Recon: Merck signs royalty-free deal with Medicines Patent Pool for molnupiravir; Cortexyme's Alzheimer's candidate misses primary endpoint

• Cortexyme's Alzheimer's treatment fails to meet main goals in study (Reuters) (STAT)
• Democratic senators raise concerns with potential FDA pick (STAT)
• This May Be Democrats’ Best Chance to Lower Drug Prices (NYTimes)
• Pharma Campaign Cash Delivered to Key Lawmakers With Surgical Precision (KHN)
• Democrats pitch industry-friendly Medicaid workaround to win Manchin’s support (Politico)
• J&J strikes $297 million Texas-specific opioid settlement (Reuters) (Fierce)
• Drugmakers Undercut Rivals With New Patent Tactic as Law Shifts (Bloomberg)
• GAO: FDA didn't inspect any Covid-19 vaccine manufacturing facilities prior to issuing EUAs (Endpoints)

• Merck signs pact to broaden generic manufacturing of COVID-19 pill (Reuters) (NYTimes) (STAT)
• Novavax seeks UK authorization for COVID-19 vaccine (Reuters)
• TGA approves booster doses of the Pfizer COVID-19 vaccine, COMIRNATY (TGA)
• Philippines to receive 300,000 courses of Merck's COVID-19 pill (Reuters)
• GSK raises profit forecasts in boost for under-fire Walmsley (FT)
• Allergan, Others Appeal £260M Antitrust Fine Over Drug Prices (Law360)
• FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice (FDA)

• Province of British Columbia to offer COVID-19 booster shots to all residents (Reuters)
• WTO Nominee Sees Vaccine IP Waiver Talks As 'Sort Of Stuck' (Law360)
• Sweden to extend COVID booster shots to all aged 65 or above (Reuters)
• Pregnant and breastfeeding women are slower to respond to vaccination, researchers report. (NYTimes)

• Fewer Observations, Shift In Emphasis Seen In FDA's Pandemic-Reduced Inspections (Pink Sheet)
• Breaking: Takeda swoops in and scoops up a cell therapy startup in buyout deal, expanding oncology pipeline (Endpoints)
• Eli Lilly scraps a tau program for Alzheimer’s, echoing past failures and casting doubt on entire approach (Endpoints)
• Issuance of Priority Review Voucher; Rare Pediatric Disease Product (FDA)
• Inclusion of women in stroke trials hasn't changed in 30 years: study (Fierce)
• Feds arrest popular Twitter day trader over alleged 'pump and dump' scheme (Endpoints)
• Medable trots its way to unicorn status amid virtual trial craze. Is a public debut next? (Endpoints)
• Exclusive: A year into his role, Ipsen's CBO is on a $3B mission to get the company 'back on the right track' (Endpoints)
• US FDA Should Explain How It Uses Patient Experience Data In Drug Approvals – Report (Pink Sheet)
• The vast majority of genes have been tied to cancer — and that can complicate research (STAT)
• Angion's organ damage drug strikes out again, this time in high-risk kidney transplant patients (Endpoints)
• With Covid-19 vaccine in limbo, China's Fosun inks $628M deal for a Prevnar 13 rival (Endpoints)
• A quiet cardio upstart makes some noise, getting $300M from Bain and diving deep into the clinic — with some real money for pipeline deals (Endpoints)
• Harpoon CEO resigns in wake of dwindling market cap and sliding stock price (Endpoints)

• Boston Scientific CEO projects better Q4 and 2022 as delta surge wanes (MedtechDive)
• One Drop launches Bayer-boosted AI program for preventing heart disease (Fierce)

• Theranos investor Betsy DeVos was misled by Elizabeth Holmes on the tech and financials, representative testifies (CNBC)
• ‘Skinny Label’ Case Gives Brands A ‘Blueprint’ To Alter Use Codes In Patent Litigation (Pink Sheet)
• DOJ Accuses Kaiser Of $1B Medicare Fraud, Fake Diagnoses (Law360)
• Study Coordinator Pleads Guilty in Scheme to Falsify Clinical Drug Trial Data (FDA)
• International Law Enforcement Operation Targeting Opioid Traffickers on the Darknet Results in 150 Arrests Worldwide and the Seizure of Weapons, Drugs, and over $31 Million (FDA)