Recon: Nektar Withdraws Opioid NDA After FDA Panel Votes Unanimously Against Approval – Regulatory Focus

Posted 15 January 2020 | By Michael Mezher 

Recon: Nektar Withdraws Opioid NDA After FDA Panel Votes Unanimously Against Approval
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • Nektar withdraws NDA for opioid after FDA panel's unanimous vote against it (Reuters) (Endpoints) (Press)
  • FDA staff highlights neurological safety concerns with Durect's pain drug (Endpoints)
  • More Than 100 Billion Pain Pills Saturated The Nation Over Nine Years (Washington Post)
  • New York drug distributor exits opioids after admitting role in crisis (Reuters)
  • Drug Pricing: What Happened In 2019, What To Watch In 2020 (Law360-$)
  • Nationwide Children's, a gene therapy leader, launches manufacturing spinout (BioPharmaDive) (Columbus Dispatch)
  • UPMC Plans $800 Million Investment in Life Sciences (WSJ) (Endpoints)
  • Goldman-Backed Medical Device Maker REVA Files for Bankruptcy (WSJ PRO-$)
  • Top product forecasts for 2020 (Nature)

In Focus: International

  • HIV combo drug Dovato gets Japan approval (PharmaLetter-$) (Press)
  • Takeda hops onto $61M round for CRISPR player synthesizing Cas9 alternatives (Endpoints)
  • UK cell and gene clinical trials up 45% from 2018 (PharmaTimes)
  • UK's NICE isn't convinced by Merck's Keytruda in head and neck cancer (Endpoints) (PharmaTimes)
  • PTC submits MAA for new gene therapy (PharmaTimes)
  • UK Heads For Full Trial Transparency (Pink Sheet-$)
  • Pfizer's Ibrance combo authorised via the Cancer Drugs Fund for advanced breast cancer (Pharmafile)

Pharmaceuticals & Biotechnology

  • JPM Tuesday roundup: Pfizer CEO talks up pipeline, bolt-on deals the name of the game in 2020? (Fierce)
  • JPM20: Neuroscience's decade, a biotech's 'crown jewel,' and Ionis gets selective (BioPharmaDive)
  • JPM: Mayo Clinic, nference launch ambitious data platform initiative (Fierce)
  • J.P. Morgan Notebook Day 2: Bourla Feels Pfizer's Underappreciated, GSK Prepares For Myeloma First And More (Pink Sheet-$)
  • JPM: Alexion to take Ultomiris into tough ALS study as switching campaign exceeds expectations (Fierce)
  • JPM: With Tesaro staff and expertise in the mix, GSK gears up for 3 oncology launches in 2020 (Fierce)
  • Endpoints at #JPM20 — newsmakers on dealmaking, pricing and manufacturing (Endpoints)
  • Galapagos finds a new normal at biotech's biggest dealmaking event (BioPharmaDive)
  • Galapagos beefs up its fibrosis pipeline, lassoing 4 more programs and taking a stake in small Canadian partner (Endpoints) (Fierce)
  • Intellipharmaceutics’ Oxycodone ER Returns To US FDA Panel Looking For Abuse-Deterrence Claim (Pink Sheet-$)
  • US/EU MRA Implementation, US Congressional Hearings, and Industry Surveys Shed Light on Global GMP Inspection Challenges and Collaboration Opportunities (IQP)
  • Pfizer Taps Insilico Medicine to Use AI for Drug Target Discovery (Xconomy)
  • Phage Therapy Firm APT Lands DoD Contract for Antibiotic Alternative (Xconomy)
  • Bluebird Bio taps ex-Celgene exec Heffron to lead its first gene therapy launch (Fierce) (Endpoints)
  • Some good news for Innate as it gets French regulator’s nod to resume lacutamab trial (PharmaLetter-$)
  • University of Minnesota Twin Cities and Windgap Medical receive $3.2 million NIH grant to develop cyanide antidote autoinjector (University of Minnesota)
  • After a single patient drives a big stock surge, Patrick Soon-Shiong makes his case to investors (STAT)
  • Regeneron’s Yancopoulos is still bitter over Praluent sales. Can Novartis do better? (STAT)
  • On the cusp of FDA approval for its NASH drug, Intercept’s CEO talks payers, pruritis, and price (STAT)
  • FDA approves Lannett's cocaine-based nasal spray (Pharmafile)
  • Who Are The Scofflaws On Reporting Clinical Data? Surprisingly, Not Big Pharma. (Forbes)
  • Novel Excipients: New Hope for Therapeutic Innovations (USP)
  • Canadian generics firm JAMP Pharma moves into biosimilars (PharmaLetter-$)
  • CDISC Adds Four New Members and Re-appoints Two to 2020 Board of Directors (Press)

Pharmaceutical & Biotechnology: Study Results, Filings & Designations

  • Clovis Oncology’s Rubraca® (rucaparib) Granted FDA Priority Review for Advanced Prostate Cancer (Press)
  • U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in First-Line Non-Small Cell Lung Cancer (Press)
  • Tmunity Announces First Patient Dosed in Phase 1 Clinical Trial with CART-TnMUC1 (Press)

Medical Devices

  • The Vanishing PMA Device Advisory Panel Meeting (FDA Law Blog)
  • RTI Surgical inks $490M deal to sell OEM unit to private equity (MedtechDive)
  • Nevro, NuVasive, Integra, others preview earnings at JPM (MedtechDive)
  • US FDA recognizes latest edition of ISO 14971 as medical device consensus standard (Emergo) (AAMI)
  • Medtronic at JPM: More tuck-ins under Martha and key trial results ahead (MedtechDive)
  • ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations (MedtechDive)
  • Amid Q4 letdown, Boston Scientific targets $1B in structural heart, $2B single-use endoscope market (MedtechDive)
  • LabCorp, Quest push for M&A-driven growth despite difficulties closing deals (MdedtechDive)
  • Robotic surgeries surge to 15% of all procedures, despite limited evidence (MedtechDive)
  • FDA clears Cleveland Clinic 3D-printed airway stents (MassDevice)

US: Assorted & Government

  • Biosimilar Patent Litigation May Be On The Rise In 2020 (Law360-$)
  • Two moments on health care from the Democratic debate (Politico)
  • Warren and Klobuchar Say They Can Lower Drug Prices Without Congress’ Help (KHN)
  • Sanders Targets Health Industry Profits. Are His Figures Right? (KHN)
  • Hospira, Inc. v. Fresenius Kabi USA, LLC (Fed. Cir. 2020) (Patent Docs)
  • Court Rolls Up CBD Class Action (at least for now) (Drug & Device Law)
  • USMCA Trade Deal Slated For Final Passage This Week (Law360-$)
  • House GOP reopens investigation into opioid manufacturers over role in crisis (The Hill) (FDA News-$)
  • Feds Say 'Concise' Charges Against Ex-Theranos Exec Suffice (Law360-$)
  • UK Pharma Co. Scores Patent For Magic Mushroom Treatment (Law360-$)
  • Son Of Ex-Ariad Pharma Director Found Guilty Of Insider Trading (Law360-$)
  • House Bill Would Let FDA Regulate CBD As A Supplement (Law360-$)
  • NJ Appeals Court Shuts Down Injury Suit Over Bayer's Essure (Law360-$)

Upcoming Meetings & Events Europe

  • MDR Watch: Are Regulatory Affairs departments in need of more adequate support? (Emergo)

India

  • Alembic gets USFDA nod for Tizanidine hydrochloride capsules used to treat spasticity (Economic Times)
  • Sun Pharma, US-based Rockwell Medical enter into licensing pact for Triferic in India (Economic Times)
  • IP Alliance asks finance ministry to provide safe harbour rules for contract manufacturing for pharma industry (Pharmabiz)
  • DoP rejects Geltec's review petition against price fixation on ibuprofen capsule 400mg (Pharmabiz)
  • DCGI directs state DCs to ask cos to get product licenses of 2,131 FDCs approved by Kokate Committee (Pharmabiz)

Canada

  • Juul Labs to stop selling fruit-flavored pods in Canada (Reuters)

General Health & Other Interesting Articles

  • That Lead Apron in the X-Ray Room? You May Not Need It (NYTimes)
  • Heart Disease Strikes Back Across the US, Even in Healthy Places (WSJ)
  • ‘How long do I have?’ A website on cancer survival rates, from the co-founder of GoodRx, seeks to provide clarity (STAT)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Source: https://www.raps.org/news-and-articles/news-articles/2020/1/recon-nektar-withdraws-opioid-nda-after-fda-panel


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