Regulatory Focus™ > News Articles > 2019 > 2 > Recon: Pfizer Japan Recalls Blood Pressure Drug; Seres Lays Off 30% of Staff

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

Posted 08 February 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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 $375,000 a year (NBC)
  • 8,000 Flu Deaths Prevented Last Year With Vaccine: Study (Medpage)
  • Measles outbreak sends vaccine demand soaring, even among the hesitant (NBC)
  • Trump’s Pediatric Cancer Crusade A Drop In Bucket Compared With Past Presidential Pitches (KHN) (STAT)
In Focus: International
  • Pfizer Japan recalls high blood pressure drug over cancer-causing impurity (Reuters)
  • UniQure gene therapy shows rise in blood-clotting protein levels (Reuters) (Endpoints)
  • Final Deadline for Falsified Medicines Directive Set for Saturday (Focus)
  • Drugmakers say UK could lose out on EU anti-counterfeit drugs push (Reuters) (Pharmafile)
  • Turkey Braces For More Drug Access Problems As New Fixed Euro Rate Nears (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Unexpected FDA delay for Incyte’s Jakafi sNDA (PharmaLetter-$)
  • Finch Therapeutics’ Investigational Drug CP101 Granted Breakthrough Therapy Designation from FDA for Recurrent C. Difficile Infection (Press)
  • Kodiak Sciences Announces Upcoming Presentation of KSI-301 12-Week Phase 1a Study Data at Angiogenesis, Exudation, and Degeneration 2019 Meeting (Press)
Medical Devices
  • Additional Cancer Cases Linked to Use of Breast Implants, FDA Finds (Focus)
  • Grifols Gets FDA Approval for Babesia Assay (GenomeWeb) (Press)
  • Orthofix wins FDA PMA nod for M6-C artificial cervical disc (MassDevice)
  • Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy (Drug Delivery)
  • Inspire Medical wins coverage from five more BCBS plans (MassDevice)
  • Cardinal Health shares rise on FY2019 Q2 earnings beat (MassDevice)
US: Assorted & Government
  • FDA Raises Concerns With 505(q) Petitions (Focus)
  • ‘Cloud of secrecy’ in Medicare Advantage plans can create an environment for fraud (STAT)
  • Shutdown: The Questions — and the Answers — Continue! (Alliance for a Stronger FDA)
  • Altria's Snuff Safer Than Cigarettes, FDA Panel Agrees (Medpage)
  • Suit: Pharmacy Officer Knew but Didn't Stop Excessive Dosing (NYTimes)
  • Momenta Pharmaceuticals, Inc. v, Bristol-Myers Squibb Co. (Fed. Cir. 2019) (Patent Docs)
  • SCOTUS extends stay on Louisiana abortion law (Politico)
  • Arnold & Porter Gets Product Liability Atty Back From FDA (Law360-$)
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia
  • Access Pains After Approval In China? Consider The 'Three Ps' (Pink Sheet-$)
India
  • Indian drugmakers urged to tap cancer market and innovation (PharmaLetter-$)
Australia
  • Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances (TGA)
General Health & Other Interesting Articles
  • Dr. Doris Wethers, 91, on Front Lines Against Sickle Cell, Dies (NYTimes)
  • Scientists' 'Craziest Experiment Possible' Actually Works On Mosquitoes (NPR)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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