Regulatory Focus™ > News Articles > Regulatory Recon: Report Raises Safety Concerns for New Hep C Drugs; Novartis Says Court Battle Will

Regulatory Recon: Report Raises Safety Concerns for New Hep C Drugs Novartis Says Court Battle Will Delay Enbrel Biosimilar Until 2018 (25 January 2017)

Posted 25 January 2017 | By Michael Mezher 

Regulatory Recon: Report Raises Safety Concerns for New Hep C Drugs Novartis Says Court Battle Will Delay Enbrel Biosimilar Until 2018 (25 January 2017)

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

In Focus: US

  • Biosimilars In 2017: Crowded US FDA Review Queue, Key Legal Decisions (Pink Sheet-$)
  • Potential Trump FDA Commissioner Choice: A Q&A With Dr. Joseph Gulfo (Focus)
  • Are New Drugs for Hepatitis C Safe? A Report Raises Concerns (NYTimes)
  • The FDA Wants to Regulate Edited Animal Genes As Drugs (Wired)
  • FDA Staff Shortages May Get Worse With Trump's Federal Hiring Freeze (Focus)
  • Federal agencies ordered to restrict their communications (Washington Post) (Vox)
  • Hospira Files IPR Petitions on Genentech's Trastuzumab-Related Patents (Big Molecule Watch)
  • A Return To Republican Antitrust Policies For Pharma (Law360-$)
  • Realizing the potential of CRISPR (McKinsey & Co)
  • Tom Price's Heated Hearing Is Unlikely to Derail His Nomination (NYTimes) (Wyden) (Hatch)
  • Trump's First Order Has Strong Words On Health. Actual Impact May Be Weak. (KHN)
  • Trump health pick favors insurance for people with prior illness (Reuters)
  • For Conservatives, A New Day In Health Care (KHN)
  • Everything You Need to Know About Block Grants — The Heart of GOP's Medicaid Plans (KHN)
  • To Modulate Drug Prices, We Need Less Regulation and More Competition  (National Review)
  • Trump Administration Makes Drug and Medical-Device Companies Nervous (WSJ)
  • A year of arm-twisting: How the drug industry flexed its lobbying muscle in 2016 (STAT)
  • Drug Industry Spending Jumped As Cures Crossed Finish Line (Roll Call)
  • Novartis says court battle will delay its Enbrel copy until 2018 at least (Reuters)
  • Novartis launches $5bn share buyback as it eyes Alcon spin-off (Financial Times) (PMLive)
  • Novartis chases rivals with next wave of cancer immunotherapy (Reuters)
  • Should the federal government seize patents on a Biogen drug that starts at $750,000 a year? (STAT)
  • Doctors Without Borders Objects to Sanofi Receiving an Exclusive License for a Zika Vaccine (Focus)
  • J&J's Forecast Disappoints as Drugmaker Mulls Diabetes Unit Sale (Bloomberg) (Financial Times) (NYTimes) (WSJ)
  • Bigger, Better, Faster, Stronger: The New Orange Book Makes Its Debut (FDA Law Blog)
  • National Survey Suggests that Off-Label Status is Material to Informed Consent (Harvard Bill of Health) (Consumer Reports)
  • ACA Replacement Bill From Cassidy And Colleagues Offers State Options, Roth HSAs (Health Affairs Blog)

In Focus: International

  • NICE Cost Recovery Plans Pause Is Welcome News For UK Industry (Pink Sheet-$)
  • EU Committee to Discuss Options for Improving Access to Medicines (ENVI)
  • EMA Reflects on its First Decade of Conditional Marketing Authorizations (Focus)
  • Chuikyo Agrees to Shed US Price from Foreign Price Adjustment Rule (PharmaJapanWeb)
  • Rothschild Europe to lobby interests of Pfizer and Rusnano in Russia (PharmaLetter-$)
  • UK sees first global launch of AZ' diabetes combo Qtern (PharmaTimes)
  • Chinese regulators tightening distribution chain (BioCentury)
  • Gilead investigates counterfeit Harvoni in Japan (PharmaLetter-$) (PharmaJapanWeb)
  • Asia Regulatory Roundup: CFDA Offers Technical Guidance on Clinical Trials (Focus)
  • India Health ministry to come up with draft guidelines on constant upgradation of GMP on par with global regulations (PharmaBiz)
  • EMA Updates Q&A on Article 31 Referrals (Focus)
  • Biosimilars Boost In Europe: 2017 Kicks Off With Three Approvals And Backing From ESMO (Pink Sheet-$)
  • Takeda UK names new market access director (Pharmafile)
  • The ICH E6(R2) addendum - an intro to the what and why of the changes (part 1) (imarc)
  • Health Groups Welcome Johns Hopkins University and Medicines Patent Pool Agreement for Development of Promising New TB Drug (MSF)

US: Pharmaceuticals & Biotechnology

  • Ajanta Explains FDA Sildenafil Action, Shares Rebound (SCRIP-$)
  • Antibiotic over-use triggered 'superbug' epidemic (MRC)
  • Frances Kelsey Syndrome (Marginal Revolution)
  • Hospira Issues A Voluntary Nationwide Recall For One Lot Of Vancomycin Hydrochloride for Injection, USP Due To The Presence of Particulate Matter Within a Single Vial (FDA)
  • Victims Of Contaminated Steroids Still Hurting: 'My Life's Upside-Down' (NPR)
  • TCGA study identifies genomic features of cervical cancer (NIH)
  • After the save: A drug can reverse an overdose. Then what? (CT Mirror)
  • 6 Million Visits for ADHD by U.S. Kids Each Year (Medpage)
  • Entering the RAT race? FDA issues instructions for new cell therapy designation (BioPharmaReporter) (Focus)
  • Sun declines to comment on New Jersey plant sale speculation (InPharmaTechnologist)
  • Report: Biotech VCs Perpetuate Boardroom Gender Gap (Xconomy)
  • How women are fighting to be part of the new world order in healthcare, life sciences and beyond (MedCityNews)
  • How to make sure participants make it to clinical trials? Enter Lyft (Crain's)
  • Anthem Caps Coverage Of Biogen Spine Drug Despite Wide FDA Approval (Xconomy)
  • 113m illicit drugs seized in Africa in joint operation (Securing Industry)
  • ADMA to buy US Biotest plant and fix problems that derailed RI-002 (InPharmaTechnologist)
  • Purdue's On Target Laboratories Lights Up the Fight Against Cancer (Xconomy)
  • Intrexon to buy floundering GenVec for gene delivery tech (Fierce)

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

  • Onxeo Completes Enrollment in Phase III Study of Livatag® for the Treatment of Hepatocellular Carcinoma (Press)
  • The Medicines Company to Present Results from ORION-1 Phase 2 Study of Inclisiran at the American College of Cardiology's 66th Annual Scientific Session (Press)
  • AbbVie Initiates Phase 2 Clinical Trial Programs for ABBV-8E12, an Investigational Anti-Tau Antibody, in Early Alzheimer's Disease and Progressive Supranuclear Palsy (Press)
  • NARCAN® (naloxone HCl) Nasal Spray 2mg Approved by U.S. Food and Drug Administration (FDA) (Press)
  • Phase III trial of anticancer agent lenvima® as first-line treatment for unresectable hepatocellular carcinoma meets primary endpoint (eisai)

US: Medical Devices

  • Market Access in an Era of Accountability: How Medical Device Companies Can Prove Efficacy (MDDI)
  • Staying ahead on cyber security (McKinsey & Co)
  • Abbott Shares Dip on Mixed Fourth-Quarter Earnings (The Street) (MassDevice)
  • Understanding Low-Friction Coatings for Medical Devices (MDDI)
  • Proposed Changes to the NIST Cybersecurity Framework (National Law Review)
  • Intuitive Surgical expects slowdown in da Vinci sales growth (MassDevice)
  • Stryker Q4 earnings take hit from recalled hip implants (MassDevice)
  • Medtronic touts In.Pact Admiral drug-coated balloon data (MassDevice) (Press)
  • Prescient Surgical wins de novo FDA nod for CleanCision surgical wound cleaning device (MassDevice)
  • InVivo touts 6th patient conversion in regenerative spinal scaffold trial (MassDevice)
  • MiMedx touts data from study of AmnioFix, EpiFix allograft (MassDevice)
  • FDA clears Cantab Mobile, a tablet-based memory assessment tool (mobihealthnews)

US: Assorted & Government

  • Glaxo Looks To Bar FDA, Plea Evidence From Paxil Trial (Law360-$)
  • Ranking Member Lewis Opening Statement at Oversight Subcommittee Hearing on GOP Efforts to Undermine the ACA (Democrats – Ways & Means)
  • Are scientists going to march on Washington? (Washington Post)
  • Hemp Industries Association Files Petition Against DEA Marijuana Extract Rule Implementation (FDA Law Blog)
  • Calif. rep asks Trump to repeal or delay e-cig rule (The Hill)

Upcoming Meetings & Events


  • NHS Scotland and RPS Scotland publish best practice standards for managing medicine shortages (Pharmaceutical Journal)
  • Suspended manufacturing and wholesale distribution authorisations (MHRA)
  • Children and young people should be taught simple hygiene measures to help curb the spread of infections (NICE)
  • Quarterly reports on the import of unlicensed medicines (MHRA)


  • Asterias' embryonic stem cell therapy linked to sustained improvements in motor function in small spinal injury trial (Fierce)
  • Biocon bags Rs 460-crore contract from Malaysia (Economic Times)


  • FC&DK urges govt to amend clause (ii) sub-rule (64) of D&C Rules to make only regd pharmacists eligible to grant or renewal of wholesale license (PharmaBiz)
  • USFDA makes 6 observations at Natco Pharma's Kothur facility (Economic Times)


  • Shortage of Neo-Mercazole (carbimazole) (TGA)


  • Consultation on the Prescription Drug List: Naloxone (Health Canada)

General Health & Other Interesting Articles

  • The risk of death from cancer may depend on where you live (Reuters)
  • Whether to Intubate During Cardiopulmonary Resuscitation: Conventional Wisdom vs Big Data (JAMA)
  • The World Health Organization Fetal Growth Charts: A Multinational Longitudinal Study of Ultrasound Biometric Measurements and Estimated Fetal Weight (PLOS)
  • Bolstering Community Cooperation in Ebola Resurgence Protocols: Combining Field Blood Draw and Point-of-Care Diagnosis (PLOS)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.