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Regulatory Focus™ > News Articles > 2022 > 1 > Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device

Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device shortage list

Posted 20 January 2022 | By Joanne S. Eglovitch 

Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device shortage list

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US preparing for possible future COVID variants -White House (Reuters)
  • The scientists, they’re learning more’: A defiant Biden defends the CDC amid mounting criticism (STAT)
  • Avastin Withdrawal Showed Accelerated Approval Hearing Process No Easy Task For US FDA (Pink Sheet)
  • FDA adds all blood sample collection tubes to medical device shortage list (Reuters)
  • A Senate bill wants to even an 'unlevel playing field' for domestic, foreign inspection drop-ins amid backlog (Endpoints)
In Focus: International
  • Dozens of firms to make cheap version of Merck COVID pill for poorer nations (Reuters)
  • European Parliament signs off on strengthening drug regulator's ability to tackle shortages (Endpoints) (Pink Sheet)
  • Sputnik V shows higher Omicron-antibody levels than Pfizer in preliminary study (Reuters)
  • Valneva says early studies show COVID-19 vaccine effective against Omicron (Reuters)
  • Bloodletting at Zymeworks as new CEO axes half of senior leaders, plans 25% reduction in headcount (Fierce) (Endpoints)
  • NICE Board Approves Landmark Changes To Increase Flexibility Of Drug Evaluation Methods And Processes In England (Pink Sheet)
  • India's expert panel advises full approval for Covishield, Covaxin (Reuters)
Coronavirus Pandemic
  • Analysis: How Omicron highlights fading hope of herd immunity from COVID (Reuters)
  • Some U.S. Hospitals See Covid-19 Patient Counts Decline as Omicron Retreats (WSJ)
  • Rise of the preprint: how rapid data sharing during COVID-19 has changed science forever (Nature)
  • Moscow's COVID-19 cases surge to pandemic high (Reuters)
  • Brazil approves Sinovac's Coronavac for those aged 6 to 17 (Reuters)
  • Britain must learn to live with COVID-19, it could be with us forever – Javid (Reuters)
Pharma & Biotech
  • Novartis-backed ImmPACT Bio snags $111M and new CEO as cancer CAR-T yields phase 1 results (Fierce)
  • New global data showing 1.27 million deaths a year reveal the urgent need to address antimicrobial resistance (STAT)
  • Lilly, Novartis execs commend Pfizer on Paxlovid, but where does that leave them in the COVID market? (Fierce)
  • Eleusis joins cooled-off SPAC market with $288M to bankroll psychedelic-based depression drug (Fierce)
  • Fierce JPM Week: Sage wants to ‘raise the bar’ on depression meds with quick start zuranolone (Fierce)
  • Fresh from $86M series A, Metis poaches Kala CSO to support move into the clinic (Fierce)
  • Next-gen CAR-T player steps on the gas with a $111M boost and a positive glimpse at early data (Endpoints)
  • A new RNA-based drug startup launches with Rutgers science and money connections (STAT)
  • A Tony Coles Parkinson's biotech, Yumanity, continues its backslide as lead program earns a partial hold (Endpoints)
  • Merck commercial chief Frank Clyburn departs for CEO role at DuPont co-owned additives company (Endpoints)
  • Commission Publishes Draft Implementing Regulation For Insufficiently Regulated Products (MedTech Intelligence)
  • Tandem CEO on Omnipod 5 competition, pharmacy distribution, Type 2 growth (MedTech Dive)
  • NIH Aims To Stimulate Neuromodulation Device Development With $9.8M Competition (MedTech Intelligence)
  • Artificial pancreas app delivers stronger control of Type 1 diabetes in toddlers and young children in Cambridge study (Fierce)
Government, Regulatory & Legal
  • Charges dismissed against MIT professor accused of hiding research ties to China (Washington Post)(Law360)
  • Merck’s $1.4 Billion Insurance Win Splits Cyber From ‘Act of War’ (Bloomberg)
  • Sanofi Tells 10th Circ. It Paid $36M To Access EpiPen Market (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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