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Regulatory Focus™ > News Articles > 2020 > 2 > Recon: GSK, Immatics Partner on Immunotherapies; Teva’s Austedo Fails in Two Tourette’s Studies

Recon: GSK, Immatics Partner on Immunotherapies; Teva’s Austedo Fails in Two Tourette’s Studies

Posted 20 February 2020 | By Michael Mezher 

Recon: GSK, Immatics Partner on Immunotherapies; Teva’s Austedo Fails in Two Tourette’s Studies

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA deems Abbott Vascular, ResMed, Teleflex recalls high risk (MedtechDive)
  • Fisher Wallace files citizen petition over FDA’s class III designation for CES (BioWorld)
  • AI discovers antibiotics to treat drug-resistant diseases (Financial Times) (STAT)
  • Lawmakers to Trump: Don’t give ‘monopolies’ to companies that develop coronavirus treatments with taxpayer funds (STAT)
  • Orphan Indications In Medicare: OIG Will Examine Top-Selling Drugs (Pink Sheet-$) (OIG)
  • People often skip neurological meds when out-of-pocket costs rise (Reuters)
  • SmileDirectClub’s top dentist risks losing license in California crackdown (Reuters)
In Focus: International
  • Teva’s weak pipeline hit by Tourette’s drug trial failure (PMLive) (Endpoints) (Press)
  • Germany's Immatics ties up with GSK to develop immunotherapies (Reuters) (Endpoints) (GEN) (Press)
  • Private Equity Bet on German Drugmaker Goes South Quickly (Bloomberg)
  • Merck KGaA divests allergy business to Dermapharm (PMLive) (Fierce)
  • Bluebird, cleared for Zynteglo launch, aims to dose first patients soon (Fierce)
  • China posts sharp drop in new coronavirus cases after criteria change (Reuters)
  • Coronavirus Shows That Supply Chains are Outdated and Unfit For Modern Manufacturing (Forbes)
Pharmaceuticals & Biotechnology
  • 2019 Office of Generic Drugs Annual Report (Report) (FDA)
  • Generics Approvals Will Decline, US FDA Predicts, But Supplement Work May Grow (Pink Sheet-$)
  • Medicare and Commercial Plans Fail to Get New Generics to Patients (AAM)
  • Sen. Chuck Grassley takes your questions on drug prices, insulin, and innovation (STAT)
  • Gilead Appoints Michael Quigley To Lead Research Biology Group (Reuters)
  • Macrolide Antibiotics Early in Pregnancy Tied to Birth Defects (NYTimes)
  • Updated - Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (FDA)
  • Heron's Groundhog Day; Vifor forms JV with Fresenius Kabi in China (Endpoints)
  • Spruce Bio Raises $88M for Clinical Tests of Rare Endocrine Disease Drug (Xconomy)
  • Eli Lilly vet Kerry Blanchard takes the helm at one of China's top dealmakers, steering toward first approvals (Endpoints) (Fierce)
  • Fresh off $100M round, GV-backed real-world data startup woos Duke researcher as CMO (Endpoints)
  • Merck loses its chief digital officer, spotlighting talent hunt for the hottest title in Big Pharma (Endpoints)
  • Armed with a batch of positive biomarker data, a rare disease player reaps $88M for the next big push in the clinic (Endpoints)
  • Hospira, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • FORMA Therapeutics Announces FT-4202 Granted Fast Track Designation and Rare Pediatric Disease Designation for Treatment of Sickle Cell Disease (Press)
  • Galderma Announces New England Journal of Medicine Publication from Phase 2 Study of Investigational Therapy Nemolizumab in Patients with Moderate to Severe Prurigo Nodularis (Press)
  • Magenta Therapeutics Announces Updated Phase 2 Data on MGTA-456 Cell Therapy, Demonstrating Continued Durability in Inherited Metabolic Disorders (Press)
  • Cyclo Therapeutics Announces Completion of Enrollment in its Phase I/II Trial to Evaluate Trappsol® Cyclo™ for the Treatment of Niemann-Pick Disease Type C (Press)
  • IMV to Host Conference Call & Webcast to Report Updated Results from DeCidE1, its Ongoing Phase 2 Study of DPX-Survivac in Patients with Advanced Recurrent Ovarian Cancer (Press)
  • Moleculin Announces Positive Independent Report of No Cardiotoxicity in Annamycin Phase 1 To Date (Press)
Medical Devices
  • DHS warns of WannaCry-like vulnerability in Spacelabs Healthcare systems (MedtechDive) (MassDevice)
  • Teleflex down despite Street-beating Q4, raised guidance (MassDevice)
  • Teleflex strikes $260M deal, gaining parts used in TAVR procedures (MedtechDive)
  • Abbott, Dexcom outline plans for CGM compatibility with Insulet's Horizon (MedtechDive)
  • Study: FDA should have banned pelvic mesh long before it did (MassDevice)
  • Senseonics' implantable CGM wins Cigna coverage, shares soar (MedtechDive)
  • Cancer, Pathology Organizations Developing Clinical Guidelines for MMR, MSI Testing (GenomeWeb)
  • Cardiovalve Receives ‘Breakthrough Device Designation’ for Its Transcatheter Tricuspid Valve Replacement System (Press)
  • Microbiology Devices: Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests (FDA)
US: Assorted & Government
  • Health care anchors Democrats' debate night fight (Politico) (KHN)
  • National Biodefense Strategy: Additional Efforts Would Enhance Likelihood of Effective Implementation (GAO)
  • J&J offered doctors free services and profit-making advice to boost Remicade scripts: whistleblower suit (Fierce)
  • Glaxo Says FDA Call About Zofran Suits Not 'Covert Lobbying' (Law360-$)
  • FDA-FTC Biosimilar Push Clarifies Antitrust Stance (Law360-$)
  • PTAB Upholds Most Of J&J Unit's Robotic Surgical Patent (Law360-$)
  • IQVIA Calls For Sanctions After Docs 'Magically Disappeared' (Law360-$)
  • FTC Seeks Public Comment on its Endorsement Guides (FDA Law Blog)
  • More on Genetic Testing Orders (Drug & Device Law)
Upcoming Meetings & Events Europe
  • ATMPs Put EU Cross-Border Healthcare On The Map (Pink Sheet-$)
  • ABPI responds to UK points-based immigration system (EPR) (ABPI)
  • ‘Transformative’ surgical robot trialled on NHS (PharmaTimes)
  • Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A/10) (MHRA)
India
  • Covid-19 impact: Govt won’t penalise companies hit by supply shortages (Economic Times)
  • Coronavirus: Niti CEO to find ways to reduce drug import dependence on China (Economic Times)
Coronavirus Outbreak
  • Speed science: The risks of swiftly spreading coronavirus research (Reuters)
  • New coronavirus spreads more like flu than SARS: Chinese study (Reuters)
  • How many? The coronavirus is prompting a burst of clinical trials in search of a treatment (STAT)
  • Hunt For New Coronavirus Treatments Includes Gene-Silencing And Monoclonal Antibodies (NPR)
  • Super-spreaders: What are they and what do they do? (Reuters)
  • South Korea confirms first death of person infected with coronavirus (Reuters)
  • 'Like a zombie apocalypse': Residents on edge as coronavirus cases surge in South Korea (Reuters)
  • More coronavirus cases in Iran's Qom; religious gatherings under threat (Reuters)
  • India Is In The Middle Of A Coronavirus YouTube Frenzy, And It’s Going To Get People Killed (BuzzFeed)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
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