Recon: Amazon Hires Former FDA Official; Trump Targets Opioids

Posted 19 March 2018 | By Ana Mulero 

Recon: Amazon Hires Former FDA Official; Trump Targets Opioids

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In Focus: US

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In Focus: International Pharmaceuticals & Biotechnology
  • GlaxoSmithKline scores retail deal with CVS, spreading Shingrix to thousands of pharmacies (Fierce)
  • Drug companies are beginning to wake up to this new risk factor (MarketWatch)
  • JPMorgan Tells Clients to Sell Biotech It Helped Take Public (Bloomberg)
  • Pharma considerations loom in spending bill (Politico)
  • Investigators say his fingerprints are all over financial crimes at Theranos. Why is he a virtual ghost? (STAT)
  • Affimed hires CMO with Big Pharma background to oversee I-O R&D (Fierce) (Press)
  • Five Prime Therapeutics licenses out inflammatory disease drug to UCB (Fierce)
  • Former Insys employees agree to cooperate with the feds in kickback probe (STAT-$)
  • Drug makers jostle over potential Medicare changes in congressional spending deal (STAT-$)
  • Stand Up to Cancer executives talk celebrities, partnerships and research for pharma marketers (Fierce)
  • Insys Therapeutics Reiterates Commitment to Compliant and Ethical Business Practices and Advancing Innovative Product Pipeline (Press)
  • Martin Pharmaceuticals launched to repurpose drugs for orphan indications (The Pharma Letter) (Press)
  • Q&A: Holding drugmakers accountable for the opioid crisis (The Washington Post)
  • Digital R&D: Emerging technologies can boost clinical development (Fierce)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Novo Nordisk's semaglutide spurs major weight loss in phase 2 obesity study (Fierce) (Press)
  • Boehringer progresses nintedanib in new indication (The Pharma Letter) (Press)
  • Cardiology World Erupts Into Controversy Over Change In Major Clinical Trial (Forbes)
  • Denali launches a clinical quest on Alzheimer’s drug, banking $155M in Takeda cash and scoring monkey data on BACE (Endpoints) (Press)
  • With Novartis and Roche gunning to carve up Eylea franchise, Regeneron has another PhIII success story to tell (Endpoints) (Press)
  • Trendy anti-aging biotech Unity adds $55M as it preps first human trial to flush senescent cells (Endpoints) (Press)
  • ShangPharma boosts Bay Area reach for early-stage research (Fierce)
  • HIV-prevention drug use rises, but is still slow among non-white patients (MedCity News)
  • Is TapImmune’s cancer vaccine the real deal? (MedCity News) (Press)
  • Real-World Data Support Use of Ofev in IPF Management, Study Finds (Pulmonary Disease News)
  • Aclaris Therapeutics Announces Positive Update on Phase 2 Results after a 3-month Follow-Up of A-101 45% Topical Solution for Potential Treatment of Common Warts (Press)
  • Autolus’ solid tumour CAR-Ts will have ‘off switch’ (pharmaphorum)
  • Jury out on liquid biopsies for cancer (Nature)
Medical Devices US: Assorted & Government
  • Kentucky bid to tax prescription opioids is dropped (AP News)
  • Lawmakers must act on limiting antibiotic use in food animals (STAT)
  • HHS Secretary Azar’s Remarks to the National Association of Community Health Centers (HHS)
  • Ex-PharMerica Exec Shakes Trade Secrets Suit (Law360-$)
  • For the MedTech Industry, Safety is Job #1 (AdvaMed)
  • Wyoming Governor Mead Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines (Biotechnology Innovation Organization)
  • AAM White Paper: Ensuring the Future of Accessible Medicines in the U.S. (White Paper)
  • Is Regulation Killing Innovation In Health Care? (Forbes)
  • FDA’s Quality Metrics Program: The Sound of Silence (FDA Law Blog)
  • Bipartisan, Bicameral Leaders Urge CMS to Further Improve Medicaid Data System (Press)
  • Former FDA commissioners say right-to-try bills could endanger ‘vulnerable patients’ (The Washington Post)
  • The Political Economy of the Hatch-Waxman Amendments (Elsevier)
  • The Struggle to Build a Massive ‘Biobank’ of Patient Data (NYT)
  • It's do-or-die week for ACA stabilization (Axios)
  • CVS Intensifies Anti-Tobacco Fight In Third Year (Forbes)
  • Study Illustrates How Medicaid Expansion Can Pay For Itself (Forbes)
Upcoming Meetings & Events Europe
  • MDxHealth (R): SelectMDx Liquid Biopsy Test for Prostate Cancer included in the 2018 European Association Urology Guidelines (Press)
  • Valneva Reports Positive Phase I Interim Results for Its Lyme Vaccine Candidate VLA15 (Press)
  • Data bolsters Fidia’s claims in papillary bladder cancer (The Pharma Letter-$) (Press)
  • Cost of drugs in 2017 in England dropped 0.41%, but more items dispensed (The Pharma Letter-$)
  • Public Hearing on the SCHEER Opinion: 'The need for non-human primates in biomedical research, production and testing of products and devices (update 2017)' (EC)
  • ExThera Medical Announces Creation of European Subsidiary (Press)
Asia
  • Asia Pharma Expo to boost Bangla pharma manufacturing standards (Pharmabiz)
  • New rules in Taiwan pharma to enact patent linkage (Asia Business Law Journal)
  • Local partnerships key to pharma’s success in China (pharmaphorum)
  • Ono brings Taiwan first I-O therapy for liver cancer (The Pharma Letter)
  • Time to End Tuberculosis in Asia – and the World (The Diplomat)
  • BioArctic Receives Patent Protection in Japan for a Medical Device for Treatment of Patients With Complete Spinal Cord Injury (Press)
  • Regenerative commercial potential on the horizon for Avita Medical (Small Caps)
  • MHLW Health Policy Chief Questions Volume-Focused Sales Strategies, Urges Drug Makers to Shift to Healthy Lifespan Extension (Jiho)
India
  • Why Earlier Government Health Insurance Failed? That Is Like Asking a Foster Parent About The Child’s Low Grades (Bloomberg)
  • Over half a million children in India are smoking cigarettes everyday (Quartz)
  • Top Body of National Health Mission Has Quietly Become an All-Bureaucrat Affair (The Wire)
  • NFHS data shows over one in seven Indian women don't receive antenatal care, highlights need to sensitise men on women's healthcare (Firstpost)
  • CDSCO flags drug firms for making and selling combination medicines without approval (Economic Times)
  • Wockhardt under NPPA lens over essential blood pressure medicine price (Economic Times)
Australia
  • Feedback invited on implementation plan for Australia’s National Digital Health Strategy (OpenGov)
  • Mayne pharma launches generic version of Monodox in Australia (BioSpectrum)
  • Dental report finds only half of all Australians brush their teeth twice a day (ABC News) (SBS News)
  • Senate inquiry to examine claims Indigenous suicide prevention funding misspent (The Guardian)
  • Medical devices and IVDs: Cancellations of certain devices within an entry (TGA)
Canada
  • Resverlogix Exceeds Full Enrollment for the Pivotal Phase 3 BETonMACE Clinical Trial (Press)
  • Health Canada to launch consultations on how high-alcohol mixed drinks should be sold (CBC  News)
  • Close the gap between Indigenous health outcomes and the rest of Canada (CBC News)
  • RAMcare Selects the Reacts Platform to Power Its Virtual Medical Care Program for Marginalized Patients (Press)
  • Senior left covering cost of knee braces after Manitoba Health refuses to pay (CBC News)
  • Medical Device Application Forms (Health Canada)
General Health & Other Interesting Articles
  • Take This App and Call Me in the Morning (NYT-$)
  • Are consumers overpaying at the pharmacy counter? (STAT-$)
  • A new kind of doctor's office that doesn't take insurance and charges a monthly fee is 'popping up everywhere' — and that could change how we think about healthcare (Business Insider)
  • The Other Opioid Crisis: Hospital Shortages Lead To Patient Pain, Medical Errors (KHN)
  • Heart Devices Vulnerable to Hacking: Here's How to Protect Yourself (Newsmax)
  • Record Numbers of College Students Are Seeking Treatment for Depression and Anxiety — But Schools Can't Keep Up (Time)
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.

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