Regulatory Recon: Astellas to Buy Belgian Drug Discovery Co Odega for €500M; BMS Says Immunotherapy Combo Extends Survival in Melanoma (3 April 2017)

Posted 03 April 2017 By Michael Mezher

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

In Focus: US

  • The cost of cancer: new drugs show success at a steep price (Reuters)
  • Sanofi Pasteur Agrees to Pay $19.8 Million to Resolve Drug Overcharges to the Department of Veterans Affairs (DoJ)
  • Mallinckrodt reaches $35 million settlement in U.S. drug probe (Reuters)
  • The government's struggle to hold opioid manufacturers accountable (Washington Post)
  • Gottlieb's Job One (BioCentury)
  • Wellness Apps Evade the FDA, Only to Land in Court (Wired)
  • Promising cancer drugs may speed tumours in some patients (Nature)
  • Drug Middlemen Have Slim Profit Margins—Just Ask Them (Bloomberg)
  • Modernizing And Strengthening Existing Laws To Control Drug Costs (Health Affairs Blog)
  • An FDA Weakened by Obama Will Be Conflicted Under Trump (UnDark)
  • Takeda lays off more than half of Ariad's US staff (Pharmafile)
  • Merck's Keytruda cancer drug records sales surge (Financial Times)
  • AACR17 roundup: Bristol-Myers, Merck KGaA and Pfizer in the spotlight, marking progress with checkpoints (Endpoints)
  • For Bristol-Myers, A Victory And A Mystery (Forbes) (Reuters) (Press) (Press)
  • US Zika vaccine begins second phase of testing (Reuters) (Washington Post) (NIH)
  • US judge invalidates Acorda multiple sclerosis drug patents (Reuters) (The Street) (BioCentury)
  • Biogen wins Tecfidera US patent dispute with Forward Pharma (Reuters) (BioCentury)
  • More Bad News For The Once Promising Bioresorbable Stent (CardioBrief)
  • Mylan extends its EpiPen recall to the US and many other parts of the world (STAT) (Reuters) (Fierce) (FDA 1, 2, 3)
  • Pfizer Gets Full Approval for Ibrance in Breast Cancer in Post-Menopausal Women  (Press)
  • Kite completes FDA CAR-T filing, posts improved data (Fierce) (Endpoints) (Press)
  • Also Made in Mexico: Lifesaving Medical Devices (NYTimes)
  • Obamacare Choices Could Go From One to Zero in Some Areas (NYTimes)
  • Trump talks healthcare with Republican critic on golf course (Reuters)

In Focus: International

  • Four big challenges Emma Walmsley faces at the helm of GSK (Financial Times)
  • Japanese man is first to receive 'reprogrammed' stem cells from another person (Nature)
  • Bayer's UK boss spending 30% of time working on Brexit issues (PharmaLetter-$)
  • EU OKs Novartis' Tafinlar/Mekinist combo for lung cancer (PharmaTimes) (PharmaLetter-$)
  • Astellas to buy GPCR specialist Ogeda for €500M upfront (PharmaTimes) (Fierce) (Press)
  • Pharma warns new NICE rules will delay access to meds (PharmaTimes) (PharmaLetter-$) (ABPI)
  • Praxbind earns new UK status as antidote to Pradaxa (PharmaLetter-$)
  • Israel's medical marijuana pioneers look to cash in on $20bn market (The Guardian)
  • Australian Yasmin Case Sets New Yardstick For Damages Claims; Stings Lupin Arm (SCRIP-$)
  • Health Canada and FDA Joint Public Consultation on ICH Guidelines for Registration of Pharmaceuticals for Human Use (Health Canada)
  • Russian Regulators Clarify Technical File Requirements for Medical Devices and IVDs (Emergo)
  • Singapore HSA Adjust Medical Device Field Safety Notice (FSN) Requirements (Emergo)

US: Pharmaceuticals & Biotechnology

  • Annual Report to the Nation: Cancer Death Rates Continue to Decline (NIH)
  • 4 FDA Decisions to Watch Out for in Apr 2017 (NasDaq)
  • Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature (BMJ)
  • Novo Nordisk's Hemophilia B Drug Faces Safety Scrutiny By US FDA Panel (Pink Sheet-$) (PharmaLetter-$)
  • Fresh from Merck embrace, fast-growing Incyte pivots into a PhIII IDO1/Opdivo tie-up with Bristol-Myers (Endpoints) (The Street) (Press)
  • Sarepta nabs Regeneron exec Stehman-Breen as new CMO (Fierce)
  • Mylan won't say if it will begin paying a much higher Medicaid rebate in April (CNBC)
  • International scientific teams find potential approach against parasites (NIH)
  • Crunch Time: The Impact of Serialisation Requirements on Packaging Operations (Pharmafile)
  • Can Anyone Buy Non-Serialized Drugs After 11-27-2019? (RxTrace)
  • Pharmacy chain works to help curb opioid epidemic (Reuters)
  • Progenics On Way To The FDA With Second Product Offering Azedra (SCRIP-$)
  • Fledgling biotech Vtesse in $200M buyout from struggling Sucampo (Fierce)
  • Aducanumab Seen As Potential ALS 'Time Bomb' For Health Budgets (Pink Sheet-$)
  • Vaccines: The Greatest Live-Saving Health Success (BIO)
  • Puma Biotechnology Launches Expanded Access Program for PB272 (Neratinib) for US Patients with HER2-Positive Breast Cancer or HER2-Mutated Cancers (Press)

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

  • Phase III ALUR study supports the use of Roche's Alecensa for people with advanced ALK-positive lung cancer (Press)
  • Switching To Sanofi's Toujeo Showed Significant Reductions In Blood Sugar And Significantly Lower Incidence Of Hypoglycemia In A Real-World Observational Study (Press)
  • Audentes Therapeutics Announces FDA Clearance of Investigational New Drug Application for AT132 to Treat X-Linked Myotubular Myopathy (Press)
  • US Food and Drug Administration Grants Kitov a Waiver for New Drug Application Filing Fee (Press)
  • Genexine Releases Positive Interim Phase 2 Clinical Data from PGHD Trial with long-acting growth hormone, GX-H9 at ENDO 2017 (Press)
  • Puma Biotechnology Presents Interim Results of Phase Ib/II FB-10 Trial of PB272 in Combination with Trastuzumab Emtansine (T-DM1) in HER2-Positive Metastatic Breast Cancer (Press)
  • Kite Presents Ongoing Response Rate in Plenary Session from its Pivotal CAR-T Trial of Axicabtagene Ciloleucel in Patients with Aggressive Non-Hodgkin Lymphoma (Press)
  • Baxter Unveils Design Enhancements to FLOSEAL and TISSEEL Hemostatic Agents at AORN Meeting (Press)

US: Medical Devices

  • Brain cancer survival improves with novel electrical device, data suggest (Washington Post)
  • 7 companies in the race to make an artificial pancreas (Medical Design & Outsourcing)
  • At congressional hearing, FDA's Shuren talks digital health, patient engagement, real-world evidence (MobiHealthNews)
  • ETS Wound Care Gains FDA Clearance for MIRRAGEN™ Advanced Wound Matrix (Press)

US: Assorted & Government

  • Senate Bill Would Improve Medicare LCD Process (AdvaMed)
  • CDC Coalition Calls on Congress to Provide at Least $7.8B to CDC in FY2018 (GHTC)
  • Senate Dems Test Out 'Reasonable' Price Criteria With Antibiotic Incentive (Pink Sheet-$)
  • Proposed Changes to the Device Intended Use Regulation (FDA Law Blog)
  • Tom Price Intervened on Rule That Would Hurt Drug Profits, the Same Day He Acquired Drug Stock (ProPublica)
  • Ex-Siemens Executive Donald Rucker To Head ONC (Forbes)
  • Parallel Claims in PMA Medical Device Complaint Warrant Federal Question Removal (Drug & Device Law)
  • PTAB Life Sciences Report -- Part I (Patent Docs)
  • Patient-Centered Outcomes Research Institute: Review of the Audit of the Financial Statements for Fiscal Year 2016 (GAO)
  • President Trump's FY 18 Proposed Budget: More Qs and More As (Alliance for a Stronger FDA)
  • Philip Morris asks for FDA nod to sell heated tobacco device (Reuters)
  • Hedge Fund Drug Patent Challenges In Doubt After Bass' Test (Law360-$)

Upcoming Meetings & Events

Europe                                               

  • Lonza confirms drug firm was biggest customer in 2016 (BioPharmaReporter)
  • Agenus trimming 50 jobs at Basel facility as it focuses on cancer vaccines and antibodies (BioPharmaReporter)
  • Concept paper on the need to revise Condition – Specific guidance, Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man (EMA)
  • Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (EMA)
  • ABPI responds to NHS Five Year Forward View (ABPI)
  • UK biotech inks stem cell engineering deal with Singapore researchers (BioPharmaReporter)
  • Roche launches cobas Liat PCR System with four assays into CE-markets (Press)

Asia

  • China reports six new bird flu cases, one death (Reuters)
  • Korea announces $100 mn fund for bio startups (BioSpectrum)

India

  • Pharma companies optimistic on Indo-US deal corridor: Report (Economic Times)
  • Indoco Remedies slumps to near 3-year low on FDA concerns (Economic Times)
  • USFDA okays abridged clinical trial for antibiotic: Wockhardt (Economic Times)
  • Government increases stent prices by around 2 per cent (Economic Times)
  • Two pharma cos seek fresh WHO-GMP certifications after state FDA canceled their licenses (PharmaBiz)
  • India's biosimilar norms of August 2016 on par with global requirements: Dr Bobby George (PharmaBiz)
  • Text mining with automation becomes boon for ADR reporting (PharmaBiz)
  • Maha FDA cancels license of Mulund based blood bank, directs to convert into blood storage centre (PharmaBiz)

Other International

  • Cholera spreads in famine-threatened Somalia (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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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