Regulatory Focus™ > News Articles > Regulatory Recon: Broad Triumphs in CRISPR Patent Dispute; FDA Approves Valeant Psoriasis Drug Siliq

Regulatory Recon: Broad Triumphs in CRISPR Patent Dispute FDA Approves Valeant Psoriasis Drug Siliq (16 February 2017)

Posted 16 February 2017 | By Michael Mezher 

Regulatory Recon: Broad Triumphs in CRISPR Patent Dispute FDA Approves Valeant Psoriasis Drug Siliq (16 February 2017)

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

In Focus: US

  • FDA Nod for Valeant's Psoriasis Drug Siliq (PharmaTimes) (Pharmafile) (FDA)
  • US healthcare costs to escalate over next decade: government agency (Reuters) (Health Affairs Blog)
  • Pharma Lobby May Boot Company That Introduced High-Priced Drug (Bloomberg) (STAT)
  • Patent Office Hands Win in CRISPR Battle to Broad Institute (MIT Technology Review) (Patent Docs) (Reuters) (NYTimes)
  • UC undeterred by CRISPR patent ruling (BioCentury)
  • Stop Freaking Out About CRISPR! (Except For One Thing) (Forbes)
  • Alzheimer Outlook Far From Bleak (JAMA)
  • AbbVie, Novartis Criticize FDA's Guidance on Nonproprietary Names for Biologics and Biosimilars (Focus)
  • FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials (Focus)
  • Sweeping FDA Changes Could Have "Disastrous Consequences" For Biotech Investment (SCRIP-$)
  • Time For Big Pharma To Take Back Orphan Drugs (Pink Sheet-$)
  • Would Pfizer, Roche or Novartis megamerge with BMS? Rumors say they're crunching numbers now (Fierce)
  • White House Proposes New Rules to Steady Insurance Markets Under Health Law (NYTimes) (Reuters) (Health Affairs Blog)
  • Aetna CEO says Obamacare individual plans are in 'death spiral' (Reuters)
  • Pharma lobby launches crusade against Cuomo's 'flawed' drug pricing plan in NY (Fierce)
  • Biosimilars Could Face 'Litigation Backlog' Without Patent Reforms, AAM Fears (Pink Sheet-$)
  • Biosimilar group set to lobby new HHS Secretary to reverse reimbursement policy (BioPharmaReporter)
  • FDA Regulation of Prescription Drugs (NEJM)
  • Promotion of Drugs for Off-label Uses: The US Food and Drug Administration at a Crossroads (JAMA)

In Focus: International

  • NICE rejects AbbVie's leukaemia drug (Pharmafile) (PharmaTimes) (Fierce)
  • Milan mayor sees EU picking new home for drugs agency by June (Reuters)
  • Chinese Regulators Amend IVD Classification Requirements (Emergo)
  • A Contentious List of Finalists for Global Aid Fund Group's Director (NYTimes)
  • Scientists May Have Solved The Mystery Of Nodding Syndrome (NPR) (NIH) (Science)
  • China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications (Focus)
  • EDQM on biosimilars: Ph. Eur. monographs are flexible and evolving standards (EDQM)
  • Australia's A$200 million pledge to fight the A$14.7 billion Alzheimer's economic cost (PharmaLetter-$)
  • Sanofi Upbeat On China Growth, Investment Despite Q4 Weakness (SCRIP-$)
  • Takeda Extends PRA Alliance To Japan With New JV (SCRIP-$)
  • China pushes further on drug quality and price control (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • CDER Plans Guidance on Drugs Labeled as Homeopathic in 2017 (FDA)
  • Cook Serves Up Numbers and Observations (Lachman Consultants)
  • An Alternative to GMP Quality System Auditing in the Pharma Industry (Unger Consulting)
  • Celgene Could Have One More Powerful Move Higher (The Street)
  • New Jersey to Limit Amount of Opioid Pills in Prescriptions (WSJ)
  • Sentinel May Expand To Generic Equivalence Studies (Pink Sheet-$)
  • Alkermes' MDD candidate heads for FDA submission (BioCentury)
  • USP Backs FDA Proposed Criteria for Evaluating Bulk Substances for Compounded Drugs in 503A List (Regulations.gov)
  • Guest Post: Johnson and Johnson is celebrating outstanding scientists: Who will be next? (PhRMA)
  • Early collaboration is key in drug-device development, experts say (Drug Delivery)
  • NIH research helps explain how antibody treatment led to sustained remission of HIV-like virus (NIH)
  • Peak viremia HIV-specific CD8+ T cells reduce viral reservoirs (BioCentury) (Science)
  • Bio-outsourcing share to drop as Big Pharma invests heavily in-house, analyst (BioPharmaReporter)
  • Long-Term Opioid Use Could Depend on the Doctor Who First Prescribed It (NYTimes)
  • Addressing the Fentanyl Threat to Public Health (NEJM)
  • FDA Debars Two For Distributing Misbranded Drugs (FDA 1, 2)

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

  • FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Pegfilgrastim for Review (Press)
  • More data from Lilly's Phase III baricitinib study released (PharmaLetter-$) (Press)
  • Pfizer Announces Top-Line Results from the Oral Strategy Trial of XELJANZ (tofacitinib citrate) Compared to Humira (adalimumab) (Press)
  • FDA Expands Approval of SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children (Press)
  • Zymeworks Receives Second Orphan Drug Designation for ZW25 in Gastric Cancer (Press)
  • Malaria vaccine displays 100% success rate in clinical trial (Pharmafile)

US: Medical Devices

  • Why medtech companies should implement regionalized sales models (MassDevice)
  • Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate (FDA)
  • Interview with Dexcom CEO & President Kevin Sayerf (medGadget)
  • FDA expands indication for Medtronic's OsteoCool (MassDevice)
  • Glaukos Completes Patient Enrollment in Pivotal Phase of US IDE Clinical Trial for iStent SUPRA (Press)
  • FDA warns Thermogram Assessment Services over unapproved marketing claims (MassDevice)
  • FDA moves to block Chinese surgical drape maker over failed inspection (MassDevice)
  • FDA clears Biotronik's Pro-Kinetic Energy cobalt chromium stent (MassDevice)
  • Medtronic Introduces Signia(TM) Stapling System, Innovative Surgical Stapler for Minimally Invasive Surgery (Press)
  • Real-world data shows Abbott Freestyle users scan often, and that correlates with lower HbA1Cs (MobiHealthNews)

US: Assorted & Government

  • VA Health Care: Actions Needed to Ensure Medical Facility Controlled Substance Inspection Programs Meet Agency Requirements (GAO)
  • Retail Clinic Check Up: CVS Retrenches, Walgreens Outsources, Kroger Expands (Drug Channels)
  • Dr. Reddy's Generic Infringes Aloxi Patents, Judge Rules (Law360-$) (Pharmafile)
  • Sunovion Gets 2 Latuda Generics Blocked, Sues Over A 3rd (Law360-$)
  • What Is "Product Liability"? (Drug & Device Law)
  • Medical Liability Reform in a New Political Environment (JAMA)
  • DEA Administrative Hearings Update: Rethinking DEA's Summary Disposition Power in "Loss of State Authority" Cases (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • Norgine rejoins ABPI after eight year absence (PharmaTimes)
  • Biological Quality In The Spotlight As UK MHRA Consults On Standard-Setting (Pink Sheet-$)

Asia

  • China Blacklists Carfentanil, Closing A Deadly Loophole (NPR)
  • Eisai Enters Into Marketing And Distribution Agreement With Orion Concerning Parkinson's Disease Drugs In China (Press)
  • Emerging HCP Payment Regulations in Japan (Cutting Edge Info)

India

  • India defends IP rights despite threats from US pharma lobby groups (Economic Times)
  • USFDA warns Bengaluru-based Resonance Labs of manufacturing norms violations (Economic Times)
  • Lupin gets USFDA nod for generic cough relief oral (Economic Times)
  • Bulgarian firms are keen to invest in the pharmaceutical sector in Assam (Economic Times)
  • USFDA inspects Cadila Healthcare's Moraiya facility (Economic Times)
  • Sun Pharma gets European Medicines Agency nod for Tobramycin (Economic Times)

Other International

  • 13th Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) for prequalification (WHO)

General Health & Other Interesting Articles

  • How Silicon Valley Is Trying to Hack Its Way Into a Longer Life (Time)
  • Cancer: In Maintenance Mode, Living in the Moment (NYTimes)
  • Mammogram Results Can Be Misleading (NYTimes)
  • Survival rates for extremely preterm babies improving in US (Reuters)
  • U.S. Cancer Deaths Down Overall, Up in Some Regions: Clin Onc News Report (Medpage)

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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