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

• With cash and a call for new ideas, Bill Gates tries to boost the campaign for a universal flu vaccine (STAT) (Quartz) (The Atlantic) (USA Today) (NPR) (Axios)
• Eyeing blockbuster migraine market, Allergan unloads second set of positive PhIII results for ubrogepant (Endpoints) (Reuters) (Fierce)
• FDA moves to encourage A.I. in medicine, drug development (CNBC) (Focus) (MedCity News)
• Trump administration to release healthcare data for researchers (Washington Examiner)(Fierce)(Healthcare Dive)
• Vertex keeps focus on CF as sales climb 33% (BioPharma Dive) (Reuters) (Endpoints)
• Alexion preps an FDA pitch on Soliris successor while signaling more deals ahead for rare disease drugs (Endpoints) (Fierce)
• Two more top FDA officials hit the exits as an exodus of senior regulators continues (Endpoints) (STAT-$)

• Abbott India stops importing Xience Alpine stents (Economic Times) (Business Standard)
• Only three new meds recommended for approval at April EMA/CHMP meeting (The Pharma Letter) (EMA)
• Dupixent stumbles as Sanofi muddles through tough times (BioPharma Dive) (PMLiVE) (Financial Times) (Fierce) (Reuters) (The Pharma Letter)
• Ahead of Hong Kong listing changes, WuXi preps for a biotech boom with a new R&D center in Shanghai (Endpoints) (The Pharma Letter)
• Abortion pill prescribed more than 4,000 times in 2017, Health Canada says (Toronto Star) (CBC News) (The Canadian Press)
• Study finds widespread belief in “mythical” causes of cancer (PharmaTimes) (Forbes)
• Adocia partners for insulin Lispro in China (The Pharma Letter) (Pharmabiz)
• China to cut import value-added tax on cancer drugs from May 1 (Reuters)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)