Regulatory Focus™ > News Articles > 2 > Recon: Merck to Buy Australian Oncolytics Firm Viralytics for $394M; NICE Backs Gilead's Pan-Genotyp

Recon: Merck to Buy Australian Oncolytics Firm Viralytics for $394M; NICE Backs Gilead's Pan-Genotypic Hep C Combo

Posted 21 February 2018 | By Michael Mezher 

Recon: Merck to Buy Australian Oncolytics Firm Viralytics for $394M; NICE Backs Gilead's Pan-Genotypic Hep C Combo

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

In Focus: US

  • Tool 'names and shames' hidden drug trials (BBC)
  • The I/O 2.0-combo tech race is on: Merck bags oncolytics player Viralytics in $394M buyout (Endpoints) (PharmaTimes) (Fierce)
  • Deal Making Just Got Tougher for Struggling Generic Drugmakers (WSJ)
  • 10 BREAKTHROUGH TECHNOLOGIES 2018 (MIT Technology Review)
  • Pacemakers, defibrillators are potentially hackable (Reuters) (JACC)
  • Trump pushing ahead on Koch-backed experimental drugs 'Right to Try' agenda (CNBC)
  • New Medicare rule could limit cancer patients' access to genetic testing, physicians warn (STAT)
  • The good, the bad and the ugly for the top 15 spenders in the global drug R&D business: 2018 (Endpoints)
  • More than a half-dozen teams are pursuing genetic therapies for sickle cell (STAT)
  • CRISPR could end sickle cell disease, but signing up black patients for clinical trials will be a hard sell (STAT)
  • AbbVie rolls up another big win for elagolix as the prospective blockbuster sweeps endpoints in latest PhIII (Endpoints)
  • Top 15 US Pharmacies of 2017: Market Shares & Key Developments For The Biggest Companies (Drug Channels)
  • The Budget Blindside: Did Pharma Fight The Wrong Battle? (Pink Sheet-$)
  • ER Reduces Opioid Use By More Than Half With Dry Needles, Laughing Gas (NPR)
  • Caution: Benefits from earlier trials may be (a lot) smaller than they later appear (STAT)
  • Amazon has quietly launched an exclusive line of over-the-counter health products (CNBC)

In Focus: International

  • Doctors In China Lead Race To Treat Cancer By Editing Genes (NPR)
  • Europe Saw 4-Fold Increase In Measles Cases In 2017 (NPR)
  • South Africa's Mo-99 plant back online after hydrogen leak scare (Reuters)
  • On a journey to find and fuel new biotech ventures, Arix adds France's Ipsen to its network of partners (Endpoints) (Fierce)
  • NICE nod for Gilead's pan-genotypic hepatitis C therapy (PharmaTimes)
  • Two Hopefuls And A 'No': EMA Decisions On Accelerated Access (Pink Sheet-$)
  • Aurobindo Pharma eyes European business of Apotex (Economic Times)
  • Sanofi again denies Dengvaxia refund request as Philippine officials prep lawsuit (Fierce)
  • In China, UK trade delegation bags £500 million plus in healthcare deals (PharmaLetter-$)
  • UK Patent 'Plausibility': Landmark Lyrica Case May Get Supreme Court Ruling By Early Summer (Pink Sheet-$)
  • Hospitals prescribe drugs excluded from price control to boost profit: NPPA (Economic Times)

Pharmaceuticals & Biotechnology

  • This nation pioneered modern life. Now epic numbers of Americans are killing themselves with opioids to escape it. (New York Magazine)
  • A Female Biotech CEO Says She Was Denied Investment Because She 'Wasn't Aggressive Enough' (Forbes)
  • A Perspective On Prescription Drug Copayment Coupons (USC)
  • Immuno-Oncology's Revolutionary Impact – On US FDA (Pink Sheet-$)
  • Cancer drugs could treat rare blood-vessel disorder (BBC)
  • Sun Pharma Recalls Over 17,500 Bottles Of Nasal Spray From US  (Bloomberg) (Economic Times)
  • Can you vaccinate yourself against cancer? (CNN)
  • Facility and Excipient Information Shortfalls Identified by FDA As Among Key Contributors to ANDA Review Delays; GDUFA II Driving Expanded Guidance (IPQ)
  • Top Pfizer research exec John Davis joins migration to biotech, lands at Magenta as CMO (Endpoints)
  • Clinical Trials Supplement Celebrates One Decade Of CTTI Impact (CTTI)
  • War on science threatens 'moonshots' to cure cancer and other diseases (CNBC)
  • AllTrials urges FDA to fine sponsors for not publishing trial results (OutsourcingPharma)
  • Studies Find Small Risk From Rotavirus Vaccine (NBC)
  • Senior R&D exec Sue Dillon jumps ship at J&J, launches mystery biotech startup Aro with Centyrins tech (Endpoints)
  • Pfizer consumer health sale: Reckitt Benckiser plays down rumours (InPharmaTechnologist)
  • Dynavax secures $175M to fuel Heplisav-B marketing, immuno-oncology trials (Fierce)
  • Pacira's Long Day With Exparel (Pink Sheet-$)
  • EHRs do not lower administrative billing costs, study finds (Modern Healthcare)
  • Celgene Receives Antitrust Clearance for Juno Acquisition (Press)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Evofem Biosciences Receives Fast Track Designation for Amphora for Prevention of Chlamydia (Press)
  • Medigene gets OK for first trial of T cell receptor therapy (Fierce)
  • Centrexion Therapeutics Announces First Patient Dosed in Phase 3 Trial of CNTX-4975 for the Treatment of Moderate to Severe Knee Osteoarthritis Pain (Press)

Medical Devices

  • Approval of first tumor gene panel sends shockwaves through labs (Nature)
  • This 22-Year-Old Is Partnering With Industry Powerhouses To Revolutionize Prosthetics (Forbes)
  • FDA removed 10% of medtech establishments from its registration database: Here's why (MedicalDesign&Outsourcing)
  • Roche's Accu-Chek diabetes management app receives its fifth FDA recall (MobiHealthNews)
  • MemoryMD gets FDA clearance for wireless EEG amplifier (MobiHealthNews)
  • BD Gets CE Mark for Circulating Cell-Free DNA Blood-Collection Tube (GenomeWeb)
  • New Vaginal Mesh Implant Material Could Reduce Complications, Accelerate Healing (MDDI)
  • Medtronic expands insulin pump portfolio with MiniMed Mio infusion set (MassDevice)
  • Corindus wins FDA 510(k) PVI indication for CorPath GRX (MassDevice)
  • Baxter approves $1.5B addition to share repurchase plan (MassDevice)

US: Assorted & Government

  • Kratom blamed for salmonella outbreak in 20 states (NBC)
  • Senior HHS official placed on leave for promoting unfounded claims and conspiracy theories on social media (CNN)
  • Meet The Attys At The Opioid MDL's Negotiating Table (Law360-$)
  • Pharmaceutical Titan's Senate Bid Will Test Voters' Views on Drug Prices (Bloomberg)
  • Biotech Co. Says Rival Violated Deal With Press Releases (Law360-$)
  • Amgen Seeks To Hold Off Generics In FDA Denial Challenge (Law360-$)
  • California Congressman Introduces Bill to Promote Genetic, Genomic Testing (GenomeWeb)
  • Allergan and Co-Defendants to Pay $9 Million for Product-Hopping to Stifle Generics (FDANews-$)
  • EDNY Lays Out Disclosure/Report Requirements for Nonretained Treating Doctor Experts (Drug & Device Law)
  • Medicaid Demonstrations: Evaluations Yielded Limited Results, Underscoring Need for Changes to Federal Policies and Procedures (GAO)
  • About Time: DEA Acknowledges that Long-Collected ARCOS Data is an Effective Enforcement Tool That Can Assist Manufacturers and Distributors (FDA Law Blog)
  • The US Health Provider Workforce (Mercatus Center)
  • Arizona Did Not Bill Manufacturers for Some Rebates for Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations (HHS OIG)

Upcoming Meetings & Events

Europe

  • What does the UK Life Sciences Strategy mean for the pharma and biotech sector? (PharmaLetter-$)
  • Italian court convicts Boston Scientific employee in criminal case (MassDevice)
  • Eudamed Accessibility for Non-European Authorities (Emergo)

Asia

  • Philippines' Duterte Mocks Condom Use Amid Skyrocketing HIV Rates (NPR)
  • Further 40 million euros to be invested in Merck's manufacturing and distribution in Asia (PharmaLetter-$)
  • Biocon gets 6 observations from USFDA for Malaysia facility (Economic Times) (InPharmaTechnologist)

India

  • New committee to examine safety, rationality of over 300 drugs banned since 2016 (Economic Times)
  • Curbs on oxytocin production and trade to check misuse (Economic Times)

Australia

  • Submissions received: Therapeutic Goods Advertising Code (TGA)
  • Mandatory requirements for an effective application (TGA)

Canada

  • Tandem Diabetes bids for Health Canada nod (MassDevice)

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.


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