Regulatory Recon: China Looks to Speed Approvals for Imported Drugs; Highlights from ACC17 (20 March 2017)

Posted 20 March 2017 By Michael Mezher

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

In Focus: US

  • Lilly takes a stab at pricing transparency, but is it enough of the right data? (STAT-$)
  • American College of Cardiology (ACC) 2017 Scientific Sessions (Medscape)
  • J&J, Bayer's Xarelto cuts recurrence of dangerous blood clots (Reuters) (WSJ) (NEJM) (PharmaTimes) (Press)
  • Medicines Co drug shows long-term cholesterol lowering (Reuters) (CardioBrief)  (Press) (NEJM)
  • AstraZeneca diabetes drug cuts death rates in real world trial (Financial Times) (Press)
  • Novartis heart-failure med Entresto cuts A1c, insulin starts in diabetics: analysis (Fierce) (Press)
  • Esperion Therapeutics Sees Clear FDA Path for Heart Drug (Forbes)
  • Lilly's breast cancer drug combination succeeds key study (Reuters) (Fierce) (Press)
  • Biopharma facing stiffer opposition (Boston Globe)
  • FDA Delays Final Rule on Intended Uses (Focus) (STAT-$)
  • Bills Introduced in March: Importation, Cancer Drugs and PBM Transparency (Focus)
  • Trump Plan Eliminates a Global Sentinel Against Disease, Experts Warn (NYTimes)
  • Should The US Government Buy A Drug Company To Save Money? (NPR)
  • Prescription Drug Costs Are On The Rise; So Are The TV Ads Promoting Them (KHN)
  • Opinion: Scott Gottlieb for FDA Is a Big Win for Science (The Observer)
  • Dems Ask HELP Committee to Postpone User Fee Hearing to Discuss Healthcare Bill (HELP)
  • What If We Win? Off-Label Promotion & Product Liability (Drug & Device Law)
  • Trump ramps up fight for votes on US healthcare overhaul (Reuters) (WSJ)

Sponsored Content: IDMP is Delayed Again

In Focus: International

  • EMA Management Board: highlights of March 2017 meeting (EMA)
  • China considers ways to speed up time to market for imported drugs (Reuters) (Pharmafile)
  • Takeda scouts for deals to ramp up global push (Financial Times)
  • Canada Prevails In $383M Eli Lilly Case (Law360-$)
  • Pregnancy test's alleged link to birth defects to be reviewed by UK regulator (The Guardian) (The Independent) (Pharmafile)
  • Malaysia Update: ASEAN ratification, Medical Device Regulation revisions on the way (Emergo)
  • Emergo Survey: Most Medical Device Firms Need Better Understanding of European MDR, IVDR (Emergo)
  • CAR-T drugs worth up to $649K in childhood leukemia, says UK report (Fierce) (NIHR)
  • Sanofi's New Gaucher Drug Cost Doesn't Add Up For NICE (Pink Sheet-$)
  • Czech President Signs Law Limiting Medicine Re-Exports – But Will It Work? (Pink Sheet-$)
  • Doctors in New Zealand—the only non-US country that allows DTC advertising—call for bans (Fierce)

US: Pharmaceuticals & Biotechnology

  • What PCSK9 Is Telling Us About Drug Discovery (In The Pipeline)
  • Bristol-Myers Squibb, CytomX pen expanded $3.6B biobucks research deal (Fierce) (Press)
  • Array walks back its FDA pitch on binimetinib, derailing plans for commercial launch (Endpoints)
  • Circassia strikes drug collaboration deal with AstraZeneca (Financial Times) (Press)
  • A Pathway, Not A Shortcut: 505(b)(2) NDAs Have Longer Reviews Than NMEs (Pink Sheet-$)
  • How a Boy's Lazarus-like Revival Points to a New Generation of Drugs (MIT Technology Review)
  • B-ing Persistent (BioCentury)
  • Avexis Climbs On Latest SMA Gene Therapy Results (BioCentury)
  • 5 Biotech Products US Regulators Aren't Ready For (MIT Technology Review)
  • Analysis: Reports of drug side effects increase fivefold in 12 years (USA Today)
  • 80% of Rx claims for PCSK9 inhibitors in USA initially rejected, new findings show (PharmaLetter-$)
  • How a Big Wager on Valeant Played Out (NYTimes)
  • Positive Real-World Data for Naloxone Nasal Spray (Medpage)
  • Express Scripts says Amgen data opens door to patients (Reuters)
  • With Trial Results, Should Amgen Reconsider Its Pricing For Repatha? (Forbes) (CardioBrief)
  • Glaxo's Parodontax Brings Bleeding Gums Claim To US Toothpaste Battle (Pink Sheet-$)
  • Editas Raises $90m In Follow-On (BioCentury)
  • Patheon: Biologics seeds to bloom in 2018 as products shift to commercial (BioPharmaReporter)
  • Sanofi debuts first Xyzal ad campaign with wise old spokes-owl (Fierce)

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

  • Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery (NEJM)
  • Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation (NEJM)
  • NantKwest Announces FDA Grant of Orphan Drug Designation for the Company's aNK Natural Killer Cell Therapy in Merkel Cell Carcinoma (Press)
  • Genentech plans second Phase 3 Alzheimer's trial following endpoint failures (Pharmafile)
  • Boehringer Ingelheim Phase III study now enrolling patients with progressive fibrosing lung diseases (Press)
  • Nektar's opioid painkiller succeeds in key late-stage study (Reuters) (The Street)
  • BioLineRx Provides Update on Phase 2 Open-Label Study for BL-8040 as Novel Stem Cell Mobilization Treatment (Press)
  • NightstaRx Commences first Phase I/II Gene Therapy Clinical Trial for Patients with X-Linked Retinitis Pigmentosa (Press)
  • JUVÉDERM VOLLURE XC Approved by U.S. FDA for Correction of Facial Wrinkles and Folds in Adults over the Age of 21 (Press)

US: Medical Devices

  • 5 Warning Signs Your Supplier's Quality May Be Failing (MDDI)
  • 4 milestones to get your medical device idea from prototype to commercialization: Interview with Eric Stone, CEO of Velano Vascular (MassDevice)
  • In-depth: The path to market for digital tools for mental health and neurological conditions (MobiHealthNews)
  • FDA clears Toshiba Medical's Aplio i900 cardiovascular ultrasound (MassDevice)
  • Trovita Health Science Announces FDA Marketing Clearance of New SAFE-T FEED Nutrition Delivery Device for Tube Feeding (Press)

US: Assorted & Government

  • Oh Canada! Drug Importation Bills Look North to Address Accessibility and Cost (FDA Law Blog)
  • 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (HHS)
  • GOP's Health Care Tightrope Winds Through the Blue-Collar Midwest (NYTimes)
  • Gripes About Obamacare Aside, Health Insurers Are in a Profit Spiral (NYTimes)
  • Republican healthcare bill would harm state finances: Moody's (Reuters)
  • US investigates four insurers over Medicare payments (Reuters)
  • Fired US Attorney Preet Bharara Said to Have Been Investigating HHS Secretary Tom Price (ProPublica)
  • Ex-CDC chief opposes public health block grants in Trump budget (Reuters)
  • What's Behind 2.5 Million New Health Jobs? (Health Affairs Blog)
  • Slavitt to join Bipartisan Policy Center (Modern Healthcare)
  • Galena Lied About Illegal Fentanyl Marketing, Investor Says (Law360-$)

Upcoming Meetings & Events

Europe

  • Tuberculosis deaths fall in Europe (Reuters)
  • Government to extend protections for NHS whistleblowers (UK DOH)

India

  • Pharma companies must follow skills deadline (Economic Times)
  • Piramal acquires Mallinckrodt LLC's pain drug portfolio (Economic Times)
  • Daiichi availed Rs 8,000 crore monetary benefits while it had stake in Ranbaxy: Singh brothers (Economic Times)
  • Centre plans e-portal to track sale of medicines (Economic Times) (PharmaBiz)
  • Glenmark gets tentative nod from USFDA for Fingolimod capsules (Economic Times)
  • Sun Pharma unit Taro acquires Thallion (PharmaLetter-$)

Asia

  • Korea to inaugurate country's first biosafety level-4 lab (BioSpectrum)
  • Pakistan's problem with diabetes - with 7 million diabetics (Pharmafile)

Australia

  • Consultation: Strengthening monitoring of medicines in Australia (TGA)
  • Consultation: Provisional Approval pathway for prescription medicines (TGA)
  • EpiPen 300 microgram adrenaline injection syringe auto-injector (TGA)

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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