Regulatory Recon: Egypt's Military to Form National Drug Company Health Canada Looks to Add New Warning Stickers on Opioids (23 January 2017)

Posted 23 January 2017 | By Michael Mezher 

Regulatory Recon: Egypt's Military to Form National Drug Company Health Canada Looks to Add New Warning Stickers on Opioids (23 January 2017)

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

In Focus: US

  • Trump Executive Order On ACA: What It Won't Do, What It Might Do, And When (Health Affairs Blog) (NYTimes) (Reuters) (NPR) (WSJ)
  • Merck, Bristol-Myers agree to settle Keytruda patent suit (Reuters) (PharmaTimes) (EP Vantage) (Press)
  • Trump may not enforce individual health insurance mandate: aide (Reuters)
  • Trump's Health Plan Would Convert Medicaid to Block Grants, Aide Says (NYTimes) (NPR)
  • Trump's Vow to Repeal Health Law Revives Talk of High-Risk Pools (NYTimes)
  • 22 Case Studies Where Phase 2 and 3 Results Diverge: New FDA Report (Focus) (In The Pipeline) (Forbes)
  • Grassley hasn't forgotten about prescription drug prices (Axios)
  • Democrats to Hold Hearing on GOP Efforts to Undermine ACA's Successful Individual Mandate (Ways & Means Committee)
  • Facing a deepening political crisis, PhRMA launches a major counterattack against its legion of critics (Endpoints) (Thomson Reuters) (GoBoldly)
  • How Will Trump Change The FDA? (National Law Review)
  • Will Trump Appoint a Great FDA Commissioner? (Marginal Revolution)
  • Wider Racial Gap Found in Cervical Cancer Deaths (NYTimes)
  • Why the 'Free Market' For Drugs Doesn't Work and What We Can Do About It (The Wire)
  • ICER Releases Draft Evidence Report on Treatments for Rheumatoid Arthritis (ICER)
  • Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees (Focus)
  • FDA Begins Accepting Regenerative Therapy Applications for RAT Designation (Focus)
  • Bristol-Myers shares slide on immunotherapy setback (Financial Times) (BioCentury) (SCRIP-$)
  • Actelion drug setback unlikely to derail J&J talks: analysts (Reuters) (PharmaTimes) (The Street)
  • Trump's HHS Pick Favored Drugmakers, Device Makers And Doctors (KHN) (Roll Call)

In Focus: International

  • At least seven countries are jockeying to host the EU's medicine watchdog after Britain leaves (Science)
  • World must not miss early signals of any flu pandemic – WHO (Reuters) (WHO)
  • Humira UK Patent Trial Began Monday (Big Molecule Watch)
  • French court says German firm must compensate for faulty breast implants (Reuters)
  • Canada seeks warnings on prescription painkillers amid rising deaths (Reuters)
  • European Regulatory Roundup: The Netherlands Bids to Host EMA (Focus)
  • UK pharma slams new drug evaluation plans (PMLive)
  • NICE seeks positive future with life sciences industry (NICE)
  • Egypt's military to enter pharmaceutical industry (Reuters) (Financial Times)
  • Report stresses Chinese need for enhanced cancer drug innovation and access (PharmaLetter-$)
  • China FDA Video Showcasing 'Hard Work' Grips Social Media (Pink Sheet-$)
  • Japanese regulator grants priority review status to Bayer's regorafenib (PharmaLetter-$)
  • EMA grants accelerated review status to Gilead's new hepatitis C therapy (PharmaLetter-$) (BioCentury)
  • Volume and value of pharma/biotech M&A slowed down in 2016 (PharmaLetter-$)
  • Industry Wants Fixes To EMA's Guidance on Clinical Data Publication (Pink Sheet-$)
  • ICH – Rules of Procedure of the MedDRA Management Committee (ICH)
  • CTD: Revisions to the M4 Granularity Document (ICH)

US: Pharmaceuticals & Biotechnology

  • First Amendment Does Not Block Off-Label Enforcement Actions, FDA Reiterates (Pink Sheet-$)
  • FDA Says Yes to Pre-Approval Communications with Payors but Reaffirms its Approach to Restrictions on Off-Label Communications (National Law Review)
  • Biotech School: When Cellceutix CEO Rants About 'Criminal' Short, Smart Investors See Red Flags (The Street)
  • Chemists pin hopes on deep learning for drug discovery (C&EN)
  • The search for a painkiller that works without danger of addiction (Washington Post)
  • Biotech reporters look ahead (San Diego Union-Tribune)
  • FDA Mulls Tighter Regulation of Gene-Edited Animals (MIT Technology Review)
  • Heartburn pills tied to serious bacterial infections (Reuters)
  • Drug-Resistant Gonorrhea Finally Gets Attention (Medpage)
  • Keeping Track: Trulance Is First Novel Drug Of 2017; Vantrela ER Is Year's Second Abuse-Deterrent Opioid (Pink Sheet-$)
  • Lilly to lay off about 500 after drug fail (USA Today)
  • Enteris BioPharma signs oral diabetes pact with Sanofi (Fierce)
  • Sinking Marinus gets a lifeline with new ganaxolone data (Fierce)
  • Biotech Modeling Done Right: More Than Guesswork And Better Than Fake News (Forbes)
  • Pfizer partners with Cambridge matchmaker Milner (PharmaTimes)
  • Eisai 483 Handed Form 483 after Investigators Cite Control Records, CAPA Procedures (FDA News-$)
  • Biopharma survey: Shortage of bioprocessing talent key threat to sector (BioPharmaReporter)
  • OTC Self-Care Device Market Counts TENS As Growth Predictor (Pink Sheet-$)
  • PixarBio scraps bid for InVivo, citing management credibility (Fierce) (Press)
  • Influenza Vaccines and Birth Outcomes Protocol (PRISM) (Sentinel)

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

  • Eagle Pharmaceuticals Completes NDA Submission for Ryanodex for Exertional Heat Stroke to FDA (Press)
  • Ocular Therapeutix™ Resubmits NDA for DEXTENZA™ for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery (Press)
  • FDA Grants Deuterated CF Therapy Orphan Drug Designation (MPR)

US: Medical Devices

  • OssDsign wins FDA nod for 3D-printed cranial reconstructive implants (MassDevice)
  • Mammography Facility Adverse Event and Action Report - July 15, 2015 (Updated January 20, 2017): Bio Family Clinic PC (FDA)
  • Smith & Nephew pulls the trigger on planned CFO succession (MassDevice)
  • J&J's Ethicon picks up electrosurgical tool maker Megadyne Medical (MassDevice)
  • Roche Launches New Cobas m 511 Analyser (Press)
  • BIOLASE Announces the FDA Clearance and Worldwide Launch of Its New Epic Pro™ Diode Laser System (Press)
  • PleurX™ Catheter System Receives FDA 510(k) Clearance for Specific Non-Malignant Recurrent Pleural Effusions (Press)
  • Camber Spine Technologies Announces 510(k) Clearance For Their Siconus™ SI Joint Fixation System (Press)
  • 7D Surgical Receives FDA 510(K) and Health Canada MDL Clearance for Its Breakthrough Image Guidance System for Spine Surgery (Press)
  • Bone Index wins FDA 510(k) for osteoporosis diagnostic device (MassDevice)

US: Assorted & Government

  • Scientists join massive protest against Trump (Nature)
  • Conway replaces Slavitt as acting CMS administrator (BioCentury)
  • Sen. Klobuchar Introduces Bill to Expedite Generic Drug Reviews and Allow Re-Importation During Shortages or "Noncompetitive"
  • Pitfalls Of Judges, Lawyers, And Experts Citing Wikipedia (Drug & Device Law)
  • Update on the DeCosters' Case: Here Comes the U.S. Supreme Court (Maybe) (FDA Law Blog)
  • Transforming healthcare in the era of Trump: An opportunity to disrupt (EPR)

Upcoming Meetings & Events


  • Committee for medicinal products for human use (CHMP)  Draft Agenda 23-26 January (EMA)
  • France's Ethypharm to buy UK speciality pharma Martindale (PharmaTimes)
  • Where is the "pull" to tackle antimicrobial resistance? (ABPI)
  • Pharmaceutical Price Regulation Scheme PPRS Payment for 2017 (ABPI)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 January 2017 (EMA)
  • France to review food whitener additive for health risks (Reuters)


  • WuXi AppTec acquires biology focused CRO (PharmaLetter-$)
  • Daiichi Sankyo says Ranbaxy founders Malvinder and Shivinder Singh misled court (Economic Times)


  • Pharma firms lure doctors with gold coins to push its vaccines (Economic Times)
  • CDSCO Issues Notice that Clinical Trial Waivers Should Be Considered by Central Licensing Authority, Not Technical or Apex Committees (CDSCO)
  • Now smaller firms developing antibiotics but will society, politicians accept high prices? (Economic Times)
  • Pankaj Patel owned Cadila ups its India game with AZ's brands (Economic Times)
  • Health ministry to begin drafting of Drugs and Cosmetics (Amendment) Bill after Union Budget  (PharmaBiz)
  • Orphan drugs likely to deliver best revenue opportunities: CPhI Worldwide experts (PharmaBiz)
  • Gujarat FDCA to crackdown on circulation of spurious drugs by firms operating under fictitious names (PharmaBiz)
  • Gujarat FDCA to tie up with leading French company to equip drug officers on microbial testing (Press)
  • DoP directs NPPA to desist from fixing ceiling prices on its own derived principles; asks it to stick to provisions of DPCO 2013 (PharmaBiz)
  • Health ministry initiates procurement of equipment for setting up first medical device testing lab in Gujarat (PharmaBiz)
  • Bihar branch of IPA welcomes draft proposal by Union govt for amending D&C Rules (PharmaBiz)
  • Suven Life gets patent for neuro-degenerative drug (Economic Times)


  • Medical Devices Safety Update, Volume 5, Number 1, January 2017 (TGA)

General Health & Other Interesting Articles

  • John Arnold Made a Fortune at Enron. Now He's Declared War on Bad Science (Wired)
  • UK scientists give cancer risk warning on overdone chips, toast (Reuters)
  • Preterm birth linked to health problems in adolescence (Reuters)
  • Cancer patients with depression have resources (Reuters)

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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