Recon: Pfizer Buys Stake in French Gene Therapy Developer Vivet

ReconRecon | 20 March 2019 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Flagship Pioneering raises $824 million in venture capital round, its most ever (STAT)
  • Julie Dohm, FDA’s top compounding official, set to leave agency (STAT)
  • Their tissue turns to bone. Their joints freeze in place. And, finally, their hopes for treatment may be realized (STAT)
  • J&J and Sientra get FDA warning letters over breast implants (Focus) (Reuters) (FDA)
  • Former DEA official now working for OxyContin maker Purdue Pharma (NBC)
  • Sage gets US approval for first postpartum depression therapy (Reuters) (Endpoints) (NYTimes) (FDA) (NIH) (Press)
  • Catalyst says its pricey rare disease drug is doing ‘better than expected’ despite patient anger (STAT)
  • Novo Nordisk submits diabetes pill for US approval (Reuters)
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In Focus: International
  • Canada to create national drug agency to help cut cost of medicines (Reuters)
  • Pfizer buys stake in French gene therapy firm Vivet (CNBC) (Endpoints) (WSJ) (Press)
  • Novartis Probe Finds No Trace of Payoffs to Greek Officials (Bloomberg)
  • EU urged to safeguard post-Brexit medical supplies from UK (Financial Times)
  • ‘Keep Planning For No-Deal Brexit,’ UK Govt Tells Pharma As Chaos Grows (Pink Sheet-$)
  • Danish Agency Claims A First In Raw Data Analysis (Pink Sheet-$)
  • Saudi FDA Consults On Compassionate Use Program Requirements (Pink Sheet-$)
  • EU Publishes First Corrigenda for MDR, IVDR (Focus)
  • Report: French commission calls for massive medtech regulation overhaul (MassDevice)
  • Pfizer, Merck KGaA throw in the towel on another Bavencio PhIII as once bright hopes shrivel fast (Endpoints) (Press)
  • GSK reports positive data from trial of endometrial cancer drug (Reuters) (PharmaTimes)
  • WHO Panel Calls for Global Gene Editing Registry (Focus)
  • New WHO recommendations to accelerate progress on TB (WHO)
Pharmaceuticals & Biotechnology
  • Biosimilar approval and adoption in the US needs to be expedited (STAT)
  • Biosimilar Groups Offer Proposals to Help US Better Mirror EU Successes (Focus)
  • FDA Finalizes Two Guidances on HIV Drug Development (Focus)
  • With eye on revenue stabilization, Gilead takes 4.9% hike on a basket of drugs (Endpoints)
  • What’s behind sky-high valuations of biopharma startups? (MedCity)
  • FDA Inspectors Focusing Attention On Traditional Manual Aseptic Filling Lines (Pink Sheet-$)
  • Gottlieb Touts US FDA's Organizational Structure For Advancing Policies During His Tenure (Pink Sheet-$)
  • Motif Bio Granted Meeting with US FDA regarding Iclaprim (Press)
  • A World Without Rebates: Predictions for How the Channel Will Evolve and Why Drug Prices Will Go Down (Drug Channels)
  • NASH drug in hand, Merck forges ahead with 2-year extension of NGM Bio collaboration deal (Endpoints)
  • GlaxoSmithKline sets its sights on a quick leap into the big PD-1/L1 game — will anyone notice? (Endpoints)
  • Following Syntimmune buyout, Alexion antes up $25M to double down on anti-FcRn pathway (Endpoints)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Trizell Ltd. announces Phase 3 pivotal study of interferon alfa-2b gene therapy in malignant pleural mesothelioma (Press)
  • Syntrix Announces First Patient Cohort Dosed in Phase 2 Study of Desmetramadol in Diabetic Neuropathic Pain (Press)
  • Knopp Biosciences Enters Collaboration with Leading UK Investigators to Commence Phase 2 Clinical Trial of Dexpramipexole in Severe Eosinophilic Asthma (Press)
Medical Devices
  • First Device to Treat Alzheimer's Is Up for Approval by the FDA (IEEE)
  • CDRH Talks Up Timeliness of NEST (Focus)
  • FDA Warns Integra’s TEI Biosciences Over Contamination Issues (Focus) (MassDevice)
  • Johnson & Johnson Plans Virtual Clinical Trial, Builds On Apple Heart Study Results (Forbes)
  • Baxter, Biomérieux ink acute kidney injury biomarker dev deal (MassDevice)
  • Siemens wins FDA nod for Mobilett Elara Max mobile X-ray (MassDevice)
  • Boston Scientific touts Luminize catheter study (MassDevice)
  • Younger knee replacement patients have more complications (Reuters)
  • A liquid biopsy that combines Illumina’s ‘ultra-deep’ sequencing with Grail’s machine learning (Fierce)
US: Assorted & Government
  • Bayer shares slide after latest Roundup cancer ruling (Reuters)
  • Gottlieb predicts further FDA action on e-cigarettes (Politico)
  • Athenex Says FDA Wrongly Policing Practice Of Medicine (Law360-$)
  • AbbVie faces class action lawsuit from New York grocery union over Humira 'patent thicket' (Fierce)
  • Washington must change the system that encourages high drug prices (The Hill)
  • Chinese Citizen Sentenced in Scheme to Sell Mislabeled Dietary Supplements (DoJ)
  • Tech's fight against anti-vaccine content prompts free speech debate (CBS)
  • University of Illinois at Chicago Missed Warning Signs of Research Going Awry, Letters Show (ProPublica)
  • Gottlieb Quits – Now What? (Drug & Device Law)
  • HP&M Attorney Pens the Case for Use of Patient and Caregiver Perception of Change Assessments in Rare Disease Clinical Trials (FDA Law Blog)
Upcoming Meetings & Events Europe
  • New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices (Focus)
  • Abbott Receives CE Mark for Alinity Molecular Diagnostics System, Assays (GenomeWeb)
  • Guidance on registration of clinical trials for investigational medicinal products and publication of summary results (MHRA)
  • Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018 – risk of batteries overheating or igniting (MDA/2019/017) (MHRA)
  • Export drugs and medicines: special rules (MHRA)
  • Asia Regulatory Roundup: Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository (Focus)
  • Abbott jumps on to digital health service bandwagon (Economic Times)
  • Notice: Device Advice: Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada (Health Canada)
  • Updated Notice: eCTD Pilot for Clinical Trial Regulatory Activities – Extension (Health Canada)
  • Pharmacovigilance Inspection Program metrics report: Sep 2017 - Dec 2018 (TGA)
  • Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices (TGA)
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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