Regulatory Focus™ > News Articles > 9 > Recon: US Appeals Court Upholds Broad Institute’s CRISPR Patent

Recon: US Appeals Court Upholds Broad Institute’s CRISPR Patent

Posted 10 September 2018 | By Michael Mezher 

Recon: US Appeals Court Upholds Broad Institute’s CRISPR Patent

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

In Focus: US
  • Appeals court upholds CRISPR patents awarded the Broad Institute (STAT) (Bloomberg) (Broad)
  • Pharma Billionaire Charged With Penny Stock Fraud (Forbes) (Endpoints) (BioCentury)
  • GSK says U.S. FDA wants more information on pulmonary drug (Reuters)
  • Cheap Custom-Made Versions of High-Cost Drugs Spur Backlash (WSJ)
  • Biotech Venture Deal Terms Are More “Startup-Friendly” Than Ever (LifeSciVC)
  • The Dark Side of a Wonderful Investment Story (In The Pipeline)
  • Marijuana-Research Applications Go Nowhere at Justice Department (WSJ)
  • Of Vampires And The Challenges Of Longevity Drugs (Forbes)
  • How Purdue’s ‘one-two’ punch fueled the market for opioids (Financial Times)
  • FDA kills off Amicus’ 2018 accelerated approval plan (Fierce) (STAT) (Endpoints)
  • Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals (NYTimes) (Endpoints)
  • MSK Cancer Center Orders Staff to ‘Do a Better Job’ of Disclosing Industry Ties (NYTimes)
  • A Battle Plan for a War on Rare Diseases (NYTimes)
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In Focus: International
  • Roche faces UK pricing row over multiple sclerosis drug Ocrevus (Reuters) (PharmaTimes) (BioCentury)
  • Merck's Keytruda clocks up new win as EU approves chemo cocktail (Reuters) (Pharmafile) (Press)
  • What’s Next For Regulatory, IP Reform In China After Bi’s Departure (BioCentury)
  • Ebola fight has new science but faces old hurdles in restive Congo (Reuters)
  • European Commission Explains Impact Of Brexit On Clinical Trials (Pink Sheet-$)
  • ‘We’ll Manage,’ Danish Medicines Agency Head’s View On Brexit (Pink Sheet-$)
  • Ahead of Brexit, U.K.'s top insulin provider Novo Nordisk plans to double its stockpile (Fierce)
  • Vaccines Against H.I.V., Malaria and Tuberculosis Unlikely, Study Says (NYTimes)
  • NICE turns down Opdivo for adjuvant melanoma therapy (PMLive)
  • Consort, Opiant to develop nasal spray for opioid overdose treatment (Reuters)
  • CDSCO to change name, logo soon in line with its current role and responsibilities (PharmaBiz)
  • Oxford regenerative medicine spinout brings on GlaxoSmithKline drug hunter as CSO (Fierce)
  • Chinese pharma powerhouse Hansoh joins fledgling biotechs in the Hong Kong IPO line (Endpoints)
  • First meeting of the Global Preparedness Monitoring Board (WHO)
Pharmaceuticals & Biotechnology
  • OGD Update: Welcome to much more than GDUFA II (FDA)
  • Sarepta Therapeutics CEO has a 'big ambition' for muscular dystrophy gene therapy (CNBC)
  • Teva wins FDA nod for sublingual film to treat opioid dependence (Drug Delivery) (Press) (FDA)
  • That alarm about the cancer risks of CRISPR? It’s still ringing (STAT)
  • Amid Launch Troubles, Portola Commercial Chief Fu Resigns (Biocentury)
  • Crohn's disease patients test experimental stem cell treatment (CBS)
  • Elevian set up to pursue disputed approach to aging diseases (Fierce)
  • HIV prevention pill reaching more people who need it (Reuters)
  • Traditionalists at Takeda spark a family feud with CEO Christophe Weber over his $62B Shire takeover deal (Endpoints)
  • Circled by rival pharma giants and a biotech powerhouse, Kodiak asks for a $100M-plus IPO for new eye drug (Endpoints)
  • End-Stage Lung Cancer Patients Still Taking Preventive Meds (Medpage)
  • Belviq Study Results May Improve The Fortunes Of Weight-Loss Drugs (Forbes)
  • Expensive pills on the bill? PhRMA takes aim at hospitals in drug pricing campaign (Fierce)
  • Why Foresite Led An $80m Series B Round For Gene Regulation Play Fulcrum. (Biocentury)
  • AstraZeneca stands up to respiratory rivals with tezepelumab breakthrough (Fierce)
  • Study: More Than 14,000 Americans Die Each Year From This Preventable Cancer (Forbes)
  • Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Five Prime Therapeutics Completes Phase 1 Safety Lead-In and Initiates Phase 3, Global Registrational Trial of Bemarituzumab in Front-Line Advanced Gastric and Gastroesophageal Junction Cancers (Press)
Medical Devices
  • Commentary: Why FDA’s software precertification program may be bad for business (mobihealthnews)
  • Boston Scientific's Aggressive M&A Strategy Continues with Augmenix Deal (MDDI)
  • FDA clears Surgical Innovation’s DuraSorb bioresorbable mesh (MassDevice)
  • Cybersecurity: Innovating staff buy-in and avoiding silver bullet tools (HealthcareITNews)
  • BD deals bioprocessing biz to Thermo Fisher (MassDevice)
  • BTG to pay up to $150M for Irish IVC filter startup (Medical Design & Outsourcing)
  • Masimo Announces FDA Clearance of the rainbow Acoustic Monitoring RAS-45 Sensor for Infant and Neonatal Patients (Press)
  • Iridex wins FDA 510(k) for TruFocus LIO premiere ophthalmological laser (MassDevice)
  • Boston Scientific launches trial for drug-eluting peripheral stent (Drug Delivery)
US: Assorted & Government
  • Brett Kavanaugh appears on track to confirmation (Politico)
  • Timing, Knowns, and Unknowns: FDA’s FY 19 Appropriation (Alliance for a Stronger FDA)
  • Re-Examining the Ethics of Removal (Drug & Device Law)
  • Industry Submits Comments (Nearly 3000) and the Agency Listens: Revised Draft Standard MOU Addressing Section 503A’s Limits on Interstate Shipments of Compounded Medications (FDA Law Blog)
Upcoming Meetings & Events Europe
  • Advertising investigations: August 2018 (MHRA)
  • The Family-run Fake Pill Factory: trio busted following drugs raid (MHRA)
Asia
  • The State Food and Drug Administration has thoroughly investigated the vaccine production enterprises and found no impact on the quality and safety of vaccines. (CNDA)
  • How Chinese R&D Incubator Jacobio Plans To Deploy Its $55m Series C (Biocentury)
  • South Korean man infected by MERS virus, first case in 3 years (Reuters)
India
  • Supreme Court prescribes pain relief for 15 banned combination drugs (Economic Times)
Australia
  • Publication of interim decisions proposing to amend, or not amend, the current Poisons Standard, September 2018 (TGA)
Other International
  • GMTA IMDRF UDI Workshop - Monday, September 17, 2018 (GMTA)
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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