Regulatory Recon: FDA Nominee Califf's Ties to Industry Worry Some (21 September 2015)

Posted 21 September 2015 | By

Regulatory Recon: FDA Nominee Califf's Ties to Industry Worry Some (21 September 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA Nominee Received Industry Fees (NY Times)(WSJ-$)
  • Drug Goes From $13.50 a Tablet to $750, Overnight (NY Times) (FierceBiotech) (Forbes)
  • Use Medicare’s Muscle to Lower Drug Prices (NY Times)
  • Clinton to offer new prescription drug proposal this week (AP)
  • FDA Revisits Safety Of The Essure Contraceptive Device (NPR)
  • The Promoting Life-Saving New Therapies for Neonates Act of 2015: A New Twist on Transferable Vouchers (FDA Law Blog)
  • FDA's Evolving Position On Next-Gen Sequencing – And Using Data It Produces (Pink Sheet -$)
  • CDER Dispute Resolution Data Show Few Wins For Sponsors (Pink Sheet-$)

In Focus: International

  • Indian Drug Plants are Freaking out the FDA (Vice News)
  • Brazilian regulators overhaul IVD regulations (Mass Device)
  • Shire Receives European Approval for INTUNIV as a Non-stimulant ADHD Treatment for Children and Adolescents (Press) (Pharmafile)(PharmaLetter-$)

US: Pharmaceuticals and Biotechnology

  • Drug companies must share trial data, Paxil saga shows (Boston Globe)
  • Tackling reproducibility in academic preclinical drug discovery (Nature Drug Discovery)
  • Biotech Valuation Inflation: Public Exuberance Meets Private Rounds? (Forbes)
  • Turning to drugs and treatments before they are “ready for prime time” (Harvard Health Blog)
  • Biosimilar Tracking Still Possible With Shared Medicare Codes, Woodcock Suggests (Pink Sheet-$)
  • Kinase focused Deciphera gets marquee backing for a big $75M venture round (FierceBiotech) (Xconomy)
  • East Coast Biotech Roundup: CAR-T, Celgene, Aerie, ITCI, IPOs, & More (Xconomy)
  • ANI Pharmaceuticals to Acquire Two NDAs from Merck for $75 Million (Press)
  • Experts: FDA's Made 'Laudable' Progress, But Efforts Fall Short (SCRIP-$)
  • FDA criticized for lack of biosimilar guidance (BNA Health Care Blog)
  • The Printed Pill (JAMA)
  • Gloucester chief gets meeting with Pfizer on opioid crisis (Boston Globe)
  • Palatin Technologies and Gedeon Richter Terminate Female Sexual Dysfunction Pact (Press)
  • U. of Colo. Says Amgen Withholding Arthritis Med Royalties (Law360-$)
  • Pfizer, FDA Updating Pregnancy Caution On Zoloft Label (Law360-$)
  • 3rd Circ. Urged To Revive Avandia Suit Against GSK (Law360-$)
  • Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study (BMJ)
  • Sanofi, Pfizer Said to Express Interest in Buying Mexico's Rimsa (Bloomberg)
  • FDA Eyes Social Media Data, ASCO Touts EHRs As Post-Market Tool (InsideHealthPolicy)

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

  • Merck antibody reduces risk of Clostridium difficile recurrence: study (Reuters) (FierceBiotech) (SCRIP-$)
  • Gilead Announces SVR12 Rates from Four Phase 3 Studies Evaluating a Once-Daily, Fixed-Dose Combination of Sofosbuvir and Velpatasvir for the Treatment of All Six Hepatitis C Genotypes (Press)
  • FDA Accepts ADMA Biologics License Application for RI-002 (Press)
  • UniQure beats a path to Phase III after eyeing promise in a tiny gene therapy trial (FierceBiotech)
  • Fed designation could give Durham drug developer lots of perks (Triangle Business Journal)
  • New data will be presented for Roche’s Esbriet in idiopathic pulmonary fibrosis at European Respiratory Society Congress 2015 (Press)
  • FDA Grants Fast Track Designation to Alcobra's MDX for Fragile X Syndrome (Press)
  • FDA Grants Priority Review for Amgen's Supplemental New Drug Application for Expanded Labeling of Kyprolis (Carfilzomib) in Relapsed Multiple Myeloma (Press)
  • FDA Grants QIDP Designation to Cempra’s Taksta (FDANews-$)
  • Chin Fat Not A 'Serious Condition' Worthy Of Priority Review, FDA Says (Pink Sheet-$)
  • AstraZeneca: Combinations Are Key For GLP-1’s Next Evolutionary Step (Pink Sheet-$)
  • Patient-Reported Outcomes Data Earned Kybella A Claim For Emotional Impacts (Pink Sheet-$)
  • Abuse-Deterrent Opioids Forcing FDA To Better Define 'Food' (Pink Sheet-$)

US: Medical Devices

  • Medicare’s Proposed Changes on Prosthetics Stirs a Fight (WSJ-$)
  • SynCardia Systems, Freedom Driver System - Part May Fail Causing Device to Stop Working (FDA)
  • Bard, Whistleblower Agree To End Catheter FCA Suit (Law360-$)
  • Boston Scientific Says Plaintiff Trying To Reopen Discovery (Law360-$)
  • Cook Medical Receives FDA Approval For The Zenith Alpha Thoracic Endovascular Graft (Med Device Online)
  • Siemens Mammomat Fusion Full-Field Digital Mammography System FDA Cleared (MedGadget)
  • Invuity touts data from device-assisted mastectomy study (Mass Device)
  • Medtronic launches improved delivery catheter for its stroke-fighting Solitaire stent (Fierce)
  • Stryker eliminates international prez Subrahmanian’s role | Personnel Moves (Mass Device)

US: Assorted and Government

  • CDC to issue draft guideline on opioid prescribing (Drug Store News)
  • Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Bioindustry Association (Patent Docs)

Upcoming Meetings and Events              


  • National Audit Office agrees CDF is 'unsustainable' (PMLive)
  • ABPI statement on clinical trial transparency​ (ABPI)
  • Satisfactory outcome of USFDA inspection of API facility perks up Vivimed Labs (Business Standard)


  • Australia's Pharmaceutical Benefits Scheme 'is sustainable' (PharmaLetter-$)


  • The marketing of unproven drugs for diabetes and dyslipidaemia in India (Lancet)
  • Health ministry begins process of strengthening of drug regulatory systems in states with Rs. 850 cr fund (PharmaBiz)
  • Pharmexcil to organise interactive meeting with govt & top drug regulatory officials in Hyderabad (PharmaBiz)


  • INSIDE CHINA: The Hurdles For Medtech Uptake In Emergency Medicine (Clinica)
  • E&C GOP Leaders Ask Obama To Discuss Heparin Contamination With Chinese President During State Visit (InsideHealthPolicy)
  • Imaging player Analogic cuts 90 employees in China manufacturing move, offers SEC settlement (Fierce)

Ebola Outbreak

  • Regeneron Announces Agreement with BARDA for the Development of New Antibody Treatment for Ebola (Press)
  • How bureaucracy, bungling hurt Ebola response (AP)

Other International

  • Op Ed: Are Brazil, China and Russia making it harder for device companies to enter their markets? (Mass Device)
  • SA police shut down three counterfeit drugmaking facilities in INTERPOL swoop (InPharma-Technologist)
  • Dollars not drug donations: Aid agencies seek cash not meds for refugees (InPharma-Technologist)

General Health and Other Interesting Articles

  • Bipartisan Effort Fights Health Law Rule That Could Raise Premiums (NY Times)
  • Americans' Views of Pharmaceutical Industry Take a Tumble (Gallup)
  • Colbert on the new female libido drug (YouTube)
  • A third of Britons born in 2015 will develop dementia: study (Reuters)
  • Medical Societies to CMS: Not Ready for Stage 3 Meaningful Use (MedPage Today)
  • Regenerative Medicine Sector Still Running with the Bulls (Reuters)
  • Arkansas bought execution drugs from British company that banned state's use (Guardian)
  • Trapped in the System: A Sick Doctor’s Story (NY Times)
  • Why nutritional supplements may not be useful (Economist)

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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