Recon: Alnylam Won’t Seek Accelerated Approval for Second RNAi Drug; Roche Expands SQZ Cell Therapy Pact

• Trump set to force drugmakers to post prices in ads (Politico) (Axios)
• Alnylam Won’t Seek Quick FDA Nod For Second RNAi Drug (Xconomy) (Fierce) (Press)
• Despite growing pressure, major drug companies will stop short of disclosing prices in ads (STAT)
• Harvard and the Brigham call for more than 30 retractions of cardiac stem cell research (STAT)
• Roche puts up $125M to expand SQZ cell therapy pact (Fierce) (Reuters) (Endpoints)
• Roche preps new Kadcyla filings after phase 3 trial win (PMLive) (Fierce) (Press)
• PPD Biotech panel: Five biotech leaders offer their surprising takes on the big trends shaping the industry in the Bay Area and beyond (Endpoints)
• Sanofi Genzyme seeks up to 400,000 square feet in Cambridge (Boston Globe) (Endpoints)
• FDA advisory panel backs AcelRx's opioid pain drug Dsuvia (Pharmafile) (Endpoints) (Fierce)
• Sloan Kettering Cancer Researchers Correct the Record by Revealing Company Ties (ProPublica)
• Hip and knee surgeons to use Apple Watch to monitor patients (Reuters)
• PhRMA Members Take New Approach to DTC Television Advertising (PhRMA)

• AstraZeneca: building a new ‘open innovation’ pharma company (PMLive)
• Chugai files patent infringement lawsuit over Herceptin in Japan (PharmaLetter-$)
• Unease Grows Over Brexit Drug Shortage Risk (Pink Sheet-$)
• New leader at Medivir after setbacks (PMLive)
• Buyout deal looming, Novo Nordisk raids AstraZeneca for a new chief to run its struggling biopharma business (Endpoints)
• Innovent to seek $400M-plus on Hong Kong IPO, reports say; will it revive biotech’s fortunes on HKEX? (Endpoints)
• The promise of ESCAT: a new system for evaluating cancer drug–target pairs (Nature)
• Ebola experts from CDC were pulled from outbreak zone amid security concern (STAT)
• UN employee in eastern Congo tests positive for Ebola (Reuters)
• International aid saves 700 million lives but gains at risk: report (Reuters)

• Developing tomorrow’s leaders in life sciences (McKinsey)
• #BIIS18 Interview: OrbiMed Asia’s Jonathan Wang on his upbringing, deciding against a consulting career, blunt advice for Chinese entrepreneurs, and more (Endpoints)
• Following the exodus at Immunocore, Eliot Forster takes the reins at F-star — how long before the crossover and an IPO? (Endpoints)
• TimesRivals line up to take on world’s best-selling drug (Financial Times)
• Last Year, The Flu Put Him In A Coma. This Year He's Getting The Shot (NPR)
• New York biotech snaps up Eli Lilly neuro veteran as CSO (Fierce)
• Andreas Halvorsen Discloses Stake In Urovant Sciences (Forbes)
• Science2Startup 2019: Bringing Venture & Academia Together (LifeSciVC)
• Roche launches NGS AVENIO Tumor Tissue Analysis Kits for oncology research (Press)
• ASPREE Results Support FDA Aspirin Label Guidance On Cardiovascular Disease (Pink Sheet-$)
• 7 drugmakers to watch on Q3 earnings (BioPharmaDive)
• Chugai May Not Win Race For $500m Neuromyelitis Optica Market, But May Best Soliris On Ease Of Use (SCRIP-$) (Press)
• Primex Pharmaceuticals Plots Launch Plans For Oral Pediatric Sedative (SCRIP-$)
• Pharma TV buys so far top last year's $1B spend; AbbVie, Pfizer lead September (Fierce)
• Got tech ideas for diabetes? Novo wants you for its crowdsourcing challenge (Fierce)
• AI, big data: Making a case for faster drug discovery (Pharmafile)
• Immugenyx and Janssen to develop humanised mouse model of lupus (PharmaTimes)
• Almac opens new facility at NC-based campus following increased customer demand (Outsourcing Pharma)
• Neopharma snatches Dr. Reddy's API business as it continues global expansion (Fierce)
• Iqvia inks genomics deal to advance discovery of precision meds (Outsourcing Pharma)

• X4 Pharmaceuticals Receives Orphan Drug Designation from the FDA for X4P-001-RD for the Treatment of WHIM Syndrome (Press)
• Santhera’s cystic fibrosis drug POL6014 in line for EU orphan status (PharmaTimes)
• Innovent Receives IND Approval to Initiate Clinical Trials in China with Sintilimab in Combination with its Biosimilar to Bevacizumab (Press)
• Peptilogics Receives Regulatory Approval to Initiate First-in-Human Safety Study for Therapeutic Peptide PLG0206 (Press)
• Karuna Announces First Patient Dosed in Phase 2 Study of Lead Product Candidate KarXT for the Treatment of Schizophrenia (Press)
• Aura Biosciences to Present Phase 1b/2 Clinical Data for AU-011 at the American Academy of Ophthalmology 2018 Annual Meeting (Press)
• Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1 Study of ARO-ANG3 (Press)
• FluGen Completes Dosing of Phase 2 Study to Assess Effectiveness of Novel Influenza Vaccine Designed to Protect Against Mismatched Strains (Press)
• Aimmune Therapeutics Announces Initiation of Phase 2 Study With Regeneron and Sanofi of AR101 With Adjunctive Dupilumab in Peanut-Allergic Patients (Press)
• PellePharm Presents Updated Data from Two Phase 2 Studies Demonstrating the Potential of Patidegib Topical Gel to Treat Basal Cell Carcinomas in Patients with Gorlin Syndrome and in Patients with Non-Gorlin Sporadic BCCs (Press)

• Digital health startups may not want to do randomized trials, but they need to (STAT)
• Fertility apps are increasingly being used as contraception and one has even gained FDA approval (CNBC)
• FDA Seeks to Enable Patient Access to Diagnostic Tests While Ensuring Reliability (Pew)
• Vital Therapies Evaluating Options After Clinical Trial Failure (MDDI)
• FDA clears Transseptal Solutions’ TP Crosser transseptal access device (MassDevice)
• FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence (Drug Delivery)
• Presbia plunges on one-year delay for Flexivue Microlens approval (MassDevice)
• NeoTract says real-world prostate study beats clinical trial results (MassDevice)
• Abiomed claims Impella pump not at fault in patient death (MassDevice)
• Auris Health touts robotically-assisted bronchoscopy study results (MassDevice)

• MEDICAID: Access to Health Care for Low-Income Adults in States with and without Expanded Eligibility (GAO)
• Merck, Glenmark Tear Apart Zetia Pay-For-Delay MDL Claims (Law360-$)
• PTAB Axes Most Of Boston Scientific Stent Patent As Obvious (Law360-$)
• Biotech Co. Slapped With Stock-Drop Suit Over Patent Failure (Law360-$)
• K2M Shareholders Move To Block $1.4B Stryker Merger Vote (Law360-$)
• Ranbaxy Abused 'First-To-File' For Heartburn Treatment: Suit (Law360-$)
• What Akorn Teaches Us About Delaware MAC Clauses (Law360-$)
• Twiqbal for Defendants? Not If We Can Help It. (Drug & Device Law)
• Supernus Pharmaceuticals, Inc. v. TWi Pharmaceuticals, Inc. (Patent Docs)

• FDA Advisory Committee Calendar

• Hope for Hungarian access to innovative meds (PharmaLetter-$)

• Dr Reddy’s to sell Hyderabad API unit to Therapiva (Economic Times)
• Sun Pharma adds $1.6m sterile manufacturing line in Guwahati, India (InPharmaTechnologist) (Economic Times)
• Global pharma cos to shell out more to export products to India as govt raises site registration, inspection fees steeply (PharmaBiz)

• Tandem wins approval for insulin pump in Canada (Drug Delivery)

• Patient implant cards and consumer device information leaflets (TGA)
• AIVC recommendations for the composition of influenza vaccine for Australia in 2019 (TGA)