Regulatory Recon: House Vote on Healthcare Bill Set for Friday Afternoon Pfizer, German Merck mAb Gets First Approval for MCC (24 March 2017)

Posted 24 March 2017 | By Michael Mezher 

Regulatory Recon: House Vote on Healthcare Bill Set for Friday Afternoon Pfizer, German Merck mAb Gets First Approval for MCC (24 March 2017)

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

In Focus: US

  • FDA approves Pfizer, German Merck immunotherapy for skin cancer (Reuters) (FDA) (Medpage) (Press) (Endpoints)
  • House votes to begin debate on ObamaCare repeal bill (The Hill)
  • Republicans scramble for health bill votes after Trump ultimatum (Reuters) (NYTimes)
  • Even if Health Bill Passes the House, It Still Has a Way to Go (NYTimes)
  • Trump the Dealmaker Projects Bravado, but Behind the Scenes, Faces Rare Self-Doubt (NYTimes)
  • Loss Aversion, Trump and the New Opening for Medicare for All (NYTimes)
  • Did President Trump just jump the shark on drug prices? (Endpoints)
  • Gottlieb's FDA: Specialized Groups Could Create Review Consistency, Speed (Pink Sheet-$)
  • Alexander Meets with FDA Commissioner Nominee Dr. Scott Gottlieb (Senate HELP)
  • Drug Companies Are Buying Ads on Shows They Know Donald Trump Watches (Bloomberg)
  • New data needed to improve prescribing, combat threat of antibiotic resistance (Pew)
  • Drugmaker Lilly to invest $850 million in U.S. operations in 2017 (Reuters) (Press)
  • With patients demanding experimental drugs, 'right to try' is becoming the law of the land (STAT)
  • Olympus' redesigned scope is linked to infection outbreak (LA Times)
  • Prescription Drug Regulation, Promotion, And Advocacy Has Gotten More Vexing In 2017 (Health Affairs Blog)
  • Most Cancer Is Bad Luck And Early Detection Is A Cure, Say Hopkins Researchers (Forbes) (Reuters)
  • Pharma development budgets grow as Roche remains a believer (EP Vantage)
  • Sanofi on verge of $1B-plus deal for arthritis-focused biotech Flexion (Fierce) (The Street)
  • Different drugs for bad bugs: antivirulence strategies in the age of antibiotic resistance (Nature)

Sponsored Content: IDMP is Delayed Again

In Focus: International

  • Shares slump after Xenon Pharmaceuticals abandons acne drug (Reuters)
  • Teva to Cut Undisclosed Number of Jobs as It Seeks to Pare Costs (Bloomberg) (PharmaLetter-$) (Fierce) (Endpoints)
  • MHRA Details Common Issues in Clinical Trial Applications (Focus)
  • European Regulatory Roundup: EMA Reports Year-Long Shortage of BMS Kidney Transplant Drug; UK Rejects Indication-Specific Drug Pricing (Focus)
  • Six medicines recommended for EU approval, including three orphans (EMA) (Reuters) (Merck) (BMS)
  • EMA Posts 2017/2018 Deadlines for Submitting Applications for Orphan Designation (EMA)
  • EU recommendations for 2017/2018 seasonal flu vaccine composition (EMA 1, 2)
  • Valeant awarded CEO Papa $62.7M last year despite missing financial targets (Fierce)
  • From coast to coast: Africa unites to tackle threat of polio (WHO)
  • Denmark Leads New EU Task Force Exploring Use Of Big Data In Medicines Assessment (Pink Sheet-$)
  • BioLineRx buys UK firm to expand immuno-oncology pipeline (PharmaLetter-$) (Fierce)
  • India's New National Health Care Policy Recycles Old Targets (Pink Sheet-$)
  • Brexpiprazole filed with EMA for adult patients with schizophrenia (PharmaLetter-$)
  • European Medicines Agency to assess dermatology candidate tildrakizumab (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Quick Commercial Standouts Lacking Among 2016 US Launches (SCRIP-$)
  • FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients (Focus)
  • Merck Ends Development Of cCAM Compound (BioCentury)
  • Noninvasive measurement of transdermal drug delivery by impedance spectroscopy (Nature)
  • Delivery technologies for genome editing (Nature)
  • Sentinel Data Quality Assurance Practices (Sentinel)
  • C4, Calico Partner To Treat Aging-Related Diseases (BioCentury)
  • Lilly and the William Sansum Diabetes Center announce a five-year research collaboration (Press)
  • Novartis offloads phase 2 mTORC1 programs to PureTech (Fierce)
  • A Stem Cell Library to Predict Which Drugs Are Heart Safe, and an Injectable Treatment for Clogged Arteries (CIRM)

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

  • Once-daily Symproic approved by FDA for OIC patient with non-cancer pain (PharmaLetter-$) (Press)
  • FDA Grants Breakthrough Therapy Designation for Rituxan® (Rituximab) in Pemphigus Vulgaris (Press)
  • FDA Provides Cornerstone Pharmaceuticals Approval to Initiate Pivotal Study for CPI-613, its Metabolism-Directed Anticancer Compound (Press)

US: Medical Devices

  • REACH Updates and a Comparison to RoHS (MDDI)
  • Biosensors International launches US pivotal for BioFreedom DCS (MassDevice)
  • BioStable Science & Eng wins FDA nod for Haart 300 aortic annuloplasty device (MassDevice)
  • FDA Approves NanoCoated Coronary Stent System Using DSG's eClinical Systems (Press)

US: Assorted & Government

  • BIO, Two Drugmakers Side With Amgen in Biosimilar Case (FDANews-$)
  • Supreme Court declines review of Retractable Tech case against BD (MassDevice)
  • Reducing Administrative Burden Under New 'Common Rule' (Law360-$)
  • GAO Identifies Gaps in Oversight of Use of Medically Important Drugs in Food Animals (FDA Law Blog) (NPR)
  • District Judge in SDNY Adopts Magistrate's Recommendation to Dismiss Failure to Warn Claim Based on Lack of Proximate Causation (Drug & Device Law)
  • Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)]in Schedule II (DEA)

Upcoming Meetings & Events


  • UK charity invests £10 million in precision medicine for pancreatic cancer (PharmaLetter-$)
  • Guideline on the plant testing strategy for veterinary medicinal products (EMA)
  • HTG Molecular Gets CE Mark for Lung Cancer CDx (GenomeWeb)



  • Maha FDA finds no ceiling price violation of stents in city hospitals based on verification reports (PharmaBiz)
  • To invest Rs 305 crore Mankind Pharma to foray into diagnostics (Economic Times)
  • Civil society groups urge Swiss negotiators not to include harmful IP measures in India-EFTA negotiations (PharmaBiz)
  • Anti-diabetic drug cartel issue reaches CCI, Health Ministry (Economic Times)
  • Almirall seeks nod for tildrakizumab in Europe: Sun Pharma (Economic Times)


  • A patent analytics study of the Australian pharmaceutical industry (Pharmafile)
  • Australian TGA Releases New Clinical Guidelines for Medical Devices (Emergo)

Other International

  • Israel looks to leverage tech in $50 billion medical marijuana market (Reuters)

General Health & Other Interesting Articles

  • Protein Hints at a Fountain of Youth in Blood (MIT Technology Review)
  • Asbestos-Linked Cancer Remains A Killer, Just As Asbestos Remains Commonly Used (Forbes)
  • Scientists Use IBM Power Systems to Assemble Genome of West Nile Mosquito (IBM)

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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