Recon: FDA Puts CRISPR Trial on Hold

• Gene-Therapy Company Crispr Drops as FDA Puts Trial on Hold (Bloomberg-$) (Xconomy) (Boston Business Journal-$) (Endpoints) (BioPharma Dive)
• Minnesota sues opioid maker Insys over improper drug marketing (Reuters) (Minneapolis Star Tribune) (CBS Minnesota) (Phoenix Business Journal-$)
• Madrigal shares jump on midstage NASH results (Fierce) (STAT-$) (Reuters) (BioPharma Dive)
• Triclosan, a common antimicrobial in toothpaste and other products, linked to inflammation and cancer in the gut (Houston Chronicle) (Los Angeles Times) (BuzzFeed News) (GEN) (Quartz)
• Indivior subpoenaed by California on opioid addiction treatment (Reuters) (The Times) (Fierce)
• Nokia sells digital health venture, executive to leave (Reuters) (TechCrunch)
• Denali bags F-Star Gamma (European Biotechnology) (Fierce) (Endpoints)
• Following ASCO preview flop, Syndax bets on new combo deal with Nektar (Endpoints) (Fierce)
• Trump Predicts 'Massive Drops in Prices' for Drugs. Here's Why That Probably Won't Happen (Fortune)(Reuters) (Fierce) (CNBC)
• New Stroke Technology to Identify Worst Cases Gets FDA Approval (WSJ-$) Medical Design & Outsourcing) (Medscape) (MD Magazine)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• 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 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)

• 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)

• 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)