Recon: J&J, Arrowhead Forge $3.7B Gene-Silencing Deal; FDA Expands Use of Roche's Hemlibra

• This brand-new advocacy group is an unapologetic defender of high drug prices (STAT)
• Sarepta Gene Therapy Appears To Help Fourth Boy With Duchenne Muscular Dystrophy (Forbes) (STAT) (Endpoints)
• Precision medicine needs a business mindset in order to flourish (STAT)
• J&J, Arrowhead in gene-silencing drug deal worth up to $3.7 billion (Reuters) (Endpoints) (Fierce)
• Blackstone to buy Clarus as part of its life sciences push (Reuters) (Endpoints) (Fierce)
• BIO warns members: No more raucous after-hours events — and start putting women in senior posts, now (Endpoints) (BioCentury)
• FDA expands use of Roche's bleeding disorder drug Hemlibra (Reuters) (Press)
• Roche just heralded a great set of placebo comparisons for their new flu drug — too bad it flopped against generic Tamiflu (Endpoints) (Reuters) (Press)
• Fast, nimble, and on demand: the pursuit of a new way to mass produce medicines (STAT)
• What House Democrats want to investigate at HHS (Politico)
• Hemophilia pressures have Bayer laying off 227 at California plant (BioPharmaDive)

• Adapt Pharma profits hit €16m as overdose drug boosts sales (Independent)
• No-deal Brexit threatens access to new medicines, says regulator (Financial Times)
• UN Security Council meeting on the Ebola Outbreak in North Kivu, Democratic Republic of the Congo (WHO)
• Attack on Congolese Red Cross Ebola ambulance wounds three volunteers (Reuters)
• Disgruntled Takeda alums demand a window into $62B Shire buy (Fierce)
• EU-Wide Joint Clinical Assessments Edge Closer (Pink Sheet-$)
• Korea Seeks Fast Tracks For Innovative And Public Health Crisis Drugs (Pink Sheet-$)
• Russian watchdog suspects Bristol-Myers of cartel activities in state tenders last year (PharmaLetter-$)
• Russia’s Biocad to start production of drugs in China (PharmaLetter-$)
• Zimbabwe vaccinates 1.4 million to combat worst cholera outbreak in a decade (Reuters)

• Chemistry Nobel awarded to evolutionary scientists whose work led to cancer, arthritis drugs (STAT) (NYTimes)
• FDA could set record low for drug marketing warning letters — again (BioPharmaDive)
• Paratek eyes 800 key hospital accounts for new antibiotic's rollout (BioPharmaDive)
• The Biosimilar Nocebo Effect? A Systematic Review of Double-Blinded Versus Open-Label Studies (Journal of Managed Care & Specialty Pharmacy)
• The Priority Review Voucher: An Untapped Asset (Patent Docs)
• Daily Baby Aspirin May Lower Ovarian Cancer Risk (NYTimes)
• Opioid Prescribing Guidelines Put US FDA In Unfamiliar Territory (Pink Sheet-$)
• Nimbus chief Don Nicholson hits the exit, handing top job over to Jeb Keiper (Endpoints)
  LPAD As An Afterthought? Insmed’s Arikayce Reaches US Market Thanks To Limited Population Pathway (Pink Sheet-$)
• Insight: How Novartis built a ‘money-filled moat’ to market Kymriah (BioPharmaReporter)
• The hidden dangers of testosterone replacement therapy you should know about (CNBC)
• FDA Says Start With Kids in Pediatric Drug Trials for Atopic Dermatitis (FDA News-$)
• Pennsylvania Manufacturer Called Out for Contamination Problems (FDA News-$)
• VelosBio raises $58M in Series A round for antibody-drug conjugate development (MedCityNews)
• Guardant, Kodiak Price IPOs (BioCentury) (Xconomy)
• Industry Involvement in Clinical Trials Huge, Often Downplayed (Medpage)
• Most older breast cancer patients do not suffer mental decline after chemo (Reuters)
• GSK to move to 'simplified' distribution model (Pharmaceutical Journal)

• Lilly's diabetes drug data impresses, hurts rival Novo's shares (Reuters) (Endpoints) (Press)
• Allergan Receives FDA Clearance To Treat Area Below The Jawline With CoolSculpting® (Press)
• Alnylam Reports Updated Positive Results from Phase 1/2 Study of Lumasiran in Patients with Primary Hyperoxaluria Type 1 (Press)
• Boehringer Ingelheim and Lilly present full results from EASE Phase III program for empagliflozin as adjunct to insulin in type 1 diabetes (Press)
• Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-AHEAD Study Evaluating DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) for the Treatment of HIV-1 in Treatment-Naïve Patients (Press)
• Horizon Pharma plc Announces Presentation of Data From 48 Week Off-Therapy Follow-Up to the Phase 2 Trial of Teprotumumab (Press)
• Cidara Therapeutics Presents Results from Successful Phase 2 STRIVE Trial Evaluating Rezafungin at IDWeek 2018 (Press)
• Viking Therapeutics Announces VK2809 Phase 2 Study Results Selected for Oral Late-Breaker Presentation at The Liver Meeting® 2018 (Press)
• New Data from Phase 2 Flu Challenge Study Demonstrates Vaxart’s Oral H1 Flu Vaccine Generated Protective Mucosal Immunity (Press)
• Ophthotech Completes Patient Recruitment As Planned for its Phase 2b Clinical Trial of Zimura® Monotherapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (Press)
• Esanex Announces Successful End-of-Phase 2 Meeting for SNX-5422 in Neuroendocrine Tumors (Press)
• Cavion to Announce Results of its Phase 2 Essential Tremor Clinical Trial (Press)
• Poxel Presents Complete PXL770 Phase 1 Results, Cardiac Safety Profile and Preclinical Efficacy Data in NASH at AMPK - From Mechanisms to New Therapies Scientific Congress (Press)
• Vedanta Biosciences Announces Successful Phase 1a/1b Data Demonstrating Safety, Tolerability, and Proof of Mechanism for Lead, Rationally Defined Bacterial Consortium Product Candidate, VE303 (Press)

• A startup’s bold plan for a mood-predicting smartphone app is shadowed by questions over evidence (STAT)
• Tech breakthrough offers early warning system for heart attacks (Reuters)
• Will Single Port Robots Revive the Perineal Radical Prostatectomy? (MDDI)
• BD promotes Polen to COO | Personnel Moves – October 3, 2018 (MassDevice)
• Pari Pharma lands FDA nod for Lamira nebulizer (Drug Delivery)
• Novanta spends nearly $46 million on rest of Laser Quantum (Medical Design & Outsourcing)
• Acessa Health wins FDA nod for 3rd-gen ProVu (MassDevice)
• Illinois EPA seeks temporary shutdown of Sotera Health’s Sterigenics plant (MassDevice)
• Study: U.S. hospitals charged more for implantable cardiac devices (Medical Design & Outsourcing)

• A 9/11 fund compensating sick victims is running out of money (NBC)
• PhRMA Revives its Lawsuit against Enforcement of California Drug Pricing Transparency Bill SB 17 (FDA Law Blog)
• Deductibles Hit $2,000 As Employers Intensify Cost Shift (Forbes)
• NJ Justices Say Garden State Law Topples Accutane Cases (Law360-$)
• Bard Says Vein Filter Risks Reasonable As Trial Wraps (Law360f-$)
• Accutane Litigation Goes Out with a Bang, Not a Whimper (Drug & Device Law)
• With hung jury, second straight talcum case against Johnson & Johnson ends in mistrial (Fierce)

• FDA Advisory Committee Calendar

• NICE guidelines on antidepressant withdrawal in ‘urgent need of correction’, say researchers (Pharmaceutical Journal)
• Digital pregnancy tests recalled in new alert amid false positive results (MHRA)

• DCC proposal to make WHO GMP mandatory for public drug procurement to hit MSMEs hard (PharmaBiz)

• First-of-its-kind study analyzes effects of video games on brain and body (CBS)