Regulatory Focus™ > News Articles > 4 > Recon: Bill Gates Donates $12M for Universal Flu Vaccine, Abbott Pulls Stents from India Market

Recon: Bill Gates Donates $12M for Universal Flu Vaccine, Abbott Pulls Stents from India Market

Posted 27 April 2018 | By Ana Mulero 

Recon: Bill Gates Donates $12M for Universal Flu Vaccine, Abbott Pulls Stents from India Market

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In Focus: International Pharmaceuticals & Biotechnology
  • The hepatitis C duopoly (Axios)
  • Big pharma's monster early haul in Q1 (Axios)
  • Doctors Receive Opioid Training. Big Pharma Funds It. What Could Go Wrong? (Mother Jones)
  • Maybe Sanofi Needed Those Expensive Deals After All (Bloomberg)
  • New York panel votes to lower the cost of a pricey Vertex drug for cystic fibrosis (STAT-$)
  • A metabolite will make or break Celgene's ozanimod (BioPharma Dive)
  • Investors are angry with Botox-maker Allergan — and they're trying to get an activist involved to shake it up (Business Insider-$)
  • Biogen to boost stake in biosims joint venture as competition to its MS meds mounts (Fierce)
  • GlaxoSmithKline's next-generation HIV battle against Gilead is already taking a toll on growth (Fierce)
  • IPO plans brewing, Innovent Biologics raises $150M and eyes hundreds of millions more (Endpoints)
  • Why pharma needs to embrace AI to reimagine drug discovery (The Pharma Letter-$)
  • Boehringer Ingelheim rolls-out COPD digital adherence programme (pharmaphorum)
  • The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Guidance for Industry (FDA)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Novel Endocannabinoid Modulator Improves Tics in Tourette's (MedPage Today)
  • GI toxicity hits midstage Sanofi GLP-1 drug as patients drop out (Fierce)
  • Allergan's ubrogepant aces second phase 3 migraine trial (Fierce)
  • FDA demand puts Compugen’s solid tumor checkpoint trial on ice (Fierce)
  • Anti-HIV drug combination does not increase preterm birth risk, study suggests (NIH)
  • How big pharma is using AI for drug discovery, clinical trials, and more (MobiHealthNews)
  • Diabetes drug reverses PAH (European Biotechnology)
  • Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa (NEJM)
  • Galapagos presents strong disease-modifying effects in preclinical model of osteoarthritis with GLPG1972 at OARSI 2018 (Press)
  • Advantagene Announces Clinical Trial Collaboration (Press)
  • ACADIA Pharmaceuticals Announces Presentation of Clinical Experience Data for NUPLAZID (Pimavanserin) at 2018 American Academy of Neurology (AAN) Annual Meeting (Press)
  • Zogenix Announces Initial Quality of Life and Cognitive Function Data From Phase 3 Trial of ZX008 in Dravet Syndrome (Press)
  • Sangamo Announces $8 Million CIRM Grant For ST-400 -- A Gene-Edited Cell Therapy Candidate -- To Treat Transfusion-Dependent Beta-Thalassemia (Press)
  • ACADIA Pharmaceuticals Issues Statement Reaffirming Benefit/Risk Profile of NUPLAZID (Press)
Medical Devices
  • 10x Genomics raises $50M, secures $75M credit facility (Fierce)
  • FDA’s Proposed Expansion of the Abbreviated 510(k) Program (FDA Law Blog)
  • US Regulators Propose Expanded Medical Device Cybersecurity Approach (Emergo Group)
  • Qure.ai launches AI platform to identify brain bleeds and fractures (MobiHealthNews)
  • Nvidia looks to AI for the future of medical imaging technologies (MobiHealthNews)
  • Surgeon Cleared In 1st Trial Over Alleged Off-Label Use Of Medtronic’s ‘Infuse’ Spinal Implant (Courtroom View Network)
  • FDA warns of issues with MR-guided laser interstitial thermal therapy devices (MassDevice)
  • Stryker Q1 beats The Street (MassDevice)
  • Decades-old Medtronic mission statement offers lessons today (Star Tribune)
  • 2018 Meeting Materials of the Clinical Chemistry and Clinical Toxicology Devices Panel (FDA)
  • User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - May 10, 2018 (FDA)
  • BD Launches BD FACSymphony S6 High Parameter Cell Sorter to Enable Sorting of Rare Cell Types (Press)
  • Siemens Healthineers Announces First Installation of the Atellica Solution with Aptio Automation in the United States (Press)
  • Real-world study shows INVOKANA (canagliflozin) 300mg demonstrates better blood glucose control than Farxiga (dapagliflozin) 10mg in patients with Type 2 diabetes (Press)
  • Two-Year Feasibility Study Results Encouraging with Medtronic Harmony Transcatheter Pulmonary Valve (Press)
  • LivaNova Announces One-Millionth Inspire Adult Oxygenator Patient (Press)
US: Assorted & Government
  • Democrats, Public Health Experts Highlight Lack of Funds as Opioid Bills Advance (Morning Consult)
  • FDA Denies Petition to Ban Caffeine Because the Requested Action Is Not Necessary; Issues Guidance Instead (FDA Law Blog)
  • The Million-Dollar Cancer Treatment: Who Will Pay? (WSJ)
  • Readers Weigh In On Vitamin Use And The Big Pharma-Patient Advocacy Connection (KHN)
  • Senator blasts DoD EHR rollout as 'putting patient lives at risk' (Healthcare IT News)
  • E. coli outbreak from romaine lettuce continues spreading (Axios)
  • VA Choice reforms face tight timeline as focus turns to Trump's next nominee for secretary (Modern Healthcare)
  • Autism Disorder Increases in U.S. Children, CDC Study Finds (Bloomberg)
  • All you need to know for round 2 of the CRISPR patent fight (STAT-$)
  • Hospitals rejoice at death of the 25% rule, following years of temporary delay (Fierce)
Upcoming Meetings & Events Europe
  • Guidance: Good laboratory practice (GLP) for safety tests on chemicals (MHRA)
  • European Medicines Agency closed 1 May 2018 (EMA)
  • Europe gets tough on low vaccination rates (The Pharma Letter-$)
  • Vyaire Medical acquires Acutronic, inks deal to acquire IMTmedical (MassDevice)
  • EFCCA Report Highlights Unequal Access to Biologics and Biosimilars for IBD (The Center for Biosimilars)
  • EU to Widen Ban on Pesticides Linked to Harming Bees (Bloomberg)
  • Siemens Healthineers, Hermes Pardini Group to Create an Unprecedented Automated Lab featuring the Atellica Solution (Press)
  • Asarina Pharma: First Patients Begin Phase IIB Trials of World's First-ever Therapy Developed Specifically to Treat PMDD (Press)
  • Fresenius Medical Care holds groundbreaking ceremony for new technology development center in Schweinfurt (Press)
Asia
  • Chugai files for Japanese approval of additional indication for Hemlibra (The Pharma Letter)
  • New twist in Fortis fight: Renuka Ramnath resigns from panel reviewing offers (Economic Times)
  • Air pollution linked to fertility treatment failure (Reuters)
  • PMDA updates (April, 2018) posted (PMDA)
  • Foundation Medicine, Roche and DIAN Diagnostics Collaborate to Advance Personalized Cancer Care in China (Press)
  • Trevena and Pharmbio Korea Announce License and Commercialization Agreement for Oliceridine in South Korea (Press)
India
  • NPPA has fixed/revised ceiling prices/retail prices of 37 formulations under Drugs (Prices Control) Order, 2013 in related Notification /order dated 26.04.2018 (NPPA)
  • Working Sheet Related to Ceiling Price Revised in Review Notified on 26th April, 2018 in 56th meeting (NPPA)               
  • Working Sheet Related to Retail Price Notified on 26th April, 2018 in 56th meeting (NPPA)
  • Tender for outsourcing of Young Professionals(Pharma) and Young Professionals (Cost) in NPPA (NPPA)
  • 4 years on, code to punish pharma firms for bribing doctors still in works (Times of India)
Australia
  • Medical technology at the hub of good health (The University of Queensland)
  • EpiPen (adult) adrenaline auto-injector: Medicines shortages (TGA)
  • Number of Tasmanians travelling interstate for abortions rises fivefold (The Guardian)
  • Groovin the Moo Canberra pill testing trial attacked by ACT Opposition, Chief Minister uninterested (ABC Online)
Canada
  • Updated Register of Certificates of Supplementary Protection and Applications (Health Canada)
  • Notice of Compliance (NOC) Data Extract (Health Canada)
  • Commentary: Canada’s Health Care Is Abysmal. Why Would We Copy It? (Fortune)
  • ‘Purple heroin’ found in fatal overdoses in Peterborough: Health Canada (Global News)
  • Feds get guilty plea in Canadian counterfeit internet drug sales case (Fierce)
  • Innovus Pharma Announces the Launch of its Hemorrhoid Drug Xyralid in Canada (Press)
General Health & Other Interesting Articles
  • Opioid Crackdown Has Patients Struggling to Get Their Meds (WSJ)
  • He was a champion of public health — but played a role in the horrors of Tuskegee. Should a college expunge his name? (STAT)
  • Friends and family may help counter diabetes stress (Reuters)
  • How 'promoting interoperability' will take health data sharing to another level (Healthcare IT News)
  • ‘Desperation Oncology’: when patients are dying, some cancer doctors turn to immunotherapy (NYT)
  • Three-Minute Brain Stimulation Sessions Enough To Reduce Depression Symptoms, According To Study (Forbes)
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.
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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