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)
- 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)
- 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)
- 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)
- 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)
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