Regulatory Recon: Merck's Keytruda Gets FDA Nod for Hodgkin Lymphoma; FDA Panel Says Opana Risks Outweigh Benefits (15 March 2017)

Posted 15 March 2017 By Michael Mezher

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

In Focus: US

  • Merck's Keytruda wins FDA nod for treating blood cancer (Reuters) (PharmaTimes) (Pharmafile) (Press)
  • By The Numbers: Trump's Choice For FDA Chief Is Versatile, Entrenched In Pharma (KHN)
  • Scott Gottlieb's Sham Ideology Rejects Clinical Trials (CardioBrief)
  • For Scott Gottlieb, Business Trumps Health (CardioBrief)
  • Generic Drugmakers Can Live With a Speedier FDA (WSJ)
  • FDA Advisory Panel Says Benefits of Painkiller Opana ER No Longer Outweigh Risks (WSJ) (Reuters) (Medpage)
  • New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India (Focus)
  • FDA Hands Pfizer's Hospira 483 for Quality System, Production Issues (FDA)
  • 'Right To Try' Bill Contradicts US FDA's Mission, Former Official Says (Pink Sheet-$)
  • How Do We Protect Patients From False Promises In Right-To-Try Laws? (Health Affairs Blog)
  • CRISPR Could Change The World, But Right Now $90 Million Is Enough  (Forbes)
  • "Chaos" Theory: Amgen's SCOTUS Merits Brief (FDA Law Blog)
  • Emergo Study: FDA 510(k) Submissions from US Companies on the Decline (Emergo)
  • Sticker Shock Forces Thousands Of Cancer Patients To Skip Drugs, Skimp On Treatment (KHN) (NPR)
  • Republicans weigh health bill changes as doubts mount (Reuters)
  • Americans Not Sold On Cost And Coverage Claims In GOP's Health Bill (KHN)
  • GOP Senators Say House Health Bill Won't Pass Without Changes (WSJ) (NYTimes)
  • Make America uninsured again: CBO says 52M uninsured by 2026 (Politico) (Forbes) (WSJ)
  • When will biopharma speak up about 24 million uninsured? (EP Vantage)
  • WH Explains Why CBO Health Care Report 'Doesn't Add Up' (NBC)
  • Obamacare Isn't in a 'Death Spiral.' (Its Replacement Probably Won't Be Either.) (NYTimes)

In Focus: International

  • Takeda transferring some drug development to joint venture (Nikkei) (BioSpectrum)
  • Celgene, Takeda and Others Found in Breach of UK's Pharma Code of Practice (Focus)
  • UK on Brexit Implications: 'Significant Benefits' to Remain Part of EMA (Focus)
  • Asia Regulatory Roundup: Pfizer Asks TGA to Rethink Timeline for Biologics AE Reporting (Focus)
  • Glaxo to Pay First Woman CEO Less, Cites Lack of Experience (Bloomberg) (The Guardian) (Financial Times) (Fierce)
  • In Africa, Scientists Are Preparing to Use Gene Drives to End Malaria (MIT Technology Review)
  • Drug groups criticize cost rules for rare diseases (Financial Times) (PharmaLetter-$)
  • NICE recommends against Opdivo for classical Hodgkin lymphoma (Pharmafile) (PharmaTimes)
  • Japan next to give AbbVie's hep C regimen priority review (PharmaLetter-$)
  • Pharma Showing More Interest In Conditional Approvals; Back On EU Expert Group Agenda (Pink Sheet-$)
  • Germany Heads For Ratification Of Unified Patent Court; Spanish MPs Push For Membership (Pink Sheet-$)
  • Oral cholera vaccination campaign launched in Somalia (WHO)
  • Two-part Ebola vaccine offers long-lasting protection (Reuters)
  • Indian Pharma Exits the Trauma Room (Bloomberg) (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Why clinical trial outcomes fail to translate into benefits for patients (Trials)
  • Gilead on HIV: New research, new treatments and the potential for a cure (EPR)
  • This Pharma Company Stays Innovative by Doing Two Things (Harvard Business Review)
  • Exploring Continuous Manufacturing Technology and Applications in the Pharmaceutical Industry (USP)
  • FDA-approved preterm birth drug has no benefit and may cause harm, study suggests (Pharmafile)
  • Better out than in as pharma continues to find value externally (EP Vantage)
  • On again, ex-Google superstar Bill Maris is said to bankroll a $100M biotech fund (Endpoints
  • FDA commissioner nominee would be a 'strong partner,' says ACRO (Outsourcing Pharma)
  • Turning Pfizer Discards Into Novartis Gold: The Story Of Ziarco (Forbes)
  • NIH-funded scientists deploy CRISPR to preserve photoreceptors in mice (NIH)
  • PARP Inhibitors Do It Again (In The Pipeline) (BioCentury)
  • Mixed pathologies and neural reserve: Implications of complexity for Alzheimer disease drug discovery (PLOS)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

US: Medical Devices

  • How to Name Your New Medical Device (MDDI)
  • Report: New version of "Medjack" malware a risk for older hospital systems (MassDevice)
  • DJO Global Announces FDA 510(k) Clearance for Exprt Revision Hip (Press)
  • First Ray Receives FDA 510(k) Clearance for Expanded Stealth Staple Product Line (Press)
  • Pulse Biosciences seeks FDA 510(k) for PulseTx system (MassDevice)
  • Medtronic wins extended FDA indication for bone cement (MassDevice)
  • Teleflex wins FDA nod for Twin-Pass torque dual access cath (MassDevice)
  • Medtronic wins expanded FDA indication for Melody TPV (MassDevice) (Press)
  • FDA announces updates to Medtronic's Class I recall for SynchroMed drug pumps (MassDevice) (FDA)

US: Assorted & Government

  • Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations (FDA)
  • Zostavax patients sue Merck, claiming shingles shot caused injuries and death (Fierce)
  • FTC Fights Impax Bid For Fees In Pay-For-Delay Case (Law360-$)
  • Patent Office Affirms Four of Acorda's Patents on MS Drug Ampyra Pending Court Ruling (FDANews-$)
  • PTAB Life Sciences Report -- Part II (Patent Docs)
  • There'll Always Be Posner: Reversal of Class Certification in the Blink of an Eye (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • $62m injection in Hungary is latest boost for GSK vaccine production (BioPharmaReporter)
  • Pfizer Launches Zavicefta™ (ceftazidime-avibactam) in the U.K. and Germany, a New Antibiotic to Treat Complicated Infections Caused by Gram-Negative Bacteria (Press)
  • BodyCap wins CE Mark for e-Celsius ingestible temp sensor (MassDevice)
  • AngioDynamics wins CE Mark for Solero microwave tissue ablation system (MassDevice)

Asia

  • Japanese firms agree licensing deal for autoimmune candidate (PharmaLetter-$)
  • Officials in Taiwan say fake Crestor used Chinese ingredients (Securing Industry)

India

  • Government gets Rs 672 crore fine from pharma companies for overcharging (Economic Times)
  • Indian pharma must comply with govt's Jan 1, 2018 deadline to upgrade staff skill sets for pharma industry (Pharmabiz)
  • Indian Pharmaceutical Alliance to release quality culture monitoring guidelines next year (Pharmabiz)
  • NPPA warns of action against cos selling notified medical devices without MRP (Pharmabiz)
  • Glenmark's Ankleshwar plant gets EIR report from USFDA (Economic Times)

Canada

  • Notice: Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales (Health Canada)
  • Roche EGFR Mutation Test Approved in Canada (GenomeWeb)

Other International

  • Hikma reports better-than-expected 2016 performance (PharmaLetter-$)
  • WHO and partners re-open Qayyara Hospital in Mosul with support from ECHO (WHO)

General Health & Other Interesting Articles

  • Want to Make It as a Biologist? Better Learn to Code (Wired)
  • Makers of thalidomide to be tried - archive, 1967 (The Guardian)

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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