Recon: FDA authorizes GSK’s JAK inhibitor for rare blood cancer; Industry needs EU funding to comply with GMP rules

• FDA approves GSK's JAK inhibitor for rare blood cancer after three-month delay (Endpoints)
• Novo Nordisk shares fall after media report about quality lapses at U.S. plant (Reuters)
• Exclusive: Biden to nominate U.S. surgeon general to join WHO executive board, official says (Reuters)
• Doctors urge U.S. FDA to add miscarriage management to abortion pill label (Reuters)
• Novavax’s ’23-’24 COVID Vaccine Can Bypass Another CDC Cmte Meeting – If FDA Authorizes It (Pink Sheet)
• Chamber of Commerce, government clash at first court hearing on Medicare drug prices (STAT)
• J&J to phase out Janssen name in corporate rebrand (MedTech Dive)

• AstraZeneca/Daiichi Sankyo’s Enhertu To Get Lung Cancer Label For EU (Pink Sheet)
• Pfizer’s $43 Billion Seagen Takeover Gets EU Merger Review (Bloomberg)
• Companies Need EU Funding To Cover ‘Enormous Expenditure’ Of Complying With Revised GMP Rules (Pink Sheet)
• South Africa investigates Johnson & Johnson over ‘excessive pricing’ for its TB drug (STAT)
• Climate change impeding fight against AIDS, TB and malaria (Reuters)
• Germany kicks off autumn COVID vaccine campaign targeting high-risk groups (Reuters)
• Novartis makes sculptures to shape knowledge of cancer symptoms, laying groundwork for Jakavi use (Fierce Pharma)

• Lonza CEO Pierre-Alain Ruffieux to leave CDMO amid reduced growth (Endpoints)
• David Liu startup to focus on getting CRISPR therapy to hard-to-reach cells (STAT)
• BioNTech wins up to $90 mln in funding for mpox vaccine development (Reuters)
• Novo Nordisk shares fall after media report about quality lapses at U.S. plant (Reuters)
• Anthos to stop factor XI trial in atrial fibrillation early after 'overwhelming benefit' (Endpoints)
• CDMOs Nephron and Canton each raise hundreds of millions in financing (Endpoints)
• In the Lab: Regeneron brings its antibody chops to gene editing's biggest problem, aiming to 'change the field' (Endpoints)
• Nobel laureate Carolyn Bertozzi joins cell therapy biotech Acepodia as chief scientific advisor (Endpoints)
• Exclusive: Backed by Illumina, Broken String Biosciences raises $15M to find off-target gene edits (Endpoints)
• Samsung Biologics adds to BMS manufacturing partnership with new $242M antibody agreement (Fierce Pharma)
• Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data near (Fierce Pharma)
• The First Annual BioTechX USA: Blending Science and Technology (BioSpace)
• Are GLP-1 Major Threat To The Insulin Delivery Tech Market? (MedTech Insight)

• FDA clears wearable ECG patches from Samsung spinout Wellysis, SmartCardia (Fierce)
• Novo Nordisk hires private U.S. firm to handle some Wegovy pen assembly -source (Reuters)
• GE HealthCare gets $44 mln grant to develop AI-assisted ultrasound tech (Reuters)
• VERIGRAFT Is Taking A Fresh Approach To Personalized Tissue Grafting (MedTech Insight)
• AdvaMed Proposes Comprehensive Strategy for CMS To Encourage Access to AI and Software (MedTech Insight)
• Taking Steps Towards Improving Innovation Opportunities In The EU Regulatory Environment (MedTech Insight)
• Bigfoot CEO talks Abbott acquisition, future of diabetes tech (MedTech Dive)
• Hospital, lab equipment makers brace for China demand slowdown (MedTech Dive)
• GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI (MedTech Dive)

• Where are HHS and the FTC on online privacy for people with substance use disorder? (STAT) Medicare wants to increase payments for heart rehab. Hospitals see an opening to get more (STAT)
• Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid Formats (FDA Law Blog)