Regulatory Focus™ > News Articles > Regulatory Recon: NICE Denies Keytruda for Second-Line NSCLC; Novartis Moves Singapore Tropical Dise

Regulatory Recon: NICE Denies Keytruda for Second-Line NSCLC Novartis Moves Singapore Tropical Disease Research Facility to California (5 October 2016)

Posted 05 October 2016 | By Michael Mezher 

Regulatory Recon: NICE Denies Keytruda for Second-Line NSCLC Novartis Moves Singapore Tropical Disease Research Facility to California (5 October 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter

In Focus: US

  • Our 20th Patient-Focused Drug Development meeting: Enhancing the patient's voice in FDA's approach to drug review and development (FDAVoice)
  • FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk (Focus) (WSJ)
  • Prescription Drug Costs (GAO WatchBlog)
  • FDA's Naloxone Product Approval Standards May See Changes (Pink Sheet-$)
  • Molecular Machinery: the 2016 Nobel Prize in Chemistry (In The Pipeline) (Nature)
  • With new calls for congressional hearings, PBMs could be next on Capitol Hill's hot seat (Fierce)
  • Preferred Pharmacy Networks Are Back in 85% of the 2017 Medicare Part D Plans (Drug Channels)
  • Cheap EpiPen alternative risks patients' lives. I've seen it myself (STAT)
  • Pricey New Treatment Roils Issues Of How To Treat Prostate Cancer (KHN)
  • HHS Inspector General Calls on CMS to Incorporate UDIs Into Claims Forms (Focus) (Bloomberg)
  • McConnell Plugs 'Cures' To Address Regenerative Medicine As FDA Regs Criticized (InsideHealthPolicy)
  • Ticagrelor No Better Than Clopidogrel In Peripheral Artery Disease (CardioBrief)
  • More Bleeding Linked To Rivaroxaban In Observational Study (CardioBrief)
  • Who should take statins? A vicious debate over cholesterol drugs. (Washington Post)
  • 340B Spotlight: Program continues to grow with no end in sight (PhRMA)
  • FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers (Focus)
  • NIH Common Fund announces 2016 High-Risk, High-Reward Research awards (NIH)
  • Nike Stands In Michael J. Fox's Shoes (Forbes)
  • Roche gets boost from FDA in bid to expand uses for Actemra (Reuters) (Press)

In Focus: International

  • Researchers Nanoengineer Kryptonite For Antibiotic Resistant Superbugs (Forbes)
  • Novartis to shift Singapore research facility to California (Financial Times) (The Straits Times)
  • WHO Quality of  Medicines Survey: Life Saving Commodities for Women and Children (WHO)
  • Exclusive: Intas set to buy Teva's UK & Ireland assets for $775 million (Economic Times)
  • Sailing in Uncharted Waters: Carefully Navigating the Polio Endgame (PLOS 1, 2)
  • NICE rebuffs Keytruda for second-line NSCLC (BioCentury)
  • Report: EU regulators to rule on $25B Abbott-St. Jude Medical tie-up by Nov. 9 (MassDevice)
  • Fujifilm invests in Australian regenerative medicine venture Cynata (PharmaLetter-$)
  • Samsung Enters Oncology as Trastuzumab Accepted For EU Review (SCRIP-$)
  • FDA Warns Brazilian OTC Drug Manufacturer (Focus)
  • Vantage point – What Brexit means for medtech patents (EP Vantage)
  • EMA Post-Brexit: 'It Can't Stay In The UK' … Or Can It? (Pink Sheet-$)
  • Existential Crisis in Canada Could Lead To More Pricing Pressure (Pink Sheet-$)
  • Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (Focus)

US: Pharmaceuticals & Biotechnology

  • FDA Precedent Suggests Dynavax Hep B Vaccine Faces High Rejection Risk (The Street)
  • Mapping the biomedical research funding landscape (Medical Research Council)
  • Pediatric Priority Review Vouchers Saved in the Eleventh Hour (FDA Law Blog)
  • A 7-year-old told her bus driver she couldn't wake her parents. Police found them dead at home. (Washington Post)
  • FDA Warns Company for Failing to Fulfill Postmarketing Reporting Requirements (FDA)
  • Emergent inks anthrax combo vax deal with BARDA worth up to $1.6bn (BiopharmaReporter)
  • This 8-year-old is free of cancer — for now — after a 'breakthrough' treatment (Washington Post)
  • Pfizer's Troxyca And The Limits Of Advisory Committee Review For Opioids (Pink Sheet-$
  • AstraZeneca licenses respiratory drug to Insmed (Reuters)
  • Empirical Antifungal Therapy in Critically Ill Patients With Sepsis (JAMA)
  • Amgen to pay up to $410 million per target in deal with Nuevolution (PharmaLetter-$)
  • Botox shots little better than nerve stimulation for incontinence (Reuters)
  • Seattle Genetics expands Bothell campus to accommodate new growth (Puget Sound Biz Journal)
  • Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers (NIH)
  • Biomarkers for Alzheimer's Disease – Where are we now and Where are we going? (BioClinica)
  • Genzyme vet joins CRISPR player Editas as CMO (Fierce)
  • Elanco Animal Health Enters Agreement to Acquire Boehringer Ingelheim Vetmedica's U.S. Feline, Canine and Rabies Vaccines Portfolio (Press)
  • Pharma's social media activity is up, but there's still work to be done on audience insights: Review (Fierce)
  • Daiichi does I/O research deal with Portland upstart (Fierce)
  • Compounder Empower opens FDA-registered 503B outsourcing facility (Outsourcing Pharma)

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

  • Velicept Therapeutics Announces FDA Acceptance of IND Application of Novel, Once-Daily Formulation of Solabegron for the Treatment of Overactive Bladder (Press)
  • Characterization of Novel Antimalarial Compound ACT-451840: Preclinical Assessment of Activity and Dose–Efficacy Modeling (PLOS)
  • Bone Therapeutics Reports Positive Efficacy Data for the ALLOB® Phase IIA Spinal Fusion Trial (Press)
  • Ocular Therapeutix™ Begins Enrollment in First Phase 3 Clinical Trial with OTX-TP (Sustained Release Travoprost) for the Treatment of Glaucoma and Ocular Hypertension (Press)

US: Medical Devices

  • How do you know when it's time to hire a consultant? (Emergo)
  • Reducing Risks Associated with Medical Device Misconnections (FDA)
  • FDA Seeks Additional Nominations for CDRH Patient Engagement Advisory Committee (FDA)
  • 10 Key Takeaways from FDA's Draft Guidance on 510(k) Modifications (National Law Review)
  • Nurse Assist Initiates Nationwide Voluntary Recall of All Unexpired Lots of I.V. Flush Syringes (FDA)
  • Vascular Solutions, Inc. Issues Recall of Twin-Pass® Dual Access Catheters (FDA)
  • FDA Warns Texas Company for Marketing Unapproved Skin Device (FDA)
  • Device offering colonoscopy workaround to boost compliance wins FDA clearance (MedCityNews)
  • Heart Test Labs Completes Regulatory Submission for Both FDA 510(k) and CE Mark (Press)
  • FDA approves St. Jude Medical's BurstDR spinal cord stimulation for chronic pain (MassDevice)
  • Xenoscope™, the Revolutionary Cost-effective Laparoscope, Wins FDA Fast Track Clearance (Press)
  • Etiometry Receives FDA 510(k) Clearance on its first Algorithm, the IDO2 Index Powered by Risk Analytics for Neonates (Press)
  • Siemens Receives FDA Clearance of the Xprecia Stride™ Coagulation Analyzer (Press)
  • SonaCare Medical Paves the Way with the First HIFU Device Cleared by the FDA for Prostate Tissue Ablation - A Year in Review (Press)

US: Assorted & Government

  • Boston Scientific loses bid to toss $19m pelvic mesh loss (MassDevice)
  • CVS pushed out of Tricare pharmacy network (Modern Healthcare)
  • Baxter Gets Blood-Thinning Drug Lawsuit Chopped In Half (Law360-$)
  • U.S. Circuit Court Finds Operator of Affiliate Marketing Network Responsible for Deceptive Third-Party Claims Made for LeanSpa Weight-loss Supplement (FTC)
  • Enzo Hits Hologic With Suit Over DNA Patent (Law360-$)
  • J&J Hid Talc Baby Powder Cancer Risks, Jury Told (Law360-$)
  • Massachusetts Rebuffs Latest Plaintiff Attack on Reproductive Choice (Drug and Device Law)

Upcoming Meetings & Events

Europe

  • Health Investments By European Structural And Investment Funds (ESIF) 2014-2020 (EC)
  • European cooperation on HTA: what's next? Register TODAY! (EC)
  • Guidance on class 1 medical devices (MHRA)

India

Australia

  • Jubilant Life arm gets Australia TGA nod for lung scan drug (Economic Times)

Zika

  • Zika Fight in Congress Drives Away Potential Manufacturers (Bloomberg)

Other International                           

General Health & Other Interesting Articles

  • Alzheimer's Disease, A Humanitarian Crisis That Leaves Patients Needing Asylum (Forbes)
  • Meditation Helps Tame The Brain's Emotional Response, Study Finds (Forbes)
  • 'Concussion' distorts the scope of traumatic brain injury (Harvard Bill of Health) (NYTimes)
  • Whole Genome Sequence Analysis of a Large Isoniazid-Resistant Tuberculosis Outbreak in London: A Retrospective Observational Study (PLOS)

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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