Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Valeant's Glaucoma Drug Vyzulta; Former GSK Head Witty to Lead UK Acc

Regulatory Recon: FDA Approves Valeant's Glaucoma Drug Vyzulta Former GSK Head Witty to Lead UK Accelerated Access Scheme (3 November 2017)

Posted 03 November 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Valeant's Glaucoma Drug Vyzulta Former GSK Head Witty to Lead UK Accelerated Access Scheme (3 November 2017)

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

In Focus: US

  • Valeant finally wins long-delayed FDA OK for its glaucoma drug, which is more good news for Aerie (Endpoints) (Press)
  • Senators call for crackdown on pharmaceutical industry 'revolving door' (Washington Post) (STAT)
  • GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits (Focus)
  • 7 ways biopharma would win — and lose — under the new tax bill (STAT)
  • Pfizer has a big swamp to drain before Hospira plant woes are fixed (STAT)
  • Novartis and Amgen launch new Alzheimer's study (Endpoints) (Fierce)
  • CMS Shifts Coding and Payment Policy for Biosimilars Under Medicare Part B (Focus)
  • 2017: A Banner Year for State Laws on Drug Pricing, Price Reporting, and Discounting (FDA Law Blog)
  • Sanofi falls short in Q3 as diabetes and MS sales disappoint (Fierce)
  • Where could Allergan's cost cuts fall? DTC spending, for starters (Fierce)
  • Alnylam RNAi drug reverses progress of rare fatal disease: study (Reuters)
  • AmerisourceBergen expects tumbling generic drug prices to settle (Reuters)
  • Insys posts loss after founder charged in US opioid bribe case (Reuters)
  • Study Raises Questions About Stents in Some Heart Patients (WSJ) (NYTimes) (Star Tribune)

Sponsored Content: Advice from Regulatory Leaders

In Focus: International

  • Former GSK boss to lead new UK accelerated drug access scheme (Reuters) (Fierce) (UK DOH) (Pharmafile) (ABPI)
  • GSK's chief scientist leaves for senior UK government job (Financial Times) (Endpoints)
  • European Regulatory Roundup: Rise of Cell Therapies Prompts EC to Float Orphan Drug Changes (Focus)
  • Torrent Pharma to buy Unichem Labs' India business for $558 million (Reuters)
  • China disputes Trump's claims of fentanyl 'flood' into United States (Reuters)
  • EU-Mercosur Trade Deal Could See Brazilian Drug Spending Soar (Pink Sheet-$)
  • Health Canada approves Otsuka and Lundbeck's Once Monthly Abilify (Press)
  • Deadly Plague Outbreak in Madagascar Appears to Wane (NYTimes)
  • Religious Festivals Linked to Major Flu Outbreaks (MIT Technology Review)
  • WHO Global Leadership Meeting concludes with new commitment to delivering results in countries (WHO)

Pharmaceuticals & Biotechnology

  • FDA Drafts Guidance on Controlled Correspondence Under GDUFA II (Focus)
  • FDA's Morrison Says ORA Reorganization Will Mean More Foreign Inspections (FDA News-$)
  • 'Bridging' Of Generic Review Goal Dates Makes Progress At US FDA (Pink Sheet-$)
  • ICER Weekly View 11-03-17 (ICER)
  • Q&A: An open-data evangelist preaches creative cooperation to speed drug development (STAT)
  • Bioprocessing survey report: Is the CHO CHO train slowing down? (BioPharmaReporter)
  • Investors crown Alnylam winner of face-off against Ionis (Fierce)
  • Good gut microbes may help immunotherapy drugs shrink tumors (Reuters)
  • Is Neurocrine primed for takeover? Revenue soars on Ingrezza sales (Endpoints)
  • Peer Review: aTyr promotes data expert Sanjay Shukla as CEO (Endpoints)
  • Ash 2017 preview – Blueprint and Stemline celebrate (EP Vantage)
  • Biogen lures former Merck exec to lead new marketing team (PharmaLetter-$)
  • Agios' data on leukemia drug ivosidenib doesn't excite investors (Fierce)
  • Amazon should buy these companies if it wants to get into selling drugs (CNBC)
  • Klotho Therapeutics Raises $10M to Test Drug in Kidney Disease (Xconomy)
  • Determination That REVEX (Nalmefene Hydrochloride Injection), 0.1 Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA Reviewing Valeant's Psoriasis Candidate (BioCentury)

Medical Devices

  • Fresenius shares fall on Q3 sales miss (MassDevice)
  • Smith & Nephew takes $5m hit from hurricanes (MassDevice)
  • Insulet raises full-year sales forecast after Street-beating Q3 (MassDevice)
  • Medtronic Releases Fiscal Year 2017 Integrated Performance Report (Press)
  • Second Sight wins full FDA clearance for Orion cortical prosthesis feasibility trial (MassDevice)
  • Medacta Announces FDA Clearance and First Surgeries Utilizing 3DMetalTM Tibial Cones for Knee Revision (Press)
  • Medtronic Evolut(TM) PRO TAVR System with Advanced Sealing Maintains Excellent Outcomes Over Time (Press)

US: Assorted & Government

  • House Subcommittee To Hold Hearing On Sovereign Immunity, Leaves Allergan Out (BioCentury)
  • Thune, Senate Health IT Working Group Members Reintroduce Legislation to Improve Meaningful Use Program (HELP)
  • Feds charge Osiris execs with cooking the books as stock price soared (Endpoints)
  • AmerisourceBergen Eyes $575M FCA Deal After Criminal Plea (Law360-$)
  • Ex-Pharma Exec Admits Insider Trading On Cancer Drug Info (Law360-$)
  • Prescriber Declaration Resulting from Ex Parte Communications with Plaintiff's Lawyer Does Not Stave Off Summary Judgment (Drug & Device Law)

Upcoming Meetings & Events

Asia

  • Dong-A Mulls Fresh Options After Allergan Ends Evogliptin Deal (SCRIP-$)

India

  • DoP rejects review plea filed by Sanofi-Synthelabo against price fixation of "Amiodarone injection–50mg/ml" (PharmaBiz)
  • Top pharma cos hit by action against price fixing by US govt refuse to comment on charges (PharmaBiz)
  • Natco's partner Alvogen gets nod for influenza drug in US (Economic Times)

Australia

  • TGA presentation: GMP clearance information session, 5-7 September 2017 (TGA)
  • Complementary medicine reforms information sessions (TGA)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (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.


Categories: Recon, Regulatory News

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