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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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-$)
• NJ Appeals Court Shuts Down Injury Suit Over Bayer's Essure (Law360-$)

• FDA Advisory Committee Calendar
• FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop – 4 May 2020
• Advancing Animal Models for Antibacterial Drug Development – 5 May 2020

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

• 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)

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

• 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)