Recon: Pfizer Buys Stake in French Gene Therapy Developer Vivet

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)