Regulatory Focus™ > News Articles > Regulatory Recon: Merck Hit in Global Ransomware Attack; Califf Shares Ideas on Real World Evidence

Regulatory Recon: Merck Hit in Global Ransomware Attack Califf Shares Ideas on Real World Evidence (28 June 2017)

Posted 28 June 2017 | By Michael Mezher 

Regulatory Recon: Merck Hit in Global Ransomware Attack Califf Shares Ideas on Real World Evidence (28 June 2017)

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

In Focus: US

  • Merck Hit in Global Ransomware Attack (NYTimes) (Fierce) (The Independent) (Washington Post) (Endpoints)
  • Dr. Robert Califf Shares Ideas About Real-World Evidence And Health Data (Forbes)
  • Analysis: Mitch McConnell Plans To Hide Trumpcare's Pain Until After Midterms (KHN)
  • Vote Delayed as G.O.P. Struggles to Marshal Support for Health Care Bill (NYTimes 1, 2)
  • White House opioid crisis commission misses due date for preliminary report (STAT)
  • House Drafts FY 2018 FDA Budget With Same Appropriation Levels as 2017 (Focus)
  • FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition (Focus) (Pink Sheet-$)
  • Valeant Most Exposed by FDA Generics Push (CNBC)
  • GAO: FDA Needs a Plan for GDUFA Carryover Fees (Focus)
  • AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process (Focus)
  • The FDA may move to shorten that grim list of side effects on every drug ad. Advertising execs can't wait (STAT)
  • NYC Mayor de Blasio puts up first cash for ambitious life sciences project (Fierce)
  • AstraZeneca cancer drug trial prompts investors to take options cover (Reuters)
  • AstraZeneca's struggling FluMist loses out on crucial CDC vaccine backing—again (Fierce)
  • Senators lay into Sanofi for Zika vaccine deal, call for public hearing (Fierce)
  • Coherus restructures, axes 51 staffers in wake of an FDA rejection of its knockoff of Amgen's Neulasta (Endpoints)
  • Parkinson's As An Autoimmune Disease: More Evidence (In The Pipeline)
  • How the drug industry blew it in Md. (Baltimore Sun)
  • SEC Charges Two Ex-Ariad Executives, Husband of a Third with Insider Trading (GEN) (Endpoints)

In Focus: International

  • Lonza cleared to acquire Capsugel in $5.5 billion deal (Pharmafile) (InPharmaTechnologist)
  • FDA, EMA Officials Stress Potential For FDA, EMA Collaboration On Generic Drug Review (IHP-$)
  • WHO hopes Yemeni cholera outbreak is half done at 218,000 cases (Reuters)
  • Shrouded in secrecy: the Pharmacy Guild resists deeper scrutiny (The Guardian)
  • Asia Regulatory Roundup: Australia Opens Priority Review Pathway (Focus)
  • After stents, Indian government mulls price cap for four more devices (Economic Times)
  • WHO: Medtech could accelerate universal healthcare in Africa (MassDevice)
  • NICE backs Afinitor, Sutent for neuroendocrine tumours (PharmaTimes)
  • Australian Industry Rejects Planned Tendering System For Off-Patent Drugs (Pink Sheet-$)
  • Are You Ready? EU Launches Test Environment For New EudraVigilance System (Pink Sheet-$)
  • Brazil tells Bayer to recall 13 lots of Gynera contraceptive (InPharmaTechnologist)
  • Novo Nordisk's diabetes drug recommended for expanded indication in Europe (Pharmafile)
  • A UK Surgeon Is Using Microsoft HoloLens To Train Medical Staff Using VR On The Operating Table (Forbes)
  • Global coalition calls for urgent action by the G20 to address growing international health challenges (GHTC)
  • Joint United Nations statement on ending discrimination in health care settings (WHO)
  • EC Approves Kevzara, Skilarence (BioCentury)

Pharmaceuticals & Biotechnology

  • Vantage Point – CAR-T value calculation in the firing line (EP Vantage)
  • Researchers develop microneedle patch for flu vaccination (NIH)
  • Hep C Experts Condemn Cochrane Review Dissing Direct Antivirals (Medpage)
  • Esperion Expects Speedy Regulatory Path For Bempedoic Acid/Zetia Combo (Pink Sheet-$) (BioPharmaDive) (Press)
  • How Could The 21st Century Cures Act And The Joint Commission Improve Eating Disorder Care? (Health Affairs Blog)
  • With deep ties to China, Vivace exits stealth mode with a lead cancer program, platform and $40M (Endpoints)
  • Hammered on a gene therapy setback, Dimension cuts staff and circles the wagons (Endpoints)
  • Mersana scores a $75M IPO as Wall Street continues to embrace biotech (Endpoints)
  • Fagron and Advanced Pharma pull drugs made at Pfizer's Rocky Mount site (InPharmaTechnologist)
  • ICER Collaborating With VA's PBM (BioCentury)
  • Roll up, roll up: It's the call for the Fierce 15 nominations (Fierce)
  • Vaccination may be curbing ER visits for shingles (Reuters)
  • Biogen's drug discovery program gets quantum boost from improved molecular design (Outsourcing Pharma)
  • Global Blood Shares Pop on Priority Designation; Kite Pharma Rises on Patent News: Biotech Movers (The Street) (Press)
  • BI, Lilly hit the streets to talk up Jardiance's cardiovascular benefits (Fierce)
  • Joe and Jill Biden launch new cancer initiative (Fierce) (GenomeWeb)
  • Arix leads $45M series B for gene therapy biotech LogicBio (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Grants Profounda Inc. Orphan Drug Designation for treatment of Granulomatous Amebic Encephalitis (GAE) with Miltefosine (Press)
  • In a move to widen Nucala's reach, GlaxoSmithKline jump-starts nasal polyps trial (Fierce) (PMLive) (PharmaTimes)
  • Clarus resubmits oral hormone therapy to FDA (BioPharmaDive)
  • Eyeing a $6B market, Bavarian Nordic posts positive phase 2 data for universal RSV vaccine (Fierce)

Medical Devices

  • Philips Buys Medical Device Maker Spectranetics Corp.; Deal Has Enterprise Value of $2.15 Billion (The Street) (MassDevice)
  • FDA clears Custom Ultrasonics to resume manufacturing System 83 endoscope washer-disinfector (MassDevice)
  • J&J's DePuy Synthes buys spinal tech dev Sentio (MassDevice)
  • New Way to Optimize Exoskeletons Helps to Drastically Improve Their Efficiency (medGadget)
  • FDA Approves Abbott's Molecular CMV Assay (GenomeWeb)
  • Finding a strategic cybersecurity model (McKinsey)
  • Philips wins FDA 510(k) for IntelliSpace Portal 9 informatics platform (MassDevice)
  • InVivo enrolls 17th patient in Inspire trial (MassDevice)

US: Assorted & Government

  • Nantkwest, Inc. v. Matal (Fed. Cir. 2017) (Patent Docs)
  • Physician and Wife to Pay $1.2 Million to Settle False Claims Act Allegations that They Billed Medicare and Medicaid for Unapproved Drugs (DoJ)
  • Linde's Lincare settles U.S. whistleblower case for $20 million (Reuters)
  • Judge rejects defense bid for mistrial in Martin Shkreli fraud case after lawyer blasts negative press coverage (CNBC) (The Street)
  • BMS, Sanofi Escape Plavix FCA Suit Under Escobar Standard (Law360-$)
  • Feds don't need warrant to subpoena Oregon drug data (Modern Healthcare)

Upcoming Meetings & Events

Europe

  • Innovation office has a new advisory inbox (Fimea)
  • Sanofi could increase its Russian revenue by $50 million over next two years (PharmaLetter-$)
  • STP cuts will affect 'millions of patients', says BMA (PharmaTimes)
  • QS Pharma gets nod from EMA for commercial manufacture (Outsourcing Pharma)
  • Myeloma UK's new CEO begins her role (Pharmafile)
  • Medtronic wins CE Mark for SureTune3 deep-brain stimulation software (MassDevice) (Press)

India

  • CDSCO Lists Measures Taken to Streamline Regulatory Procedures (CDSCO)
  • NPPA notifies revised ceiling prices of 761 drugs ahead of GST roll out (Economic Times)
  • Government eyes veggie alternative for gelatin capsule coating (Economic Times)
  • NIPER Ahmedabad ties up with J&J to integrate industry practices in medical devices curriculum (PharmaBiz)
  • Fortis' diagnostic arm may be listed on bourses by August (Economic Times)
  • USFDA gives nod to Zydus Cadila's overactive bladder tablets (Economic Times)
  • Capsule manufacturing cos plead for lower GST rate of 12-18 per cent (PharmaBiz)
  • NPPA sets up 'GST Facilitation Cell' to help pharma sector, industry in MP still wants clarity (PharmaBiz)
  • DoP rejects Sun Pharma's review petition on "Histac EVT 2's AI strip"; gets favourable ruling on "Fucibet cream 15 gm AI tube" (PharmaBiz)

Asia

  • Sinovac Going Private (BioCentury) (Press)
  • Tokyo drift? Large molecule R&D shortfall threat to Japanese pharma, says Chugai (BioPharmaReporter)
  • Medtronic SureTune(TM)3 Earns CE Mark for Deep Brain Stimulation Therapy

Canada

  • CRO Altasciences sees opportunity in fragmented early clinical development space (Outsourcing Pharma)

Australia

  • Biological standards (TGA)

General Health & Other Interesting Articles

  • Hospitals Ramp Up Hyperbaric Therapy For Diabetics, Despite Concerns (KHN)
  • Elimination of mother-to-child transmission of HIV and Syphilis (EMTCT): Process, progress, and program integration (PLOS)
  • Vaccination to prevent human papillomavirus infections: From promise to practice (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.


Categories: Recon, Regulatory News

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