Regulatory Recon: FDA Approves Tesaro's Zejula for Ovarian Cancer Trump Pushes Congress to Cut NIH 2017 Budget (28 March 2017)

Posted 28 March 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Tesaro's Zejula for Ovarian Cancer Trump Pushes Congress to Cut NIH 2017 Budget (28 March 2017)

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

In Focus: US

  • FDA approves Tesaro's ovarian cancer drug (Endpoints) (Forbes) (FDA) (Press)
  • Trump pushes Congress to cut domestic programs this year (Politico) (STAT) (The Hill)
  • Top heart doctors warn proposed NIH cuts would be catastrophic (Reuters)
  • Gottlieb Nomination Heads To Senate (BioCentury) (White House)
  • After GOP Bill's Failure, Health-Law Lawsuit Takes Center Stage (WSJ)
  • Five Lessons From The AHCA's Demise (Health Affairs Blog)
  • Wildcard: How TrumpCare's Failure Could Hurt Big Pharma (Forbes)
  • 2018 Dilemma for Republicans: Which Way Now on Obamacare? (NYTimes)
  • A Faster, More Flexible, and Frugal FDA? (PharmExec)
  • The Politics Of Opana: US FDA's Opioid Problems Won't Go Away (Pink Sheet-$)
  • Abuse Deterrence: US Exclusivity Update May Ride User Fee Coattails (Pink Sheet-$)
  • Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations (Focus)
  • Pharma Profits Continue to Dwarf R&D Spending as Pressure Mounts (Focus)
  • Liver cancer miss adds to litany of trial failures for ArQule's tivantinib (Fierce)
  • Myth busters take on drug prices, or do they? (BioWorld)
  • Mylan underpayment on EpiPen could exceed proposed settlement (Reuters)
  • Testosterone Therapy Is Popular, but Studies Are Mixed (NYTimes)
  • Is This the Anti-Aging Pill We've All Been Waiting For? (MIT Technology Review)
  • New Vaccine Recommendation Cuts Number Of HPV Shots Children Need (KHN)
  • Down the Tubes: FDA Settles PREPOPIK NCE Exclusivity Dispute; ANDA Submissions in Unsettled State (FDA Law Blog)

In Focus: International

  • Gilead faces a fresh challenge to a key hepatitis C patent in Europe (STAT) (Reuters)
  • It's Time To 'Get Moving' To Meet ICH Q3D Deadline, Industry Told (Pink Sheet-$)
  • Pfizer resurrects its OTC bid for Viagra in the UK (PMLive) (MHRA)
  • New budget test puts UK on front line in global drug price fight (Reuters)
  • NHS England plans cull of 'low-value' prescriptions (PharmaTimes) (Financial Times)
  • Patients call for halt to NICE changes (PharmaTimes)
  • Final NICE no for Shire's pancreatic cancer drug (PharmaTimes)
  • European Commission Recommends Changes to SmPC, Package Leaflets (Focus)
  • EC To Consult On Ways To Boost Generics & Biosimilars Industry, Introduce EU-wide SPC (Pink Sheet-$)
  • Just 55% of UK healthcare professionals disclosing pharma payments (PharmaTimes) (Pharmafile) (ABPI)
  • EMA To Improve Dialogue With Registry Holders To Support Drug Evaluation (Pink Sheet-$)
  • UK-US Trans-Atlantic Precision Collaborations Target Pancreatic Cancer (Pink Sheet-$)
  • French approval for Eprex for symptomatic anemia (PharmaLetter-$)
  • Australia slashes prescription prices across therapeutic areas (PharmaLetter-$)
  • Germany's G-BA confirms added benefit of Kisplyx (PharmaLetter-$) (Press)
  • As Cholera Spreads, Somalia Begins Vaccination Campaign (NYTimes)
  • Indian Tycoons Known for Lucky Timing Find Time In Short Supply (Bloomberg)
  • Berkeley Team Gets European CRISPR Win After PTAB Loss (Law360-$)
  • Industry: EMA Needs to Focus on Real-World Evidence for Tracking Pharmacovigilance (FDANews-$)

US: Pharmaceuticals & Biotechnology

  • Sanofi gives up certain regional rights to Stendra (PharmaLetter-$)
  • Antimicrobial Resistance Diagnostic Challenge selects 10 semifinalists in first phase of competition (NIH)
  • PCSK9 Rejections: It's Not Just You (Medpage)
  • A lot to GAIN: Zavante awaits pivotal data on retro-antibiotic (MedCityNews)
  • Scientists grew beating human heart tissue on spinach leaves (CNBC)
  • Mylan set to close Meda US manufacturing facility (Pharmafile)
  • Allergan's CEO pay plummets by 80% without big M&A and strong financials (Fierce)
  • Renowned scientist Owen N. Witte joins Kite Pharma Board of Directors (Pharmafile)
  • Alexion leadership uncertainty ends as ex-Baxalta CEO steps in (Pharmafile)
  • Novartis Scientists Extend Half-Life Of Ocular Therapies (BioCentury)
  • Ex-Actavis CEO Paul Bisaro gets top job at Impax to send shares soaring (PharmaLetter-$)
  • Pharmas acquiring exclusive rights to gain access to new markets and innovation will be a strong trend in 2017 (PharmaLetter-$)
  • Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb and the Cancer Research Institute Announce Collaboration to Accelerate Immuno-Oncology Research (Press)

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

  • Biogen to Present Data at the 13th International Conference on Alzheimer's and Parkinson's Diseases (Press)

US: Medical Devices

  • Medtech Startup Showdown 2017: Round 2 (MDDI)
  • What Technical Debt Means for Medical Device Developers (MDDI)
  • Cardiologist Dr. Kereiakes: the Synergy bioabsorbable stent boasts flexibility & safety (MassDevice)
  • Defense Dept. reups $77m Philips Healthcare contract (MassDevice)
  • Most states don't require lifesaving heart device in schools (Reuters)

US: Assorted & Government

  • Third Circuit Reinterprets Wyeth v. Levine for the Worse and Finds Preemption is a Jury Question (Drug & Device Law)
  • Senator Joe Manchin: Time for a new 'war on drugs' to tackle opioids (STAT)
  • Former Obama Official Outlines What Parts Of Obamacare Need Strengthening (NPR)
  • Would legalizing medical marijuana help curb the opioid epidemic? (Reuters)
  • In Health Bill's Defeat, Medicaid Comes of Age (NYTimes)
  • Former Valeant CEO Michael Pearson sues over $30m unpaid shares (Pharmafile)

Upcoming Meetings & Events


  • BIA sets out of fact-finding trip to prepare for Brexit (PharmaLetter-$)
  • Kiadis may pursue EMA submission in blood cancer earlier than expected (PharmaLetter-$)
  • Roche announces launch of cobas HPV on the cobas 6800/8800 Systems for cervical cancer screening in markets accepting the CE mark (Press)


  • Wuxi Apptec Planning China IPO (BioCentury)
  • Kyowa Hakko suffers on cancer drug flop despite AstraZeneca deal news (PharmaLetter-$)
  • Astellas - Transfer of 16 Long-Listed Products in Japan (Press)


  • NPPA identifies 634 suspected cases of overcharging (Economic Times)
  • Incentives to promote API manufacturing in India: study (PharmaLetter-$)
  • Suven Life gets patent for neuro-degenerative molecule (Economic Times)
  • Integra, Dr. Reddy's ink deal for DuraGen in India (MassDevice)

General Health & Other Interesting Articles

  • Elon Musk Launches Neuralink to Connect Brains With Computers (WSJ)

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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