Recon: Regeneron and Express Scripts Reach Deal on Cholesterol Drug


Posted 01 May 2018 | By Zachary Brennan 

Recon: Regeneron and Express Scripts Reach Deal on Cholesterol Drug

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

In Focus: US

  • Regeneron And Express Scripts Reach A Deal On Embattled Cholesterol Drug (Forbes) (CNBC) (Endpoints) (Press)
  • Bristol-Myers dumps late-stage IDO studies in wake of Incyte’s pivotal implosion in yet another setback (Endpoints) (Fierce) (In the Pipeline)
  • It’s ‘going to be tough’: UC Berkeley struggles to find sympathetic court in CRISPR patent appeal (Stat)
  • Value-Based Pricing for Drugs: Theme and Variations (JAMA)
  • Merck lifts earnings forecast after currency boost (FT-$) (Reuters) (Press)
  • Pfizer tops profit estimates, driven by Prevnar sales (Reuters) (FT-$) (Press)
  • Management tracks: Orbimed and Pfizer (BioCentury)
  • Scientists downsize bold plan to make human genome from scratch (Nature News)
  • Novartis receives FDA approval of Tafinlar + Mekinist for adjuvant treatment of BRAF V600-mutant melanoma (Press) (PharmaTimes)

In Focus: International

  • Exclusive: India rejects U.S. request on price caps on medical devices – sources (Reuters)
  • Clinical trial to find new treatment for kala-azar begins in eastern Africa (Uganda’s New Vision)
  • Opdivo first anti-PD-1 therapy oked by TGA for adjuvant treatment of melanoma (PharmaLetter-$)
  • AZ’s Tagrisso looks set for first-line lung cancer label in EU (Pharmaphorum)
  • Final Guidelines on Consent Requirements Under the EU General Data Protection Regulation: Implications for Scientific Research (Bloomberg)
  • Porton Biopharma opens new leukaemia drug production facility (Pharmafile)
  • A vaccination day in Cox’s Bazar (WHO)
  • ICH Advances Q&A on the Nonclinical Evaluation of Cancer Drugs (Focus)

Pharmaceuticals & Biotechnology

  • Gilead To Pay Verily $90 Million To Probe Immune Cells (Forbes)
  • Under pressure, Peter Hecht splits Ironwood into two biotechs, spinning out an R&D operation (Endpoints) (Press)
  • CRISPR: The gene-editing tool revolutionizing research (60 Minutes)
  • Tertiary Patents: An Emerging Phenomenon (Harvard Bill of Health)
  • Judge Sets Preliminary Injunction Briefing Schedule in Genentech v. Sandoz (Big Molecule Watch)
  • Wisconsin Governor Walker Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines (Press)
  • George Church, CRISPR Pioneer, Embraces Alternative Tech In Project To Recode A Human Genome (Forbes)
  • Can Blockchain Fix the Opioid Epidemic? Intel Wants to Find Out (Bloomberg)
  • Right From The Beginning: Returning To The Origins Of The Orphan Drug Movement (Life Sci VC)
  • Harvard’s Wyss Institute partners with Cellectis to recode the human genome (Press)
  • PTAB May Terminate Some IPR Institution Decisions In Wake Of Supreme Court Ruling (Pink Sheet-$)
  • Corners of the immunotherapy space are getting crowded. Is that a problem? (Stat-$)
  • Pfizer, Insurer Duel Over Venue For $30M Coverage Fight (Law360-$)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Navigating Ethics Review of Human Infection Trials With Zika (Hastings Center)
  • Omega Funds leads $35M Series A to fuel Attenua’s cough program, set for proof-of-concept this year (Endpoints)
  • Sanofi’s latecomer PD-1 gets date for FDA verdict (PMLive)
  • Eyeing Eylea’s $5B sales, Novartis touts solid 12-week dosing data for its rival RTH258 (Endpoints)
  • Biogen and Neurimmune Announce Option Exercise for Alzheimer’s Disease Investigational Treatment Aducanumab (Press)
  • Tonix Pharmaceuticals Receives IND Clearance by U.S. FDA for TNX-102 SL in Agitation in Alzheimer’s Disease (Press)
  • Acceleron Receives FDA Fast Track Designation for ACE-083 in Facioscapulohumeral Muscular Dystrophy (FSHD) (Press)
  • AbbVie Commences Self-Tender Offer for Up to $7.5 Billion of its Common Stock (Press)

Medical Devices

  • Spectrum Pharmaceuticals Enters into a Next-Generation Sequencing Companion Diagnostic Partnership with Thermo Fisher Scientific (Press)
  • Orthofix closes $105m Spinal Kinetics buyout, cuts earnings outlook (Mass Device)
  • Behind the Scenes, America’s Medical Technology Companies Are Fighting the Cybersecurity Battle (AdvaMed)

US: Assorted & Government

  • NIH announces national enrollment date for All of Us Research Program to advance precision medicine (NIH)
  • Removal of FDA Pregnancy Drug Categories: More Harm than Good? (MedPage Today)
  • FDA comparison of characteristics of hemoglobin-based oxygen carriers could guide development of safe and effective artificial blood products (FDA)
  • CDER Ombudsman Report 2017 (FDA)
  • FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal) (FDA)
  • Treating the Patient, Not the Symptoms – FDA and Digital Health (EyeonFDA)

Upcoming Meetings & Events

Europe

  • BioCryst Receives European Medicines Agency Approval for ALPIVAB for the Treatment of Influenza (Press)
  • MRC awards Bristol researcher £1.2M to investigate immune defence against microbes (PharmaTimes)
  • Report: Drug overdose leading cause of death among men under 40 in Finland (Uutiset)
  • Takeda announces new UK MD, ahead of Shire transformation (Pharmafile)

India

  • Public relations office at CDSCO (CDSCO)
  • Telangana: All’s not well with pharma firms and medicines they make (Indian Express)

General Health & Other Interesting Articles

  • The Race to Learn What’s Really Happening in the Opioid Crisis (City Lab)
  • New stem cell clinic insights from trio of critical media pieces (The Niche)

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? Email us at news@raps.org.

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

 




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