Recon: FDA approves Bristol Myers Opdivo for early-stage lung cancer; Pfizer recalls two blood pressure drugs in Canada over carcinogen concerns

ReconRecon | 07 March 2022 | By

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
In Focus: International
  • 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)
Coronavirus Pandemic
  • ‘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)
Pharma & Biotech
  • 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
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

5;6;11;16;18;20;25;31;