Regulatory Focus™ > News Articles > 2021 > 10 > Recon: Pfizer, Voyager sign $630M gene therapy deal; WHO backs malaria vaccine for children in Afric

Recon: Pfizer, Voyager sign $630M gene therapy deal; WHO backs malaria vaccine for children in Africa

Posted 06 October 2021 | By Michael Mezher 

Recon: Pfizer, Voyager sign $630M gene therapy deal; WHO backs malaria vaccine for children in Africa

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Polarean Imaging says FDA rejects new drug application, shares slump (Reuters)
  • FDA center directors on lessons from the EUA pathway: Flexibility serves us well (Endpoints)
  • Troubled Voyager’s gene therapy relaunch gets a boost with $630M Pfizer deal (Endpoints)
  • FDA offers support for Takeda's potential cytomegalovirus drug ahead of adcomm (Endpoints)
  • AstraZeneca to pay $560,000 to settle claims of discriminating against women sales reps (STAT)
  • Employees warned pharmacy chains they needed more safeguards for prescription opioids (NPR)
  • Boston Scientific puts down $1.75B to pair its cardiac devices with Baylis Medical’s heart access hardware (Fierce)
  • White House says Covid-19 home-testing market on track to quadruple by year's end (Politico)
  • Top Covid experts privately urge Biden admin to scale back booster campaign (Politico)
  • Merck on deals hunt as patent cliff looms for top cancer drug (FT)
In Focus: International
  • WHO experts back using malaria vaccine on African children (Reuters) (STAT) (NYTimes)
  • Pfizer study to vaccinate whole Brazilian town against COVID-19 (Reuters)
  • India's Bharat Biotech submits data on COVID-19 drug trial in children (Reuters)
  • Two scientists win chemistry Nobel for discovering a new way to construct molecules, speeding up drug development (STAT)
  • NICE backs Novartis' Adakveo via special channel despite 'high uncertainty' about cost, long-term efficacy (Fierce)
Coronavirus Pandemic
  • Sweden, Denmark pauses use of Moderna COVID-19 vaccine for younger age groups (Reuters)
  • UAE authorises Sputnik Light COVID-19 vaccine -Russia's RDIF (Reuters)
  • German to weigh need to purchase Merck & co's COVID-19 drug (Reuters)
  • Convalescent plasma 'futile' in treating severe COVID-19 cases: research (The Hill)
  • False positives spur Ellume recall of COVID-19 tests from DoD, retailers (MedtechDive)
  • Fourth person dies from rare blood-clotting syndrome after receiving J&J vaccine (The Hill)
Pharma & Biotech
  • Is the biotech boom starting to fade? The roaring ‘20s starts to look a little fatigued. Plus: Top 5 deals, IPOs, pacts of Q3 (Endpoints)
  • Lawyers for Henrietta Lacks estate say more companies to be sued over use of her cells (STAT)
  • Takeda flashes red light on 'breakthrough' narcolepsy drug after PhII trials turned up mysterious safety signal (Endpoints)
  • An ultra-rare disease drug missed on function but hit on survival and mortality. Is it enough for the FDA? (Endpoints)
  • Northwest Bio marks ignominious anniversary of brain tumor study delay with silence (STAT)
  • Vedanta touts positive new data for its C. diff microbiome therapeutic — but is it too late? (STAT)
  • UBS wants to make an 'impact' with a new fund, shelling out $650M to join MPM (Endpoints)
  • After a brief stint in the top cancer research spot at Gilead, Valeria Fantin jumps over to Sanofi (Endpoints)
  • Breaking: Pfizer development chief Rod MacKenzie is retiring after a lengthy career capped by historic success (Endpoints)
  • A short-sell attack sends Ginkgo's share price spinning, underscoring investors' concerns over synbio field (Endpoints)
  • Unfazed by OS flop, Zai Lab eyes imminent China filing for MacroGenics' HER2 drug (Endpoints)
  • NFX targets seed and pre-seed companies with latest $450M round (Endpoints)
Medtech                                                                                                                      
  • FDA clears thumb-sized robot for placing cochlear implants (Fierce)
  • MDUFA IV Report: US FDA Needs To Publish Digital Health Guidance (MedtechInsight)
  • Digital health funding shatters record again with $21.3B so far this year (MedtechDive)
  • SyncThink clocks FDA nod for concussion test based on AI-powered eye tracking (Fierce)
  • Medtronic expands two Class I recalls of MiniMed insulin pumps, spanning nearly 500K devices (Fierce)
  • EU Is Heading For Partial IVD Market Collapse, Recent Analysis And Figures Suggest (MedtechInsight)
  • Updated Guidance Tackles Extent To Which Notified Bodies Can Provide Training Services (MedtechInsight)
Government, Regulatory & Legal                
  • Senate Bill Targets Generic Drug Delay Tactic (Law360)
  • Fed. Circ. Upends St. Jude's PTAB Win In Heart Valve IP Row (Law360)
  • Former Theranos lab director says he was under ‘tremendous pressure’ to show technology worked (CNBC)
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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