Regulatory Focus™ > News Articles > 2021 > 3 > Recon: J&J, African Union reach deal for 400M COVID shots; Bluebird prices multiple myeloma CAR-T at

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Posted 29 March 2021 | By Michael Mezher 

Recon: J&J, African Union reach deal for 400M COVID shots; Bluebird prices multiple myeloma CAR-T at $420K

2781 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Pfizer, Moderna vaccines reduce COVID-19 infection risk by 90% after second dose (Reuters)
  • US vaccination campaign gains steam as White House speeds shipments (Reuters)
  • Biden admin remakes vaccine strategy after mass vaccination sites fizzle (Politico)
  • Moderna says shipped 100 million COVID-19 vaccine doses to United States (Reuters)
  • U.S. FDA approves Bristol-Myers Squibb's multiple myeloma therapy (Reuters) (STAT) (FDA)
  • Bluebird bio sets list price for multiple myeloma therapy at $419,500 (Reuters)
  • Novartis closes U.S. gene therapy site as Zolgensma sales fell from Q3 to Q4 (Reuters)
  • Qiagen receives FDA emergency approval for coronavirus PCR test (Reuters)
  • J&J CEO pay irks investors upset with opioid lawsuits fallout (Reuters)
  • White House weighs temporarily lifting intellectual property shield on Covid-19 vaccines (CNBC)
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  • Company with Trump administration tie may be COVID-19 vaccine bottleneck (Roll Call)
  • House Dems call on the FTC to investigate potential collusion among top three insulin manufacturers (Endpoints)
  • Democrats gear up for major push to lower drug prices (The Hill)
In Focus: International
  • J&J, African Union in deal for up to 400 million COVID-19 shots (Reuters)
  • Russia registers one-shot Sputnik Light vaccine for use against COVID-19: TASS (Reuters)
  • Paris court fines Servier 2.7 million euros over weight-loss drug: BFM TV (Reuters) (Endpoints)
  • WHO says virus origins report will be released on Tuesday (Reuters)
  • GSK to manufacture 60m doses of Novavax Covid vaccine in UK (FT)
  • South Korea's expert panel says J&J COVID-19 vaccine safe, effective for approval (Reuters)
  • Canada says drug spending keeps rising due to increasingly expensive specialty meds (STAT)
  • COVAX updates participants on delivery delays for vaccines from Serum Institute of India (SII) and AstraZeneca (WHO)
Coronavirus Pandemic
  • CDC chief warns of 'impending doom' as Covid cases surge (Politico)
  • WHO probe finds lab leak of Covid ‘extremely unlikely’ (Politico) (NYTimes)
  • Vaccines: Commission hosts first EU matchmaking event to mobilise Europe’s full potential for the production of COVID-19 vaccines (EC)
  • Sinopharm needs trial results to decide if COVID-19 vaccine needs booster shot: executive (Reuters)
  • Russia's RDIF signs deal to produce Sputnik V vaccine in China (Reuters)
  • Serum Institute delays expected launch of Novavax vaccine in India (Reuters)
  • Scientists Seek Covid Treatment Answers in Cheap, Older Drugs (KHN)
  • Moderna’s Covid vaccine to be rolled out in UK from April (FT)
  • Abbott, Quest, Roche among cos pitching K-12 COVID-19 test plan to tap into Biden's $10B fund (MedtechDive)
  • Mexico receives 1.5 million does of AstraZeneca COVID-19 vaccine from U.S (Reuters)
  • Health Canada responds quickly to potential medical device shortages during COVID-19 (Health Canada)
  • Brazil suspends deadline to analyze request for emergency use of Sputnik V vaccine (Reuters)
  • Abu Dhabi launches new COVID-19 vaccine plant with China's Sinopharm (Reuters)
  • Taiwan says no progress in BioNTech vaccine talks (Reuters)
  • Sweden says will not meet vaccine target due to delay in deliveries: SVT (Reuters)
  • Humanigen declares win in severe Covid-19, delivering much-needed pandemic weapon and vaulting ahead on post-Shkreli turnaround (Endpoints)
  • Lilly, Vir Biotechnology and GSK announce positive topline data from the phase 2 BLAZE-4 trial evaluating bamlanivimab with VIR-7831 in low-risk adults with COVID-19 (Press)
  • Amazon’s homegrown COVID test nets FDA green light for employee screening (Fierce)
Pharma & Biotech
  • Researchers Look for Ways to Make Drug Trials More Diverse (WSJ)
  • FDA CDER Compliance Office Answered Pandemic With Fewer Inspections, Greater Discretion (Pink Sheet)
  • Ionis unveils positive PhII data for in-house rare disease drug, paving way to blockbuster rivalry with Takeda (Endpoints)
  • 5 FDA approval decisions to watch in the second quarter (BioPharmaDive)
  • Tempest Therapeutics jumps onto Nasdaq in merger with struggling Millendo Therapeutics; Biohaven hits $100M milestone as it gears up for a late-stage study in migraine patients (Endpoints)
  • It's a brave new world for SomaLogic, as the proteomics biotech rides Eli Casdin's newest SPAC to Nasdaq with $1.2B valuation (Endpoints)
  • Looking to lift clinical hold, uniQure contends its gene therapy was likely not the cause of single liver cancer case (Endpoints) (STAT)
  • Orphazyme's pipeline-in-a-product whiffs in second trial, though FDA decision still awaits (Endpoints)
  • With $190M in investor cash to play with, China's Chime Biologics looks to build 15x manufacturing capacity by 2024 (Endpoints)
  • TCR2 snags Maryland manufacturing plant with aim to bring cell therapies to market by 2023 (Fierce)
  • CDMO Raybow adding 74 jobs in the hills of North Carolina at its U.S. headquarters (Fierce)
Medtech
  • Medtronic's Harmony pulmonary valve wins FDA approval (MedtechDive)
Government, Regulatory & Legal
  • U.S. Supreme Court takes up bid to revive defense of Kentucky abortion law (Reuters)
  • Former top Lilly lobbyist sues the company for alleged sex discrimination and harassment (STAT)
  • Mylan Settles Out Of Diabetes Drug Patent Fight At PTAB (Law360)
  • HHS OIG Issues Advisory Opinion Regarding Free Drugs (FDA Law Blog)
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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