Regulatory Recon: Novo Bets $145M on Oxford Research Center UK Review Finds Steep Price Increases for Old Cancer Drugs (30 January 2017)

Posted 30 January 2017 | By Michael Mezher 

Regulatory Recon: Novo Bets $145M on Oxford Research Center UK Review Finds Steep Price Increases for Old Cancer Drugs (30 January 2017)

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

In Focus: US

  • A Republican Plan for Medicare Gets a Revival (NYTimes)
  • In Private, Republican Lawmakers Agonize Over Health Law Repeal (NYTimes) (Forbes)
  • For Some, the Affordable Care Act Is a Lifesaver. For Others, a Burden. (NYTimes)
  • Consider drug efficacy before first-in-human trials (Nature) (In the Pipeline 1, 2)
  • Trump agenda threatens US legacy of science diplomacy (Nature)
  • Geneticist launches bid for US Senate (Nature)
  • Meet the scientists affected by Trump's immigration ban (Nature) (ProPublica)
  • Mold-contaminated mouth rinse found at NIH, spokeswoman says (Washington Post)
  • Trump Migration Ban Met With Silence From Biotech Execs (The Street)
  • Trump's Crusade on Drug Pricing Puts Both Parties on the Spot (Bloomberg)
  • AbbVie's Cancer Expansion Is Paying Off (SCRIP-$)
  • Getting Patients Hooked On An Opioid Overdose Antidote, Then Raising The Price (KHN)
  • If An Anti-Parasitic Drug Fights Cancer, Will It Remain Affordable? (NPR)
  • ICER finds Lemtrada most cost-effective in MS (BioCentury) (ICER)
  • Industry Argues Against FDA Home-Use Device Label Database (Focus)
  • FDA warns against use of homeopathic teething products (Reuters) (FDA)
  • FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence (Drug & Device Law)
  • In Which I Go Under The Knife And Learn About Medicine In The Real World (CardioBrief)

In Focus: International

  • The Medicines Patent Pool Announces First License for Tuberculosis Treatment (WHO) (Medicines Patent Pool)
  • Old Cancer Drug Gets 1,227% Price Hike in Frugal UK (Bloomberg) (Reuters) (The Guardian)
  • Novo Nordisk bets $145 million on post-Brexit UK science (Reuters) (Endpoints) (Drug Delivery) (SCRIP-$)
  • WHO Releases Revised Bioequivalence Trial Information Form (WHO)
  • A trade deal between the United Kingdom and United States (The BMJ)
  • Colombia, cancer and Novartis: why the Gleevec price war matters (PharmaLetter-$)
  • HC allows Indian firm to export drug in which Bayer has patent (Economic Times)
  • Will war on neglected diseases hit target? (Financial Times)
  • EMA To Address Industry Concerns in Revised Signal Management Guideline (Pink Sheet-$)
  • Quitting EU regulator 'would leave UK waiting longer' for new drugs (The Guardian)
  • Brexit uncertainty hangs over EU medicines agency (AFP)
  • Brexit or not, drug discovery needs reform, says Peter Kellner (PharmaLetter-$)
  • Sarepta Eyes Patient Outcomes To Boost Exondys 51's European Review (Pink Sheet-$)
  • EMA Recommends Two Amgen Humira Biosimilars (Focus) (Pharmafile) (SCRIP-$)

US: Pharmaceuticals & Biotechnology

  • The top 10 drug launches of 2017 (Fierce)
  • Jounce IPO Review (Biotechr)
  • Certify, Little viii, or Verification Must Now Be in Amendments for Certain Applications (Lachman Consultants)
  • Ask About Adherence: Q&A on appointment-based medication synchronization (PhRMA)
  • AbbVie hoping for early data read-out for anti-tau Alzheimer's drug (Fierce)
  • Trump, TPP and America First threaten US biomanufacturing jobs, says expert (BioPharmaReporter)
  • Molecule to combat antibiotic resistance found (Manufacturing Chemist)
  • Novan pummeled on Phase III acne miss (BioCentury)
  • Biogen cancels MS drug deal, "due to strategic objectives" (PharmaLetter-$)
  • Meet the Regenerative Advanced Therapy Designation (FDA Law Blog)
  • Juno Therapeutics bring in new executive vice president (Pharmafile)
  • Regulus hits further setbacks as clinical hold upheld (BioPharmaDive) (Regulus)
  • Ban DTC or fix it? Docs sound off about patient confusion over ads (Fierce)

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

  • BELMONT Phase 2 Clinical Data to be Presented at IMCAS World Congress 2017 (Press)
  • Astellas and Ironwood release positive Phase 3 results for constipation drug (Pharmafile) (Press)
  • FDA Approves Allergan's sNDA for AVYCAZ® (ceftazidime and avibactam) to include new Phase III data in Patients with Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis (Press)
  • Acucela Initiates Phase 2a Study of Emixustat Hydrochloride Addressing Patients with Stargardt Disease (Press)
  • Aurinia Selects Worldwide Clinical Trials as its CRO for Phase 3 Lupus Nephritis Trial (Press)
  • Sunovion's Latuda® (lurasidone HCl) Receives FDA Approval to Treat Adolescents with Schizophrenia (Press)

US: Medical Devices

  • C.R. Bard's Q4 sales, earnings beat estimates (MassDevice)
  • FDA Approves First Balloon Expandable Stent Graft for Use in the Iliac Artery (Press)
  • Teva Announces FDA Approval of Two New RespiClick® Maintenance Inhalers for the Treatment of Asthma (Press)

US: Assorted & Government

  • Pacemaker data lead to arson charges for Ohio man (MassDevice)
  • Shire Prevails In Patent Trial Over Mylan's Generic Lialda (Law360-$)
  • Zimmer Biomet logs 3rd win in NexGen Flex bellwether trials (MassDevice)
  • Patents Under The Trump Administration (Law360-$)
  • Judge pares $20m verdict in doc's patent spat with Medtronic (MassDevice)

Upcoming Meetings & Events


  • Former Biogen exec joins Sanofi executive committee (PharmaLetter-$)
  • Celgene's Revlimid scores first-of-its-kind myeloma indication in EU (Pharmafile)
  • Pfizer's Xeljanz Set To Lag Lilly's Olumiant In Europe Following Past Rebuffs (SCRIP-$)
  • Sandoz Sanguine On Market Opportunity Despite Biosimilar Neulasta Setback (SCRIP-$)
  • Merger Rules Shouldn't Stifle Drug Development: Vestager (Law360-$)
  • MHRA warns athletes to avoid potentially dangerous DMAA (MHRA 1, 2)


  • The Intrigue Contained In The New China Drug Code (RxTrace)


  • Piramal to acquire drugs from UK's Mallinckrodt for Rs 1,162crore (Economic Times)
  • Prescriptions for major depression up 14% in 2016 (Economic Times)
  • Gujarat FDCA to tie up with Abbott India to equip drug officers on medical devices (PharmaBiz)
  • DoP rejects review application of USV against price fixation of "Amlodipine 5 mg, clopidogrel 75 mg tablets" (PharmaBiz)


  • Updated list of 'permissible ingredients' for use in listed medicines (TGA)


  • Regulatory decision summary for INTELLANAV OPEN-IRRIGATED ABLATION CATHETER (Licence number 98243) (Health Canada)
  • Regulatory decision summary for NMARQ CATHETER (Licence number 98210)
  •  (Health Canada)


  • Containing Zika while we wait for a vaccine (The BMJ)

General Health & Other Interesting Articles

  • Depression and Anxiety Tied to Cancer Deaths (NYTimes)
  • Patients with type 1 diabetes may need to check ketones more often (Reuters)
  • Sepsis Is Now The Leading Cause Of Unplanned Hospital Readmissions (Forbes)

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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