Recon: Congress gives FDA tight budget but seeks to boost inspections; Perrigo’s OTC birth control drug Opill begins shipping in U.S.

• Where’s Lilly’s Alzheimer’s approval? (STAT)
• Congress Gives US FDA Austere Budget But Seeks Boosts On Inspections, IT, And ALS Activities (Pink Sheet)
• First over-the-counter birth control pill in U.S. begins shipping to stores (STAT)
• Covid-19 increases risk of developing autoimmune disease, but vaccination helps, large study shows (STAT)
• How the U.S. is sabotaging its best tools to prevent deaths in the opioid epidemic (STAT)
• FDA denies hearing to Vanda on jet lag indication for sleep disorder drug (Endpoints)
• Marching On: Eight Novel Agents Among March Goal Dates For US FDA (Pink Sheet)

• WTO proposal for Covid diagnostics and therapeutics waiver is abandoned (STAT)
• Australian biopharma buys radioisotope producer in its next step to ‘double’ capacity in 2024 (Endpoints)
• EU Regulators Developing Tools For ‘N-Of-1’ Drugs & Platform Technologies (Pink Sheet)
• European R&D Industry Warns SPC Proposals Could Cause Delays & Invite Abuse (Pink Sheet)
• EMA ‘Trying Its Best’ To Offer More Early Scientific Support For Sponsors (Pink Sheet)
• French Shortages Bill Would Impose ‘Dissuasive’ Penalties On Firms That Fail To Meet Tougher Obligations (Pink Sheet)

• Novo Nordisk’s diabetes drug Ozempic cuts risk of kidney disease progression, trial shows (STAT)
• Bayer on job cuts, pipeline gaps, obesity and Monsanto litigation as execs defend keeping current structure (STAT)
• Bayer says no breakup ‘for now,’ focuses instead on fixing ‘badly broken’ areas (Endpoints)
• Amylyx readies for make-or-break PhIII, looking to address uncertainty over controversial ALS drug (Endpoints)
• BridgeBio's $250M offering; ViiV's PhI data for ultra-long-acting HIV treatment (Endpoints)
• Regenxbio gives glimpse at early Duchenne gene therapy results, plans pivotal study for accelerated approval (Endpoints)
• Roche, Alnylam’s zilebesiran succeeds in another PhII hypertension test (Endpoints)
• Q&A: Ken Song details RayzeBio’s path from Series A to IPO in 3 years, taking a down round and being disciplined (Endpoints)

• Q&A: Microsoft research head explains how generative AI could help doctors be more human (STAT)
• How Apple’s vice president of health views opportunities in healthcare (Endpoints)
• FDA Set To Drop Final Rule On LDTs, Sends Draft To White House (MedTech Insight)
• Cardio Conversations: ‘Much More Than Just A Patch,’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics (MedTech Insight)

• Q&A: Nora Volkow on how to get ‘at least 50% less people dying’ from opioid overdose (STAT)
• Watch: Why fentanyl withdrawal is agony and how medication can prevent it (STAT)
• How ideas from ancient Greece like ‘a bun in the oven’ continue to affect reproductive health policy (STAT)
• Mark Cuban: Pharma’s Secret Weapon In The Fight Against PBMs (Pink Sheet)
• Breakthrough Designation Binge In February By US FDA Didn’t Extend To Approvals (Pink Sheet)