Recon: Pfizer Japan Recalls Blood Pressure Drug; Seres Lays Off 30% of Staff

• Johnson & Johnson to be first drug maker to list prices in TV commercials (STAT) (Reuters)
• Gene therapy stocks plunge after poor trial data (Reuters)
• Seres Lays Off 30% of Staff, CSO Leaves After Pipeline Review (Xconomy) (Fierce)
• Does the NIH Deserve A Piece Of Biopharma's Profits? (Forbes)
• Philly city council defeats move to license sales reps and ban gifts to doctors (STAT)
• Apple recently hired a prominent obstetrician, signaling interest in women's health (CNBC)
• Pea-sized pill delivers insulin shot from inside the stomach (AP) (NYTimes)
• Family outraged over life-changing treatment going from free to $375,000 a year (NBC)
• 8,000 Flu Deaths Prevented Last Year With Vaccine: Study (Medpage)
• Measles outbreak sends vaccine demand soaring, even among the hesitant (NBC)
• Trump’s Pediatric Cancer Crusade A Drop In Bucket Compared With Past Presidential Pitches (KHN) (STAT)

• Pfizer Japan recalls high blood pressure drug over cancer-causing impurity (Reuters)
• UniQure gene therapy shows rise in blood-clotting protein levels (Reuters) (Endpoints)
• Final Deadline for Falsified Medicines Directive Set for Saturday (Focus)
• Drugmakers say UK could lose out on EU anti-counterfeit drugs push (Reuters) (Pharmafile)
• Turkey Braces For More Drug Access Problems As New Fixed Euro Rate Nears (Pink Sheet-$)
• ICH Generic Drug Harmonization May Be Another Cost-Lowering Opportunity (Pink Sheet-$)
• Industry aghast as EU Parliament backs biosimilar rule change (PMLive)
• European measles cases highest in a decade as pockets refuse vaccination (Reuters)

• Doctor payments drove scripts for cancer drugs from Pfizer, Novartis and more: study (Fierce) (Study)
• 2019’s second unicorn Gossamer raises $276M in upsized IPO offering, MPM’s Harpoon makes its Nasdaq debut with $75.6M bounty (Endpoints)
• FDA Seeks to Establish DSCSA Pilot Projects (Focus)
• Shared REMS: FDA Explains Policies and Procedures (Focus)
• To Halt HIV, Advocates Push For PrEP Outreach To Black Women (NPR)
• Merck KGaA invests $70M to expand Massachusetts R&D hub (BioPharmaDive)
• Renamed Axovant could see big gains in 2019: analysts (Fierce)
• Stock price effects of breakthrough therapy designation (Nature)
• Sanofi’s latest R&D remodeling spotlights what’s hot (bispecifics) and what’s not (CTLA-4) in oncology today (Endpoints)
• Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS) (FDA)
• New York Biotech Raises $61 Million To Keep Cancer Cells Dormant, Bucking Conventional Treatments (Forbes)
• FDA Announces Second Approved Insulin for Use in Dogs with Diabetes (FDA)
• Acyclovir labeling now includes details for treating premature infants infected with herpes virus (NIH)
• Industry's Drug Pricing Power is Running on Fumes (Scrip-$)
• Competition, Not Confiscation, is Key to Lower Drug Prices (Law360-$)
• InventaBioTech, Formerly CytoBioScience, Replaces CEO (Xconomy)
• US FDA Wants Opioid Prescribing Guidelines To Be Highly Specific, But It May Have To Compromise (Pink Sheet-$)
• Forget Bristol-Myers: Regeneron takes on Merck for the heavyweight title in non-small cell lung cancer (Endpoints)
• Should J&J win an OK for a flawed depression drug after notable trial failures? FDA review offers a path forward (Endpoints)
• A tweet from Alexandria Ocasio-Cortez prompts a deeper debate over how drugs are made (STAT)
• Why my patient advocacy organization is investing in CRISPR (STAT)
• Rutgers scientists form immuno-oncology biotech to develop pipeline of TAM inhibitors (Endpoints)
• Researchers spotlight a basket of ‘good’ response rates for the next ADC in Seattle Genetics’ pipeline (Endpoints)
• Determination of Regulatory Review Period for Purposes of Patent Extension; EXONDYS 51 (FDA)

• Unexpected FDA delay for Incyte’s Jakafi sNDA (PharmaLetter-$)
• Finch Therapeutics’ Investigational Drug CP101 Granted Breakthrough Therapy Designation from FDA for Recurrent C. Difficile Infection (Press)
• Kodiak Sciences Announces Upcoming Presentation of KSI-301 12-Week Phase 1a Study Data at Angiogenesis, Exudation, and Degeneration 2019 Meeting (Press)

• Additional Cancer Cases Linked to Use of Breast Implants, FDA Finds (Focus)
• Grifols Gets FDA Approval for Babesia Assay (GenomeWeb) (Press)
• Orthofix wins FDA PMA nod for M6-C artificial cervical disc (MassDevice)
• Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy (Drug Delivery)
• Inspire Medical wins coverage from five more BCBS plans (MassDevice)
• Cardinal Health shares rise on FY2019 Q2 earnings beat (MassDevice)

• FDA Raises Concerns With 505(q) Petitions (Focus)
• ‘Cloud of secrecy’ in Medicare Advantage plans can create an environment for fraud (STAT)
• Shutdown: The Questions — and the Answers — Continue! (Alliance for a Stronger FDA)
• Altria's Snuff Safer Than Cigarettes, FDA Panel Agrees (Medpage)
• Suit: Pharmacy Officer Knew but Didn't Stop Excessive Dosing (NYTimes)
• Momenta Pharmaceuticals, Inc. v, Bristol-Myers Squibb Co. (Fed. Cir. 2019) (Patent Docs)
• SCOTUS extends stay on Louisiana abortion law (Politico)
• Arnold & Porter Gets Product Liability Atty Back From FDA (Law360-$)
• Zetia Pay-For-Delay MDL Should Press On, Magistrate Says (Law360-$)
• Ill. Construction Unions Sue Pharma Cos. Over Opioid Crisis (Law360-$)
• The First Circuit Creates Havoc By Ignoring Facts And An Elephant In The Room (Drug & Device Law)

• FDA Advisory Committee Calendar
• Enhancing the Incorporation of Patient Perspectives on Clinical Trials; Public Workshop – 18 March 2019

• Medicines and Healthcare products Regulatory Agency Privacy Notice (MHRA)
• Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening (MDA/2019/006) (MHRA)

• Access Pains After Approval In China? Consider The 'Three Ps' (Pink Sheet-$)

• Indian drugmakers urged to tap cancer market and innovation (PharmaLetter-$)

• Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances (TGA)

• Dr. Doris Wethers, 91, on Front Lines Against Sickle Cell, Dies (NYTimes)
• Scientists' 'Craziest Experiment Possible' Actually Works On Mosquitoes (NPR)