Recon: Clinical labs trade group sues to block FDA’s LDT rule; FDA expands use of BMS blood cancer drug Breyanzi

• What the rescheduling of marijuana might — and might not — mean for scientific research (STAT)
• Did Sarepta Therapeutics earn $4 billion from exon-skipping drugs that don’t work? (STAT)
• Black voices, Black bodies: Life in the age of Ozempic (STAT)
• US FDA expands use of Bristol's cell therapy to treat rare blood cancer (Reuters)
• FDA approves Tris Pharma's non-stimulant pediatric ADHD liquid medication (Endpoints)
• C3TI's Mission: Leverage FDA Trial Innovation Expertise, Educate Inspectors (Pink Sheet)
• Genome Editing: US FDA Eyes Platform-Based Approach To Development And Approval (Pink Sheet)
• US FDA Oncology Team Says Sponsor Meetings Are Still Mostly Virtual, And That’s OK (Pink Sheet)
• ANDA Suitability Petitions: The Timelines They Are A-Changin' (Pink Sheet)
• US nears deal to fund Moderna's bird flu vaccine trial, FT reports (Reuters)

• Catalent stockholders approve buyout by Novo Holdings (Reuters)
• BioNTech gets $145 mln funding for African vaccine plants (Reuters)
• India's pharma export sales to grow faster this year, trade body says (Reuters)
• Pandemic Treaty Talks Flounder But WHO Still Holds Out Hope For Eventual Agreement (Pink Sheet)
• DREAMM Comeback Prompts GSK To Seek Fast-Track EMA Review For Blenrep (Pink Sheet)
• Feedback Sought On The Tricky Business Of Handling CoIs Under EU HTA Regulation (Pink Sheet)
• EU Member States Told To Step Up Efforts On Transitioning Trials To CTR (Pink Sheet)

• Biohaven’s autoimmune drug disappoints, and other biotech news updates from the week (STAT)
• Flush with cash, Novo Nordisk Foundation now plans to reinvest some GLP-1 profits into regenerative medicines (Endpoints)
• J&J's drug eases depression and insomnia symptoms in late-stage study (Reuters)
• Compugen, Nxera disclose milestone payments; Insmed aims for $650M offering (Endpoints)
• Novartis ends development of KRAS drug, citing 'increasing options available' (Endpoints)
• Ikena Oncology weighs ‘strategic options’ as it drops cancer asset, trims headcount to save cash (Endpoints)
• New York startup raises $33M for fertility treatment based on George Church’s stem cell research (Endpoints)
• Wegovy maker Novo Nordisk sues nine spas, clinics and pharmacies over copycat drugs (Reuters)
• Bluebird bio appoints new CFO to oversee financial restatements (Reuters)
• Merck to buy eye-focused drug developer EyeBio for as much as $3 bln (Reuters)

• Sherlock Bio evaluates over-the-counter rapid test for STIs, aims launch in 2025 (Reuters)
• Clinical lab trade group sues FDA over plan to regulate lab-developed tests (STAT)
• Akili, maker of a video game to treat ADHD, to be acquired for $34 million (STAT)
• Scientists install ‘window’ in the skull to record brain activity using ultrasound (STAT)
• The uphill battle to provide noninvasive treatment for fibroids (STAT)
• Fresenius Medical Care plans layoffs ahead of California plant closure (MedTech Dive)

• NIH-funded clinical trials often miss racial, gender diversity enrollment goals, report finds (STAT)
• Value-based payment is getting renewed attention. What it means isn’t getting any clearer (STAT)
• Stigma and the return of syphilis (STAT)
• Updated: Dollar General shuts down mobile clinic program (Endpoints)
• Exclusive: US proposes bulk milk testing for bird flu before cattle transport (Reuters)
• US health insurer shares fall after UnitedHealth flags Medicaid medical use (Reuters)
• Exclusive: Nicotine-like chemicals in U.S. vapes may be more potent than nicotine, FDA says (Reuters)