Regulatory Recon: Gottlieb Appoints Sherman as Top Lieutenant Potential Bidders Emerge for Teva's Women's Health Unit (23 August 2017)

Posted 23 August 2017 | By Michael Mezher 

Regulatory Recon: Gottlieb Appoints Sherman as Top Lieutenant Potential Bidders Emerge for Teva's Women's Health Unit (23 August 2017)

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

In Focus: US

  • Gottlieb Appoints Rachel Sherman as Principal Deputy Commissioner (Politico) (BioCentury)
  • What It's Like to Be the FDA's Top Lawyer (Bloomberg)
  • How one small biotech exploits a loophole in a federal transparency law (STAT)
  • Paratek shares soar as the antibiotic developer posts a 'for sale' sign (Fierce) (Endpoints)
  • Prices for cholesterol drugs would have to drop a lot to be cost effective (STAT) (Medpage)
  • Can Amgen beat down payer resistance to Repatha with its own cost analysis? (Endpoints)
  • These companies actually want to pay higher fees — and the FDA is poised to make that happen (STAT)
  • PhIII bust forces Ultragenyx to scrap drug for rare muscle disease (EndpointsPharmafile) (BioCentury)
  • How Roche Tweaked an Aging Drug to Keep Profits Rolling In (Bloomberg)
  • Why the FDA Can't Fix the Opioid Crisis (Gizmodo)
  • How Not to Handle the Opioid Crisis (Foreign Policy)
  • Utah's Largest Hospital Group To Curtail Opioid Use (Forbes)
  • Intent On Reversing Its Opioid Epidemic, A State Limits Prescriptions (NPR)
  • Does Baby Powder Cause Cancer? A Jury Says Yes. Scientists Aren't So Sure (NPR)
  • Sickle-Cell Patients See Hope in CRISPR (MIT Technology Review)
  • 'Breakthrough' Leukemia Drug Also Portends 'Quantum Leap' In Cost (KHN)
  • No big growth in 10 years for Big Pharma's workforce, but lots of restructuring (Fierce)
  • FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II (Focus)

In Focus: International

  • Teva Women's Health Unit Attracts Interest of Church & Dwight, Cooper (Bloomberg) (Fierce)
  • The Difficulties of Cloning a CEO (Bloomberg)
  • NICE rejects thyroid cancer drugs (PharmaTimes)
  • Professor Stephen Hawking gives NHS a stark warning (Manufacturing Chemist)
  • Eli Lilly partners at CRUK tackle the first human study of a new p53-targeted cancer drug (Endpoints) (PharmaTimes) (Pharmafile)
  • Orchard's 'bubble baby' therapy awarded PIM status (PharmaTimes)
  • Parexel, Osaka International Cancer Institute combine for Japan trial work (Fierce)
  • EMA Multinational Assessment Teams Move Into Post-Authorization After Delay (Pink Sheet-$)
  • EMA Outlines Generic Drugmaker Decisions for Setting Dissolution Specifications (FDANews-$)
  • Asia Regulatory Roundup: China's Supreme Court Clarifies Legal Scope to Punish Trial Data Fraudsters (Focus)
  • Pfizer Wins Indian Patent on Prevnar 13 Vaccine (Focus)
  • GlaxoSmithKline partners with Alibaba for China HPV vaccine market grab (Fierce)
  • Mexican Antitrust Authority Study on Generic Drug Entry -- On Patents and Marketing Authorizations -- Part II (Patent Docs)

Pharmaceuticals & Biotechnology

  • 'Smart' Pill Bottles Aren't Enough To Help The Medicine Go Down (NPR)
  • FDA Warns Compounding Pharmacy, Finds Wood in Drug Sample (Focus)
  • Using unproven methods to tackle cancer could be deadly (Reuters)
  • Here's why 23-year-old Laura Deming is betting $22M on anti-aging R&D (Endpoints)
  • Oral Contraceptives Tied to Lower Rheumatoid Arthritis Risk (NYTimes)
  • Are we on the verge of a biosimilars breakthrough in the USA? (PharmaLetter-$)
  • Krystal files for IPO to move gene therapies into clinic (Fierce)
  • Microbiome startup Axial gains DepoMed executive as new CMO (Fierce)
  • Extractables – leachables correlations for packaging (EPR)
  • FDA Clears Way for Filing on Psych Drug From Intra-Cellular, Shares Climb (Xconomy)
  • Lilly pens deal for Evotec spinout's immune tolerance drugs (Fierce)
  • Encore makes pipeline play, licensing psoriasis drug from Dr. Reddy's (Fierce)
  • Akari Taps Zealand Ex-CEO Solomon To Reboot Tick-Based Group's Prospects (SCRIP-$)
  • Guidance: Oncology Drugs for Companion Animals (FDA)
  • Guidance: Studies To Evaluate The Safety Of Residues Of Veterinary Drugs In Human Food: General Approach To Establish An Acute Reference Dose (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Jupiter Orphan Therapeutics Receives Orphan Drug Designation for its Trans-Resveratrol Product JOTROL for Treatment of Friedreich's Ataxia (Press)
  • Epygenix Therapeutics Receives US FDA Orphan Drug Designation for EPX-300 for the Treatment of Patients With Dravet Syndrome (Press)
  • First Patient Dosed in Phase 3 MORPHO Trial Evaluating Gilteritinib as Maintenance Therapy Following Hematopoietic Stem Cell Transplant in Patients with FLT3 Mutation-positive Acute Myeloid Leukemia (Press) (PMLive)
  • Alliance Foundation Trials Opens Global Trial Investigating First-in-Class Palbociclib in HR+, HER2+ Metastatic Breast Cancer (Press)
  • Bonti Announces Start of LANTERN-1 Phase 2 Clinical Study Evaluating EB-001 in Reducing Musculoskeletal Pain (Press)
  • Octapharma USA Announces FDA Approval of NUWIQ® New Product Strengths, Expanding Hemophilia A Patient Treatment Options (Press)

Medical Devices

  • How to Improve Your KLAS Score (MDDI)
  • AdvaMed Names Fielding Greaves to Lead First Regional U.S. Office (AdvaMed)
  • What FDA Medical Device User Fee Reauthorization Means for Registrants (Emergo)
  • Medtronic Receives CE Mark for Attain Stability(TM) Quad MRI SureScan(TM) Active-Fixation Heart Lead (Press)
  • BIOTRONIK's Tiny Quadripolar Cardiac Resynchronization Therapy Pacemaker FDA Approved (MedGadget)
  • FDA approves Malin's Hourglass peripheral embolization plug (MassDevice)
  • XSTAT FDA Cleared to Stop Gun and Knife Wounds in Arms and Legs (MedGadget)
  • Preceptis launches trial of its Hummingbird ear tube system (MassDevice)

US: Assorted & Government

  • HHS Releases Semi-Annual Agency Regulatory Agenda (HHS)
  • Should A Biosimilar Sponsor Do The 'Patent Dance?' It Depends On Many Things (Pink Sheet-$)
  • U.S. Bioservices to resolve kickback claims for $13.4 million: filing (Reuters)
  • AbbVie, Patient Both Say Jury On Their Side In $150M Award (Law360-$)
  • J&J Unit Seeks To Boot Pelvic Mesh Cases From Philly Court (Law360-$)
  • Good Risperdal Times, Part Three: Summary Judgment for Janssen in Philadelphia (Drug & Device Law)
  • Punitive Damages in Mass Torts Cases: Outrageous and in Reckless Disregard of Fairness (Drug & Device Law)
  • Building a Customized Plan to Help Ensure Food Safety (FDA Voice)

Upcoming Meetings & Events


  • Invest in cutting-edge R&D centres and make UK best place in the world for future medicines (ABPI)
  • European Research Council readies €2bn in science funding (PMLive)
  • Hikma upping injectables capacity by as much as 500% by end of 2017 (InPharmaTechnologist)


  • ICMR inks pact with International Vaccine Institute to spur vaccine development in India (PharmaBiz)
  • Maha FDA issues show cause notices to hospitals for reuse of catheters, overcharging patients (PharmaBiz)
  • Pharma City to get environment clearance soon, govt alleys all doubts on pollution in its EIA report (PharmaBiz)


  • TGA customer service standards (TGA)


  • Erelzi (etanercept biosimilar) is available in Canada for the treatment of multiple inflammatory diseases (BiosimilarNews)

Other International

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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