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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar
• Gastrointestinal Drugs Advisory Committee; Notice of Meeting – 18 October 2018
• Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting – 12 October 2018

• Advertising investigations: August 2018 (MHRA)
• The Family-run Fake Pill Factory: trio busted following drugs raid (MHRA)

• 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)

• Supreme Court prescribes pain relief for 15 banned combination drugs (Economic Times)

• Publication of interim decisions proposing to amend, or not amend, the current Poisons Standard, September 2018 (TGA)

• GMTA IMDRF UDI Workshop - Monday, September 17, 2018 (GMTA)