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Regulatory Recon: EMA Recommends 11 Drugs for Approval, Including Cancer Drugs From Lilly, Pfizer and Takeda (16 September 2016)

Posted 16 September 2016 | By Michael Mezher 

Regulatory Recon: EMA Recommends 11 Drugs for Approval, Including Cancer Drugs From Lilly, Pfizer and Takeda (16 September 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

  • Valeant Heart Drug Discounts Haven't Materialized, Hospitals Say (Bloomberg)
  • Amgen Files Suit Against Sandoz Over Neulasta Biosimilar (FDA) (Claim)
  • Judge Upset 'Entire Balance' Of Biosimilar Law, Amgen Says (Law360-$)
  • FDA Rolls Out a New Form—You May Want to Pay Attention to This One (FDA Law Blog)
  • FDA permits marketing of balloon device to treat persistent Eustachian tube dysfunction (FDA)
  • FDA Neurology Clinical Team Leader Departure May Be Mountain Disguised As Molehill (Pink Sheet-$)
  • Turmoil at federal agency threatens oversight of biomedical research (Washington Post)
  • EpiPen Maker's Tactics Could Quell Protests Over Prices (NYTimes 1, 2) (Boston Globe)
  • Rare Diseases Are Becoming Too Common. Sound Impossible? Here's Why It's Not (Forbes)
  • Thinking straight about orphan drugs, Part 5. (The Incidental Economist)
  • Are We Unprepared For Another Ebola Outbreak? (Forbes)
  • Living With Cancer: Unplugged and Unmoored (NYTimes)
  • The Lancet Versus BMJ: Dispatch From The Statin Wars (CardioBrief)
  • SPRINTing to Lower BP Targets? Not So Fast (CardioBrief)
  • Rapid Biomedical Innovation Calls For Similar Innovation In Pricing And Value Measurement (HealthAffairsBlog) (Response) (Healthcare Economist)
  • Minnesota doc creates $50 EpiPen alternative (MassDevice)
  • FDA Approves Modified Dosing Regimen for Bristol-Myers Squibb's Cancer Treatment Opdivo (Focus)
  • Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (FDA)
  • Astrazeneca says Forxiga combination beats use of drug alone (Reuters)
  • Novavax Shares Plummet After Unfavorable Results of Trials (WSJ) (Reuters)

In Focus: International

  • EMA's CHMP Recommends Ban of US CMO's Medicines (Focus) (EMA)
  • EMA survey on initial marketing authorisation application 2016 (EMA)
  • CHMP Recommends Eleven Medicines for Approval (EMA)
  • CHMP Recommends Lilly's Lartruvo for Soft Tissue Sarcoma (EMA) (Press) (Fierce)
  • CHMP Recommends Pfizer's Ibrance for Advanced or Metastatic Breast Cancer (EMA) (Reuters)
  • The Open Source Malaria Project, So Far (In The Pipeline)
  • Russian government to change tender conditions for public procurement of high-priced drugs (PharmaLetter-$)
  • Bayer CEO Sets Course With Monsanto Deal (WSJ)
  • Department of Health introduces Bill for new drug pricing controls (PharmaTimes) (PMLive) (PharmaLetter-$)
  • IQWiG reverses added benefit opinion on ticagrelor (PharmaLetter-$)
  • Australia Plans New Approval Pathways To Foster Earlier Access To Novel Drugs (Pink Sheet-$)
  • Australian regulators to take GI Dynamics EndoBarrier off the market (MassDevice)
  • How Government Partnerships Can Fuel Middle Eastern Growth For Janssen (Pink Sheet-$)
  • Combatting EU drug shortages (PMLive)

US: Pharmaceuticals & Biotechnology

  • Intarcia Raises $215m As NDA For ITCA 650 Slips To Fourth Quarter (SCRIP-$)
  • Francis Collins: Privacy a priority for Precision Medicine Initiative (Fierce)
  • Total Kidney Volume Qualified as a Biomarker by FDA for ADPKD Trials (Focus)
  • FDA Responses to Action Items From November 16-17, 2015 Inter-governmental Working Meeting on Pharmacy Compounding (FDA)
  • Making Eye Health a Population Health Imperative: Vision for Tomorrow (National Academies)
  • Statement by NEI Director Paul A. Sieving, M.D., Ph.D., on National Academies' report outlining public health strategies to promote and protect healthy vision for all Americans (NIH)
  • Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry; Availability (FDA)
  • After licensing out tremelimumab to AZ, Pfizer pays for another CTLA-4 mAb (Fierce)
  • Fragile X drug developer Fulcrum to use Horizon's CRISPR to find gene targets (Outsourcing-Pharma)
  • Gilead's Pipeline, Maligned by Investors, Still Packed With 4Q Clinical Trial Readouts (The Street)
  • Depomed, heeding activist's advice, prepares to go up for sale (Fierce)
  • ​Welcome to the Cystic Fibrosis Foundation's new Lexington labs (Boston Biz Journal)
  • New way of testing drugs could speed up development of breast cancer treatments (MNT)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; LUMASON (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ENTYVIO (FDA)

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

  • Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (NEJM) (Fierce)
  • OptiNose Presents Data from Phase 3 Trials with Investigational Product Using Exhalation Delivery System Technology for Treatment in Patients with Chronic Rhinosinusitis (CRS) with and without Nasal Polyps (Press)
  • Oral Ozanimod Efficacy and Safety Results at 2 Years from Phase 2 RADIANCE Trial of Patients with Relapsing Multiple Sclerosis Presented at 32nd ECTRIMS (Press)

US: Medical Devices

  • Surgical robotics herald the super-surgeon (MassDevice)
  • Ex-HHS chief Sebelius joins Solera Health board (MassDevice)
  • Waivers From the Requirement To Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Draft Revised Guidance for Industry; Availability (FDA)
  • Zimmer Biomet picks up imaging company Clinical Graphics (MassDevice)
  • Tissue-engineered human liver made from stem & progenitor cells (MassDevice)
  • Former St. Jude exec Craig seeks Minn. Congressional seat (MassDevice)
  • High-capacity nanoparticle holds potential for targeted cancer therapies (MassDevice)
  • Medtronic's new ops chief is PE exec Ploof | Personnel Moves Sept. 15, 2016 (MassDevice)
  • Varian wins FDA clearance for Nexus DR digital X-ray (MassDevice)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; RESQCPR SYSTEM (FDA)
  • Shockwave Medical Announces FDA Clearance of the Company's Lithoplasty® System, the First and Only Technology to Use Sound Waves to Treat Calcified Peripheral Artery Disease (Press)

US: Assorted & Government

  • Hotel California Stays Open: Another Look At Specific Jurisdiction in BMS (Drug and Device Law)
  • FDA Cracks Down on Online Sales by E-Cigarette Industry (WSJ)
  • Poll shows 66 percent of California voters favor drug price initiative (Reuters)
  • New Mexico Sues Bristol-Myers For False Marketing Of Plavix (Law360-$)
  • UPDATED: USDA releases response plan for emerging animal diseases (Fierce)
  • LONG-TERM CARE WORKFORCE: Better Information Needed on Nursing Assistants, Home Health Aides, and Other Direct Care Workers (GAO)
  • Strategic plan sets priorities, research direction for nursing science (NIH)

Upcoming Meetings & Events


  • Government's progress in preventing drug resistant infections (UK DOH)
  • European Commission clears acquisition of Anda Distribution by Teva (PharmaLetter-$)
  • European Medical Device Regulatory News You May have Missed (Emergo)
  • Cell therapy newco GammaDelta launched (BioCentury)
  • Takeda Receives Positive CHMP Opinion for Conditional Approval of NINLAROTM (ixazomib), the First Oral Proteasome Inhibitor, for Use in Patients with Multiple Myeloma (Press)
  • Pfizer Receives Positive CHMP Opinion For IBRANCE® (palbociclib) In Combination With Endocrine Therapy For The Treatment Of HR+/HER2- Metastatic Breast Cancer In Europe (Press)
  • Navidea's Lymphoseek® Receives Positive Opinion in Europe for a New Reduced Mass Vial (Press)
  • Glyxambi® (empagliflozin/linagliptin) approval recommended by CHMP for adults with type 2 diabetes in the European Union (Press)
  • Janssen Receives CHMP Positive Opinion for STELARA® (ustekinumab) Recommending Approval for the Treatment of Moderately to Severely Active Crohn's Disease in the European Union (Press)


  • Basilea licenses isavuconazole to Asahi Kasei in Japan (PharmaLetter-$)


  • Dr Reddy's Laboratories inks pact with Amgen to commercialise three drugs in India (Economic Times)
  • Government moves to Supreme Court over ban on combination drugs (Economic Times)


  • Guidance Document: Notice of Compliance with Conditions (NOC/c) Enters Into Effect Today (Health Canada)
  • Summary of Stakeholder Engagement Sessions to Discuss the Safe Use of Acetaminophen (Health Canada)


  • Public submissions on scheduling matters referred to the ACMS#18, July 2016 (TGA)


  • Aides: Congress makes progress on Zika, spending (Modern Healthcare)
  • Study confirms Zika causes brain birth defects, questions remain (Reuters)
  • Indonesia hopes to guard against Zika virus with airport larvae traps (Reuters)

Other International

  • Global goal to reduce maternal deaths threatened by lack of access to quality care: study (Reuters)

General Health & Other Interesting Articles

  • Brain cancer now deadliest for U.S. children: study (Reuters)
  • More than 1 in 4 US adults over 50 do not engage in regular physical activity (CDC)
  • Early menopause tied to heart risk and early death (Reuters)
  • Too soon to tell if 9/11 firefighters face increased cancer risk (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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