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

• 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)