Regulatory Recon: Clovis Wins FDA Approval for Rubraca; Japan Review Drug Prices Annually (19 December 2016)

Posted 19 December 2016 By Michael Mezher

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed Friday's Recon? Read it here.

In Focus: US

  • FDA May Outlast Trump's Change Agenda (MDDI)
  • After an R&D odyssey filled with setbacks, Clovis wins an FDA OK for rucaparib (Endpoints)
  • Grilled About Deadly Superbug Outbreaks, Execs At Scope Maker Olympus Take Fifth (KHN)
  • Chantix, Zyban Lose Boxed Warning on Psych Effects (Medpage) (Reuters) (FDA 1, 2) (Press)
  • U.S. lawmakers press Heritage Pharma on high prices for antibiotic (Reuters)
  • Will $2.5Bn Jury Verdict Against Gilead Stand? Future Royalties, Willful Infringement Penalty Uncertain (Pink Sheet-$)
  • Hospitals Alter Routines to Control Drug Spending (WSJ)
  • When Genetic Tests Disagree About Best Option For Cancer Treatment (NPR)
  • Looking For Bargains, Many Americans Buy Medicines Abroad (NPR)
  • Defunct Deals Show Companies Want to Get Hitched or Die Trying (Bloomberg)
  • CMS Drops Medicare Part B Drug Payment Pilot (Focus)
  • FDA Warns Two Pharma Companies Over Misleading Ads (Focus) (FDA Law Blog)
  • FDA Bans Powdered Gloves (Focus)
  • The Best Biopharma CEOs of 2016 Are... (The Street)
  • Ionis Pharma's rare metabolic disorder drug succeeds key study (Reuters)
  • 'Extraordinary growth' on the cards for cancer immunotherapies (PharmaTimes)
  • US drugmaker charges 200 times UK price for common worm pill (Financial Times)
  • Big pharma braces for further bruising publicity over drug prices (Financial Times)
  • Trial watch: Opportunities and challenges of the 2016 target landscape (Nature)
  • PTAB Life Sciences Report (Patent Docs)
  • CRISPR companies team up to defend IP (BioCentury)

In Focus: International

  • EMA to Launch Tailored Biosimilar Scientific Advice Pilot (Focus)
  • Privacy by design and data portability (MedicalDevicesLegal)
  • Takeda lashes out again over NICE's no to Adcetris (PharmaLetter-$)
  • AstraZeneca oncology head jumps ship to become Innate CEO (Reuters)
  • China's OxyContin Boom Is a Gold Mine for This Drugmaker (Bloomberg)
  • Japan to review drug prices annually vs every two years previously: sources (Reuters)
  • India: Norms eased for makers of biologic products (Economic Times)
  • Richter withdraws marketing application for biosimilar drug (Reuters)
  • Indian anti-trust regulators approve $25B Abbott-St. Jude Medical tie-up (MassDevice) (Economic Times)
  • Medigene eyeing more immunotherapy deals after Bluebird pact (Reuters)
  • Japan's Ministry of Health, Labour and Welfare Approves Gilead's Vemlidy® for Patients With Chronic Hepatitis B Virus Infection (Press)

US: Pharmaceuticals & Biotechnology

  • Robert Ross joins Surface Oncology as chief medical officer (Press)
  • Induced pluripotent stem cell technology: a decade of progress (Nature)
  • The Uncertain Future of Biosimilars in the United States (Policy and Medicines)
  • Actelion surges again as Sanofi rumors intensify (BioCentury)
  • GSK opens first US vaccine R&D site in Maryland next to non-profit public health unit (BioPharmaReporter)
  • 21st Century Cures: Modernizing Public and Private Research (National Law Review)
  • In Colorado, A Low-Price Drug Cocktail Will Tamp Down Cost Of Death With Dignity (KHN)
  • US approval gives Bangladeshi company competitor to B-MS' Glucophage (PharmaLetter-$)
  • After Setback, Ophthotech Restructures, Dials Down Eye Drug Studies (Xconomy)
  • Genomic Testing, Reflective Equilibrium and the Right Not To Know (Harvard Bill of Health)
  • AbbVie, U of C choose first batch of cancer research projects (Chicago Business)
  • Boehringer Ingelheim and Lilly Welcome New Recommendation for Jardiance® (empagliflozin) Tablets in Updated American Diabetes Association's 2017 Standards (Press)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; TRULICITY (FDA)

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

  • Flamel Technologies dose first patient in Phase III narcolepsy trial (Drug Delivery)
  • AmpliPhi Biosciences Reports Favorable Final Results From Phase 1 Trial of AB-SA01 in Chronic Rhinosinusitis Patients (Press)
  • Poxel Announces Phase 1 Initiation of EYP001 for the Treatment of Chronic Hepatitis B Virus Infection by Licensing Partner ENYO Pharma SA (Press)
  • GSK Starts Phase III Study of Once-Daily Closed Triple Combination Therapy FF/UMEC/VI in Patients with Asthma (Press)
  • Sage Therapeutics Announces Initiation of Phase 2 Clinical Development for SAGE-217 in Mood Disorders (Press)

US: Medical Devices

  • FDA issues Class I recall for select Greatbatch offset cup impactors (MassDevice) (FDA)
  • Pediatric device consortia wants to close the supply-demand gap (MedCityNews)
  • FDA Describes Policy for Emerging Medical Device Signals in Final Guidance (National Law Review)
  • FDA Grants QT Vascular Full IDE Approval to Begin Pivotal Trial Of Its Drug-Coated Balloon, Chocolate Touch™ (Press)
  • Cepheid Announces FDA Clearance of Next-Generation Test for MRSA Colonization (Press)
  • BioTrace Medical Announces First U.S. Patients Treated with Company's Innovative Temporary Pacing Lead (Press)
  • PAVmed Files 510(k) FDA Submission for PortIO™ Intraosseous Infusion System (Press)
  • Masimo Announces FDA 510(k) Clearance for TFA-1™ Single-Patient-Use Forehead Sensor (Press)

US: Assorted & Government

  • Appeals court denies ex-Cyberonics rep's False Claims Act lawsuit (MassDevice)
  • Want to Get Rid of Obamacare? Be Careful What You Wish For (NYTimes)
  • The Multi-District Litigation Statute Needs Rewriting (Drug and Device Law)

Upcoming Meetings & Events

Europe

  • Pfizer Receives Approval in the European Union for Nimenrix™ (Meningococcal Group A, C, W-135, and Y Conjugate Vaccine) in Infants Six Weeks of Age and Older (Press)
  • CHMP recommends EU conditional approval of Roche's Alecensa (alectinib) for people with previously treated ALK-positive NSCLC (Press)

Asia

  • KEYTRUDA® (pembrolizumab) Approved as First Anti-PD-1 Therapy in Japan for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express High Levels of PD-L1 (Press)
  • Novocure's Optune® (NovoTTF-100A) Approved in Japan for the Treatment of Newly Diagnosed Glioblastoma (Press)
  • Marketing Approval of LINZESS®, Treatment for Irritable Bowel Syndrome with Constipation in Japan - Provides a new therapeutic option for adult patients suffering from irritable bowel syndrome with constipation (IBS-C) (Press)
  • Anticancer Agent Treakisym® Approved In Japan For Additional Indication As First-Line Treatment For Low-Grade B-Cell Non-Hodgkin's Lymphoma And Mantle Cell Lymphoma (Press)

India

  • PvPI recommends CDSCO to initiate action against 24 drugs for showing ADRs (PharmaBiz)
  • PCI urges Union govt to initiate steps to implement Section 42 of Pharmacy Act in all states (PharmaBiz)
  • Top pharma firms hike complex drug R&D spend to Rs 8,500 crore in 2015-16, eye buyouts (Economic Times)
  • Final study on spurious drugs survey not laid in winter session of parliament (PharmaBiz)

Canada

Australia

  • Direct-acting antiviral medicines (TGA)
  • Medtronic CRT-Ds - various models (TGA)
  • Review of listed sunscreen products (TGA)

Zika

  • Malaysia confirms its eighth Zika virus case (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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