Regulatory Focus™ > News Articles > Regulatory Recon: Valeant in Talks to Sell Eye-Surgery Assets to Carl Zeiss; Trump Will Keep Collins

Regulatory Recon: Valeant in Talks to Sell Eye-Surgery Assets to Carl Zeiss Trump Will Keep Collins as NIH Director (7 June 2017)

Posted 07 June 2017 | By Michael Mezher 

Regulatory Recon: Valeant in Talks to Sell Eye-Surgery Assets to Carl Zeiss Trump Will Keep Collins as NIH Director (7 June 2017)

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

In Focus: US

  • Trump keeps Francis Collins as NIH director (STAT) (Washington Post) (Fierce)
  • Senate panel to hold hearing on drug prices (The Hill) (Pink Sheet-$)
  • Editorial: In Washington, everyone is for lower drug prices, but only in theory (St. Louis Post-Dispatch)
  • Valeant Is in Talks to Sell Eye-Surgery Assets to Carl Zeiss (Bloomberg)
  • Vertex goes all-in on its effort to conquer cystic fibrosis (Boston Globe)
  • AbbVie's rheumatoid arthritis drug succeeds in late-stage trial (Reuters) (Endpoints)
  • FDA Eyeing Patient-Reported Outcomes in Huntington's, Parkinson's (Medpage)
  • Medical Journal Editors Squander An Opportunity (Medpage) (STAT)
  • AstraZeneca sells migraine drug for up to $302 million (Reuters) (PharmaTimes)
  • BMS' Opdivo, Merck's Keytruda lead their class in cancer vaccine combo studies: report (Fierce)
  • Failure to warn: An early warning system for drug risks falls flat (STAT)
  • It's time to get serious about the safety of medical devices (STAT)
  • How Donald Trump Shifted Kids-Cancer Charity Money Into His Business (Forbes)
  • PhRMA Lashes Out at Price Setting by Foreign Governments (PhRMA)
  • Why U.S. first may be the new medical device development strategy (Medical Design & Outsourcing)
  • Ex-FDA Head Says AbbVie Promoted Off-Label Androgel Use (Law360-$) (Fierce)
  • Pharmacoeconomic Communications To Payers Getting Multiple Pilots By Genentech (Pink Sheet-$)

In Focus: International

  • India regulator wants medical devices added to price control list, document shows (Reuters)
  • DCGI eases norms for HIV paediatric drugs production (Economic Times)
  • Teva turns the last corner in the CGRP migraine drug race with its 2nd round of promising PhIII data (Endpoints) (Press)
  • Roche faces biggest fall since January 2015 on cancer therapy disappointment (Financial Times)
  • Costs for generic hepatitis C drugs in India paid back in 5 years (EPR) (PLOS)
  • EU nod for Novo's long-acting haemophilia drug (PharmaTimes)
  • China Direct-Acting HCV Drug Race Rapidly Gathering Pace (SCRIP-$)
  • The World Is His Oyster (Less N. America) – Novo Nordisk's Mike Doustdar (SCRIP-$)
  • uniQure hires ex-AstraZeneca exec as CMO (PharmaLetter-$) (Press)

Pharmaceuticals & Biotechnology

  • Blood and bone marrow therapies grab spotlight at world's top cancer meeting (Reuters)
  • Adieu, "Orange Book FR Safety or Effectiveness Determinations List"; Hello, "Orange Book Patent Listing Dispute List" (FDA Law Blog)
  • Insider Q&A: Drug industry learns to listen to patients (AP)
  • Asco – Bristol-Myers fails to stem the losses (EP Vantage)
  • NantKwest uses ASCO to say it wants to expand its cancer vaccine work (Fierce)
  • 'Don't underestimate Merck's vaccine business,' says CEO (BioPharmaReporter)
  • FDA Panel To Discuss Avastin, Herceptin Biosimilars (BioCentury) (FDA) (Pink Sheet-$)
  • FDA Panel To Review PTC'S Translarna For DMD (BioCentury)
  • Advisory Committee To Review Novartis' CAR T Therapy (BioCentury) (FDA)
  • FDA'S ODAC To Review New BLA For Pfizer's Mylotarg (BioCentury) (FDA)
  • Roivant launches Urovant with phase 3 Merck med (Fierce)
  • 1 in 6 US patients are given wrong dose of blood-thinners, study suggests (Pharmafile)
  • Perrigo CEO Exits After 14 Months (Pharmaceutical Manufacturing)
  • The Tower Of Babel In Clinical Research: PCORnet's Common Data Model Cracks The Foundation (Health Affairs Blog)
  • Kelly Martin once again finds himself at the helm of a biotech, sailing in choppy seas (Endpoints)
  • Op-Ed: FDA Budget Cuts and Increased User Fees Are Bad for America (Morning Consult)
  • Identifying another of cancer's wily tricks: Masking pain so tumors can grow unnoticed (STAT)
  • AMA will vote on requiring drug makers to disclose prices in consumer ads (STAT)
  • AMRI set to be acquired by private equity (Outsourcing Pharma)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Synergy Pharmaceuticals Announces Acceptance of Supplemental New Drug Application (sNDA) for TRULANCE (Plecanatide) for the Treatment of Adults with Irritable Bowel Syndrome with Constipation (IBS-C) (Press)
  • Updated Data from Phase 1 Trial of Oral IDHIFA® (enasidenib) Demonstrate Complete Responses and Duration of Response in Patients with Relapsed or Refractory AML and an IDH2 Mutation (Press)
  • Takeda and Seattle Genetics Announce Lancet Publication of Phase 3 ALCANZA Clinical Trial Data of ADCETRIS® (Brentuximab Vedotin) for CD30-Positive Cutaneous T-Cell Lymphoma (Press)
  • Jazz Pharma presents eye-opening data at annual SLEEP meeting (PharmaLetter-$)

Medical Devices

  • Apple Watch to gain direct support for Dexcom G5 glucose sensor (MassDevice) (Press)
  • FDA clears Ethicon's Surgicel powdered hemostat (MassDevice)
  • Hearables Are Making Their Way into the Device World (MDDI)
  • Clarify gets FDA clearance for connected home phototherapy device (Mobihealthnews)
  • GI Dynamics touts no complications, lowered insulin in EndoBarrier reimplantation trial (MassDevice)
  • Forbes Under 30 Alumni Score FDA Clearance For New Heart Monitor (Forbes)
  • FDA lifts warning letter on Masimo plant in California (MassDevice)
  • OrbusNeich wins FDA nod for Sapphire II Pro, NC Plus balloon dilation caths (MassDevice)
  • FDA Approves Hologic's Genius 3D Mammography™ Exam for Women with Dense Breasts (Press)
  • Gore Receives FDA Clearance for GORE® SYNECOR Preperitoneal Biomaterial Hernia Repair Device (Press)
  • Clarify Medical Core Technology Receives FDA Clearance (Press)

US: Assorted & Government

  • Anthem Will Exit Health Insurance Exchange in Ohio (NYTimes)
  • California bill would end 'purely profit-driven' practice of drug-company coupons (LA Times)
  • Georgia investigating spate of opioid painkiller overdoses (Reuters)
  • Appeals Court Hears PCSK9 Patent Case (BioCentury) (Pink Sheet-$)
  • Olympus Settles Pa. Suit Over FDA-Flagged Surgical Tool (Law360-$)
  • Georgia, Tennessee, and Texas Statutes of Repose Limit IVC Filter Cases in Different Ways (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Takeda breaks ground on $45m Ninlaro plant in Ireland (BioPharmaReporter)
  • Midatech in-licenses Novartis' panobinostat in brain cancers (PharmaLetter-$)

Asia

  • Imeglimin Phase IIb study in Japan for type 2 diabetes meets endpoint (PharmaLetter-$)

India

  • $14 billion loss in 2 years for Indian tycoon shows pharma in real bad shape (Economic Times)
  • Dismal show by 32 leading Indian pharma cos in sales & profits during 2016-17 (PharmaBiz)
  • Zydus Cadila gets USFDA nod for mesalamine tablets (Economic Times)
  • NPPA extends last date till June 9 to submit data of 19 devices notified as drugs on prescribed format (PharmaBiz)
  • Alembic Pharma looks to file 100 ANDAs in US in next 3 years (Economic Times)

Canada

  • Medtronic SureTune(TM)3 Receives Health Canada Licence for Deep Brain Stimulation Therapy (Press)
  • Purdue gains license for Aloxi in Canada (PharmaLetter-$)

Other International

  • Three Saudi hospitals report MERS outbreaks since April, WHO says (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.


Categories: Recon, Regulatory News

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