused a day after SAB study nixed completely (Fierce)
- Covid May Cause Changes in the Brain, New Study Finds (New York Times)
- Wobbly and desperate for cash, bluebird bio CFO resigns as company eyes 'cost efficiencies,' priority review voucher sale from future approvals (Endpoints) (STAT)
- Type 2 diabetes drugs and weight loss: Calibrate's model starts with pharma and builds out (Endpoints)
- Pascal Soriot budgets a final £100M to finish AstraZeneca's new HQ — now 9 years and £1B-plus in the making (Endpoints)
- GSK chief Emma Walmsley made $10.8M last year, lagging far behind fellow Big Pharma CEOs (Endpoints)
- Boehringer Ingelheim, Lifebit team up to build data platform (Outsourcing Pharma)
- With all eyes on Chinese-only oncology data, Coherus and Junshi uncork win for PD-1 drug in esophageal cancer (Endpoints)
- Women see more adverse events with chemotherapy and newer cancer treatments, study finds (STAT)
- Medtech Companies Could Face Sanctions As Italy Enforces Own Advertising Rules Under MDR (MedTech Insight)
- Rocky Road So Far For Opinions Published By Device Expert Panels (MedTech Insight)
- Dry AMD treatment developer LumiThera nets retinal diagnostic maker Diopsys (Fierce)
- Smaller smartphone accessory magnets may also pose a threat to pacemakers, defibrillators: AHA study (Fierce)
- Pharmacy Agent Study Would Show Role in Drug Price ‘Dysfunction’ (Bloomberg)
- Permanent Fentanyl Ban Garners Bipartisan Support in Congress (Bloomberg)
- Vaccine Religious Exemption Fight Turned Away by Supreme Court (Bloomberg)
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