Recon: FDA approves Janssen’s prostate cancer combo; Pfizer wins FDA accelerated approval for multiple myeloma drug

• FDA hands approval to Janssen's BRCA-positive prostate cancer combo tablet (Endpoints) (BioSpace)
• New Covid vaccines are on the way as 'Eris' variant rises (Reuters)
• In the case of a devastating disease, the FDA weighs an experimental drug’s muddled data and a desperate need (STAT)
• US FDA approves Pfizer's blood cancer therapy (Reuters)
• Insurers won’t cover new Alzheimer’s treatment for some customers (Associated Press)
• More hospital pharmacists are rationing drugs due to increasing shortages (STAT)
• Opioids expose unhealthy bankruptcy addictions (Reuters)
• Revance's Botox rival gets FDA approval for painful neck muscle condition (Reuters)
• FDA extends review on Valneva chikungunya vaccine by three months (Endpoints) (BioSpace)
• Biogen's $7.3B deal for Reata followed a bidding war with mysterious 'Party A' (Endpoints)
• Supreme Court takes on Purdue Pharma bankruptcy case (Endpoints)
• Novo Nordisk buckles down on lobbying efforts, inching toward CMS coverage of obesity treatments (Endpoints)
• Median lag between FDA authorization and Medicare coverage hits 6 years: study (MedTech Dive)

• China drugmakers axe IPO plans as they face scrutiny in anti-graft drive (Reuters)
• New Zealand removes final COVID-19 restrictions (Reuters)
• Drug marketing regulator sounds the alarm over Novartis' Entresto podcast claims (Fierce Pharma)
• ‘Deeply Troubling’ – Pharma Industry's Verdict On EU Compulsory Licensing Plan (Pink Sheet)
• New German Laws To Maximize Health Data Potential For R&D (Pink Sheet)

• New Covid vaccines are on the way as 'Eris' variant rises (Reuters)
• Covid Eris: What to know about new variant EG.5 dominating U.S. cases (Reuters)
• BioXcel cuts over 50% jobs as it pivots focus to retail market for agitation drug (Reuters)
• Insight: What happens when a $2 million gene therapy is not enough (Reuters)
• Incyte axes blood cancer collab with Syros (Endpoints)
• Thermo Fisher lays off 200-plus at clinical-stage cell and gene therapy factory in Florida (Fierce Pharma)
• Lippe Taylor taps MedFluencers to access healthcare's social media stars (Fierce Pharma)
• Another round of layoffs hits BMS, with 100+ people impacted after earnings miss (Fierce Pharma)
• Amylyx's ALS drug Relyvrio gets off the ground as company eyes new brain disorder (Fierce Pharma)
• FDA Puts 2seventy bio’s CAR-T Trial on Formal Hold After Patient Death (BioSpace)
• The Neuropsychiatric Pipeline: 10 Late-Stage Therapies to Watch (BioSpace)

• Boston Scientific’s pivotal pulsed field ablation trial expected to succeed: analysts (MedTech Dive)
• Cue Health wins $28M BARDA contract to develop rapid respiratory infection test (MedTech Dive)
• Q&A: ‘Chaotic’ digital health market needs independent evaluation, new institute says (MedTech Dive)
• Getinge’s heart assist pump shutdown problem given FDA Class I recall tag (MedTech Dive)

• Henrietta Lacks’ Family Sues Ultragenyx for Cell Use Profits (Bloomberg Law)
• Pharma’s Challenge to Drug Price Excise Tax Sits on Shaky Ground (Bloomberg Law)
• Does Kratom Need Tighter Regulation? (Medpage Today)
• FDA Issues Draft Guidance on Registration and Listing for Cosmetics Required under MOCRA (FDA Law Blog)
• Gilead agrees to pay $247M to settle HIV drug case that alleged competition blocking (Endpoints)
• Last resort: Oncopeptides formally challenges FDA's withdrawal of cancer drug's accelerated approval (Endpoints)
• Illumina faces SEC probe over Grail acquisition (MedTech Dive)
• Medicare, Medicaid Drug Payment Models Get Designated Team At CMMI (Pink Sheet)