Regulatory Recon: Merck Cholesterol Drug Surprises With Phase III Success Bain and Cinven's €4.1B Stada Buyout Falls Through (27 June 2017)

Posted 27 June 2017 | By Michael Mezher 

Regulatory Recon: Merck Cholesterol Drug Surprises With Phase III Success Bain and Cinven's €4.1B Stada Buyout Falls Through (27 June 2017)

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

In Focus: US

  • Republican healthcare bill imperiled with 22 million seen losing insurance (Reuters) (NYTimes) (Forbes) (NPR)
  • Pence to join Senate Republican leaders in healthcare push (Reuters)
  • Pharmacist Gets 9-Year Prison Term in Deadly Meningitis Outbreak (NYTimes) (NBC) (DoJ)
  • Jury Selection in Martin Shkreli Trial Begins With Name Calling (NYTimes)
  • User Fee Deadlines Slip (Politico)
  • A Merck cholesterol drug trial surprises, but is it really a game changer? (STAT) (Endpoints)  (Forbes) (Reuters) (In the Pipeline)
  • Chief Scientist At US FDA is Hinton as Borio Moves to White House (Pink Sheet-$) (BioCentury)
  • Pfizer preps new hires as it begins building a $200M R&D campus (Endpoints) (Press)
  • Pfizer Fueling Growth Of Competitors' Pipelines (Forbes)
  • Vivitrol: The Last Shot (ProPublica)
  • Subcommittee Markup - FY 2018 Agriculture, FDA Appropriations Bill  (House Appropriations)
  • After a painfully slow 2016, FDA's racking up drug approvals lickety-split (Fierce)
  • STAT forecast: Opioids could kill nearly 500,000 Americans in the next decade (STAT)
  • House Republicans backed this biotech — and lost big. Its stock is now worth 4 cents a share (STAT)
  • The Forgotten $35 Billion US Healthcare Problem (Forbes)
  • Life and death and #BIO2017 (BioWorld)
  • Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse (Focus)
  • FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years (Focus)
  • FDA, NCI to Collaborate Further on Cancer Research (Focus)
  • Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations (Focus)

In Focus: International

  • Stada buyout collapses after investor backing is not secured (Financial Times) (PMLive)
  • Sandoz launches MabThera, Enbrel biosimilars in the UK(Pharmafile) (PharmaTimes)
  • Novartis gets European OK for biosimilar of Amgen's Enbrel (Reuters)
  • EU To Defer US GMP Inspections Ahead Of Mutual Recognition Agreement Becoming Operational In November (Pink Sheet-$)
  • Identical Labels Recommended For Gilead, AbbVie's HCV Drugs In Europe (SCRIP-$)
  • Sanofi, Regeneron's biologic gets EU nod for rheumatoid arthritis (PharmaTimes)
  • EMA approves Janssen's Prezista continuous manufacturing line (EPR) (InPharmaTechnologist)
  • Biosimilars In EU: From 'New Mess' To Beacon For Safety (Pink Sheet-$)
  • Roche to invest 5 billion roubles in development of new drugs in Russia (PharmaLetter-$)
  • European biotech fund hits $74M, looks to build on previous successes (Fierce)
  • New form of Roche's Esbriet approved in Europe for lung disorder (Reuters)
  • EMA Offers New EudraVigilance Checklist for Sponsors, MAHs (Focus)
  • A 'monumental effort' revisited: New Ebola exhibit captures the intensity of the response to the crisis (STAT)
  • Stopping Pandemics Before They Start (NYTimes)
  • US Malaria Donations Saved Almost 2 Million African Children (NYTimes)
  • Israel's Mitoconix Bio raises $20 million in private funding round (Reuters)

Pharmaceuticals & Biotechnology

  • Gottlieb Statement on DQSA and Compounded Drugs (FDA)
  • Sexual equality in medical research long overdue, study finds (Reuters)
  • Biogen appoint new Head of Global Therapeutic Operations (Pharmafile)
  • Beware Of Tidy Success Narratives -- In Pharma, And In Life (Forbes)
  • FDA's Definition of Statistical Significance: P=.05 – ish (Pink Sheet-$)
  • Despite claims of 'looting,' Soon-Shiong's NantCell set to buy Altor (Fierce) (Press)
  • The Alliance for Regenerative Medicine Announces the Appointment of Janet Lynch Lambert as Chief Executive Officer (ARM)
  • Patients With Mental Disorders Get Half Of All Opioid Prescriptions (KHN)
  • The Lab Says It's Cancer. But Sometimes the Lab Is Wrong. (NYTimes)
  • FDA Warns Clinical Investigator for Enrolling Subjects That Didn't Meet Study Protocol Requirements (FDA)
  • The Solution for Skin Ailments Could Be Right Under Your Nose (NYTimes)
  • Investors cheered Portola's hard-won Bevyxxa nod. Could a takeover be next? (Fierce)
  • Huntington's Disease: Gene Editing Shows Promise in Mouse Studies (NIH)
  • Scoop: Martin Shkreli bats back a coup at Turing, new board considers a sale of assets (Endpoints)
  • New data put medicine costs and spending in context (PhRMA)
  • More than 50 medicines and vaccines in development for HIV infection, Treatment and Prevention (PhRMA)
  • FDA v. Opana ER: Opioids, Public Health, and the Regulation of Second-Order Effects (Harvard Bill of Health)
  • OSE Immunotherapeutics halts recruitment in cancer vaccine trial (BioPharmaReporter)
  • Pharmaceuticals, printers and paintballs: when variability in excipient quality is and isn't acceptable (USP)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Teva and Xenon rack up another setback as PhIIb study fails on every endpoint (Endpoints) (Press)
  • Alder's migraine drug data disappoints, shares tumble (Reuters) (Endpoints)
  • Alnylam makes a bull case for PhIII-ready porphyria drug, but shares sink anyway (Endpoints)  (Fierce)
  • Semnur touts Phase I/II trial of non-opioid pain-killer (Drug Delivery)
  • Kitov Updates on KIT-302 New Drug Application (Press)
  • Icon Bioscience touts FDA NDA submission for Dexycu (Drug Delivery)
  • Sumitomo's Napabucasin Unlikely To Meet Gastric Cancer Endpoint (BioCentury)
  • Therapy able to block both opioid high and withdrawal (Pharmafile)
  • UK trial for new bladder cancer therapy (PharmaTimes)
  • TP Therapeutics Announces FDA Orphan Drug Designation Granted to TPX-0005 for Treatment of Non-Small Cell Lung Adenocarcinomas Harboring ALK, ROS1, or NTRK Oncogenic Rearrangements (Press)
  • Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Azacitidine for Injection (Vidaza®) (Press)

Medical Devices

  • TAVR Outcomes Have Improved With Experience, Registries Show (Medpage)
  • A Medical Device's True Colors (MDDI)
  • Connect and Compete Through Open Innovation (MDDI)
  • Boston Scientific sets its sights on double-digit earnings growth (MassDevice)
  • Invacare shutters Chinese manufacturing plant (MassDevice)
  • Spineology Announces FDA Clearance of Rampart One™ Anterior Lumbar Interbody Fusion System (Press)
  • Ortho Clinical Diagnostics Receives FDA 510(k) Clearance for Ortho's VITROS® Insulin Reagent & Calibrators (Press)
  • Philips receives FDA 510(k) clearance to market multiple new applications on its IntelliSpace Portal platform for Radiology (Press)

US: Assorted & Government

  • Cardiac Monitoring Companies and Executive Agree to Pay $13.45 Million to Resolve False Claims Act Allegations (DoJ)
  • Reports of side effects with cosmetics increasing (Reuters)
  • Here are 3 health bill issues where Democrats and Republicans can actually make a deal (CNBC)
  • Medicaid cuts linked to later breast cancer diagnosis (Reuters)
  • Talks over boosting Illinois Medicaid payments fail (Reuters)
  • Texas hospitals fear losing $6.2B Medicaid deal (KHN)
  • Law Review Article on Off-label is On Target (Drug & Device Law)
  • Sounding The Alarms On Children's Health Coverage (Health Affairs Blog 1, 2)
  • Roche Defends Suit Over Alleged $89M Test Strip Scheme (Law360-$)
  • How Biotech Patents Are Linked to U.S. Food Productivity (MIT Technology Review)
  • Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017) (Patent Docs)

Upcoming Meetings & Events


  • Breast cancer drug Kadcyla to be routinely available in Wales (Pharmaceutical Journal)
  • EDQM provides guidance to Blood Establishments for managing non-conformant quality assessment results (EDQM)
  • Number of patients at risk from NHS mail mistake revealed (Pharmafile)
  • German biotech firm buys into Silicon Fen technology (PharmaLetter-$)
  • Fewer pills, more flexibility in dosing: Roche's new Esbriet tablet formulation approved in Europe for mild to moderate idiopathic pulmonary fibrosis (IPF) (Press)
  • Mobidiag Gets CE-IVD Mark for GI Virus Test (GenomeWeb)
  • Hill-Rom deals Völker bed biz to CoBe Capital (MassDevice)
  • Channel Medsystems wins CE Mark for Cerene cryotherapy device (MassDevice)


  • Report of the 51st Meeting of the Drugs Consultative Committee (CDSCO)
  • Health ministry's mini drug testing lab project gets delayed despite awarding contract (PharmaBiz)
  • Sun Pharma, NIV join hands to fight zika, chikungunya, dengue (Economic Times)
  • Glenmark gets USFDA nod for generic anti-inflammatory drug (Economic Times)


  • CFDA Minister Bi Jingquan meets Former Deputy Prime Minister of Thailand (CFDA)


  • Ontario, Canada Poised to Lead Global Biotech Innovation: Interview with Minister Reza Moridi (medGadget)

General Health & Other Interesting Articles

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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