Regulatory Recon: Study Finds Celebrex as Safe as Ibuprofen, Naproxen FDA Rejects Dynavax Hepatitis B Vaccine (14 November 2016)

Posted 14 November 2016 | By Michael Mezher 

Regulatory Recon: Study Finds Celebrex as Safe as Ibuprofen, Naproxen FDA Rejects Dynavax Hepatitis B Vaccine (14 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Former FDAers: Retaining Califf At FDA Would Maintain Continuity, Bipartisan Efforts (Inside Health Policy)
  • US Biosimilars Pathway Under Trump (Biologics Blog)
  • Trump Just Dropped a Big Hint to the Pharmaceutical Industry (Washington Post)
  • Donald Trump, in Exclusive Interview, Tells WSJ He Is Willing to Keep Parts of Obama Health Law (WSJ-$)
  • Donald Trump And The FDA (Forbes) (Focus) (Drug and Device Law)
  • US consumers will want Trump, Congress to take on drug prices (Reuters)
  • J&J arthritis drug goes up against Humira, with mixed results (Fierce) (Reuters)
  • Novartis chairman says considering sale of Alcon eye care division (Reuters)
  • Pfizer's Celebrex Shown to be as Safe as Ibuprofen or Naproxen (Reuters) (NYTimes)  (NPR) (Forbes) (NEJM)
  • Long-Term Benefit in HF Patients Elusive for Novel Vasodilator (CardioBrief)
  • Debate Ensues as USPSTF Finalizes Statin Primary Prevention Guideline (CardioBrief)
  • No Cognitive Benefit from Heart Drugs in HOPE-3 (CardioBrief) (Reuters)
  • FDA Offers Technical Rejection Criteria for Study Data (Focus)
  • Dynavax Says FDA Rejects its Hepatitis B Vaccine (Reuters)
  • Novartis Leukemia Drug Wins FDA Priority Review (Reuters)
  • Eagle Acquiring Drug Delivery Company Arsia (BioCentury) (PharmaLetter-$)
  • A Hot Souvenir From Cuba for Some Americans: Cancer Vaccine (NYTimes)
  • Corbus Drug Succeeds in Mid-Stage Scleroderma Study, Shares Surge (Reuters)
  • Trump Win Fuels Donations, IUD Demand at Planned Parenthood (Reuters)
  • USPTO Seeks Comments on New Sequence Standard (Patent Docs)

In Focus: International

  • Bayer Gets Over Compulsory Licence (Economic Times)
  • As EMA Seeks New Home, UK Expertise at Risk (BioWorld)
  • EMA Recommends Nine Drugs for Approval (Focus)
  • Patent Wins for Pfizer in India, Where NPPA Looks to be Disbanded (PharmaLetter-$)
  • NICE Rejects Earlier Use of Multiple Myeloma Drugs (PharmaTimes)
  • Roche, Bayer and More Speak Out Against German Pricing Cap Plans (Pharmafile)
  • Tackling Antibiotics Resistance in Low Income Countries (UK DoH)
  • TGA Key Performance Indicators: July 2015 to June 2016 (TGA)
  • Spurious drugs Imported From China Raises Red Flag for Pharma Regulator (Economic Times)
  • Torrent Pharmaceuticals Shelcal 500 Found Substandard, Co Claims it was Counterfeited (Economic Times)

US: Pharmaceuticals & Biotechnology

  • Ensuring and Advocating for an FDA that Works (Alliance for a Stronger FDA)
  • Report Outlines Many New Medicines in Development to Battle Diabetes Epidemic Affecting More than 30 Million Americans (PhRMA)
  • The Changing Biopharma Risk Equation (Pharmaceutical Manufacturing)
  • GMP in Cleanroom Maintenance: Myths and Facts (Pharmaceutical Manufacturing)
  • Patients who need pain drugs may want to seek care at night (Reuters)
  • FDA Issues Debarment Order to Paul S. Singh, Louis Daniel Smith (FDA 1, 2)
  • Studies Show Little Benefit in Supplements (NYTimes)
  • Take multiple biopsies in studies of personalised breast cancer treatments, study says (MNT)
  • With $100 million buy, BMS targets "richest opportunity for blockbuster drugs" (MedCityNews)

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

  • Arrowhead Pharmaceuticals Presents New Data on ARC-AAT (Press)
  • AbbVie's hepatitis C treatment shows promise (Reuters)
  • Roche announces positive results for Actemra in phase III study (Reuters) (Press)
  • Opdivo (nivolumab) and Yervoy (ipilimumab) Regimen Shows Promising Efficacy and Safety in Previously Treated Patients With Advanced Form of Bladder Cancer (Press)
  • Interim Phase 1/2 Data Show Encouraging Clinical Benefit for Lirilumab in Combination With Opdivo (nivolumab) in Patients With Advanced Platinum Refractory Squamous Cell Carcinoma of the Head and Neck (Press)
  • Phase 1/2 Data Combining Urelumab with Opdivo (nivolumab) in Hematologic and Solid Tumors Suggest Increased Antitumor Effect in Patients with Melanoma (Press)
  • ARMO BioSciences' Immunotherapy AM0010 Receives Orphan Drug and Fast Track Designations from the U.S. FDA for the Treatment of Pancreatic Cancer (Press)
  • Boston Biomedical Announces Orphan Drug Designation for Napabucasin in Pancreatic Cancer (Press)
  • Merck Announces Findings for Investigational Triple-Combination Chronic Hepatitis C Therapy Showing High Rates of Sustained Virologic Response in People with Genotypes 1, 2 or 3 Infection (Press)
  • Merck Announces Presentation of New Findings for ZEPATIER™ (Elbasvir and Grazoprevir) in Patients with Chronic Hepatitis C at The Liver Meeting (Press)
  • Merck's KEYTRUDA (pembrolizumab) Significantly Improves Overall Survival Compared to Chemotherapy in Previously Treated Patients with Advanced Bladder (Urothelial) Cancer (Press)
  • Jardiance® (empagliflozin) consistently reduced the risk of cardiovascular death in adults with type 2 diabetes regardless of the type of cardiovascular disease at baseline (Press)
  • Pfizer to Collaborate with National Cancer Institute to Study Three Immunotherapy Agents Targeting Multiple Cancers (Press)
  • Biothera Pharmaceuticals Preclinical Data Further Validate Mechanism of Its Phase 2 Cancer Immunotherapy, Imprime PGG (Press)
  • New Analyses of Phase 3 Trials Show Improvements in Rheumatoid Arthritis Symptoms Following Treatment with Baricitinib Across Diverse Population of Patients (Press 1, 2)
  • Alnylam Pharmaceuticals and The Medicines Company Announce Publication of Phase 1 Clinical Data with Inclisiran (ALN- PCSsc) in the New England Journal of Medicine (Press)
  • Leap Therapeutics Presents Data from Phase 1 Study of GITR Agonist (Press)
  • Ironwood Highlights ZURAMPIC® (lesinurad) Phase III Extension Study Data at the American College of Rheumatology 2016 Annual Meeting (Press)
  • Chi-Med Presents Phase I Clinical Data for Selective Syk Inhibitor HMPL-523 at the 2016 ACR/ARHP Annual Meeting (Press)
  • Braeburn Pharmaceuticals and Camurus Announce Positive Top-line Phase 3 Results for Long-acting Buprenorphine (CAM2038) for Treatment of Opioid Addiction (Press)
  • Data on Early Onset of Efficacy for Oral OTEZLA® (apremilast) in Active Psoriatic Arthritis Presented at American College of Rheumatology (Press)
  • Ocular Therapeutix™ Announces Successful Topline Results for Both Inflammation and Pain Primary Efficacy Endpoints from Phase 3 Clinical Trial of DEXTENZA™ (Press)

US: Medical Devices

  • Netting an Opportunity in Stenting (MDDI)
  • FDA approves Medtronic's Claria MRI quad CRT-D (MassDevice)
  • Thermo Fisher Scientific Submits Premarket Approval Application to FDA for Universal, Next-Generation Sequencing-Based Oncology Test (Press)
  • FDA Completes Transfer of Emergency Use Authorization for ReEBOV® Ebola Antigen Rapid Test to Zalgen Labs (Press)

US: Assorted & Government

  • Politics Aside, We Know How to Fix Obamacare (NYTimes)
  • Medical Device Manufacturer Pleads Guilty to Misbranding and Agrees to Pay $36M (Focus)

Upcoming Meetings & Events


  • Ultragenyx withdraws MAA for HIBM therapy (BioCentury)
  • Richter's generic osteoporosis drug gets EU recommendation (Reuters)
  • Rentschler expands cGMP manufacturing capacity following increased international demand (Manufacturing Chemist)


  • More essential medicines to become cheaper with NPPA's latest notification (Economic Times)


  • CFDA Vice Minister Sun Xianze attends Global Conference on Pharmacy and Pharmaceutical Sciences Education (CFDA)
  • CMDE Releases New Inquiry Rules on Medical Device Technical Review (Inside Medical Devices)


  • Teleflex nasal spray syringe devices recalled; may fail to deliver full dose of medication (Health Canada)

Other International

  • Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan (JAMA)

General Health & Other Interesting Articles

  • Genetic Heart Disease Risk Eased by Healthy Habits, Study Finds (NYTimes)

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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