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)
- 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 $540M deal with Fresenius and Vifor Pharma to commercialize Korsuva (Fierce)
- Diversity in the biopharma industry makes dollars and sense (Stat)
- Record-hitting series A funds redefine early science (BioWorld)
- Janssen Questions Literature Review on Biosimilar Switching Studies as Authors Defend it (Focus)
- Improvements to Prescription Drug Monitoring Programs Can Inform Prescribing (Pew)
- VirnetX Inc. v. The Mangrove Partners (Bio/PhRMA Brief)
- Interview with Novo Nordisk CEO Lars Fruergaard Jørgensen (PharmaLetter-$)
- 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)
- 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)
- 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)
- Rapid Alert system for human Tissues and Cells (RATC) and for human Blood and Blood Components (RAB) (European Commission)
- Health ministry reconstitutes Drug Technical Advisory Board (PharmaBiz)
- Lynparza - Notice of Compliance with Conditions - Qualifying Notice (Health Canada)
- Verily Advisory Board series: Linda Avey discusses health data sharing & ownership (Verily Blog)
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