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Recon: Teva Wins Ruling Tossing $235M GSK Verdict

Posted 29 March 2018 | By Ana Mulero 

Recon: Teva Wins Ruling Tossing $235M GSK Verdict

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

In Focus: US
  • Unum IPO hits bottom of range, netting $62M for cell therapy cancer trials (Fierce) (Endpoints)
  • Teva Wins Ruling Tossing $235 Million Glaxo Drug Verdict (Bloomberg) (Reuters)
  • Fired VA Secretary Says White House Muzzled Him (NPR) (NYT) (CBS News) (CNBC)
  • Faced with fresh concerns about Hemlibra’s safety, Roche spells out what it knows about 5 deaths (Endpoints) (Fierce)
  • CNBC interview with Scott Gottlieb (Transcript)
  • MediciNova's repurposed stroke drug flops in methamphetamine dependence trial (Fierce) (Endpoints)
In Focus: International
  • EU ready to review Shire’s lanadelumab for HAE (PharmaTimes) (PMLive) (The Pharma Letter)
  • Fujifilm to buy two biotech units from JXTG for $800 million (Reuters) (Endpoints)
  • Indivior inks deal for preclinical addiction treatment candidate (BioPharma Dive) (Fierce)
  • Redx Pharma calls a temporary halt to cancer trial to look at patient dosing (Fierce) (Endpoints)
  • France to spend 1.5 billion euros on artificial intelligence by 2022 (Reuters)
  • Summary record: technical expert seminar on pharmaceuticals related matters following UK withdrawal (EC) (EC)
  • First case of super-resistant gonorrhea reported (CNN) (BBC News) (Newsweek)
Pharmaceuticals & Biotechnology
  • Health-Care M&A Balloons in Busiest Start in More Than a Decade (Bloomberg)
  • Pharma Middlemen Have Targets On Their Backs (Forbes)
  • PhRMA goes after drug 'middlemen' in new ad attack (BioPharma Dive)
  • Bristol-Myers CEO Giovanni Caforio nets $18.7M in 2017 pay, a 10% raise (Fierce)
  • Washington state has the first comprehensive drug take-back program. Which state will be next? (STAT-$)
  • This Company Beat the Odds to Become One of the World's Most 'Innovative' Drug Giants (Fortune)
  • As Saline Shortages Persist, Providers Pin Hopes On Feds Demanding Backup Manufacturing Capacity (Pink Sheet)
  • Vermont transparency pricing law may show big price hikes, but disappoints lawmakers (STAT-$)
  • Judge OKs Drug Distributor Info Sharing In Opioid MDL (Law360-$)
  • Why pharma companies need to upgrade their intelligence (pharmaphorum)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Celgene-partnered Forma teams with Arpeggio to understand drug-target interactions (Fierce)
  • Pfizer Announces Positive Topline Results From Phase 3 ATTR-ACT Study Of Tafamidis In Patients With Transthyretin Cardiomyopathy (Press)
  • Denali-WashU team clears Alzheimer’s plaques in mice by targeting a faulty APOE gene (Fierce)
  • Scientists find mini gastrointestinal tract growing inside tumor (STAT)
  • CAR-T is a personalized attack on cancer. Here’s how it works (STAT-$)
  • Final results from landmark DYNAGITO trial published in The Lancet Respiratory Medicine (Press)
  • Five Prime Therapeutics Initiates Patient Dosing in Phase 1 Trial of Novel First-in-Class B7-H4 Antibody FPA150 (Press)
Medical Devices
  • Zimmer Biomet touts 7-year results in Mobi-C cervical disc trial (MassDevice)
  • LivaNova launches Microburst VNS drug-resistant epilepsy trial (MassDevice)
  • Scientists Say They Have Developed A Memory-Restoring Prosthetic For The Human Brain (Forbes)
  • Bard Exec Defends Handling Of Complaints At Vein Filter Trial (Law360-$)
  • Essure Users Must Combine 13K Injury Suits, Judge Says (Law360-$)
  • Abbott Initiates Trial to Evaluate Improved Survival And Outcomes with the CardioMEMS Monitor (Press)
  • Institut Curie and Freenome Announce a Strategic Collaboration in Cell-Free DNA Analysis Using Machine Learning Technology (Press)
  • IlluminOss Medical Executive Chairwoman Martha Shadan Named Chair of AdvaMed Accel (AdvaMed)
  • FDA Panel to Review Implanted 90-Day Glucose Monitor (MedPage Today)
US: Assorted & Government
  • Dems seek to flank Trump on drug prices (The Hill)
  • Rite Aid-Albertsons Deal Clears Key U.S. Antitrust Hurdle (Forbes)
  • House lawmakers hope to bring opioid legislation to vote before Memorial Day (STAT)
  • The government wants to free your health data. Will that unleash innovation? (STAT)
  • ‘My first reaction was OMG’: Trump’s VA pick is new to all this (Politico)
  • The antitrust case against new insurance mergers (Axios)
  • Pharmacies Again Sue Express Scripts After Talks Fail (Law360-$)
  • Walgreens Readies New Store Formats As Amazon And CVS Loom (Forbes)
  • Docs, Medical Boards Ignored FDA Warning Letters on CCSVI (MedPage Today)
  • Federal Circuit Issues Stay in St. Regis Mohawk Tribe Sovereign Immunity Appeal (Patent Law Weblog)
  • Center for Biologics Evaluation and Research within the Food and Drug Administration is seeking qualified candidates to serve as the Director, Office of Blood Research and Review (FDA)
  • Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA (FDA)
Upcoming Meetings & Events Europe
  • Building Cooperation in Cross-border Healthcare: New study maps state of play and optimal ways forward (EC)
  • LivaNova Bicarbon Aortic Valves Receive CE Mark for Expanded Use Labeling with Lower-Dose Blood Thinners in Low-Risk Patients (Press)
  • NHS England frees up millions of pounds which could be used for frontline services (NHS England)
  • Interested in responsible gene editing? Join the (new) club (Science Magazine)
  • Batch recall – Reminyl Prolonged Release Kapseln, 8 mg (Swissmedic)
  • With ‘Moneyball’ for Health Care, Israel Seeks Edge in Tech Age (Bloomberg)
  • Why empathy is crucial to transform Asia’s healthcare (GovInsider)
  • Government should fund healthcare sector, promote local industries: Dr Bindra (Times of India)
  • Inaugural Industry Forum on Good Manufacturing Practice (GMP) (TGA)
  • Australia's healthcare sector has been on a hiring frenzy (Business Insider)
  • Application for an evaluation of a new complementary medicine substance (TGA)
  • Consultation: Draft therapeutic goods advertising code 2018 and associated guidelines (TGA)
  • Mandatory requirements for an effective registered complementary medicine application (TGA)
  • Medical device industry calls for My Health Record to include medical device data (MTAA)
  • Updated Notice: eCTD Pilot for Clinical Trial Regulatory Activities – Extension (Health Canada)
  • Cogstate Receives Health Canada Marketing Authorization for Latest Healthcare Offering (Press)
  • BioMarker Strategies Announces that Both of Its Core Diagnostics Technologies for Solid Tumor Cancers Are Now Covered by New Patents Granted in Canada (Press)
  • Acerus expands its urology franchise (The Pharma Letter-$)
General Health & Other Interesting Articles
  • Millions have been traumatized by female genital mutilation. The practice must end (STAT)
  • It only feels like we’re paying more for health care (Axios)
  • Genetic Testing: Do You Really Want to Know? (WebMD)
  • A Radical Solution For Saving America's Hospitals (Forbes)
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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