Recon: FDA approves Pfizer’s RSV vaccine for older adults; Roche eyes sale of California biologics facility

• FDA approves Pfizer’s RSV shot for older adults, teeing up a competitive $17B vaccine market (Endpoints) (Reuters) (Fierce)
• AstraZeneca Wins FDA Nod in Prostate Cancer, Trims IBD Pipeline (BioSpace) (Endpoints) (Fierce)
• After FDA’s delayed hold for multiple myeloma drug, Molecular Templates is back in action (Fierce) (Endpoints)
• FDA blocks PepGen’s attempt to get 2^nd oligonucleotide into the clinic (Fierce)
• FDA warns about compounded semaglutide-based drugs (Endpoints) (Fierce)
• DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure (Pink Sheet)
• Medicare holds firm on Alzheimer’s drug coverage policy (STAT) (Reuters) (Bloomberg)
• Debt ceiling deal could mean cancer, disease research cuts, advocates warn (STAT)
• FDA inspection of China-based site making Coherus' potential new cancer drug ends with three observations (Endpoints) (Fierce)
• FDA's cancer chief weighs in on common chemo shortages — report (Endpoints)
• Cancer association says national budget deal threatens research funding (Endpoints)
• Psoriasis Biosimilars Appear to Match Up to Original Products, With Caveats (MedPage Today)

• International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine (Pink Sheet) (Pharma Letter)
• WHO To Review Impact Of Mechanism For Tackling Substandard & Falsified Drugs (Pink Sheet)
• 1 June Marks Historic Day For Patent Protection In Europe (Pink Sheet)
• UK Aims To Quadruple Patient Recruitment To Industry Clinical Trials By 2027 (Pink Sheet)
• NICE recommends Pfizer's migraine drug for use in the UK, with some restrictions (Endpoints)
• Peru battles record dengue outbreak, in a warning for a warming world (Washington Post)
• Tunisia's financial crisis leaves the sick struggling to find medicine (Reuters)

• Pfizer says its experimental antibiotic combo can treat some superbug infections (Reuters)
• Roche looking to sell or shut down California biologic drug plant (Reuters) (Endpoints) (Fierce)
• Novartis buys priority review voucher from Pharming for discount price of $21M (Fierce)
• Bayer inks Cedilla cancer deal, betting take on tough target will beat Pfizer and the chasing pack (Fierce)
• AstraZeneca drops Skyrizi rival after seeing R&D timeline spiral (Fierce)
• Merck KGaA earmarks €35M for Scottish expansion, plots 500 new jobs (Fierce)
• Yuhan males $325M cancer bet to challenge Boehringer, Takeda (Fierce)
• Trials In Focus: Diverse Enrollment Lagging In Oncology, IQVIA Finds (Scrip)
• Coherus works with Mark Cuban to sell biosimilar Humira at steep discounts (STAT)
• Lonza shells out $107M cash to snap up Synaffix and its ADC platform (Endpoints)

• Patient advocacy groups urge FDA to regulate lab-developed tests if VALID Act doesn’t pass (MedTech Dive)
• MedTech Europe sets out position on cybersecurity, making case for reliance on MDR (MedTech Dive)
• IRhythm Receives FDA Warning Letter After Inspection (Bloomberg) (Fierce)
• Getinge offers $290M for single-use bioprocessing equipment maker (Fierce)
• Johnson Matthey plans to sell medical device unit, Bloomberg reports (Reuters)

• Former Novartis execs cleared of Greek bribery charges after yearslong investigation (Fierce)
• US appeal in high-stakes Gilead patent case garners support from patient advocates (Fierce)
• U.S. Supreme Court gives boost to whistleblowers in drug pricing case (Reuters)
• J&J faces new trial over talc cancer claims, amid settlement push (Reuters)
• Pfizer Settles Trade Secret Lawsuit Over ‘Revolutionary’ Drug (Bloomberg)
• After price cuts, Eli Lilly inks $13.5M settlement in long-running insulin lawsuit (Fierce)