Recon: Roche Buys Promedior for up to $1.4B; HHS Releases Hospital Price Transparency Rules

• Roche buys US drugmaker Promedior for up to $1.4 billion to get lung drug (Reuters) (Endpoints)
• China's BeiGene gets FDA approval for drug to treat rare form of lymphoma (Reuters) (Financial Times) (Endpoints) (FDA)
• After positive panel vote, Shionogi antibiotic scores US approval (Endpoints) (Press) (FDA)
• A drug maker courted controversy when it shut out a family-run rival. Now some patients say the medicine isn’t working (STAT)
• ResTORbio stops testing lead drug for respiratory illness; shares plummet (Reuters) (Endpoints) (Endpoints)
• One Problem With Flu Shot? Not Enough People Get It (WSJ)
• Majority of anti-vaccine ads on Facebook were funded by two groups (Washington Post)
• Trump Administration Releases Transparency Rule in Hospital Pricing (WSJ) (The Hill) (HHS)

• Former deputy head of China's drug regulator sentenced to 16 years in prison (Reuters)
• EMA Lands at Permanent Amsterdam Building as CHMP Recommends 5 New Medicines for Approval (Focus)
• Takeda highlights 12 NMEs with $10bn-plus sales potential at R&D day (PMLive)
• Germany Mandates Measles Vaccine (NYTimes)
• AZ bags EU approval for Qtrilmet (PharmaTimes)
• How To Make Cross-Country Collaborations On Pricing Work (Pink Sheet-$)
• Pakistan deploys new vaccine against 'superbug' typhoid outbreak (Reuters)
• GSK sees breakthrough in shingles vaccine output in 2024 (Reuters)

• FDA Advisory Committee Votes Unanimously in Favor of Expanding Amarin’s Vascepa Label (Focus)
• When bio-Twitter greets a sincere thread with snark, what can a Silicon Valley VC say? (STAT)
• Acting Commissioner Giroir Emphasizes 'Transitional' Period, Suggesting Time At US FDA Will Be Short (Pink Sheet-$)
• How to Cure the Antibiotic Industry’s Profitability Infection (Fortune)
• Offline: The gravy train of systematic reviews (The Lancet)
• FDA Seeks to Pull 4 NDAs After Companies Failed to Submit Annual Reports (Focus)
• Celltrion Pushes ‘Biobetters’ Concept With Remsima SC (Generics Bulletin-$)
• NIH, NIST researchers use artificial intelligence for quality control of stem cell-derived tissues (NIH)
• Oncology Pilot To Highlight Disagreements Between US FDA And Sponsor For Advisory Committees (Pink Sheet-$)
• As first lab-made yeast genome nears completion, scientists set sights on improved human ones (STAT)
• The U.S. needs extra action to eliminate viral hepatitis, the nation’s deadliest infectious disease (STAT)
• FDA Warns Dollar Tree for Importing Unsafe OTC Drugs (Focus)
• Adult vaccination saves lives. Why do so few adults get vaccinated? (STAT)
• Sarepta pays StrideBio $48M for preclinical gene therapies (Fierce)
• Arrowhead R&D lead steps down, biotech vets step in (Fierce)
• Cadila Retreats From US Injectables Market After Tough FDA Inspection (Pink Sheet-$)
• Sanofi Pasteur Head Loew On The Vaccine Unit's Future Growth Drivers (Scrip-$)
• Atomwise's X-37 spinout gets $14.5 million to launch AI discovery efforts (Endpoints)
• Dumping STAT3 in the trash (Nature)
• Phages fight alcoholic hepatitis (Nature)
• EpicentRx raises $35M to fund late-phase lung cancer trial (Fierce)
• Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal (FDA)

• Bristol-Myers Squibb and Pfizer Announce Randomized, Controlled Trial to Evaluate the Effect of Atrial Fibrillation Screening on Health Outcomes in Older Individuals (Press)
• UCB adds on more positive PhIII data for IL-17A/17F inhibitor bimekizumab, clearing a path to the FDA (Endpoints) (Press)
• Tricida Announces FDA Acceptance of New Drug Application for Veverimer (Press)
• Fractyl Announces New Data from Revita-1 Clinical Study Showing Durable Benefits after a Single Treatment Through Two Years of Follow Up (Press)
• Phase 1/2 Clinical Trial Progress for IDE196 to be Presented at Society for Melanoma Research Congress (Press)

• Axonics wins FDA approval for sacral neuromodulation device (MassDevice)
• Edwards issues recall for Pascal guide sheaths (MassDevice)
• BARDA backs Inflammatix test to improve antibiotic use (MedtechDive)
• Titan Medical puts robot system on hold amid cash crisis (MedtechDive)

• Generic Drug Development: Stakeholders' Views of Risk Evaluation and Mitigation Strategies Differ (GAO)
• Booker, Sanders propose new federal agency to control drug prices (The Hill)
• US vaping-related deaths rise to 42, cases of illness to 2,172 (Reuters)
• Opinion: Trump’s Patent Trolls: A dubious lawsuit tries to cash in on Gilead’s anti-HIV drug. (WSJ)
• Rare HHS Patent Suit May Impact HIV Drug Pricing, Access (Law360-$)
• “Permissible Inference” Supplants Product ID in Case from Washington Court of Appeals (Drug & Device Law)
• The End May Be Here: Court Grants DOJ Motion to Dismiss Whistleblowers’ FCA Suit (FDA Law Blog)
• Feds sue South Dakota surgeon, distributorships over alleged spinal implant kickbacks (MedtechDive)

• FDA Advisory Committee Calendar

• EMA Finalizes Clinical Development Guideline for New Gout Treatments (Focus)

• Digital thermometer, BP monitoring devices to come under regulation from January 1, 2020 (Pharmabiz)

• Consultation: Draft standards for faecal microbiota transplant (FMT) products (TGA)

• Latin America’s pharma industry staying optimistic despite economic uncertainty (PharmaLetter-$)

• Dr. Wayne Bardin, 85, Innovative Researcher on Birth Control, Dies (Reuters)