Regulatory Focus™ > News Articles > Regulatory Recon: Merck to Invest £1B in New UK Research Hub; Teva Overhauls Management in Restructu

Regulatory Recon: Merck to Invest £1B in New UK Research Hub Teva Overhauls Management in Restructuring Effort (27 November 2017)

Posted 27 November 2017 | By Michael Mezher 

Regulatory Recon: Merck to Invest £1B in New UK Research Hub Teva Overhauls Management in Restructuring Effort (27 November 2017)

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

In Focus: US

  • Tangled Incentives Push Drugmakers Away From an Opioid Solution (Bloomberg)
  • He Raised Drug Prices at Eli Lilly. Can He Lower Them for the US? (NYTimes)
  • The Trump administration is taking on drug prices — but not drug companies (Washington Post)
  • As Health Care Changes, Insurers, Hospitals and Drugstores Team Up (NYTimes)
  • FDA Cautions Against DIY Gene Therapy (FDA) (STAT) (Gizmodo)
  • The RNA drug hunters (C&EN)
  • Regeneron drops eye-drug combination as Novartis chases Eylea (Reuters) (Endpoints) (Fierce)
  • With $2.5B in Herceptin sales on the line, Roche sues Pfizer for biosim patent infringement (Fierce)
  • Scientists shrug off failures in hunt for Alzheimer's treatments (Financial Times)
  • How health care fits in Congress's jammed agenda (Politico)
  • The Insurance Company Paid For Opioids, But Not Cold Therapy (NPR)
  • Schumer warns DNA-home tests could be gathering personal info (NY Post) (NBC)
  • FDA Approves ViiV's Two-Drug Hiv Tablet (BioCentury) (FDA)
  • FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients (FDA)
  • BioMarin Sells Second Priority Review Voucher for $125 Million (Press)
  • Celltrion Seeks Interlocutory Appeal of Standing Issue in Janssen V. Celltrion (Big Molecule Watch)

RAPS Book Release: Fundamentals of EU Regulatory Affairs, Eighth Edition

  • Get the new, updated ultimate reference guide which includes the latest information on the new Medical Device and In Vitro Device Regulations, developments in implementation of the Clinical Trial Regulation and a number of new topics.
  • Learn more and shop now.

In Focus: International

Pharmaceuticals & Biotechnology

  • Drugs intended to calm people with Alzheimer's may lead to early death (Washington Post)
  • Catalyst heads back to the FDA in search of an elusive OK after Firdapse scores high in new PhIII (Endpoints)
  • Supporting opportunities for enhanced competition in the marketplace (PhRMA)
  • When replacement becomes reversion (Nature Biotech)
  • Juno Therapeutics Appoints Ann L. Lee as EVP of Technical Operations and Patrick Y. Yang as EVP, Senior Advisor to the CEO (Press)
  • US FDA Staff Slams Agency Hiring Policies In Report Ahead Of Public Meeting (Pink Sheet-$)
  • CDER Conversation: The FDA's Sentinel Initiative (FDA)
  • Real-World Evidence, Public Participation, and the FDA (Hastings Center)
  • FDA Publishes DSCSA Grandfathering Guidance Exactly 2 Years Late (RxTrace)
  • Serial pursuit: Second phase of US track and trace rules begins today (InPharma)
  • After rare disease failure, Biohaven pushes the gas on oral migraine drug (Fierce)
  • No More 'Hidden' Facilities, US FDA Tells Generic Sponsors (Pink Sheet-$)
  • Cytokinetics cans lead drug after phase 3 ALS wipeout (Fierce)
  • Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems (FDA)
  • Innate hopes dosing tweak will save BMS-partnered lirilumab (Fierce)
  • FDA Reviewing US Worldmeds' Opioid Withdrawal Candidate (BioCentury)
  • Khondrion gears up for pivotal mitochondrial disease trial after taking an early look at midphase data (Fierce)
  • FDA lifts second trial hold for Prescient's lead drug, with one to go (Fierce)
  • Clinical Trials Bring Hope to Kids with Spinal Muscular Atrophy (NIH)
  • Toxicity knocks Ardelyx's hyperkalemia hopes back to preclinic (Fierce)
  • GlaxoSmithKline taps breath data analyzer to improve COPD patient selection (Fierce)
  • Big Pharma's Partnering Process: An Insight Into The Nitty-Gritty (SCRIP-$)
  • Emergent wins approval to bring smallpox vaccine manufacturing to US (BioPharmaReporter)
  • Biologics Manufacturers Need More Adaptable, Modular Strategies: Tufts Study (FDANews-$)
  • Flagship, Arch cut their losses, quietly shutter Ensemble Therapeutics as pipeline plans fizzle out (Endpoints)
  • Biogen's answer to Alkermes' Tecfidera threat? Buy it, but don't spend too much (Endpoints) (Fierce)
  • Sun Pharma recalls two lots of diabetes drug due to microbial contamination (Economic Times) (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Biohaven Completes Enrollment In Second Pivotal Phase 3 Clinical Trial Of Oral CGRP-Receptor Antagonist Rimegepant (Press)
  • Owlstone Medical's Breath Biopsy Platform Integrated into GSK's Phase II Respiratory Disease Clinical Trial (Press)
  • Can-Fite Enrolls First Patient in Phase II NAFLD/NASH Study with Namodenoson (Press)
  • Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks (Press)
  • Eureka Announces FDA Allowance of Investigational New Drug Application for ET190L1-ARTEMIS™ T cell Therapy in Relapsed and Refractory CD19+ Non-Hodgkin Lymphoma (Press)

Medical Devices

  • Unique Device Identification (UDI) Application Guide (IMDRF)
  • Labs Mull New Regulatory Path for NGS Tumor Panels in Wake of FDA Decision on MSK-IMPACT (GenomeWeb)
  • CDRH Finalizes Guidance Regarding Sharing of Patient-Specific Information from Medical Devices (FDA Law Blog)
  • Hologic Receives FDA 510(k) Clearance of Quantra™ 2.2 Breast Density Assessment Software (Press)
  • Arterys Receives FDA clearance for Arterys MICA, its web-based medical imaging analytics platform (Press)
  • Masimo Announces FDA Clearance and Worldwide Release of NomoLine™ Capnography Sampling Lines (Press)

US: Assorted & Government

  • Excluding Noncovered Versions When Setting Payment for Two Part B Drugs Would Have Resulted in Lower Drug Costs for Medicare and its Beneficiaries (HHS OIG)
  • Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit  (Lexology)
  • Cutting the orphan drug tax credit would take away my day in the sun (STAT)
  • GAO Report Casts Shade On Sunscreen Ingredients' Chances With FDA (Pink Sheet-$)
  • The Opioid Epidemic – What Kind of a Problem Is It? (Drug & Device Law)
  • For N.D. Cal., Primary Jurisdiction is the "Natural" Outcome (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Biotech Industry Establishes a Much-Needed Presence in Geneva (BIO)
  • Medicines For Europe Calls For Greater Cooperation On Value Added Medicines To Improve Patient-Centric Innovation (Medicines for Europe)
  • ENCePP: 10 years for excellence in medicines safety (EMA)
  • EudraVigilance: User Manual (EMA); EVWEB User Manual (EMA); stakeholder change management plan (EMA); European database of suspected adverse reactions related to medicines: User Manual for online access via the adrreports.eu portal (EMA); Web Application (EVWEB) XCOMP v.3.0: Release Notes  (EMA) Web Application (EVWEB) v.1.0: Release Notes (EMA) auditable requirement project (EMA)
  • Vaccination in the spotlight: Health Commissioner awards 3 NGOs for outstanding initiatives (EC)
  • EMA Recommends New Approaches To Characterize Toxicity Of Anticancer Drugs (Pink Sheet-$)
  • Guideline on the clinical development of medicinal products for the treatment of Autism Spectrum Disorder  (EMA)
  • Draft guideline on conduct of pharmacokinetic studies in target animal species (EMA)
  • Europe is Assessing Challenges of Implementing Combination Product Regulatory Changes; Attention on CPs Increasing Globally (IPQ)
  • Founder of collapsed German drugstore chain Schlecker gets suspended prison term (Reuters)

Asia

  • Everstone buys Malaysian medical devices company Chemopharm (Economic Times)

India

  • Will Indian drug exports to other countries get stuck in EU ports? (Times of India)
  • GST makes 'orphan drugs' prices soar (Times of India)
  • India pares back planned funding for crucial public health scheme (Reuters)
  • Net profits of several top pharma cos decline by 40% in first half of 2017-18 (PharmaBiz)
  • Biocon introduces oncologic biosimilar KRABEVA in India (Economic Times)
  • India M&A Uptick: Have The Planets Aligned? (SCRIP-$)
  • Zydus gets USFDA nod for seizure, migraine drug (Economic Times)
  • More life-saving medicines to become cheaper by as much as 53% (Economic Times)
  • Indian pharma regulator joins push on excessive drug price hikes (PharmaLetter-$)

Australia

  • Workshops: Codeine up-scheduling (TGA)
  • Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected (TGA)

Canada

  • Consultation on the Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations (Health Canada)
  • Summary Safety Review - Breast Implants - Assessing the potential risk of cancer (Breast implant associated-anaplastic large cell lymphoma (Health Canada)

Other International

  • Provisional Agenda for the 142nd WHO Executive Board (WHO)
  • Statement of the 15th IHR Emergency Committee regarding the international spread of poliovirus (WHO)

General Health & Other Interesting Articles

  • The most popular genes in the human genome (Nature)
  • Why is This Bacterium Hiding in Human Tumors? (NYTimes)

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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

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


Categories: Recon, Regulatory News

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