Regulatory Focus™ > News Articles > 5 > Recon: Former Valeant Exec Found Guilty in Kickback Scheme

Recon: Former Valeant Exec Found Guilty in Kickback Scheme

Posted 23 May 2018 | By Zachary Brennan 

Recon: Former Valeant Exec Found Guilty in Kickback Scheme

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

In Focus: US
  • Congress OKs letting terminal patients try unapproved drugs (AP) (Washington Post-$) (NYT-$) (Focus) (LA Times)
  • A Preferable Path For Thwarting Pharmaceutical Product Hopping (Health Affairs)
  • Patient and Prescriber Outreach Materials for Biosimilars (FDA)
  • FDA warns teething medicines unsafe, wants them off shelves (AP)
  • Gene Therapies That Could Transform Diseases Get Easier FDA Path (Bloomberg) (Focus)
  • How to Stop Direct-to-Consumer Prescription Drug Ads (MedPage Today)
  • Merck crushes Keynote-407 study in frontline lung cancer, hitting co-primaries and setting up another quick OK (Endpoints) (Press)
  • Former Valeant executive is found guilty in kickback scheme (Stat-$) (NYT-$)
  • AstraZeneca opens South San Francisco facility housing 400 R&D staff (Fierce)
  • Should Tech Entrepreneurs Aspire to Fix Clinical Trials Or Reinvent Them? (Forbes)
  • Sun Pharma Announces US FDA Approval of Yonsa (abiraterone acetate) To Treat Metastatic Castration-Resistant Prostate Cancer In Combination With Methylprednisolone (Press)
 
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In Focus: International
  • Pharma cos marketing medicines made by third parties to soon be liable for quality lapses flagged by CDSCO (Economic Times)
  • Reclassification of medicinal products: status update (Swissmedic)
  • Li Li ,Secretary, Deputy Commissioner of CNDA, meets WHO's New Representative in China, Dr Gauden Galea (CFDA)
  • Three Ebola patients slip out of Congo hospital, medics race to control outbreak (Reuters)
  • Why the world needs more than one Ebola vaccine (Reuters)
  • Second Indian state reports suspected cases of rare virus, fanning fears of spread (Reuters)
Pharmaceuticals & Biotechnology
  • Astellas shedding 600-plus jobs as CEO shakes up R&D and sales ops in restructuring (Endpoints)
  • Teva hopes to launch migraine drug as soon as September (Reuters) (Press)
  • 30-year Gilead R&D vet Norbert Bischofberger is starting over as staffer #5 at an upstart biotech — and he’s loving it (Endpoints) (Fierce)
  • Merck Wins Again; Esperion In Increments; Gilead As A Talent Farm (Forbes)
  • Series of setbacks raises doubt on the drug industry’s next big idea to treat Alzheimer’s (Stat-$)
  • Fluoroquinolone Trouble Untangled (In the Pipeline)
  • Lava bags cash from Gilde and Versant, hires Genmab vet, to advance bispecific T-cell engagers (Fierce) (Press)
  • Verrica seeks $86M IPO to take on compounded dermatology drug (Fierce)
  • Clinigen, Mitsubishi link for early access programme (PharmaTimes)
  • Cara signs $540M deal with Fresenius and Vifor Pharma to commercialize Korsuva (Fierce)
  • Diversity in the biopharma industry makes dollars and sense (Stat)
  • Record-hitting series A funds redefine early science (BioWorld)
  • Janssen Questions Literature Review on Biosimilar Switching Studies as Authors Defend it (Focus)
  • Improvements to Prescription Drug Monitoring Programs Can Inform Prescribing (Pew)
  • VirnetX Inc. v. The Mangrove Partners (Bio/PhRMA Brief)
  • Interview with Novo Nordisk CEO Lars Fruergaard Jørgensen (PharmaLetter-$)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • New PhIII gives Esperion’s CEO a chance to push back against a legion of critics — but can he win back investors? (Endpoints)
  • FDA hits Cosmo with CRL, asks for second phase 3 (Fierce)
  • Patterns of Potential Opioid Misuse and Subsequent Adverse Outcomes in Medicare, 2008 to 2012 (Annals of Internal Medicine)
  • Cellectis submits IND to FDA for ‘off-the-shelf’ UCART22 (BioPharma-Reporter)
  • FDA Grants Breakthrough Therapy Designation for Tafamidis for the Treatment of Patients with Transthyretin Cardiomyopathy (Press)
  • FDA Grants Breakthrough Therapy Designation to Lenti-D for the Treatment of Cerebral Adrenoleukodystrophy (Press)
Medical Devices
  • FDA issues Class I recall for Abbott’s HeartMate 3 heart pump (Fierce)
  • Freenome Sets Sights On Blood Test To Detect Colon Cancer (Forbes)
  • RenovoRx Announces $10 Million Financing for Innovative Treatment for Advanced Pancreatic Cancer (Press)
  • Beta Bionics wins FDA nod for home-use trial of artificial pancreas tech (MassDevice)
  • Interview – Impulse Dynamics aims to find its niche in heart failure (EP Vantage)
  • Renal denervation goes from Symplicity to complexity (EP Vantage)
US: Assorted & Government
  • U.S. Announces Additional $7 Million Donation In Fight Against Ebola In Congo (HuffPost)
  • HHS Secretary Alex Azar World Health Assembly Plenary Remarks (Speech)
  • HHS CTO Bruce Greenstein heads back to the private sector (Fierce)
  • The Interception of Illicit Opioids by the Border Patrol (HSGAC Staff Report)
  • Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics (FDA)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements (Federal Register)
Upcoming Meetings & Events Europe
  • Rapid Alert system for human Tissues and Cells (RATC) and for human Blood and Blood Components (RAB) (European Commission)
India
  • Health ministry reconstitutes Drug Technical Advisory Board (PharmaBiz)
Canada
  • Lynparza - Notice of Compliance with Conditions - Qualifying Notice (Health Canada)
General Health & Other Interesting Articles
  • Verily Advisory Board series: Linda Avey discusses health data sharing & ownership (Verily Blog)
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.
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