Regulatory Recon: Eli Lilly to Lay Off 3,500 in Global R&D Cuts; FDA Puts Holds on BMS, Celgene Cancer Trials (7 September 2017)

Posted 07 September 2017 By Michael Mezher

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

In Focus: US

  • Eli Lilly to Cut 8% of Global Workforce, or 3,500 Jobs (WSJ) (Endpoints) (STAT) (Financial Times) (Bloomberg) (Press)
  • Safety fears spur FDA to pause checkpoint combo studies by Bristol-Myers, Celgene (Endpoints) (Reuters 1, 2) (BMS) (Celgene)
  • Bristol-Myers kidney cancer drug meets early success, study stopped (Reuters) (Press)
  • Alnylam slammed after patient death forces investigators to halt dosing of fitusiran, raising new safety fears (Endpoints) (Xconomy) (Reuters)
  • We May Soon Learn Just How Flexible Scott Gottlieb's FDA Is (Bloomberg)
  • CEO defends $300,000-per-year cost for a drug for a rare form of muscular dystrophy (CNBC)
  • PhRMA's Stephen Ubl talks pricing and politics  — and explains his reluctance to give Scott Gottlieb a grade (STAT)
  • Report: Insys faked cancer patients to sell drug (CNN) (Reuters) (STAT) (Report)
  • AstraZeneca, Amgen whip up some blockbuster excitement with a possible game-changing asthma drug (Endpoints) (Reuters) (NEJM 1, 2, 3)
  • This Shield of Patents Protects the World's Best-Selling Drug (Bloomberg)
  • FDA Form 483 for Celltrion May Offer a Glimpse Into Limited Uptake for Remicade Biosimilar (Focus)
  • CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers (Focus)
  • Novo Nordisk Pays $58M to Settle REMS Allegations (Focus)  (FDA Law Blog)
  • 23andMe is raising VC at a $1.5 billion valuation (Axios)
  • The billion-dollar gamble: Biotech CEO takes a risky second shot at an Alzheimer's drug (STAT)
  • When a Company Is Making Money From the Opioid Crisis (The Atlantic)
  • Departing Novartis CEO Sets His Eyes On Silicon Valley (Forbes)

In Focus: International

  • As China biotech booms, Fidelity group rolls out $250M fund with a big focus on drug R&D (Endpoints)
  • Ramping back up on oncology, GSK takes an option on Adaptimmune's TCR cancer drug (Endpoints)
  • UK Government Outlines Science Objectives Post-Brexit (BioCentury) (ABPI)
  • New CFDA Medical Device Classification Catalog May Require New Registrations in China (Emergo)
  • Infectious Mosquitoes Are Turning Up in New Regions (NYTimes)
  • India, Indonesia far behind in measles vaccination: WHO (Economic Times)
  • Mexican Antitrust Authority Study on Generic Drug Entry – Recommendations on Changes to Public Policy -- Part IV (Patent Docs)

Pharmaceuticals & Biotechnology

  • Patient Voices: Childhood Cancer (NYTimes)
  • To fight opioid epidemic, senators make the case for 'partial fill' prescriptions (STAT)
  • Alternative Perspectives On The Biotech M&A Environment (Forbes)
  • Deal hungry biopharma remains happy to pay up (EP Vantage)
  • Vertex Pharma bring in new CFO, shares rise (Pharmafile)
  • Merck just plowed millions into this start-up to help get drugs to market faster (Merck)
  • Rx Price Watch Report: Trends in Retail Prices of Specialty Prescription Drugs Widely Used by Older Americans: 2006 to 2015 (AARP)
  • Google helps boost Gritstone's neoantigen R&D gamble to $195M as researchers prep for first human study (Endpoints) (Fierce) (Forbes)
  • August Unofficial Approval Figures Not What Industry Had Hoped  (Lachman Consultants)
  • FDA Marketing Exclusivity Periods Limited To Same Active Moiety (National Law Review)
  • FDA Finalizes Guidance on Deviation Reporting for HCT/Ps (Focus)
  • Discussing cancer costs can reduce treatment expenses (Reuters)
  • Positive lung drug trial opens path to U.S. market for Circassia (Reuters)
  • Drug may slow early lung disease damage (Reuters)
  • Insurers, doctors battle over new heart disease drugs (CNBC)
  • 2016's Fastest-Growing, Private Specialty Pharmacies (From the Inc. 5000) (Drug Channels)
  • Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection (FDA)
  • Takeda, Johnson & Johnson and more join Clara Health's Boston-based patient empowerment push (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Approves Tracleer For Pediatric PAH (BioCentury)
  • Aerie launches Ph3 trial for Roclatan eye drug in Europe (Drug Delivery)
  • AbbVie adds more stellar data on ABT-494 — this time for atopic dermatitis (Endpoints)
  • Humacyte Completes Patient Enrollment for Phase III Clinical Trial of Human Acellular Vessel (Press)
  • vTv Therapeutics Presents Further Dose Response Analysis from Phase 2 Study of its GLP-1 Receptor Agonist at 53rd Annual Meeting of the European Association for the Study of Diabetes (Press)
  • Bayer submits marketing authorization application for BAY94-9027 for the treatment of Hemophilia A in the EU (Pipeline Review)
  • InflaRx Reports Topline Phase IIa Clinical Results of IFX-1 for the Treatment of Hidradenitis Suppurativa (Press)
  • Project ALS and Amylyx Enter Collaboration to Test AMX0035 (Press)

Medical Devices

  • Help Wanted: FDA Seeks Digital Health Entrepreneurs (Focus)
  • FDA Reviewing Candidates for Digital Health Precert Program (FDA)
  • Quest to offer cholesterol testing without fasting requirement (Reuters)
  • J&J Vision closes TearScience buyout (MassDevice)

US: Assorted & Government

  • Congress' Tight Timetable Complicates Renewal Of Children's Health Plan (KHN)
  • Senate Subcommittee Approves 2018 Funding Bill Increasing NIH Budget (GenomeWeb)
  • Anthem cuts back Obamacare coverage in Kentucky (Reuters)
  • Health-Care Industry Asks Senate For Two Years Of Obamacare Subsidies (Forbes)
  • Uninsured Rate Spiked for Some Americans in 2017 (Politico)
  • Opioid Crisis Looms Over Job Market, Worrying Employers And Economists (NPR)
  • NIH awards nearly $100 million for Autism Centers of Excellence program (NIH)
  • Boston Scientific wins FCA whistleblower suit over Cognis CRT-Ds, Teligen ICDs (MassDevice)
  • Ex-broker pleads not guilty in insider trading case involving Abbott, St. Jude merger (MassDevice)
  • AbbVie Can't Block Ads From Next AndroGel Bellwether (Law360-$)
  • Impax To Pay $4.8M To End 'Fax-Blasting' Suit (Law360-$) (Drug Delivery)
  • Good Heeding Presumption Decision in New York (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • What's stopping pharmacies doing more to reduce pressure on GPs? (The Guardian)
  • Slovak clinic treats lazy eye with virtual reality game (Reuters)
  • Spain OKs TiGenix's bigger cell therapy plant as firm preps for Cx601 (BioPharmaReporter)
  • MRC and Arts and Humanities Research Council join forces on global public health challenges (MRC)

Asia

  • Seventieth session of WHO Regional Committee for South-East Asia (WHO)
  • Taiwan's FDA Completes Draft of Medical Devices Act (Pacific Bridge Medical)

India

  • KDPMA urges Health Ministry to make replacement of gelatin with cellulose-based capsules optional (PharmaBiz)

Other International

  • Cholera spreads through camps in Nigeria's strife-hit northeast: U.N (Reuters)

General Health & Other Interesting Articles

  • Human genome data 'should be open to all (Financial Times)
  • Intimidated patients may act like hostages (Reuters)

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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