Recon: Canadian Fund Buys Keytruda Rights from UK’s LifeArc for £1B – Regulatory Focus

Posted 20 May 2019 | By Michael Mezher 

Recon: Canadian Fund Buys Keytruda Rights from UK's LifeArc for £1B
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US

  • Gates-backed Schrödinger raises $110m for new drug push (Financial Times) (Fierce)
  • Exit Of No. 2 At Amazon’s Haven Keeps Walmart Employee Health Strategy In Lead (Forbes) (STAT)
  • Dana-Farber prevails in immunotherapy dispute over patents behind blockbuster drug (STAT) (Endpoints)
  • Commentary: We need to make sure new drug cures don’t widen income gap for the poor (CNBC)
  • Biotech Startups And The Hard Truth Of Innovation (LifeSciVC)
  • Google’s AI improves accuracy of lung cancer diagnosis, study shows (STAT)
  • Allergan wins a novel case over false ads by a compounder, but gets just $48,500 for its trouble (STAT)
  • After forced sale, PatientsLikeMe founder frets that U.S. policy could chill collaboration in biotech (STAT)
  • House bundles CREATES with measures that Trump won’t sign (BioCentury)
  • Seeking to contain drug costs, CMS may have ‘killed’ a PBM billing practice (STAT)
  • Why Missouri’s The Last Holdout On A Statewide Rx Monitoring Program (KHN)
  • Recalled defibrillator among exemptions in FDA’s hidden database (CNN)
  • Millions Take Gabapentin for Pain. But There’s Scant Evidence It Works. (NYTimes)
  • A Rare Genetic Mutation Leads to Cancer. The Fix May Already Be in the Drugstore. (NYTimes)
  • Citrus Farmers Facing Deadly Bacteria Turn to Antibiotics, Alarming Health Officials (NYTimes)

In Focus: International

  • UK medical research lands £1bn from cancer drug sale (Financial Times) (Reuters) (Fierce) (Endpoints)
  • Breast cancer drug Verzenio could have serious side effects on lungs, Japan’s health ministry warns (Japan Times)
    Modi’s jobs deficit: J&J’s largest India plant idle three years after completion (Reuters)
  • South Africa’s Aspen sells Australian prescription portfolio to Mylan (Reuters)
  • Industry steps up interest in developing world, fueling doubling of R&D pipeline (Fierce)
  • Sandoz is first multinational to secure generic approval under new Chinese guidelines (Pharmafile)
  • Pushing China to the forefront: When a first-in-China regulatory strategy makes sense (BioCentury)
  • Takeda’s Entyvio beats Humira for remission in ulcerative colitis, exploratory data show (Pharmafile)
  • Europe responding to gene therapy challenge, but picture remains fragmented (PMLive)
  • Dr Reddy’s to spend upto $ 300 million on R&D in FY2020 (Economic Times)
  • ‘So Far So Good’: EMA Talks Relocation, Staff Retention, Teleworkers And More (Pink Sheet-$)
  • WHO Calls for GMPs to Limit Wastewater-Driven Superbugs (FDANews-$)

Pharmaceuticals & Biotechnology

  • Price Transparency: Why Are Drug Prices Such A Bitter Pill to Swallow? (Forbes)
  • A Waste of 1,000 Research Papers (The Atlantic)
  • Genetically engineered immune cells fight off deadly virus in mice (Science)
  • The Impact of the Orphan Drug Act on FDA-Approved Therapies for Rare Skin Diseases and Skin-Related Cancers (JAAD)
  • AstraZeneca’s Fasenra offers severe asthma patients 2 years of benefits: analysis (Fierce)
  • Some of the best connected players in the San Diego hub organize launch round for another biotech with an eye on trial data (Endpoints)
  • Friends, Parker Institute call for more flexibility in early T cell therapy development (BioCentury)
  • Boehringer Ingelheim, UCB venture arms seed hearing loss newco Rinri (BioCentury)
  • Long-term inclisiran data suggest The Medicines Company/Alnylam drug will flourish in pivotal study, disrupt ‘bad’ cholesterol market (Endpoints)
  • TRC Capital’s mini-tender offer irritates a flustered Biogen (Endpoints)
  • New insight into a struggling AstraZeneca anti-VEGF drug could expand its use in cancer (Fierce)
  • MorphoSys posts positive data for lymphoma drug, but will it compete with CAR-Ts? (MedCity)
  • AbbVie’s discounting Humira to aid Skyrizi’s launch—and a price war could follow: analyst (Fierce)
  • CSL Behring poaches top manufacturing exec from struggling Biogen (Fierce)
  • ICER releases new tools to facilitate use of its reports (PharmaLetter-$)
  • The Role of Quality Culture in Data Integrity Is Getting More Attention as Regulator and Industry DI Guidances Evolve (IPQ)
  • Eisai lures Novartis exec to its US Oncology Unit (PharmaLetter-$)
  • Exploring The Link Between Inflammation And Depression: Study Suggests Women Are Affected The Most (Forbes)
  • MedCo Touts New Data for Long-Lasting Heart Drug as Reckoning Looms (Xconomy)
  • EU Proposal To Ban Microplastics In Pharmaceutical Ingredients Has US Excipient Industry On Edge (Pink Sheet-$)
  • AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Tentatively Identified as Mold (Focus)
  • Bayer Issues Voluntary Recall of Alka-Seltzer Plus® Products (FDA)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S. (Press)
  • Can-Fite’s Phase II Liver Cancer Data Selected for Presentation at a Leading Liver Cancer Scientific Forum (ILCA) (Press)
  • Compugen Doses First Patient in COM701/Opdivo® (Nivolumab) Combination Arm of Phase 1 Study in Patients With Advanced Solid Tumors (Press)
  • SpringWorks Therapeutics Announces Initiation of Phase 3 Trial (DeFi) of Nirogacestat in Adult Patients with Desmoid Tumors (Press)
  • ACADIA Pharmaceuticals to Present Phase 2 CLARITY Results for Pimavanserin as an Adjunctive Treatment in Major Depressive Disorder at the 2019 American Psychiatric Association Annual Meeting (Press)
  • Categorical Response and Clinical Relevance as Assessed in a Phase III Study of HP-3070 (Asenapine) Transdermal Patch for the Treatment of Schizophrenia to be Presented at the American Psychiatric Association 172nd Annual Meeting (Press)

Medical Devices

  • Patient Use of Unapproved Diabetes Management Devices Poses Insulin Dosing Risks, FDA Warns (Focus) (Bloomberg)
  • MagStim wins FDA nod, launches StimGuide TMS navigation system (MassDevice)
  • Results from Spatz Medical FDA clinical trials confirm that Spatz3, the only Adjustable Gastric Balloon, delivers the highest success rates of all gastric balloons (Press)
  • J&J’s Auris touts prelim data from first-in-man study of Monarch platform (MassDevice)
  • Cook Medical partners with Ambu A/S to distro single-use duodenoscope pending FDA approval (MassDevice)
  • QIAGEN Gains 510(k) Clearance by FDA for QIAstat-Dx in the U.S. and Launches System as Next Generation Platform for Syndromic Insights (Press)
  • Body Vision Medical Receives FDA Clearance for LungVision 2.0 System, a Part of LungVision Platform, Demonstrated at ATS 2019 (Press)

US: Assorted & Government

  • AP fact check Trump’s miscues on trade and drug prices (PBS)
  • Further Thoughts on the Proposed DTC Advertising Drug Pricing Rule (Drug & Device Law)
  • Cutting through the noise: the handful of pricing proposals the Trump administration or Congress may enact (BioCentury)
  • In an Unusual Administrative Law Development, DOJ’s OLC States That FDA Has No Regulatory Authority Over Articles Used in Lawful Executions (FDA Law Blog)
  • Opioid Prescriptions Drop Sharply Among State Workers (KHN)
  • FDA official clarifies position on CBD-related ‘enforcement discretion’ (Natural Product Insider)
  • FTC Must Tackle Anti-Competitive Drug Rebate Practices (Law360-$)
  • IRS Should Use Tax Law To Combat The Opioid Epidemic (Law360-$)
  • How Supreme Court Conservatives Have Shaped The FCA (Law360-$)
  • How Might we Approach Discussions on the Implications of Using Genetic Data from a Human Rights or Social Justice Perspective? (Harvard Bill of Health)

Upcoming Meetings & Events Europe

  • As UK biotech gains steam, Syncona launches new Treg player while Cambridge spinout expands Series A (Endpoints)
  • Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications (EMA)


  • NGOs demand withdrawal of India-Japan MoU on PPH on fast-tracking of patents examination (PharmaBiz)
  • NPPA reduces prices of nine non-scheduled anti-cancer medicines by 30 to 60% (PharmaBiz)
  • CDSCO classifies 12 new notified medical devices based on intended use and associated risks (PharmaBiz)
  • CDSCO declares 31 samples as NSQ and 1064 samples as SQ in random sampling for April (PharmaBiz)
  • DCGI warns of stern action against cos which change contents of formulations without changing existing brand names (PharmaBiz)
  • Civil Society Organisations urge WHO to update Guideline on the Evaluation of Similar Biotherapeutic Products (PharmaBiz)

Other International

  • Countries move towards the elimination of mother-to-child transmission of HIV, syphilis, hepatitis B and Chagas disease (Paho)
  • Brazil: The Anvisa 2019 Pilot Report (RxTrace)

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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