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)
- 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)
- 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)
- 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)
- 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)
- 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)
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