Regulatory Recon: Judge Backs Obamacare Challenge White House Launches Microbiome Initiative (13 May 2016)

Posted 13 May 2016 | By Zachary Brennan 

Regulatory Recon: Judge Backs Obamacare Challenge White House Launches Microbiome Initiative (13 May 2016)

Happy Friday the 13th! And welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. 

In Focus: US

  • Judge Backs House Challenge to a Key Part of Health Law (NY Times) (WSJ-$) (The Hill)
  • White House Announces the National Microbiome Initiative (White House) (Atlantic) (NY Times)
  • A simple way for the government to curb inflated drug prices (Washington Post)
  • FDA Requires Stronger Warnings for Antibiotics’ Side Effects (WSJ-$) (Focus)
  • Senate to Consider 3 Proposals to Finance Fight Against Zika (NY Times) (Politico) (USA Today)
  • House Passes Dozen Opioid-Abuse Deterrent Bills; HHS Urges Vote On White House Plan (InsideHealthPolicy-$) (WSJ-$) (Huffington Post) (Bill) (Bill)
  • Scientists hold closed-door meeting at Harvard to discuss building synthetic genomes, including human (STAT)
  • PBMs, Payers Exclude Coverage for Growing Number of Priciest Drugs (Focus)
  • Aegerion to pay $40M and plead guilty to illegally marketing cholesterol drug (STAT) (FDANews-$)
  • The Improvisational Oncologist and more from issue on cancer (NY Times) (NY Times) (NY Times)
  • Tell the FDA what you fear more: Zika, or GMO mosquitoes? (AP)
  • FDA Guidance: Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification (Federal Register)
  • FDA Proposes Dedicated Biosimilar 'Unit' For BsUFA II (Pink Sheet-$) (FDA)
  • Congress’ Dubious Delegation of Legislative Authority to USP Standards Results in “Instructions”– But Not “Dismissal” – Related to the NECC Criminal Indictment (FDA Law Blog)
  • Is Friday the 13th bad for your health? (STAT)
  • The case of the $629 Band-Aid — and what it reveals about American health care (Vox)

In Focus: International

  • European Commission proposes better workers' protection against cancer-causing chemicals (PR)
  • BMS' potential standard of care skin cancer combo approved in EU (Pharmaphorum)
  • CSL’s Idelvion gets EC approval and seven years exclusivity in USA (PharmaLetter-$) (Pharmafile)
  • NICE includes Gedeon Richter's uterine fibroids drug in national guidance (Pharmaphorum)
  • US pressures Colombia over plan to sidestep patent for a Novartis drug (STAT) (KEI)
  • European Regulators Drawn Into Debate on Drug Pricing (Focus)
  • US Generics Firm Reports Counterfeit Cancer Drug Sales in Three Countries (Focus) (FDA)
  • Product Monograph Brand Safety Updates (Health Canada)
  • Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDS) (Health Canada)
  • The World Health Organization is electing a new leader. Here’s what you need to know. (Washington Post)
  • Zika virus and the Olympic and Paralympic Games Rio 2016 (WHO)
  • WHO, IFPMA launch cervical cancer campaign in Africa (PharmaAfrica)
  • PAHO launches high-level commission on inequality and health in the Americas (PAHO)
  • Laos added to WHO’s collaborative registration program (WHO)

US: Pharmaceuticals and Biotechnology

  • Mylan to Buy Renaissance Skin Drug Unit for About $1 Billion (Bloomberg)
  • Regeneron CEO says drug price critique by independent group unscientific (Reuters)
  • Valeant Haunted By Ghosts of Past, Future (Bloomberg)
  • Papa's Exit Highlights Perrigo's Shortcomings (SCRIP-$)
  • Stop Hyping Stem Cell Science, Say Stem Cell Scientists (Bloomberg)
  • Beyond immuno-oncology, AstraZeneca builds up 'DNA damage' drugs (Reuters)
  • Biotech Stock Mailbag: Why Intrexon CEO R.J. Kirk Should Not Be Trusted (TheStreet)
  • An Unintended Side Effect of Transparency (ProPublica)
  • Priority Review Voucher Expansion Could Be Bad, Program Creator Says (Pink Sheet-$) (Focus)
  • Bankrupt Biotech KineMed Owes More Than $1M To Gates, Others (Xconomy )
  • Sanofi Files Hart-Scott-Rodino notification for Medivation acquisition (Pharmafile) (Fierce)
  • JHL Biotech opens innovative biosimilars manufacturing facility in China (PharmaLetter-$) (PR)
  • UPMC and Pitt form $5 million microbiome research center (Pittsburgh Business Times)
  • Sanofi Wins Temporary Reprieve From Kickbacks Action (Law360-$)
  • Safety worries loom for Bayer’s Adempas (EP Vantage-$)

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

  • Pfizer presents positive results in meningococcal disease late-stage trials (Pharmafile)
  • Tetraphase shares tank as FDA demands new antibiotic PhIII trial (Fierce)
  • Edge a step closer to hemorrhage drug approval after FDA fast-track (Fierce)
  • Duke’s oncolytic virus study gains FDA Breakthrough: CBS (Fierce)
  • Self-Harm Lowest With Lithium in Bipolar Disorder (MedPage Today)
  • Shorter Regimens Offer New Hope to Adults and Children with MDR TB by Halving Treatment Time (PLOS)
  • Scientists discover new technology breakthrough to fight viral diseases (Manufacturing Chemist)
  • Histone Mutation Deranges DNA Methylation to Cause Cancer (GEN)
  • KaloBios Must Make Decision On Drug Trials, Hospital Says (Law360-$)
  • Oncobiologics Announces Pricing of Its Initial Public Offering of Units (PR)

Medical Devices

  • How to Design Patient-Centric Medical Devices (MDDI)
  • Patients push back at UnitedHealthcare's exclusive insulin pump pact with Medtronic (Fierce)
  • US FDA's Expedited Access Pathway: 17 Medical Devices And Counting (SCRIP-$)
  • This ingestible origami 'robot' is made of meat and unfolds in your stomach (CNBC)
  • Fed. Circ. OKs Use Of Local Patent Rule To Nix Stryker Case (Law360-$)
  • 23andMe Can't Arbitrate False Ad Suits, 9th Circ. Told (Law360-$)
  • Biosensors in pact with Cardinal Health on stent sales (Fierce)
  • Shareholder sues as Cardiovascular Systems wins extension to settle kickbacks case (Mass Device)
  • ITC opens probe of China’s BMC Medical in patent war with ResMed (Mass Device)
  • EndoStim Secures $25 Million in Funding to Expand Commercialization Efforts and Conduct a Pivotal U.S. Clinical Trial (PR)

US: Assorted and Government

  • Progress Toward Polio Eradication — Worldwide, 2015–2016 (CDC)
  • HHS Chief Counsel Bill Schultz and Assistant Secretary for Planning and Evaluation Richard Frank leaving HHS (Politico)
  • U.S. Reps. Jaime Herrera Beutler, Kathy Castor Introduce Bipartisan Bill to Improve Research on Medication Used During Pregnancy and Breastfeeding (PR)
  • Request for Information for Developing the National Cancer Moonshot Initiative (Federal Register)
  • Texas Finalizes Repeal of Medicaid Price Reporting Requirement (FDA Law Blog)
  • Draft guidance on Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food) (Federal Register)

Upcoming Meetings and Events              


  • Germany's Merck says gene editing to help it outperform (Reuters)
  • Draft reflection paper on the dissolution specification for generic oral immediate release products (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 May 2016 (EMA)
  • Inhibitor development in previously untreated patients with severe haemophilia A treated with recombinant factor VIII products (EMA)
  • Monthly report on application procedures, guidelines and related documents for veterinary medicines (EMA)
  • Monthly statistics report: April 2016 (EMA)


  • Government plans to fund projects in pharmacogenomics to expand scope of PvPI (PharmaBiz)
  • Dr Reddy’s figures hit by Venezuela crisis (PharmaLetter-$)


  • Zika is here -- Will Congress act? (CBS News)

General Health and Other Interesting Articles

  • Health Coverage Rates For Lower Income Children Improving (Kaiser Health News)
  • WATCH: What happened to astronaut Scott Kelly’s DNA during his year in space (STAT)
  • Op-Ed In science, follow the money – if you can (LA Times)
  • Harvard Medical School eases rule on faculty ties to industry (STAT)

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.

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