Recon: Sanofi Faces French Investigation Into Depakine Birth Defects; Regeneron, HHS Partner on Coronavirus Treatment

• Regeneron, HHS partner to develop coronavirus treatment (Reuters)
• BioMotiv, Bristol-Myers alliance bears fruit with new company: Anteros Pharma (Endpoints) (Xconomy) (Press)
• Patients Often Get Antibiotics Without a Doctor Visit, Study Finds (WSJ)
• Merck gets Alzheimer’s label claim for insomnia drug Belsomra (PMLive)
• Thanks to complex manufacturing, Novartis expects blockbuster Sandostatin LAR to steer clear of generics in 2020 (Fierce)
• Bioethics experts call on GoFundMe to ban unproven medical treatments (The Verge)

• Sanofi investigated over epilepsy drug linked to birth defects (Reuters) (Endpoints)
• Lonza keeps Chinese plants on 'holiday' as coronavirus builds momentum (Fierce)
• NICE to request Aimovig evidence, appeal panel rules (PharmaTimes)
• Trump will insist NHS pays more for drugs in trade deal, says ambassador (The Guardian)
• WHO outlines steps to save 7 million lives from cancer (WHO)
• World Cancer Day: how the EU is fighting cancer (European Parliament)
• China reports 64 new coronavirus deaths, total at 425 (Reuters)
• China to allow in U.S. health experts as virus shows no sign of slowing (Reuters)

• What record-high funding for neglected diseases doesn’t tell us about R&D for them (STAT)
• Arguing on AI Drug Discovery (In The Pipeline)
• Pharma Mega-Mergers – What Do They Mean for (Smaller) Biopharma Deal Making? (HBM Partners)
• Biosimilars Forum Praises FTC and FDA Action to Fight Anticompetitive Behaviors Blocking Access to Lower Cost Biosimilars (Biosimilars Forum)
• F-Prime backs a niche AI software startup hunting lofty goals in $22M Series B (Endpoints)
• The Sanofi-partnered startup finding clinical trials for the 90% (Endpoints)
• Regeneron joins the hunt for antibodies to fight a brewing pandemic as researchers whip up new trials for antivirals (Endpoints)
• Johnson & Johnson takes pharma brand crown as Pfizer's value falters: ranking (Fierce)
• After losing its CMO last summer, CytomX Therapeutics finally nabs a replacement (Fierce)
• Q&A with Jorge Conde as Andreessen Horowitz launches $750M bio fund III (Endpoints)

• Merck's Recarbrio Gets FDA Priority Review for New Indication (Press)
• Insmed’s PhII smokes and sputters, but researchers herald enough surprisingly positive data to roar on Wall Street (Endpoints)
• Urovant Sciences Announces Publication of Results from Phase 1 Clinical Trials Evaluating URO-902 Gene Therapy in Patients with Overactive Bladder (Press)
• Rebiotix, a Ferring Company, Completes Enrollment for First-Ever, Pivotal Phase 3 Clinical Trial of Microbiota-based RBX2660 (Press)
• GlycoMimetics Advances GMI-1359 Program With Patent Issuance and FDA Designations (Press)

• Qiagen Obtains CE Mark for PIK3CA Mutation Assay (Precision Oncology News)
• Edwards saw US TAVR procedures spike 40% in Q4 (MedtechDive)
• Contura nabs FDA nod for female incontinence device (MedtechDive)
• Abbott wins FDA breakthrough nod for ventricular assist system (MassDevice)
• Titan Medical may put itself up for sale (MassDevice)
• Haemonetics posts Street-beating Q3 results (MassDevice)
• Sony lands FDA clearance for NUCLeUS Operating Room (mobihealthnews)
• GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values (FDA)

• FDA to hold public meeting on testing for asbestos in talc (Reuters)
• Grassley and Wyden Tout Benefits for Insulin Users in Prescription Drug Bill (Senate Finance)
• The Rise of Biosimilars: Success of the BPCIA? (Part III) (Harvard Bill of Health)
• Biosimilar Appellate Update: Genentech v. Immunex, Genentech v. Amgen, Janssen v. Celltrion (Big Molecule Watch)
• Bicameral, Bipartisan Group of Lawmakers Form Congressional Personalized Medicine Caucus (Personalized Medicine Coalition)
• Trump administration and GOP-led states ask Supreme Court to hold off on deciding Obamacare's fate (CNN)
• One thing we learned from Iowa: Single-payer health care resonated (Politico)
• More than a dozen Democrats are bringing people with sky-high insulin bills to the State of the Union (STAT)
• Sensing an advantage, Democrats dare Trump to talk drug prices during State of the Union (STAT)
• Pfizer Fights Chinese Drugmaker Over Chantix Generic (Law360-$)
• Amgen Asks Fed. Circ. To Review Merck's $2.5B Patent Loss (Law360-$)
• More Employers Covering Workers’ Trips Abroad for Cheaper Drugs (Bloomberg Law)
• A Bit of Patchwork From Pennsylvania (Drug & Device Law)
• Federal Court Orders North Carolina Pharmacy and Pharmacist to Pay $600,000 and to Permanently Cease Dispensing Opioids or Other Controlled Substances (DOJ)
• As Out-Of-Pocket Health Costs Rise, Insured Adults Are Seeking Less Primary Care (NPR)

• FDA Advisory Committee Calendar
• The Oncology Center of Excellence (OCE), Envisioning Oncology Product Development for 2025 – 5 February 2020
• Advancing Animal Models for Antibacterial Drug Development; Public Workshop – 5 March 2020

• Drug Shortage Crisis Worsens (Pink Sheet-$)
• ABPI response to proposed UK-EU trade negotiation approaches (ABPI)
• Post-Brexit update on the validity of CE certificates issued by our UK Notified Body (0086) (BSI)
• Fees payable to MHRA for 2020 to 2021 (MHRA)
• Warning statements for labels and leaflets of certain medicines (MHRA)
• European Commission launches EU-wide public consultation on Europe's Beating Cancer Plan (EC)
• Speech by Commissioner Kyriakides - Europe's Beating Cancer Plan: Making the Personal Political (EC)

• Industry recommends prefix or suffix in existing brand name to be allowed on change in API formulation (Pharmabiz)
• Pharma companies set to supply ARVs for ‘treatment’ (Economic Times)
• German firm finds one million files of Indian patients leaked (Economic Times)
• Make plan by February 24 to pay Daiichi Sankyo, Supreme Court to Singh brothers (Economic Times)

• Study claiming new coronavirus can be transmitted by people without symptoms was flawed (Science)
• Novel Virus Brings Novel Threats To Global Pharmaceutical Manufacturing (Pink Sheet-$)
• HHS tells Congress it may transfer millions of dollars in funding to respond to coronavirus (The Hill)
• Brazil to declare emergency, quarantine people returning from coronavirus-hit Wuhan (Reuters)
• How China Built a Coronavirus Hospital in 10 Days (WSJ) (NYTimes)
• China, Desperate to Stop Coronavirus, Turns Neighbor Against Neighbor (NYTimes)
• Japan screens some 3,700 aboard quarantined cruise ship after Hong Kong coronavirus case (Reuters)
• Australian evacuees from China test negative for virus, but face 14-day quarantine (Reuters)
• All Canadians evacuated from virus-hit China will be placed in quarantine – Ottawa (Reuters)
• Repatriated Belgian tests positive for coronavirus (Reuters)
• Hong Kong reports first coronavirus death; Macau to shut casinos (Reuters) (SCMP)
• WHO working on recommendations for resuming flights to China (Reuters)
• Malaysia confirms first citizen infected with virus, total cases now 10 (Reuters)
• Vietnam to quarantine 950 people returning from China at military camps (Reuters)

• Largest-Ever Genetic Study of Autism Yields New Insights (NIH)
• The Flu Is Hitting Children Especially Hard This Season (WSJ)