Regulatory Recon: FDA Halts Three Keytruda Studies After Patient Deaths Euro Biotech Firms Raised $2.3B in First Half of 2017 (6 July 2017)

Posted 06 July 2017 | By Michael Mezher 

Regulatory Recon: FDA Halts Three Keytruda Studies After Patient Deaths Euro Biotech Firms Raised $2.3B in First Half of 2017 (6 July 2017)

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

In Focus: US

  • Gottlieb Looks To Resuscitate Competition For Shortage Drugs (Pink Sheet-$)
  • FDA puts hold on Merck multiple myeloma trials after deaths (Reuters) (WSJ) (Endpoints)
  • Trump's Agenda on Drug Prices (Public Citizen)
  • Smaller device makers stay serene in '17 (EP Vantage)
  • Personalized vaccines hold cancer at bay in two early trials (Reuters) (MIT Technology Review) (STAT)
  • The FDA is an Integral Part of Compassionate Use (Forbes)
  • Vertex hikes price of cystic fibrosis drug (Boston Globe) (BioPharmaDive)
  • E&C Subcommittees To Discuss Manufacturer Communication, Opioid Crisis on 12 July (BioCentury) (Hearing Notice – Communication, Opioids)
  • Shire will cut US locations and move HQ in consolidation push (Fierce)
  • After obesity drug flops, Arena Pharma plans a comeback. Will it work? (STAT)
  • Their children are dying. So these families are racing to raise money for research no one else will fund (STAT)
  • OPDP Study Raises Questions About the Balance of Information in Mobile Ads (Focus)
  • Researchers Find Most Expert Speakers at FDA ODAC Meetings Receive Sizable Industry Payments (Focus)
  • CDC National Stockpile of Medical Products Could be at Risk in Public Health Emergency (Focus)
  • Novo Nordisk Warns of Possible Cracks in Insulin Devices (Focus) (Reuters)

In Focus: International

  • Celgene to buy BeiGene stake, to develop tumor cancer treatment (Reuters)
  • European biotech raises $2.3B in first half of 2017 (BioWorld)
  • France to make vaccination mandatory from 2018 as it is 'unacceptable children are still dying of measles' (Independent)
  • Oxford BioMedica wins big contract for Novartis cell therapy (Reuters)
  • French implant maker Carmat pins hopes on low energy heart (Reuters)
  • Novartis receives EU approval for Cosentyx label update (Reuters)
  • Asia Regulatory Roundup: India's DCGI Asks Industry How to Further Cut Regulatory Burdens (5 July 2017) (Focus)
  • Tuberculosis: New report highlights need to better tackle world's deadliest infectious disease (MSF)
  • Marketing of unproven stem cell–based interventions: A call to action (Science) (Reuters)
  • Gilead to launch injunction against Mylan and Actavis over HIV generics in Ireland (Pharmafile)
  • EMA Laments Lack Of Brexit Contingency Reserves (Pink Sheet-$)
  • Patients Must Be Central in Any Decision on the EMA's New Home (EFPIA)
  • Despite Brexit, UK Regulator Remains Pharma Favorite – For Now (Pink Sheet-$)
  • Pfizer takes 30 cents and runs from its failing Brazilian generics venture (Fierce)
  • Medicxi's new fund jumps off the beaten biotech path to lead a $30M round for diabetes program (Endpoints)
  • Indian Government notifies 15 medical devices as drugs for price regulation (Economic Times)

Pharmaceuticals & Biotechnology

  • Seven questions CTL019 adcom should consider (and two it won't) (EP Vantage)
  • Bayer Completes $100 Million Quality Control Facility in Berkeley (The Street)
  • Google's data-crunching mavens at GV buy in to Decibel's R&D program for hearing loss, tinnitus (Endpoints)
  • NIH and collaborators identify the genomic cause for Carey-Fineman-Ziter syndrome (NIH)
  • Federal judge enters consent decree against Alabama compounder Medistat (FDA)
  • Ixico contracted for Alzheimer's vaccine clinical trial (Fierce)
  • Could a 30-year-old asthma drug lead to a new treatment for diabetes? (Fierce)
  • JLABS alumnus Sienna guns for $75M IPO months after series B (Fierce)
  • Antibiotic Pipeline Profile: Balancing Broad Spectrum And Limited Use (SCRIP-$)
  • Heartburn Drugs May Increase Risk of Early Death (NYTimes) (Reuters)
  • FDA May Push Boundaries To Speed REMS Negotiations (Law360-$)
  • Heart failure market to quadruple in ten years to $16 billion (Pharmafile)
  • Cardinal Health's Unhappy Profit Surprise: The Coevolution of Pharmacy Buying Groups and Wholesaler Economics (rerun) (Drug Channels)
  • Thermo Fisher takes rain check: storm closes clinical packaging site (Outsourcing Pharma)
  • Lilly and Purdue University Announce Strategic Research Collaboration (Press)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Array files two drugs for approval in metastatic melanoma (PharmaLetter-$)
  • Bristol-Myers Squibb's ORENCIA (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis (PsA) in Adults (Press)
  • Impax Announces FDA Approval and Launch of Additional Strengths of Generic Focalin XR® (Dexmethylphenidate Hydrochloride) Extended-Release Capsules CII (Press)

Medical Devices

  • Edwards Lifesciences wins FDA approval for Inspiris Resilia valve (MassDevice) (Medpage)
  • "Cardiologs ECG Analysis Platform" Receives FDA Clearance (Press)
  • Digirad wins $100m DoD contract for CT equipment (MassDevice)
  • San Antonio Medical Device Contractor NuPak Sold to NJ-Based Katena (Xconomy)

US: Assorted & Government

  • Low-Cost Health Insurance Limits Access to Top Cancer Doctors (Bloomberg)
  • Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2017 (HHS OIG)
  • Ted Cruz Has an Idea for How to Cover High-Risk Patients (NYTimes)
  • Shkreli prosecutors reveal plea deal request by 'pharma bro' lawyer as judge tells Shkreli to shut up (CNBC) (Forbes)
  • Hatch Floats Bill Promoting Rare Disease Treatments (Law360-$)
  • Allergan inks $13M settlement in whistleblower marketing suit (Fierce)
  • PTAB Life Sciences Report (Patent Docs)
  • A Double Whammy for California Design Defect Claims (Drug & Device Law)
  • California Court Defers to FDA Concerning the Naming of Plant-Based "Milk" Products (FDA Law Blog)

Upcoming Meetings & Events


  • Finland to delay health care reforms by one year (Reuters)
  • Norway To Grant Pediatric Extensions Of SPCs From Sept. 1 (Pink Sheet-$)
  • Strensiq new deal paves way for NICE approval of life saving drug (NICE)
  • One in three RA patients rejecting meds because of cost (PharmaTimes)
  • Warning over post-Brexit agency costs as NHS trusts report £791m deficit (PharmaLetter-$)
  • Independent Scientific experts: Call for expressions of interest for the EMA PRAC Committee (European Commission)
  • EU AMR action plan ignores pharma pollution, say NGOs (InPharmaTechnologist)
  • Artificial bile ducts transplanted into mice (MRC)
  • Silence takes Alnylam to court over RNAi IP dispute (Fierce)
  • Roche MRSA, SA Test Receives CE Mark (GenomeWeb)


  • Jubilant Life Sciences gets USFDA nod for anti-depressive drug (Economic Times)


  • Canadian I-O biotech Trillium hunts for new partners (Fierce)

Other International

  • Registration Form for the International Medical Devices Regulators Forum's Open Stakeholder Day (Health Canada)
  • Private equity firm to buy Endo's Mexican subsidiary (PharmaLetter-$)
  • Mexico Calls New Tender for Dialysis Equipment after Corruption Allegations Taint First Attempt (ABNewswire)

General Health & Other Interesting Articles

  • Your Pet's Disease Could Be Cured by Gene Therapy (MIT Technology Review)
  • Researchers discover atomic structure of suspect Alzheimer proteins (Reuters)
  • Can less invasive uterine fibroid treatment improve fertility? (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

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

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