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Regulatory Recon: PhRMA CEO: Don't Blame Pharma Companies Novartis Acquires Selexys in $665M Deal (21 November 2016)

Posted 21 November 2016 | By Michael Mezher 

Regulatory Recon: PhRMA CEO: Don't Blame Pharma Companies Novartis Acquires Selexys in $665M Deal (21 November 2016)

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

In Focus: US

  • A New Orange Book First: FDA Unilaterally Changes a Patent Use Code (FDA Law Blog)
  • NIH chief: Short-term spending bill 'painful' for medical research (The Hill)
  • Scientists hope Trump won't decrease the flow of federal research dollars (Boston Globe)
  • Celgene buys into experimental cancer med from Triphase (Fierce)
  • Obama Administration Still Wants to Release New Common Rule (Bloomberg)
  • Do cancer clinical trials exaggerate the real-world benefits of drugs? (STAT)
  • Clinical Trial Challenges: FDA Wants More Prospective Studies, Validated Biomarkers (Pink Sheet-$)
  • Rep. Price clear favorite for Trump's HHS chief (Politico)
  • Dinner and a biotech chat: Billionaire Patrick Soon-Shiong talks 'innovation' with President-elect Trump (Endpoints)
  • Acorda forced to stop development of drug (Pharmafile) (Press)
  • Partial Clinical Hold Lifted and Enrollment Resumes for Aduro Biotech LADD Clinical Trials (Press)
  • Cures Compromise Emerges With Medicare Riders; REMS Offset Replaced By Prevention Fund, Oil Reserves (IHP-$)
  • Biotech Venture Capital Mythbusting Redux (LifeSciVC)
  • Biotech Stocks May be Cheap But Large Scale M&A May Elude the Sector (The Street)
  • FDA Delays Finalization of Lab-Developed Test Draft Guidance (Focus) (GenomeWeb) (InsideMedicalDevices) (STAT)
  • GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders (Focus)
  • Sanofi Halts Production of Bladder Cancer Drug as Others Fail to Win FDA Approval (Focus)
  • Field trial of genetically modified mosquitoes gets approval in Florida (STAT) (Press)
  • GSK seeks US approval for triple lung drug (Reuters) (PharmaTimes)
  • Novartis backs off from 2016 date for testing Google autofocus lens (Reuters)
  • Adapt Pharma Urges FDA Hurdles For Teva Overdose Generic (Law360-$)
  • Don't Blame Pharmaceutical Companies (NYTimes)

In Focus: International

  • Ignore EMA Advice at own peril (BioPharmaReporter)
  • Lasting Effects: Advances in Influenza Vaccine Technology (Globe and Mail)
  • Sounding The Alarm: UK Biotech Struggles To Cope With Brexit (Forbes)
  • Mexico's COFEPRIS Provides Glimpse of Medical Device Regulatory Activities (Emergo)
  • EU expands scope of Teva's Trisenox (PharmaTimes) (Pharmafile)
  • Novartis in $665 million deal for Selexys (Pharmafile) (Press)
  • Chiesi buys Atopix for clinical-stage asthma pipeline (Fierce)
  • WHO Issues RFP for Survey on Medicines Prequalification Program (WHO)
  • Out-Going GSK CEO Andrew Witty Tells Pharma To Evolve Or Die (SCRIP-$)
  • Adaptive pathways workshop briefing book (EMA)
  • Is €20m A Reasonable Cost For An EU PIP? Consultation On Pediatric Rule (SCRIP-$)
  • Anti-smoking drug Champix in spotlight at Brisbane suicide inquest (The Guardian)
  • More than 18 million on HIV treatment, a million more than 2015: UNAIDS (Reuters)
  • How Eisai Hopes To Expand In India (SCRIP-$)
  • WHO declares end of Zika emergency but says virus remains a threat (Reuters) (Washington Post) (WHO)
  • Public consultation on assessment criteria for combination packages policy by Dutch regulator (PharmaLetter-$)
  • Russian pharmaceutical market today and tomorrow – legal overview (PharmaLetter-$)
  • 9th Global conference on health promotion: Global leaders agree to promote health in order to achieve Sustainable Development Goals (WHO)

US: Pharmaceuticals & Biotechnology

  • BMS biologics-focus trimmed network from 27 to 16 sites since 2007 (BioPharmaReporter)
  • Are We Seeing the End of OPDP? (Policy and Medicine)
  • CAR T Cell Therapy for Solid Tumors (Annual Reviews)
  • All Is Forgiven At 1000 Degrees (In The Pipeline)
  • Apricus Won't Need New Trials To Resubmit ED Cream Vitaros At FDA (Pink Sheet-$)
  • Continuous and aseptic innovations top FDA list of emerging tech requests (InPharmaTechnologist)
  • Overall Survival in Cancer Drug Trials as a New Surrogate End Point for Overall Survival in the Real World (JAMA)
  • MD Anderson to biotech billionaire Soon-Shiong: Get your own slogan. 'Moon Shots' belongs to us (Endpoints)
  • FDA Releases 2014 NARMS Integrated Report; Finds Measurable Improvements in Antimicrobial Resistance Levels (FDA)
  • FDA CDER Identifies Nanotechnology as Area of Interest for Site Visit Training Program for OPQ Staff (National Law Review)
  • Moleculin Biotech gets good verbal Ok from FDA which should cut time to Phase 1/2 trial down (The Street)
  • Primate deaths cause stock plummet for Arrowhead as RNAi PhII trials halted by FDA (InPharmaTechnologist)
  • FDA-Mandated Zika Blood Testing Catches Few Infected Donations (Medpage)
  • Childhood cancer survivors may not get needed adult care (Reuters)
  • Deaths Involving Fentanyl Rise As Curbing Illicit Supply Proves Tough (NPR)

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

  • U.S. FDA Grants Fast Track Designation for the Development of Oragenics' AG013 for Oral Mucositis (Press)
  • GSK receives FDA approval for expanded indication for FluLaval® Quadrivalent (Influenza Vaccine) for infants 6 months and older (Press)
  • Mallinckrodt touts data for Ofirmev injected acetaminophen (Drug Delivery)
  • Goodbye, San Francisco. Stanford spinout heads to Houston after bagging a $20M CPRIT grant (Endpoints)
  • Curable initiates the International PSC Genome project in partnership with the Mayo Clinic (Manufacturing Chemist)
  • CEL-SCI Submits Response to FDA in Connection with Partial Clinical Hold on Phase 3 Clinical Trial (Press)
  • Ligand Partner Retrophin Reports Additional Positive Data from Phase 2 DUET Study of Sparsentan in Focal Segmental Glomerulosclerosis at ASN Kidney Week 2016 (Press)
  • Aurinia Highlights Renal Function Data from Global Phase IIb AURA Study of Voclosporin for Lupus Nephritis at American Society of Nephrology Kidney Week 2016 (Press)
  • Positive Early Data From BioTime's Renevia Pivotal Trial Presented at IFATS Meeting (Press)

US: Medical Devices

  • A Better Approach to Developing Instructions for Use (MDDI)
  • Protecting Software as a Medical Device (MDDI)
  • Ascensia Diabetes Care Receives FDA Clearance for the App-Enabled CONTOUR®NEXT ONE Blood Glucose Monitoring System (Press)

US: Assorted & Government

  • GSK, Others Back Bristol-Myers In Plavix Jurisdiction Row (Law360-$)
  • Insurer Anthem to Defend Cigna Deal in Court (WSJ)
  • Let's Say Obamacare Is Repealed. What Then? (NYTimes)
  • Medical Marijuana Is Legal in California. Except When It's Not. (NYTimes)
  • Awful Missouri Venue/Joinder Ruling Offers Way Out – Take It! (Drug and Device Law)

Upcoming Meetings & Events


  • Artificial pancreas safe for hospitalized diabetics (Reuters)
  • UK Government launches £60 million call for global health research (UK DoH)


  • Zydus Cadila gets USFDA nod for anti-infections tablets (Economic Times)


  • Celltrion's Biosimilar Rituximab Edges Ahead With Korean Approval (SCRIP-$)
  • Discovery of Blood Biomarkers for Early Pancreatic Cancer Detection (AMED)
  • CALL FOR COMMENTS on the PROPOSED Document "Quality Management System-Medical Devices Requirements for Distributors, Importers and Authorized Representative" (AHWP)
  • GSK promotes Willemsen as China head, will 'put more energy' into growth prospects (Fierce)


  • Toward Front-of-Package Nutrition Labels for Canadians (Health Canada)


  • Hazard alert – Advance HA Coated Tibial Bases: potential for implant failure due to loosening (TGA)


  • Myanmar health authorities struggle to prepare for Zika outbreak (Reuters)

General Health & Other Interesting Articles

  • Why the FDA had to approve Audi's latest R8 (CNET)

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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