Recon: Shape Therapeutics' $112M gene therapy play; Incyte's cancer drug flops at FDA

ReconRecon | 26 July 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • At the FDA’s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11 (NYT)
  • Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues (Biopharma Dive)
  • Shelling out $5B+, PerkinElmer pays the big bucks for antibody and reagent player (Endpoints)
  • House Democrats expand probe into political interference into CDC during Trump administration (The Hill)
  • V.A. Issues Vaccine Mandate for Health Care Workers, a First for a Federal Agency (NYT)
  • California will require all state workers to get vaccinated or be tested regularly, Newsom says (NYT)
  • Major Health Care Orgs Call for Vaccine Mandates for Health Care Workers (Talking Points)
  • A Looming Challenge In The Vaccination Campaign: Syringe Shortages (NPR)
In Focus: International
  • BioNTech says it plans to develop an mRNA vaccine to prevent malaria (CNBC) (WSJ)
  • Australia kick-starts mRNA vaccine research with Phase I trial (Pharmaletter)
  • France Passes Law That Makes A Coronavirus Health Pass Required For Dining And Travel (NPR)
  • Brazil’s health regulator scraps Bharat Biotech’s EUA application of Covaxin (Economic Times)
  • Israel weighing COVID booster shots for over 60s before FDA approval (Reuters)
  • S. Korea says Moderna reports 'production issue' as vaccination widens to 50s (Reuters)
Coronavirus Pandemic
  • One-dose Vaxzevria highly effective in Beta and Delta variants (Pharmaletter)
  • Florida Now Leads the Nation in New COVID-19 Cases (NPR)
  • World Bank, COVAX unveil plan to speed vaccine supplies to developing countries (Reuters)
  • US purchases further 200M Pfizer vaccines for children and possible boosters (Pharmafile)
  • Mixed AstraZeneca-Pfizer shot boosts COVID antibody level – study (Reuters)
  • Covid Treatment Options Remain Elusive, Despite Months of Effort and Rising Delta Cases (Reuters)
Pharma & Biotech
  • Mount Sinai Health System-backed Sema4 goes public at $3B valuation (Fierce)
  • Shape Therapeutics raises $112 million series B for RNA-based gene therapies (C&EN)
  • Rivus launches with $35 million to tackle obesity, metabolic diseases (C&EN)
  • Caribou gives back early gains after pricing $304M IPO (Biocentury)
  • FDA rejects Incyte cancer drug, asking for more data to show clinical benefit (MedCity News)
  • Would Illumina’s acquisition of GRAIL constrict the expansion of the liquid biopsy space? (MedCity News)
  • Cassiopea and Sun Pharma strike deal for Winlevi in Canada and USA (Pharmaletter)
  • Lumos delays key hormone deficiency readout as COVID bites (Fierce)
  • GlaxoSmithKline earns expanded nod for Shingrix (Endpoints)
  • Pemazyre Wins Cost-Effectiveness Thumbs Up For Rare Bile Duct Cancer In England (Pink Sheet)
  • Eli Lilly pens pact with Banner Alzheimer's Institute for ‘virtual approach’ for its late-stage donanemab test (Fierce)
  • Chugai API manufacturing building for late-stage clinical development (Pharmaletter)
  • Bayer names new head of research and early development for oncology (Pharmaletter)
  • Adverum Faces Rocky Road As It Switches Gears From DME To Wet AMD (Scrip)
  • Microbiome therapy companies face the fallout of failed Seres trial (STAT)
  • Denali slips as a snapshot of early data raises some troubling questions on its pioneering blood-brain barrier neuro work (Endpoints)
  • ARCH adds FDA, biodefense expertise with appointment of Luciana Borio (Endpoints)
  • Roche’s Hong Chow given wide-ranging role at Merck Healthcare (Pharmaletter)
  • Let the games begin: Novo Nordisk takes the gold in Cowen's 'R&D pentathlon' (Endpoints)
  • Boston Scientific, Zimmer Q2 expectations lifted by Abbott, J&J, Intuitive results (MedTech Dive)
  • Happify rolls out digital therapeutic for anxiety, depression under temporary FDA guidance (MedCity News)
Government, Regulatory & Legal
  • Opioid Wholesalers, W.Va. Gov'ts Set to Wrap Bellwether (Law360)
  • Regeneron 'Kickbacks' Fueled Blockbuster Profits, Suit Says (Law360)
  • Philadelphia and Washington State Reject National Opioid Settlement, Philly Files Lawsuit (FDA News)
  • As Holdout Missouri Joins Nation in Monitoring Opioid Prescriptions, Experts Worry (KHN)
  • Chinese researcher — and former 'fugitive' — returns home after DOJ moves to drop a spate of cases (Endpoints)
  • J&J’s Remicade — the poster child for how to block biosimilars — finally settles Pfizer suit (Endpoints)
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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