Regulatory Focus™ > News Articles > 2021 > 10 > Recon: WHO aims to buy Merck COVID drug for $10 per pill; CDC study finds Pfizer vaccine highly effe

Posted 19 October 2021 | By Michael Mezher 

Recon: WHO aims to buy Merck COVID drug for $10 per pill; CDC study finds Pfizer vaccine highly effective against hospitalization in 12-18 year olds

2823 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA proposes over-the-counter hearing aids for Americans (Reuters) (FDA)
  • Pfizer-BioNTech’s vaccine is highly effective against hospitalization for those 12 to 18, a study shows. (NYTimes)
  • J&J keeps vaccine sales outlook unchanged after third-quarter miss (Reuters)
  • FDA to Allow ‘Mix and Match’ Approach for Covid Booster Shots (NYTimes) (Reuters)
  • Atea plunges after COVID-19 treatment fails to help patients in study (Reuters) (STAT)
  • Vertex reports positive results for first patient in Type 1 diabetes trial (Boston Globe)
  • This arthritis drug cost $198 in 2008. Now it's more than $10,000 (Axios)
  • With hundreds of millions spent on failed accelerated approvals, researchers call for faster FDA withdrawals (Endpoints)
  • Senate spending bill slashes funds for Biden's planned breakthrough drug accelerator at NIH (Endpoints)
  • Underpinning Sinema’s outspoken opposition to major drug pricing reforms: her close ties to Arizona biotechs (STAT)
  • J&J spent $1.4bn on legal move to shield it from talc cancer claims (FT)
In Focus: International
  • WHO-led program aims to buy antiviral COVID-19 pills for $10 (Reuters)
  • India delays COVID-19 vaccine supplies to WHO-backed COVAX, sources say (Reuters)
  • Valneva says its COVID-19 vaccine shows similar protection to AstraZeneca's, fewer side effects (Reuters)
  • South Africa regulator not authorising Russian COVID-19 vaccine for now (Reuters)
  • US biotech signs deal with NHS to deliver cheaper cancer drugs (FT)
Coronavirus Pandemic
  • Germany may miss COVID-19 vaccine donation goal, blames manufacturers (Reuters)
Pharma & Biotech
  • Sage, Biogen head to FDA with $3.1B depression drug; Sana puts down $50M to tap Beam's CRISPR tech (Endpoints)
  • FDA warns Minnesota doc for running two ketamine trials without INDs, and with children and a pregnant woman (Endpoints)
  • Boehringer Ingelheim takes next step in development of cystic fibrosis gene therapy (BioPharmaDive)
  • Novo CEO Lars Fruergaard Jørgensen on R&D risk, the deal strategy and targets for gender diversity (Endpoints)
  • Crinetics spins out radiopharma efforts into a new company, highlighting the growing field's allure (Endpoints)
  • Makena Withdrawal Hearing: US FDA Drugs Center, Covis Tussle Over Panel Composition (Pink Sheet)
  • Sofinnova hauls in $548M to build and scale startups — as European VCs step up their biopharma game (Endpoints)
  • AstraZeneca's former antibiotics unit claims a PhIII win in drug-resistant bacteria affecting sickly patients (Endpoints)
  • Galera shares take a nosedive in the wake of unexpected PhIII flop (Endpoints)
  • Can an IDO/PD-L1 combo ever work? Novo-backed company spells out how in biotech's latest IPO filing (Endpoints)
  • Still reeling from PhII failure, Calithera beefs up its oncology portfolio with a little help from Takeda (Endpoints)
  • Takeda, Wave Life Sciences revise their $230M R&D collaboration, dropping discovery work (Endpoints)
  • J&J delays Ottava robot rollout as global medtech business boosts Q3 sales (MedtechDive)
  • Abbott software causing COVID-19 test false positives, starts Class I recall fix (Endpoints)
  • Medtronic Pushes Completion Of Pivotal Renal Denervation Trial To Late 2022 (MedtechInsight)
  • Anatomy of a medical device recall: How defective products can slip through an outdated system (MedtechDive)
Government, Regulatory & Legal
  • Amarin Investors Want 3rd Circ. To Revive Heart Drug Suit (Law360)
  • Generic-Drug Group Wants Justices To Intervene Against FTC (Law360)
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.


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