Recon: Merck enters immunology space with $11B Prometheus takeover; FDA approves Gamida’s cell therapy

• Abortion Pill to Remain Available After Supreme Court Stay Lower Court Ruling (BioSpace) (Endpoints)
• FDA's Woodcock To Supreme Court: Mifepristone Ruling Will Create 'Significant Chaos’ (Pink Sheet) (Endpoints)
• PhRMA Jumps Into Battle Over Mifepristone Regulation With Supreme Court Filing (Pink Sheet)
• FDA Adcomm Votes in Favor of Rexulti for Agitation in Alzheimer’s (BioSpace)
• US approves Gamida's therapy to reduce infection risk in cancer patients (Reuters)
• FDA Panel to Weigh Limited Data on Combo for Healthcare-Acquired Pneumonia (MedPage Today)
• CBER Director Marks’ Intervention On Sarepta Gene Therapy Filing Decision Appears To Backfire (Pink Sheet)
• Soligenix shares take another dip as FDA requests 2^nd trial for rare cancer candidate (Fierce)
• FDA rejects Eli Lilly’s ulcerative colitis prospect mirikizumab, citing manufacturing shortfalls (Fierce)
• Why do some blood stem cells go rogue? Study offers clue and possible target (STAT)
• Overdose deaths of older Americans quadrupled in past 20 years (Washington Post)
• A Beauty Treatment Promised to Zap Fat. For Some, It Brought Disfigurement (NYT)
• Blackstone Unit Slashes Diabetes Costs With AI-Driven Program (Bloomberg)

• WHO To Advise On Formulation Of Next COVID-19 Vaccines (Pink Sheet)
• WHO says total Marburg cases in Equatorial Guinea rise to 15 (Reuters)
• Singapore Readies For Phased Implementation Of ICH eCTD Format (Pink Sheet)
• Argentina battles major dengue outbreak with atomic radiation (Reuters)
• Rare Opening In Tough Times: New Biotechs Rekindle CNS Development In China (Scrip)
• Nigeria regulator grants approval to Oxford’s malaria vaccine (Reuters)
• Will Liraglutide Make It To WHO's Essential Medicines List? (Scrip)

• Merck Leans into Immunology with $10.8B Prometheus Buy (BioSpace) (Reuters) (Fierce)
• GSK offers peek into antibiotic’s ‘hard fought’ success as FDA application nears (Fierce) (Endpoints) (Reuters)
• Moderna-Merck mRNA cancer vaccine shows promise in combination with melanoma drug (STAT) (Bloomberg) (Endpoints)
• Eli Lilly to invest additional $1.6 bln in 2 new plants (Reuters)
• Talaris lays off 95% of workforce, C-suite as kidney transplant company fails to find a savior (Fierce)
• Regeneron reveals data behind deprioritized BCMA/CD3 bispecific (Endpoints)
• J&J’s Janssen taps into Pipeline Therapeutics’ neuroscience asset for $50M upfront (Endpoints)
• Japanese CRO buys back penny stock spinout while awaiting FDA decision on migraine candidate (Endpoints)
• Bayer chair wins backing from major shareholder advisory firms (Reuters)
• Catalent cuts 2023 sales expectations as productivity issues and costs pile up at 3 plants (Fierce)
• Illumina taps Henry Ford Health System to explore whole-genome testing for heart disease (Fierce)

• Abbott gets clearance for Libre 3 reader, opening path to Medicare coverage (MedTech Dive) (Fierce)
• Israeli Firm Wins FDA Clearance For Novel PTSD Therapy (MedTech Insight)
• FDA warns that Philips has fully fixed ‘considerably’ fewer devices than online tally may suggest (Fierce)
• Study: Recall Risk Tied To Device Modifications (MedTech Insight)
• US Applauds Its Influence In Ensuring EU Medtech Transition Periods Were Extended (MedTech Insight)
• IVD Market Returning to Post-COVID Normal In Germany (MedTech Insight)
• Medtronic VP Mike Marinaro details the ‘full, holistic approach’ of the newly combined surgical robotics, devices unit (Fierce)

• US Supreme Court rebuffs Novartis bid to revive MS drug Gilenya patent (Reuters) (Bloomberg)
• High Court Turns Down Sanofi’s EpiPen Lawsuit Against Mylan (Bloomberg) (Reuters)
• Bayer Keeps Alka-Seltzer False Advertising Suit in Federal Court (Bloomberg)