Regulatory Focus™ > News Articles > Recon: CDC Director Resigns, Seattle Genetics to Acquire Cascadian Therapeutics for $614M

Recon: CDC Director Resigns, Seattle Genetics to Acquire Cascadian Therapeutics for $614M

Posted 31 January 2018 | By Zachary Brennan 

Recon: CDC Director Resigns, Seattle Genetics to Acquire Cascadian Therapeutics for $614M

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

In Focus: US

  • CDC Director Resigns (HHS) (Stat) (BusinessInsider) (Bloomberg)
  • The Story that led to the Resignation: Trump's top health official traded tobacco stock while leading anti-smoking efforts (Politico)
  • Seattle Genetics to Acquire Cascadian Therapeutics, Adding Late-Stage Breast Cancer Program to Its Oncology Pipeline (Press) (Xconomy)
  • Brain damage cases force an FDA hold on Bellicum’s lead cell therapy (Endpoints) (Press)
  • Trump urges Congress to pass 'Right to Try' experimental drug bill (The Hill) (BioCentury) (Focus)
  • E&C Vice Chairman Says He Will Work To Usher 'Right To Try' Through Committee, Following SOTU (InsideHealthPolicy-$)
  • Guidance on Guidance: Enforcement to be Curtailed (FDA Law Blog)
  • Linking the scientific and patent literatures (Nature TradeSecrets blog)
  • Regulating Drug Compounders: Gottlieb Discusses FDA's Flexible Approach (Focus)

In Focus: International

  • EU decision on EMA move to Amsterdam is done: EU Commissioner (Reuters)
  • Chiesi's ultra-rare genetic disorder therapy wins European backing (PMLive)
  • Assessing health technology in the EU: Commission proposes to reinforce cooperation amongst Member States (EC) (Q&A)
  • How to better apply the paediatric legislation to boost development of medicines for children (EMA)
  • Statement of Noncompliance from Danish Medicines Agency for Kadam Exports (EudraGMDP)
  • The opioid crisis and why Australia is cracking down on codeine (Guardian)
  • Drug Makers Looking to Adopt Continuous Manufacturing, Anticipating 30-40% Lower Production Costs: PMDA Official (Pharma Japan-$)
  • India Market Stares At Five-Year Growth Cutback But Buoyant (Scrip-$)
  • Astellas Appoints Kenji Yasukawa as President and CEO (Press)

Pharmaceuticals & Biotechnology

  • Severe Toxicity in non-human primates and piglets with systemic high-dose administration of AAV9-like vectors: Putting Patients First (Human Gene Therapy)
  • U.S. judge sentences Novelion's Aegerion in drug marketing case (Reuters)
  • Medical Research And Development Issues To Watch In 2018 (Health Affairs Blog)
  • Children Receive Bespoke, Lab-Grown Ears (TheScientist)
  • Analysis: Pfizer tallies an impressive array of late-stage catalysts for cancer, gene therapies and more (Endpoints)
  • The pharmaceutical industry is no stranger to fake news (Stat)
  • Fujifilm adds 6,000L and opens gene therapy plant (BioPharma-Reporter)
  • Kroger, other grocers take on generic drug industry with price-fixing suit (Fierce)
  • In conversation with: Laurence Reid, Warp Drive Bio CEO (Fierce)
  • Health Care ‘Tapeworm’ Faces New Threat (WSJ-$)
  • The fog around the new health care mega-venture (Axios)
  • Endo Gives FDA Breathing Room in Bulk Compounding Suit (BNA)
  • Is There a New Tactic for Generic Manufacturers to Use to Hit a Bullseye? (Lachman Consultants)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Eli Lilly posts fourth-quarter earnings beat, hikes 2018 guidance (CNBC) (FT-$)
  • Sunovion Parkinson’s Drug Heads to FDA, Setting Up Battle With Acorda (Xconomy)
  • Sanofi and partner seek European Medicines Agency review for sleep sickness product (Reuters)
  • FDA Upgrades Pfizer Kansas Plant (BioPharma-Reporter)
  • Focused on blockbuster indications, Sage touts evidence that 217 could work on insomnia (Endpoints)
  • Nanopore sequencing and assembly of a human genome with ultra-long reads (Nature Biotechnology)
  • Meet the company trying to democratize clinical trials with AI (Wired)
  • Startup with Johns Hopkins roots raising $40.5 million to develop cancer metabolism drugs (Endpoints)
  • Thermo Fisher Scientific Increases Quarterly Dividend (Press)
  • BeiGene Initiates Global Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab (Press)
  • Cara Therapeutics Initiates Pivotal Phase 3 Efficacy Trial of Korsuva (Press)

Medical Devices

  • CDRH Updates Guidance on Refusing to Accept 510(k)s and PMAs (Focus)
  • Companies Reflect on First Steps in Digital Health Pre-Cert Program (Focus)
  • Life Tech Rips Promega Bid To Rethink US Damages In IP Row (Law360-$)
  • Medtronic Investors Win Cert. In Revived Stock-Drop Suit (Law360-$)

US: Assorted & Government

  • Best Practices in Modeling and Simulation for Oncology Products; Public Workshop (FDA)
  • ACRO Unveils Library of Regulatory Comments (Press)
  • Statement Of Senate Appropriations Committee Vice Chairman Patrick Leahy (D-Vt.) On The Need For A Bipartisan Agreement (Senate Committee on Appropriations)
  • Much-Criticized Medicare Rule Helps Many Hospitals: Analysis (BNA)
  • Are Medicaid Work Requirements Legal? (JAMA)

Upcoming Meetings & Events

General Health & Other Interesting Articles

  • A rude awakening from tumor cells (Nature)

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? Send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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