Regulatory Focus™ > News Articles > Regulatory Recon: J&J Halts Two Drugs in Development; Novartis to Close Colorado Manufacturing Site

Regulatory Recon: J&J Halts Two Drugs in Development Novartis to Close Colorado Manufacturing Site (17 October 2017)

Posted 17 October 2017 | By Zachary Brennan 

Regulatory Recon: J&J Halts Two Drugs in Development Novartis to Close Colorado Manufacturing Site (17 October 2017)

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

In Focus: US

  • Allergan Brings the Roof Down On Its Head (In the Pipeline) (NY Times) (Focus) (Patent Docs)
  • Senator introduces repeal of 2016 law after "60 Minutes" opioid epidemic report (CBS News)
  • The secretive family making billions from the opioid crisis (Esquire)
  • Trump tweets that Marino is out of consideration for drug czar (CNN) (Bloomberg) (NY Times)
  • Trump says opioid emergency will be declared next week (Stat)
  • 450 jobs will be lost in shutdown of Novartis division in Broomfield (Denver Post) (In-Pharmatechnologist)
  • J&J is jettisoning two of its promised blockbuster drugs, and it couldn’t come at a worse time (Endpoints) (Fierce) (Reuters) (GEN)
  • Flurry of New Guidances from CDRH and Notable Changes to the Pre-Submission Process (FDA Law Blog)
  • The Cost Of Developing Drugs Is Insane. That Paper That Says Otherwise Is Insanely Bad
  • Trump’s new talk on US drug prices sends biotech stock index down (Bloomberg) (Politico)
  • Trump discussing pharmaceutical prices (NBC News)

In Focus: International

  • EMA Plots Out Priorities to Deal With Brexit Uncertainties (Focus)
  • European Ombudsman concludes her inquiry into the HPV vaccines referral (EMA)
  • EMA counters the academics who criticized the cancer drug approval process (Endpoints)
  • EMA says impending EudraVigilance launch benefits MAHs (In-PharmaTechnologist)
  • Drug companies in the crosshairs of China’s Cybersecurity Law (BioWorld-$)
  • How the University of California Is Fighting Proxy Patent Battle for Expensive Cancer Drug in India (The Wire)
  • Increase of antibiotic resistance - Antibiotic Awareness Week highlights the risks (SwissMedic)

Pharmaceuticals & Biotechnology

  • Impax Laboratories and Amneal Pharmaceuticals Near Merger Agreement (WSJ-$)
  • Mass. biotech jobs hit all-time high as drug pipeline swells (Boston Business Journal)
  • HELP takes another stab at drug prices (Politico)
  • Pfizer, NEA back Cydan II’s plans to launch a fresh slate of biotech startups focused on rare genetic diseases (Endpoints)
  • Sanofi cancer executive jumps ship to Silicon Therapeutics (Fierce)
  • Orexigen posts a ‘for sale’ sign in the yard as weak Contrave sales raise concerns (Endpoints)
  • Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports (Focus)
  • Fresenius Can't Duck FCA Claims Over Hepatitis B Tests (Law360-$)
  • Preferred Pharmacy Networks Will Dominate 2018 Medicare Part D Plans (Plus: We Review the Top Plan Sponsors) (Drug Channels)
  • New gene therapy treatment could hit $1M per patient because of additional costs (Kaiser Health News)
  • KEI finds University of Pennsylvania failed to disclose government rights in five CAR T patents (KEI)
  • FDA Finding Doesn't Absolve Forest Labs, Parents Say (Law360-$)
  • Spark Therapeutics’s success is lifting all gene therapy stocks even though risks remain (Stat-$)
  • Gemini raises $42.5m in Series A (Biocentury-$)
  • CVS Health and Epic Announce Initiative to Help Lower Drug Costs for Patients by Providing Prescribers with Expanded Visibility to Lower Cost Alternatives (Press)
  • Gilead Sciences Announces Promotion of Alessandro Riva to Executive Vice President, Oncology Therapeutics (Press)
  • Vertex Announces 10-Year, $500 Million Corporate Giving Commitment (Press)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • One Scientist’s Marathon Quest for the Exercise Pill (Bloomberg)
  • Promising data for Sanofi, Regeneron’s dupilumab (PharmaTimes)
  • AstraZeneca lung cancer drug proves able to shrink EGFR mutation-positive tumours (Pharmafile) (PharmaTimes)
  • Chi-Med, AstraZeneca lung cancer drug shrinks resistant tumors (Reuters)
  • Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA (Press)
  • Richard Lehman’s journal review (BMJ)
  • US FDA Accepts Supplemental Biologics License Application for Imfinzi (durvalumab) in Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Press)
  • FDA Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Patients with Resected High-Risk Advanced Melanoma and Grants Priority Review (Press)

Medical Devices

  • Center for Devices and Radiological Health: Experiential Learning Program (Federal Register)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking (Federal Register)
  • Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the
  • Organophosphate Test System (Federal Register)
  • Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities (Focus)
  • J&J’s DePuy launches Maxframe limb correction system (Mass Device)
  • Illumina Ventures Founder talks about investment priorities for first $230M fund (MedCity News)
  • OptiNose IPO pulls in $120m (Drug Delivery)
  • FDA Looks For Diverse CMMI 'Maturity' Pilot Enrollees; Device-Makers Expect Big Savings (MedTech Insight)

US: Assorted & Government

  •  Senator introduces repeal of 2016 law after "60 Minutes" opioid epidemic report (CBS News) (PhRMA)

Upcoming Meetings & Events

Europe

  • Batavia adding 50 jobs in US viral vector and EU cleanroom expansion (BioPharma-Reporter)
  • South London man convicted for large number of unlicensed medicines (MHRA)

General Health & Other Interesting Articles

  • New Imaging Approach Reveals Lymph System in Brain (NIH Director’s Blog)
  • Raising Concerns About a Widely Used Test to Measure Fertility (NY Times-$)
  • 7 Million American Men Carry Cancer-Causing HPV Virus (NY Times-$)

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? 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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