Regulatory Recon:  Pamplona to Buy CRO Parexel for $5B FDA Approves Melinta Antibiotic to Treat Skin Infections (20 June 2017)

Posted 20 June 2017 | By Michael Mezher 

Regulatory Recon:  Pamplona to Buy CRO Parexel for $5B FDA Approves Melinta Antibiotic to Treat Skin Infections (20 June 2017)

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

In Focus: US

  • Pamplona to buy drug testing company Parexel for $5bn (Financial Times) (Reuters) (Fierce) (Press)
  • Democrats protest Senate Republican healthcare secrecy (Reuters) (NYTimes)
  • FDA approves Melinta Therapeutics antibiotic to treat serious skin infections (Reuters)
  • Building a better antibiotic, piece by piece (STAT)
  • Johnson & Johnson nabs another combo approval for myeloma star Darzalex (Fierce)
  • Profits in the 2017 Fortune 500: Manufacturers vs. Wholesalers, PBMs, and Pharmacies (Drug Channels)
  • Biotech R&D costs are outpacing revenues, but funding is still strong, report says (STAT) (MedCityNews) (PharmaTimes)
  • Saunders: Industry Must Act Before We Lose Champions For Innovation In Congress (SCRIP-$)
  • PDUFA VI: 'Building Trust' Is Theme Of FDA-Industry Negotiations (Pink Sheet-$)
  • Adamis has not set US price for newly approved rival to Mylan's $600 EpiPen (InPharmaTechnologist)
  • Clear Sailing Likely for Victoza CV Indication (Medpage)
  • How Two Common Medications Became One $455 Million Specialty Pill (ProPublica)
  • Should investors believe 'transparent' Pfizer when it says it doesn't want to buy Bristol-Myers Squibb or AstraZeneca? Maybe so, analyst says (Fierce)
  • Bristol-Myers Squibb Slams The Door On Litigation Tourism (Drug & Device Law) (SCOTUSblog)
  • Sandoz v. Amgen: What The Court Settled, What It Didn't, And What Might Come Next (Health Affairs Blog)
  • How Trump can lower prescription drug prices fast (CNBC)
  • If drug companies are really 'getting away with murder,' Trump may be about to grant them a pardon (STAT)

In Focus: International

  • Over Objections, Italy Introduces Tough Vaccination Measure (NPR)
  • Novartis eye drug works with fewer injections than rivals (Reuters) (Pharmafile)
  • My decade leading the WHO: dirty fights and steps toward universal coverage (STAT)
  • U.S. vs Britain: Big Price Disparities for Same Cancer Drugs (Medpage)
  • ICH Assembly, Montreal, Canada, May/June 2017 (ICH)
  • Report: Activist fund takes aim at Philips (MassDevice) (Times of London)
  • Global pharma sales forecasts cut amid pricing pressures (Financial Times)
  • Merkel opens Takeda's new production facility in Germany (Pharmafile)
  • WHO Consults On Standardized Approach To Verifying Good Practices At Foreign Sites (Pink Sheet-$)
  • GSK's new pharma head to join in September after AstraZeneca tussle (Reuters)
  • Predicting the potential risk area of illegal vaccine trade in China (Nature)

Pharmaceuticals & Biotechnology

  • Meet the scientist who keeps J&J up with the Joneses (STAT)
  • Alnylam CEO John Maraganore Takes the Reins as BIO Chair (BIO)
  • A Potent Tool to Treat Pancreatic Cancer May Already Be in Your Body (MIT Technology Review)
  • Want To Speed Biomedical Research? Do It In Dog Years (Forbes)
  • Psst, the human genome was never completely sequenced. Some scientists say it should be (STAT)
  • New and Generic Drug User Fees, 21st Century Cures Act, Fuel FDA Regulatory Process and Culture Changes for Combination Products (IPQ)
  • Parker-Tessa alliance tees up solid tumor I-O combinations (Fierce)
  • BIO Notebook: Janssen, Boehringer And More Talk About Deals, Pipeline Progress And Investment (SCRIP-$)
  • Regulators Accepting Predictive Stability Data In Lieu of Long-Term Studies (Pink Sheet-$)
  • Neos Therapeutics' Controlled-Release ADHD Drug Get FDA Approval (Xconomy)
  • Economic Study Ranks San Diego Near Top in Genomics Innovation (Xconomy)
  • ICER finds anabolic agents not cost-effective to treat osteoporosis (PharmaLetter-$)
  • Biogen Upgraded at UBS on Alzheimer's Clinical Trial Progress (The Street)
  • For low-performing clinical trial sites, choose revision not rejection (MedCityNews)
  • Forget patient-centric models that don't work. Let's talk social centricity, say researchers (Fierce)
  • Scientists find new biomarker to guide cancer immunotherapy (Reuters)
  • FDA Reviewing Rigel's Tavalisse For ITP (BioCentury)
  • Most young opioid abusers don't get anti-addiction medicines (Reuters)
  • A Couple's Quest To Stop A Rare Disease Before It Takes One Of Them (NPR)
  • Pfizer recalls injectables made at Rocky Mount over potential contamination risk (InPharmaTechnologist)
  • Thermo Fisher Scientific announces single quadrupole mass spectrometer and specialised columns (Pharmafile)
  • New insight into BIA 10-2474 clinical trial shines light on preclinical testing (OutsourcingPharma)
  • Cell Medica buys clinical-phase WT1-TCR cell therapy (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Clovis plots Rubraca label expansion with new phase 3 data for its PARP inhibitor (Fierce) (Xconomy)
  • Therachon Receives EMA and FDA Orphan Drug Designation for TA-46 for Achondroplasia (Press)
  • 'Vaccine' to lower cholesterol enters human trials (Pharmafile)
  • Intezyne Technologies Granted Orphan Drug Designation for IT-139 in Pancreatic Cancer (Press)
  • AVEO Oncology Announces Pivotal Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma Reaches Enrollment Target (Press)
  • Aimmune Therapeutics Presents European Phase 3 PALISADE Screening Data at 2017 European Academy of Allergy and Clinical Immunology (EAACI) Congress (Press)

Medical Devices

  • Absorb BVS Safety Problems Keep Growing (Medpage)
  • An Interview with Medtronic's Luann Pendy (MDDI)
  • Inspired by War Zones, Balloon Device May Save Civilians From Fatal Blood Loss (NYTimes)
  • BD Receives FDA 510(k) Clearance for New Line of Customizable, 3.0mm Micro-Laparoscopic Instruments (Press)
  • Medtronic touts retrospective data in Reactive ATP therapy AF study (MassDevice)
  • Stryker buys Canadian imaging technology firm for $701M (MedCityNews)
  • BioTrace Medical touts real-world data from Tempo temporary lead (MassDevice)
  • PerkinElmer to buy Euroimmun in $1.3B deal (MassDevice)
  • Getinge's Maquet, Datascope recall select IABPs over electrical issues (MassDevice)

US: Assorted & Government

  • FTC Offers Comment on Process Aimed at Improving Security of Internet of Things Devices (FTC)
  • Texas Governor Signs Stem Cell Access Bill Into Law (BioCentury)
  • J&J Talc Trial Derailed By High Court's Plavix Ruling (Law360-$)
  • Bard Settles 75 More Suits In Pelvic Mesh MDL (Law360-$)
  • Pharma Cos. Tell Fed. Circ. To Reverse Durezol Decision (Law360-$)
  • Alaska Governor Raises Concerns About Republican Health Care Efforts (NPR)

Upcoming Meetings & Events


  • Russia's public procurement of drugs continues to be dominated by imports (PharmaLetter-$)
  • What lies ahead for the pharmaceutical sector in France? (PharmaLetter-$)
  • ABPI response to the Academy of Medical Science report: 'Enhancing the use of scientific evidence to judge the potential benefits and harms of medicines' (ABPI)


  • Dr Reddy's may file two new drugs with FDA by 2019 (Economic Times)
  • Telangana drug control administration to set up monitoring cell to check spurious drugs in state (PharmaBiz)

General Health & Other Interesting Articles

  • Study to examine effects of Zika infection in Guatemalan infants and children (NIH)
  • Scientists identify single-gene mutations that lead to atopic dermatitis (NIH)

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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