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