Recon: California Looks to Sell its Own Line of Generics; Boehringer Signs With Singapore’s Enleofen to Develop Anti-Fibrotic Drugs

• California eyes selling its own brand of generic prescription drugs to battle high costs (LA Times) (Sac Bee) (WSJ) (The Hill)
• Merck's Keytruda wins FDA approval for bladder cancer (Reuters) (Endpoints-$) (FDA) (Press)
• Amag Pharmaceuticals to divest two women's health drugs, CEO to step down (Reuters) (Press)
• Two Big Drug Flops Show How Health-Care Economics Have Changed (Bloomberg)
• The Conundrum Of Investing In Cardiovascular Versus Rare Diseases R&D (Forbes)
• Lilly looms over Blueprint as the biotech files targeted cancer drug (BioPharmaDive)
• Celgene backs out of a $55 million deal to settle claims of thwarting generics (STAT-$) (Law360-$)
• Trump should do more to bolster Senate drug pricing effort, Grassley says (STAT-$)
• Sanofi quietly ties up with a low-profile, preclinical cancer biotech — FTC signs off (Endpoints)
• Regeneron drug reduces bone growth for patients with ultra-rare disease (STAT-$) (Reuters) (Press)
• The ghosts of JPMs past: How 20 years of deals, scandal, and science have shaped health care (STAT)
• FDA real-world evidence to be made available on Google Cloud (HealthcareITNews) (Google)

• Boehringer Ingelheim inks 'Singapore's largest biotech deal,' promising $1B each for a suite of anti-fibrotic IL-11 drugs (Endpoints) (Press)
• Sanofi antes up $55M to add protein degradation tech to the R&D playbook as execs look to revive the pipeline (Endpoints)
• ‘Gold rush’: Race is on for health data in East Europe's frontier market (Reuters)
• Patient groups say Brazilian proposal to change patent reviews would favor pharma (STAT-$)
• China Identifies New Virus Causing Pneumonialike Illness (NYTimes) (STAT) (Reuters)
• Bayer extends alliance with Evotec in women’s health (PMLive)
• What Will It Take To Finally End Congo's Ebola Outbreak In 2020? (NPR)

• Engaging the FDA on Innovation in Biomanufacturing (GEN)
• US CRO market tipped to double in size (Outsourcing Pharma)
• Surprise! Brand-Name Drug Prices Fell in 2019 (Drug Channels)
• FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports (Focus)
• High Carcinogen Levels Cause More Drug Recalls (Focus) (Fierce) (FDA 1, 2)
• Researchers Investigate the Novelty of Costly Drugs (Focus)
• 2019 FDA drug approvals (Nature)
• CRLs In 2019: Steady In Number, But Biosimilar Performance Improves (Pink Sheet-$)
• Controversial Duchenne MD player Solid Bio takes another hit, laying off staffers in a bid to weather FDA hold (Endpoints-$) (Xconomy) (Fierce)
• Fostering Oncology Product Development for Kids with Cancer (FDA Law Blog)
• Top pharma industry predictions for 2020 (Pharma Manufacturing)
• Hikma, Arecor set to co-develop new injectable meds (PharmaTimes)
• Ionis finds new partner in a young biotech and its hopeful founder (Endpoints) (Xconomy)
• Novome Lands $33M to Tweak a Gut Microbe Into a Metabolic Therapy (Xconomy)
• Will Clovis' Rubraca sales shortfall revive talk of a buyout at J.P. Morgan? (Fierce)
• Novartis reveals positive efficacy data for Xolair follow-up (PMLive) (PharmaTimes)
• Schrödinger adds another big Pharma partner; Grey Wolf raises $14 million to 'illuminate' tumors (Endpoints) (Fierce)
• Eyeing the 'translatome,' Pfizer dishes out $15M for preclinical, next-gen targeted therapies (Endpoints) (Fierce)
• Struggling Abeona loses president, chief scientist (Fierce)
• Innate Pharma lacutamab trial undermined by issues with CMO (Fierce)
• Emergex completes £8.4m Series A vaccines funding (PharmaTimes)
• Shreds of Tregs: French biotech wins Medicxi backing to kill the rogue immunosuppressive agent to fight cancer (Endpoints)
• Primed for attack: Vaccine tech maker gets $11M shot to battle infectious disease (Endpoints)
• DCVC Bio, 5AM back colonizing army of genetically engineered gut bacteria with $33M (Endpoints)
• US FDA Postmarketing Drug Safety Modernization Plan Will Cut Across Review Disciplines (Pink Sheet-$)
• Bladder Pain Syndrome: US FDA Outlines A Different Approach To Personalized Medicine (Pink Sheet-$)

• New England Journal of Medicine Publishes Results of Pivotal Phase 3 Reblozyl® (luspatercept-aamt) MEDALIST Trial (Press)
• Second pivotal study bodes well for VBI's hep B vaccine (Endpoints) (Press)
• ADC Therapeutics clears a big hurdle toward its first BLA as pivotal PhII delivers upbeat ORR results (Endpoints-$)
• Newron Announces Initiation of New Clinical Trial With Evenamide in Patients With Schizophrenia, Following Approval of Plan By FDA (Press)
• Tiziana Reports Phase 1 Clinical Data Demonstrating Oral Treatment with Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, is Well-tolerated in Healthy Volunteers (Press)
• Zai Lab and Novocure Announce First Patient Enrolled in a Phase 2 Pilot Trial of Tumor Treating Fields Together with Chemotherapy as First-Line Treatment of Gastric Cancer (Press)
• Gemini Therapeutics Enrolls First Patient in Phase 1 Study of GEM103 for Dry Age-related Macular Degeneration (Press)

• Medtronic shuts Puerto Rico factories as workers dig out from quakes (Star Tribune)
• Medtronic acquires Stimgenics (MassDevice)
• Funck to move up to CFO spot at Abbott (MassDevice)
• Colospan wins IDE FDA approval for intraluminal bypass device (MassDevice)
• Polyganics’ Liqoseal sealant patch wins CE mark approval (MassDevice)
• Virtual Incision raises $20m for MIRA surgical robot (MassDevice)
• Applied BioCode Receives FDA Clearance for Syndromic Respiratory Pathogen Panel (GenomeWeb)
• Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination (FDA)
• FDA Grants Breakthrough Device Designation to Reflow Medical’s Temporary Spur Stent System (Press)
• MicroVention Announces FDA Premarket Approval of a New Flow Diverter for the Treatment of Brain Aneurysms (Press)
• Penumbra Announces FDA Clearance of Indigo® Aspiration System for Treatment of Pulmonary Embolism (Press)
• Alucent Biomedical Announces FDA Approval to Proceed with Natural Vascular Scaffolding Clinical Trial (Press)
• JenaValve Transcatheter Aortic Valve Replacement (TAVR) System Designated by FDA as Breakthrough Device (Press)
• KDx Diagnostics announces FDA Breakthrough Device designation for URO17™, Innovative urine test for Bladder Cancer (Press)

• Faced with prescriber fears of OxyContin misuse, Purdue sales reps misleadingly played up drug’s safety, documents show (STAT)
• Pfizer Beats False-Ad Suit Over FDA Approval Of Epinephrine (Law360-$)
• A government database is supposed to help people seeking treatment for opioid addiction. It often doesn’t (STAT)
• Doctor Who Conspired with Internet Pharmacy Organization to Unlawfully Sell Prescription Drugs Pleads Guilty (DOJ)
• Philadelphia-Area Doctor Sentenced to 12 Months in Prison for Unlawfully Distributing Oxycodone (DOJ)
• Walgreens begins 2020 much as it ended 2019, on a sour note (AP) (Reuters)
• Amgen Inc. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2020) (Patent Docs)
• The Only Common Issue Is Preemption (Drug & Device Law)
• Winning An Unwinnable PTAB Rehearing (Law360-$)
• Bristol-Myers, Sanofi Sue Hawaii AG Over Drug Promo Limits (Law360-$)
• Fed. Circ. Affirms PTAB Ax Of AbbVie's Humira Patent (Law360-$)
• 9th Circ. Says Woman Who Stabbed Ex Can't Blame Lexapro (Law360-$)
• ACA Insurer Wants CVS To Reveal Discounted Drug Prices (Law360-$)
• Former Medical Device Co. Workers Say Firing Was Retaliation (Law360-$)

• FDA Advisory Committee Calendar
• Public Meeting: Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc – 4 February 2020

• EU Regulatory Roundup: Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs (Focus)
• Complex Cancer Trials: Group of UK Experts Offers Recommendations (Focus)
• New Gene Therapies For Pediatric Diseases Win EMA PRIME Designations (Pink Sheet-$)
• Luxembourg To Establish New Medicines Agency (Pink Sheet-$)
• The Netherlands Swaps Germany For Norway To Set Prices (Pink Sheet-$)
• EU Looks At New Ways To Tackle Antibiotic Market Failure (Pink Sheet-$)
• UK Startups Double in Number Backed By Larger Scale Investments: Report (Xconomy)

• Reduced Duplicated Inspections & Costs Beckon In Philippines (Pink Sheet-$)
• Kyowa Kirin seeks added indication for Lumicef in Japan (PharmaLetter-$)

• Revised NLEM to classify antibiotics by usage (Economic Times)
• Experts to decide on inclusion and exclusion of antibiotics from NLEM today (Economic Times)
• Solara Active Pharma to conduct internal probe on Nizatidine API amid Mylan recall (Economic Times)
• Maharashtra FDA approves compensation of Rs.25 lakh each to 48 J&J faulty hip implant affected patients (Pharmabiz)
• MTaI urges govt to streamline taxes and duties to make medical devices affordable (Pharmabiz)

• World's Pharmaceutical Inspectorates Focus On Increased Mutual Reliance (Pink Sheet-$)

• 'Hot spotting' doesn't work. So what does? (Politico) (NYTimes) (NPR) (Reuters)
• Genetic markers not very good for predicting disease risk (Reuters)