Regulatory Recon: Government Shutdown Looms; First PARP Inhibitor Approved in Japan (19 January 2018)

Posted 19 January 2018 By Zachary Brennan

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

In Focus: US

  • Showdown Looms as Senate Democrats Prepare to Reject Spending Bill (WSJ-$) (Politico)
  • House passes stopgap bill that would delay medical device tax; Senate Dems vow filibuster (MassDevice) (MedPage Today) (Stat)
  • No One’s Interests Would Be Served by a Shutdown (Alliance for a Stronger FDA)
  • The FDA Budget FY 18: Where Does the Money Come From? (Strengthen FDA)
  • Hospitals Making Drugs? (In the Pipeline)
  • Testing the tests: If two liquid biopsies deliver different results, can they both be right? (STAT) (NPR)
  • The Next Emflaza: Acer Therapeutics Looks to Take a Page Out of Marathon's Book (Focus)
  • The Battle Over Neulasta Biosimilars in the US: What's Coming in 2018 (Focus)

In Focus: International

  • Impact of a five-dimensional framework on R&D productivity at AstraZeneca (Nature) (Reuters) (Endpoints)
  • First PARP Inhibitor Approved in Japan (Press)
  • European Commission Approves Amgen And Allergan's Mvasi (Biosimilar Bevacizumab) For The Treatment Of Certain Types Of Cancer (Press)
  • Achieving the potential of genome editing (EuropaBio)
  • BeiGene Announces Pricing of $750 Million Public Offering (Press)
  • FDA Warns 5 Drugmakers in China, Australia and Austria (Focus)

Pharmaceuticals & Biotechnology

  • Ablynx investor opens door to Novo deal at a higher price (Fierce)
  • 'We’re not going to follow the hype': Biotech VCs are concerned by the staggering size of early-stage startup funding (BusinessInsider)
  • Glimmers in illuminating the druggable genome (Nature Reviews)
  • Biogen, UCB step up to kick the tires at Acorda as buyout buzz grows — report (Endpoints)
  • Cambridge biotech startup names two top leaders (Boston Globe)
  • Insider trading scam spurred by $11.2B Gilead deal earns a stretch in prison (Endpoints)
  • Cellular Biomedicine Group adopts GE Healthcare tech for CAR-T therapy production (BioPharma-Reporter)
  • Drugmaker Raises U.S. Price of Muscular-Dystrophy Treatment (WSJ-$)
  • Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance (Focus)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Samsung Etanercept biosimilar said to be less immunogenic than Enbrel (Big Molecule Watch)
  • Remote-controlled cancer immunotherapy system (Science Daily)
  • Albireo to Receive More than $55 Million in Nondilutive Cash Payments (Press)
  • Reata Announces the Publication of Efficacy Data From the Beacon Study of Bardoxolone in Diabetic CKD in the American Journal of Nephrology (Press)
  • Merck Keytruda in Patients with Previously Treated Advanced Hepatocellular Carcinoma (HCC) to be Presented at 2018 ASCO GI Symposium (Press)

Medical Devices

  • Devices Proposed for a New Use with an Approved, Marketed Drug; Public Hearing; Reopening of the Comment Period (Federal Register)
  • DarioHealth launches iPhone-compatible glucose meter in Australia (MassDevice)

US: Assorted & Government

  • Trump again targets drug policy office, proposing 95 percent budget cut (Politico)
  • CDC director's conflicts keep her from testifying (Politico)
  • Key House Republican seeks changes in right-to-try legislation (Stat)
  • Pence says that Congress should get right-to-try legislation ‘DONE’ (Stat)
  • The Medicare drug policy war between pharma and insurers (Axios)
  • HHS Office For Civil Rights Gets New Religious Freedom Center, Authority Over Discrimination Based On Refusal To Provide Abortions (Health Affairs)
  • Hearing on “Safety of the U.S. Food Supply: Continuing Concerns Over the Food and Drug Administration’s Food-Recall Process,” Subcommittee on Oversight and Investigations (E&C)
  • FDA Offers Recommendations on Highlights Section of Labeling (Focus)

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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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