Regulatory Focus™ > News Articles > 5 > Recon: FDA Puts CRISPR Trial on Hold

Recon: FDA Puts CRISPR Trial on Hold

Posted 31 May 2018 | By Ana Mulero 

Recon: FDA Puts CRISPR Trial on Hold

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

In Focus: US In Focus: International
  • Antibiotic resistance crisis worsening because of collapse in supply (The Guardian) (Reuters)
  • Pfizer's Xalkori makes it onto Cancer Drugs Fund (PharmaTimes) (The Pharma Letter-$)
  • IUD most effective birth control method, Canadian pediatricians declare (CBC News) (National Post) (The Globe and Mail)
  • Dr Peter Groves to be new chair of the Devices Expert Advisory Committee (MHRA)
  • Indian Drugmakers Expect Pricing Pressure To Continue In U.S. (Bloomberg)
  • U.S. voices concern over increasingly deadly Bangladeshi anti-drug drive (Reuters)
  • MITA applauds lawmakers efforts to exempt medical devices from tariffs (MITA)
Pharmaceuticals & Biotechnology
  • Elizabeth Holmes' Superpower (Forbes)
  • New Analysis Shows Using ICER’s Value Assessments Would Limit Access to Life-Saving Medicines in Medicare Part B (PhRMA)
  • Trump’s drug price comments appear to catch industry off guard (Politico)
  • U.S. Struggles to Stop Smuggling of Mail-Order Opioids (NYT)
  • Drug makers push back on cost-effectiveness research for Medicare drugs (STAT-$)
  • Drug company sales rep admits bribing N.J. doctors to prescribe addictive painkillers (NJ.com)
  • YUHS, Celltrion to develop next-generation stroke therapy (Korea Biomedical Review) (Press)
  • CAMP4 Hauls in $30M to Map New Ground with Drug Discovery Tech (Xconomy) (Press)
  • Bay Area startup Cortexyme gains a $76M round to back a PhII Alzheimer’s study, with a new target in their sights (Endpoints)
  • Former Novartis U.S. oncology head Bill Hinshaw jumps ship to metabolic startup (Fierce)
  • In a twist, new Arcturus board restores old CEO (Fierce)
  • Biogen poaches Pfizer dealmaker Dan Karp for stepped-up M&A push (Fierce)
  • Arix Bioscience Forms Strategic Collaboration with Evotec AG and Fred Hutchinson Cancer Research Center to Foster New Companies in Cancer and Infectious Diseases (Press)
  • Bicycle Therapeutics Announces Formation of Scientific Advisory Board (Press)
  • Riffyn Forms Advisory Board of Biopharm and Biotech R&D Innovators (Press)
  • Cloud Pharmaceuticals forms Drug Design Collaboration with GSK (Press)
  • FORMA Therapeutics and HitGen Initiate Multiyear Research Collaboration (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • ScPharma’s stock droops on ‘deficiencies’ as FDA tosses back heart failure drug application (Endpoints)
  • Gilead and Galapagos bag promising PhII data for star immunology drug filgotinib — boosting late-stage focus (Endpoints) (Fierce)
  • FDA Grants Orphan Drug Designation to GBC0905 for FSHD (Rare Disease Report) (Press)
  • FDA priority review for Fycompa sNDA (The Pharma Letter) (Press)
  • Nektar Therapeutics Announces Submission of a New Drug Application to the U.S. FDA for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy (Press)
  • Medicortex Finland Announces Patent Approval for Underlying Technology of Drug Development Plan (Press)
  • Bicycle Therapeutics and Cancer Research UK Announce Presentation at 2018 American Society of Clinical Oncology Meeting (Press)
  • Clearside Biomedical Announces Positive Topline Results from Phase 2 Clinical Trial of CLS-TA Used with Eylea in Patients with Diabetic Macular Edema (Press)
  • Zealand Pharma to present new clinical Phase 2 results on glepaglutide for the treatment of short bowel syndrome at the DDW conference in the U.S. (Press)
  • IAVI, Selexis SA and Collaborators Publish Study Highlighting Improved Approach for Generating Complex Proteins Required for Producing HIV Vaccines (Press)
Medical Devices
  • Pioneering surgery makes a prosthetic foot feel like the real thing (STAT)
  • Trump tariffs leave medical device companies in the dark (Medical Design & Outsourcing)
  • For Some Hard-To-Find Tumors, Doctors See Promise In Artificial Intelligence (NPR)
  • Boston Scientific, IRS finalize $608m settlement over transfer pricing beef (MassDevice)
  • Baxter updates Sharesource dialysis monitoring platform (MassDevice) (Press)
  • GE and CCRM Partner with DiscGenics on New Cell Therapy (BioPharm International) (Press)
  • Kurin, Inc. Sues Magnolia Medical for Misleading Consumers about FDA Clearance and Efficacy (Press)
  • Five Prime Therapeutics Announces Collaboration with Roche to Develop Companion Diagnostics for Targeted Immuno-Oncology Investigational Drug Candidates (Press)
  • Agilent Technologies to Acquire Assets of Ultra Scientific (Press)
  • TransEnterix Announces LSU Health Completes Purchase of Senhance Surgical System (Press)
  • MicroVention Announces FDA Approval For Neuro Stent Device (Press)
  • Abbott Introduces the Afinion 2 Analyzer Rapid Test System for Diabetes Management (Press)
  • JC Medical Announces First-in-Human Treatment with the Unique Transfemoral J-Valve TAVI Device for Aortic Regurgitation (Press)
  • LivaNova Comments on the U.S. Centers for Medicare & Medicaid Services’ Reconsideration of its National Coverage Determination for VNS Therapy for Treatment-Resistant Depression (Press)
  • Baxter Supported Nine New Abstract Presentations at the 55th ERA-EDTA Congress That Further Demonstrate Value of HDx Therapy Enabled by THERANOVA (Press)
  • Philips and Dana-Farber operationalize and scale Clinical Pathways at ASCO 2018 (Press)
US: Assorted & Government
  • New Mexico governor candidate profited from high-risk insurance plans (Politico)
  • Louisiana governor signs bid to ban 15-week abortions (AP News)
  • Facebook, Instagram among tech firms called to Washington by FDA to address illicit opioid sales (STAT)
  • NIH hosts meeting on chronic pain and the opioid crisis (NIH)
  • Webinar - FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder - July 25, 2018 (FDA)
Upcoming Meetings & Events Europe
  • Field safety notices - 21 - 25 May 2018 (MHRA)
  • Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients (MHRA)
  • UK based biopharmaceutical company SiSaf closes $4.3 million interim funding round (Press)
Asia
  • HPV Vaccine Seller in China Propels Owners Up Billionaires List (Bloomberg)
  • Inefficiency is metastasising in China's healthcare system (East Asia Forum)
  • In China, industry push-back stubs out anti-smoking gains (Reuters)
  • Teikoku and Link agree deal to market Lidoderm in China (The Pharma Letter)
  • Astellas strengthens hand ahead of Japanese roxadustat filing (The Pharma Letter-$) (Press)
  • LG Chem launches Enbrel biosimilar in Japan (Korea Biomedical Review)
  • AbbVie to challenge Gilead on hepatitis C front in Korea (Korea Biomedical Review)
  • PMDA Updates Posted (PMDA)
  • vTv Therapeutics Announces Licensing Agreement with Newsoara Biopharma Co. Ltd. to Rights for vTv’s PDE4 Inhibitor in China and Other Pacific Rim Territories (Press)
India
  • Niti Aayog to work on boosting Make in India for medical devices (Economic Times)
  • Pharma analysts need to show strong commitment to ensure quality of generic drugs, says DCGI (Pharmabiz)
  • Nipah virus death toll rises to 15, two new cases found in India's Kerala (Reuters)
  • Government taking action on high cost of rare and orphan disease drugs in India (The Pharma Letter-$)
  • India to be first to protect health data of citizens with iron-clad law? (Business Standard)
Australia
  • Australia pledges to assist health sector (The Herald)
  • GSK wins Australian reimbursement for Trelegy  (The Pharma Letter-$)
  • Dolutegravir:Safety advisory - new study suggests possible risk of birth defects (TGA
  • LFIT Anatomic CoCr V40 Femoral Heads: Hazard alert - potential for components to separate (TGA)
Canada
  • Pivot Pharma enters exclusive contract manufacturing agreement with Bio V Pharma (Pharmabiz)
  • Health minister aims to cut down number of Canadians smoking, open to warnings (The Canadian Press)
  • Searchlight Pharma Announces Signing of Exclusive License for Commercialization of Estelle® in Canada (Press)
General Health & Other Interesting Articles
  • The Largest Health Disparity We Don’t Talk About (NYT)
  • Studies of space, hearing and DNA attract $1 million awards (AP News)
  • Stem cell bank opens with backing from leading scientists. Is it worth the money? (STAT)
  • Chronic diseases are taxing our health care system and our economy (STAT)
  • In Louisiana jail, inmate deaths mount as mental health pleas unheeded (Reuters)
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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