Regulatory Focus™ > News Articles > Regulatory Recon: Former Lilly Exec Said to be Front Runner for HHS Secretary; Alnylam Partners With

Regulatory Recon: Former Lilly Exec Said to be Front Runner for HHS Secretary Alnylam Partners With Vir on RNAi Hep B Treatment (18 October 2017)

Posted 18 October 2017 | By Michael Mezher 

Regulatory Recon: Former Lilly Exec Said to be Front Runner for HHS Secretary Alnylam Partners With Vir on RNAi Hep B Treatment (18 October 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA selects Box to help it modernize IT infrastructure (ZDNet)
  • With $500M-plus, a buyout and two new billion-dollar pacts, upstart Vir is ready to roll on infectious diseases (Endpoints) (Reuters) (Fierce) (Press)
  • Trump leaning toward former Eli Lilly exec for health secretary (Politico) (Endpoints)
  • US veterans sue drug companies over Iraq bribes (Financial Times) (STAT)
  • Justice Department Indicts 2 Chinese Nationals In Synthetic Opioid Case (NPR) (Reuters)
  • Drug Companies Make Eyedrops Too Big — And You Pay for the Waste (ProPublica)
  • Ultra-personal therapy: Gene tumor boards guide cancer care (AP)
  • New cancer drugs help Johnson & Johnson top profit estimates (Reuters) (WSJ)
  • J&J wins reversal of $72 million verdict over talc cancer risks (Reuters)
  • Congress isn't acting to curb drug prices, so states are stepping up. Here's how (STAT)
  • Orphan Drugs in the United States (QuintilesIMS)
  • FDA Officials Offer Advice on Efficient Orphan Drug Development (Focus)
  • Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System (Focus)
  • Here's How Drug Companies Game the Patent System (Bloomberg)
  • Drug Supply Players Point a Finger Everywhere But Themselves (Bloomberg)
  • Hunting an early FDA OK, Ignyta surges on promising snapshot of lung cancer data (Endpoints) (Forbes) (Fierce) (Press)
  • Anthem Partners With CVS Health To Launch New PBM (Forbes) (Reuters) (Press)
  • Generic Drug User Fees Reauthorization: A Victory for Public Health (FDA Voice)
  • Is FDA Set for Another Banner Year of Approvals? (Eye on FDA)

Preparing for the Spring 2018 RAC Exam?

In Focus: International

  • Eli Lilly invests in Germany's CureVac in cancer vaccine drive (Financial Times) (Reuters) (Endpoints) (Press)
  • Reckitt issues second sales warning this year, launches shake-up (Financial Times)
  • PRIME status for Ignyta's entrectinibin (PharmaTimes) (Press)
  • Bayer files for Japanese approval of extended half-life Hemophilia A compound (Reuters)
  • GSK, Plasticell sign deal to produce haematopoietic cells (PharmaTimes)
  • ICH Transparency: New Info on Funding, Expert Working Groups (Focus)
  • Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (Focus)
  • Cuban biotech royally connected in Thailand (Asia Times)
  • Shanghai Pharma bids for US Cardinal Health's China business (Reuters)
  • Intellectual property laws demand a 21st-century solution (The Guardian)
  • UK Study Finds PrEP Program Offers Cost and Clinical Benefits (Medpage)
  • EU 'Vaccine Hesitancy' And Why It's A Problem For Manufacturers And Public Health (Pink Sheet-$)
  • Takeda starts production of anti-cancer drug in Russia (PharmaLetter-$)
  • Ukraine Nod Paves Way For Panacea Sales To 49 Other Nations (SCRIP-$)
  • Canada is long overdue for a national registry of drug company payments to doctors (STAT)
  • Suspected cases from Seychelles test negative for plague (WHO)

Pharmaceuticals & Biotechnology

  • Recommendations for Strengthening the Investigator Site Community (CTTI)
  • FDA's Authority to Regulate Off-Label Promotion (TheRegReview)
  • Some Bright Spots on First Cycle Approvals (Lachman Consultants)
  • FDA Form 483 For Atlas Pharmaceuticals (FDA)
  • Antibiotic Incentives: Prize Fund Is Focus Of Presidential Report On Incentives (Pink Sheet-$)
  • Wasabi Pain Pathway in Worms May Lead to New Pain Meds for Humans (GEN)
  • Outcome Health launches internal probe, offers client audits after WSJ report (Fierce)
  • Blade Therapeutics gains rest of series B, picks leading candidate (Fierce)
  • Should donor sex influence blood transfusion practices? (Reuters)
  • Scientists Push To House More Lab Monkeys In Pairs (NPR)
  • Quality System Transformation Needed for Next-Gen Product Acceleration, Johnson & Johnson's Sallans Tells ISPE/FDA/PQRI Conference (IPQ)
  • Amgen: Industry must look to next-generation continuous cell harvesting tech (BioPharmaReporter)
  • Padding its lung cancer lead, Merck's Keytruda helped PD-L1 patients live 30 months longer (Fierce)
  • Johnson & Johnson says Puerto Rico plants 'fared well' in Maria but 'intermittent' shortages possible (Fierce)
  • First-ever study in the personalised treatment of rare cancers brings promising results (Pharmafile)
  • Google's GV and allies double down on Forty Seven with their second $75M round (Endpoints)
  • Biopharmaceutical Industry Creates Economic Opportunity for Americans (Pfizer)
  • TG stumbles on FDA feedback for cancer combo (BioPharmaDive)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Astra and Merck win speedy review for Lynparza in breast cancer (Reuters) (Press)
  • Novartis says ‍revolade shows long-term disease control for chronic/persistent immune thrombocytopenia​ (Reuters)
  • Pacira Pharmaceuticals Announces FDA Acceptance of sNDA for EXPAREL as a Nerve Block to Produce Regional Analgesia (Press)
  • Spectrum Pharmaceuticals Highlights Poziotinib Data in Non-Small-Cell Lung Cancer (NSCLC) Presented at the 18th IASLC World Conference on Lung Cancer in Japan (Press)

Medical Devices

  • A Diabetes Monitor That Spares the Fingers (NYTimes)
  • Transenterix won't compete head-on with Intuitive Surgical: CEO (Reuters)
  • How to prepare your medical device company for an FDA inspection (MedCityNews)
  • Center for Devices and Radiological Health: Experiential Learning Program (FDA)
  • Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System (FDA)
  • Robotic-Assisted Surgery – Current Challenges and Future Directions: Interview with Dr. Mona Orady (MedGadget)
  • Will the Latest Smith & Nephew Rumor Actually Pan Out? (MDDI)
  • Does Your Product Need a More-Flexible Sterilization Cycle? (MDDI)
  • FDA OKs trial for MiMedx AmnioFix knee treatment, prelims (MassDevice)
  • Arthrex to build $74m plant, add 1,000 jobs to SC over 5 years (MassDevice)
  • OptiScan's glucose monitoring system for the ICU wins 510(k) clearance (MassDevice)

US: Assorted & Government

  • Deep in Trump Country, a Big Stake in Health Care (NYTimes)
  • Health leaders blame addiction for US opioid crisis (BMJ)
  • Online sellers of designer drugs are a dark partner in the opioid epidemic (STAT)
  • Drug overdoses killed more Americans last year than the Vietnam War (CBS)
  • The Alexander-Murray Market Stabilization Package: What's In It And Where's It Going? (Health Affairs Blog) (NYTimes)
  • Trump backs away from Senate deal on stabilizing Obamacare (Reuters)
  • UnitedHealth sees growth in 2018, opportunities in Trump plans (Reuters)
  • Financial Times to "the Patent Troll Narrative" -- Much Ado About Nothing (Patent Docs)
  • Seventh Circuit Curtails RICO Application to Third-Party Payor Off-Label Suits (Drug & Device Law)
  • 50 Ways to Leave Your Lover and 56 Ways to Go to Jail (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • Call for changes to proposals on EU reform of genetic testing services in Europe (PHG)
  • BioProduction 2017 on the Green Isle: Live updates from Dublin (BioPharmaReporter)
  • GP Labs plans production of cancer drugs in Russia (PharmaLetter-$)
  • New studies point to cracks forming in NHS services (Pharmafile)
  • DarioHealth wins CE Mark for glucose meter that connects to iPhone 7, 8 devices (MassDevice)

Asia

  • National Database Initiative for Regenerative Medicine Goes Live; Use for Review, Development Eyed (PharmaJapan)
  • Momentum For ViroMed's Gene Therapy After 'Exceptional' Trial Go-Ahead In China (SCRIP-$)
  • CFDA's International Cooperation Bureau meets the Head of the Office of International Program(OIP),USFDA (CFDA)
  • Astellas Enters into a New Collaborative Research Agreement with TB Alliance to Discover Anti- tuberculosis Drugs (Press)

India

  • AstraZeneca Pharma India gets DCGI nod to market diabetes drug (Economic Times)
  • Pharma's 'No-Show' At Regulatory Meetings In India: Who Loses? (Pink Sheet-$)
  • Popular antacid samples fail quality tests, company claims they were counterfeits (Economic Times)
  • Suven gets patent from Singapore for neurological molecule (Economic Times)
  • Maha FDA issues checklist to pharmacy outlets for self-compliance of norms (PharmaBiz)
  • BDC&DA urges Centre to enhance GST composition scheme, to cut levy on cancer, HIV drugs (PharmaBiz)
  • Karnataka drugs control dept to modernise infrastructure, streamline processes (PharmaBiz)

Australia

  • Australia's Benetic Biopharma jumps 26.7% on hepatitis treatment patent (Financial Times)
  • AIVC recommendations for the composition of influenza vaccine for Australia in 2018 (TGA)

Other International

  • Viveve wins Mexican clearance for Viveve system (MassDevice)

General Health & Other Interesting Articles

  • How to Spend $1,900 on Gene Tests Without Learning a Thing (MIT Technology Review)
  • Fatty liver disease fastest-growing reason for transplants in young U.S. adults (Reuters)
  • Search Of DNA In Dogs, Mice And People Finds 4 Genes Linked To OCD (NPR)

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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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