Regulatory Recon: Pfizer and Allergan Agree to Merge, FDA Approves Takeda's Ninlaro (23 November 2015)

Posted 23 November 2015 | By Michael Mezher 

Regulatory Recon: Pfizer and Allergan Agree to Merge, FDA Approves Takeda's Ninlaro (23 November 2015)

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

  • FDA approves Ninlaro, new oral medication to treat multiple myeloma (FDA) (BioCentury) (Press)
  • Pfizer and Allergan to Merge in $160 Billion Deal (NYTimes) (WSJ-$) (Bloomberg)
  • Concerns Over Valeant Spread to Other Drug Makers (WSJ)
  • Novartis gets FDA approval for skin cancer drug combination (Reuters)
  • Sharp increases in drug costs draw hundreds to government forum (Washington Post) (NYTimes) (SCRIP-$) (Focus)

In Focus: International

  • Panels Advise Bolstering WHO for Crises Like Ebola (NYTimes) (Reuters) (WSJ-$)
  • BMS Lets Low Income Countries Copy Hepatitis C Pills (Bloomberg)
  • The Guardian View on Antibiotic Resistance: A Clear and Present Danger (The Guardian)
  • I Believed we Would Face an Antibiotics Apocalypse - Until Now (The Guardian)
  • Liberia monitors over 150 Ebola contacts as virus re-emerges (Reuters)
  • Ebola Cases in 3 Family Members Confirmed in Liberia (NYTimes)
  • Trans-Pacific Partnership and the Continuing Controversy Over the Exclusivity Period for Biologics (National Law Review)

US: Pharmaceuticals and Biotechnology

  • Duchenne moms say FDA documents 'widen the divide' between drugs by BioMarin, Sarepta (Boston Business Journal)
  • Entresto's Theoretical Alzheimer's Risk Draws Practical FDA Response (Pink Sheet-$)
  • Johns Hopkins Researchers Call for Orphan Drug Reform (Focus)
  • FDA's Neurology Division On The State Of Alzheimer's Science (Pink Sheet-$)
  • For one rare disease community, a rare moment of hope (Washington Post)
  • Off-Label, Shortage Issues Influence Telesta MCNA Review (Pink Sheet-$)
  • Data does not support nod for BioMarin's DMD drug: FDA staff (Reuters)
  • Clinical trial disclosures for new drugs are below legal and ethical standards, find researchers (Pharmaceutical Journal)

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

  • Celldex vaccine improves long-term brain cancer survival in study (Reuters) (WSJ-$) (Forbes)
  • NovoCure's cancer therapy effective in late-stage study (Reuters)
  • Roche buoyed by early data on atezolizumab in advanced melanoma (Reuters)
  • Caldolor Approved For Use In Pediatric Patients (Press)
  • Updated data showed Cotellic in combination with Zelboraf helped people with a specific type of advanced melanoma live significantly longer than with Zelboraf alone (Press)
  • AGTC Announces US FDA Orphan Drug Designation for Gene Therapy to Treat Achromatopsia (AGTC)
  • New Phase 3 Data show Optune in Combination with Second Line Chemotherapy is Superior to Second Line Chemotherapy Alone in Glioblastoma Patients at First Recurrence (Press)
  • Merck Announces Initial Results for KEYTRUDA (pembrolizumab) with Novel Immunotherapy Combinations from Three Investigational Studies (Press)
  • B-TEMIA initiates pivotal clinical trial to support commercial launch of Keeogo in the US (Press)
  • Alexar Therapeutics, Inc. Initiates Phase IIa Clinical Trial for ALX-101 Topical Gel (Press)
  • Generon Collaborating with Mayo Clinic to Initiate a Phase IIa Study with F-652, a First-in-Class Biologic, to Treat Patients with Alcoholic Hepatitis (Press)
  • Seattle Genetics Initiates Phase 1/2 Clinical Trial of SGN-CD33A (Vadastuximab Talirine) Before or After Allogeneic Stem Cell Transplant in Patients with Relapsed or Refractory Acute Myeloid Leukemia (Press)
  • BioLineRx Announces Initiation of Phase 1/2 Trial for Novel Treatment in Two Bone Marrow Failure Conditions (Press)

US: Medical Devices

  • Medtronic wins FDA panel date for DIAM spine stabilization system (MassDevice)
  • NGS Altering the Landscape of Antiviral Drug Resistance Analysis, FDA Officials Say (Focus)
  • House E&C Committee Turns Focus to the Regulation of Diagnostic Tests and Laboratory Operations (Policy and Medicine) (Focus)
  • 3 ways the FDA furthers patient engagement in the med device process (FierceHealthIT) (JAMA)
  • The Democratization Of Medical Research: Why This Biotech Startup Wants Your Blood (Forbes)
  • Neuronetrix publishes peer-reviewed paper validating the clinical application of ERP biomarkers for use in Alzheimer's disease (MNT)
  • Glaukos submits IND for Travoprost eluting iDose (MassDevice)
  • MyCareLink App-Based Pacemaker Monitor FDA Approved (medGadget)
  • FDA Approves St. Jude's iPad-Controlled Spinal Cord Stimulation System (MedDeviceOnline)
  • Artificial pancreas therapy performs well in pilot study (MNT)

US: Assorted and Government

  • States Lead Effort to Let Pharmacists Prescribe Birth Control (NYTimes)
  • After Death, Nevada Issues Cryotherapy Guidelines (NYTimes)
  • Merck CEO: Don't Judge All Pharma On Turing (SCRIP-$)
  • FTC amicus brief urges Appeals Court to reverse District Court ruling that insulates pharma companies from antitrust scrutiny (PharmaLetter-$)
  • The Government Really Means It This Time (Part II) (FDA Law Blog)
  • Albertsons Sold Unapproved ADHD Generic Drug, Parent Says (Law360-$)
  • J & J Files Cert Petition in Massachusetts Supreme Court's Unsupportable Rejection of Preemption Defense in Reckis TEN/Children's Motrin Case (Drug and Device Law)
  • A Prescription for Sticker Shock Caused by Drug Costs (NYTimes)
  • Frosh reps push Ryan on medical device tax repeal (MassDevice)
  • Perceptions of Counterfeit Medicines: Only 12% of Americans Feel They Have Enough Information (Sanofi)
  • Draft Guidance: Over-the-Counter Sunscreens: Safety and Effectiveness (FDA)
  • Draft Guidance: Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process (FDA)
  • Draft Guidance: Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request (FDA)
  • Draft Guidance: Nonprescription Sunscreen Drug Products-Content and Format of Data Submissions (FDA)

Upcoming Meetings and Events


  • EMA/CHMP recommends 6 new medicines and 3 generics for approval (PharmaLetter-$)
  • Insufficient Transitional Measures Doom The FMD-EUDA (RxTrace)
  • Novartis' secukinumab gains two landmark EU approvals (EPR)
  • CHMP Nod For Bioprojet Pharma's Narcolepsy Therapy (SCRIP-$) (EMA)
  • Gilead's Genvoya approved in Europe (PharmaLetter-$)
  • Boston Scientific Receives CE Mark For Next Generation WATCHMAN FLX Left Atrial Appendage Closure Device (MedDeviceOnline)
  • European Commission approves Amgen's cancer drug Kyprolis in combo therapy (Pharmafile)
  • The Medicines Company gets European marketing nod for Ionsys to treat post-operative pain in adult hospitalised patients (PharmaBiz)
  • Baxalta Gets EU Thumbs Up For Newly Acquired ALL Drug (Press) (SCRIP-$)


  • Canadian Researchers Recognized For Diabetes Breakthrough Using Stem Cells (Forbes)


  • NPPA exempts price controls for three insulins of Wockhardt (Economic Times)
  • Strides Shasun suspends production at Cuddalore unit block on govt orders (Economic Times)
  • Orthopedic implants may get up to 50 per cent cheaper over suggested price caps (Economic Times)
  • Strides Shasun gets USFDA nod to market Dutasteride capsules (Economic Times)
  • Aurobindo Pharma gets USFDA nod for generic of Pfizer's Revatio (Economic Times)
  • DoP to finalise incentives to boost domestic production of APIs soon (PharmaBiz)
  • India awaits results from new TB trial on drug-resistant forms (FiercePharmaAsia)


  • Experts to advance precision cardiovascular medicine in China (PharmaLetter-$)


  • Regulation impact statement: International harmonisation of ingredient names (TGA, 2)

Other International

  • Health experts to take fight to TB (EurActiv)
  • Merck KGaA rolls out big plans for expansion in Africa (FiercePharma) (Merck)
  • South American Health Ministers Negotiate Lower Prices for Antivirals, Antiretrovirals (Focus)

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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