Regulatory Focus™ > News Articles > Regulatory Recon: Google's Verily Loses Talent Under Divisive CEO, US Attorney Seeks Records in Nova

Regulatory Recon: Google's Verily Loses Talent Under Divisive CEO, US Attorney Seeks Records in Novartis Whistleblower Case (28 March 2016)

Posted 28 March 2016 | By Michael Mezher 

Regulatory Recon: Google's Verily Loses Talent Under Divisive CEO, US Attorney Seeks Records in Novartis Whistleblower Case (28 March 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Google's Bold Bid to Transform Medicine Hits Turbulence Under a Divisive CEO (STAT)
  • FDA Staff Questions Effectiveness of Acadia's Parkinson's Disease Psychosis Drug, Raise Safety Concerns (Reuters) (The Street) (Fierce)
  • Turing Pharmaceuticals CCO: I don't regret raising the price (Fox)
  • Generic Cos. Face Another Antitrust Suit Over Drug Prices (Law360-$)
  • US Seeks Records of 80,000 Novartis `Sham' Events for Doctors (Bloomberg)
  • Did FDA Remove Scientist's Name From Article and Invention in Retaliation? (Washignton Post) (Letter)
  • Orphan Drug Clinical Superiority: An Overview of Precedents Shows that MC-to-PC Clinical Superiority is Not so Unusual (FDA Law Blog)
  • Slew of Anti-Abortion Laws May Thwart Zika Research (Politico)
  • With Threat of Ad Ban Looming, Pharma is Fighting to Repair its Reputation (Adweek)
  • Regulating Genetically Modified Mosquitoes (Harvard Bill of Health)
  • Sprout Investors say Valeant Overcharging for Female Libido Pill (Bloomberg)

In Focus: International

  • China needs tougher enforcement of vaccine regulation: WHO (Reuters) (PharmAsiaNews-$)
  • CDSCO plans surprise checks at drug manufacturing sites (Economic Times 1, 2)
  • EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary (RxTrace)
  • USFDA observations on 2 units not to impact products: Natco (Economic Times)

US: Pharmaceuticals & Biotechnology

  • Among New Drug Launches, Oncology Scores Big While CV Lags (Pink Sheet-$)
  • "Reliable Drug" Recalls All Compounded Medications Due to a Potential for Mislabeling and Lack of Quality Assurance (FDA)
  • How to Stop Overprescribing Antibiotics (NYTimes)
  • Proposed quality metrics program raises operability questions (PhRMA)
  • Patients with terminal cancer live longer when cared for at home (STAT)
  • Heroin Epidemic Is Yielding to a Deadlier Cousin: Fentanyl (NYTimes)
  • Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical Amendment (FDA)
  • FDA is Advising Biotech Product Applicants to More Clearly Justify Their Excipient Usage (IPQ)
  • Dissolution Testing and the BCS Among Quality Topics High on the OPQ/PQRI Agenda (IPQ)
  • US FDA Posts Advisory Committee Materials for Acadia's Nuplazid (Pimavanserin) – MAR 29, 2016 (PDAC) (Tarius)
  • Dark, Then Dawn: ANDA Workload Approaching Steady State After 2014 Eruption (Pink Sheet-$)
  • Medical Marijuana Reduces Use of Opioid Pain Meds, Says Study (DD&D)
  • Eagle Pharmaceuticals and the National Institutes of Health (NIH/NIDA) Enter into Agreement to Explore Use of Ryanodex in MDMA (Ecstasy) and Methamphetamine Intoxication (Press)

US: Pharmaceuticals & Biotechnology: Clinical Study Results, Filings & Designations

  • Solasia Initiates Phase 2 Study of Darinaparsin (SP-02) for Peripheral T-Cell Lymphoma (Press)
  • Alder BioPharma's migraine drug succeeds in mid-stage study (Reuters) (Xconomy)
  • FDA Does Not Grant Seven Year Orphan Drug Exclusivity for BENDEKA (bendamustine hydrochloride injection) (Press)
  • Aerie Pharmaceuticals Initiates Second Phase 3 Registration Trial of RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% (Press)

US: Medical Devices

  • Design Control Snapshot: Advice About Design Change, Files, Inputs And More (Gray Sheet-$)
  • So you want to to lead an emerging medtech company? These 17 CEOs have some advice for you (MassDevice)
  • Fortimedix seeks FDA clearance for single-port surgery device (MassDevice)
  • First Human Results with V-Wave's Interatrial Shunt Published in The Lancet (Press)
  • Lawsuit claims medical device caused brain damage (Modern Healthcare)
  • Great Basin Receives FDA 510(k) Clearance for First Multiplex Panel (Press)

US: Assorted & Government

  • PhRMA takes pro-active strategy to Capitol Hill (The Hill)
  • FDA 'Intercenter Institutes' Legislation Headed For Senate Mark-Up (Pink Sheet-$)
  • Cancer Care Groups Attack Medicare Drug Payment Plan (MedpageToday)
  • '60 Minutes' The Health Wagon: Bandaid For States Not Expanding Medicaid (Forbes)
  • Sex Markers in Official Documentation – Between Biology and Self-Identification (Harvard Bill of Health)
  • Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory (Drug and Device Law)
  • Purdue Pharma L.P. v. Depomed, Inc. (Fed. Cir. 2016) (Patent Docs)
  • Express Scripts Says Pharmacies Don't Show Conspiracy (Law360-$)
  • Zimmer Biomet says federal probe to extend past deadline (MassDevice)
  • Medicaid May Offer Best Opportunity For Merck's Zepatier (Pink Sheet-$)
  • Stryker Toe Implant Suit Belongs In Fed Court, 5th Circ. Says (Law360-$)
  • 3 US hospitals hit by ransomware (MassDevice)
  • 7th Circ. Wants More Info In Suit Over Ill. Medicaid Drug Cap (Law360-$)

Upcoming Meetings & Events

Europe

  • OXiGENE Secures European Orphan Drug Status for Pancreatic Cancer Drug (FDANews-$)
  • Information graphic: sales of over-the-counter medicines in 2015 by clinical area and top 50 selling brands (PharmaLetter-$)
  • Kamada Submits Marketing Authorization Application with the European Medicines Agency for its Proprietary Inhaled Alpha-1 Antitrypsin to Treat Alpha-1 Antitrypsin Deficiency (Press)
  • Eiger BioPharmaceuticals Granted Orphan Medicinal Product Designation for Ubenimex in Pulmonary Arterial Hypertension by EMA (Press)

Asia

  • Commemoration of the "Asian Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs" (PMDA)
  • Biocon gets nod to sell its diabetes product 'Insulin Glargine' in Japan (Economic Times)
  • AstraZeneca's Tagrisso approved in Japan (PharmaLetter-$)
  • Kanuma® (sebelipase alfa) Receives Marketing Approval in Japan for Treatment of Patients with Lysosomal Acid Lipase Deficiency (LAL-D) (Press)
  • Eisai's In-House Developed Antiepileptic Drug Fycompa (Perampanel Hydrate) Approved In Japan As Adjunctive Therapy For Partial-Onset And Generalized Tonic-Clonic Seizures (Press)

India

  • Health ministry amends D&C Rules to exempt clinical trials for academic research from DCGI nod (PharmaBiz)
  • Rotavirus vaccine launched as part of Universal Immunization Programme  (Economic Times 1, 2)
  • Cost of cochlear implant operations may go down to Rs 1 lakh (Economic Times)
  • Glenmark Pharmaceuticals gets two ANDA approvals from USFDA (Economic Times)
  • DCGI's sudden ban on 344 FDCs imprudent & unfair to pharma industry and patients: IDMA president (PharmaBiz)
  • Health ministry to expand blood component separation facilities to achieve target of 4 lakh litres of plasma (PharmaBiz)

Zika

  • U.S. urges waiting period before conception after Zika infection (Reuters) (NYTimes) (WSJ-$) (CDC)
  • Chile reports its first sexually transmitted Zika case (Reuters)

Other International

  • A 'Forgotten Disease' Is Suddenly Causing New Worries (NPR)
  • Ebola, Ruthless to Families, Leaves Liberian Man Alive and Alone (NYTimes)

General Health & Other Interesting Articles

  • Not All Doctors Get 'Informed Consent,' Here's Why It's Hurting Patients (Forbes)
  • The Smallest Viable Genome Is Very Weird (In The Pipeline)

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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