Recon: Pfizer, Bain Launch CNS-Focused Startup

• Pfizer, Bain launch a startup to focus on nervous system diseases (STAT) (CNBC) (Endpoints) (Press)
• PhRMA’s on track to spend a record sum on lobbying this year (STAT)
• Opioid Crisis: Status of Public Health Emergency Authorities (GAO)
• Overdose deaths have fallen for six months. Is it temporary or a sign of a corner turned? (STAT)
• Two sick children and a $1.5 million bill: One family’s race for a gene therapy cure (MIT Technology Review)
• Look how far precision medicine has come (MIT Technology Review)
• US Abortion Pill Website, Aid Access, Under Investigation by the FDA (The Daily Beast)
• US Cancer Drug Development Outpaces E.U., Due To Favorable Regulatory And Reimbursement Policies (Forbes)
• CDC director says he pushed to keep US experts in Ebola zone but was overruled (STAT)
• Crowdfunding raises millions for unproven — and potentially harmful — treatments (STAT) (JAMA)
• AbbVie rheumatoid arthritis drug succeeds in late stage trial (Reuters)
• J&J announce promising Phase 1/2a results for HIV vaccine (Pharmafile)

• AstraZeneca digs deeper into cancer with Innate stake (Reuters) (Fierce) (Financial Times)
• Vaccine confidence low in Europe, raising disease outbreak risk (Reuters)
• J&J makes $2.1 billion offer to buy out Japan cosmetics firm Ci:z  (CNBC) (Financial Times)
• Canada's FSD Pharma to buy Israeli medical cannabis firm Therapix (Reuters)
• Switzerland's Idorsia says it has cash to launch main drugs despite losses (Reuters)
• Senior GSK VP leaves to become Idorsia CCO (PharmaLetter)
• UK’s science reputation 'at risk if academic visa issues not resolved' (The Guardian) (PMLive)
• Takeda buys stake in Enterome’s microbiome Crohn’s drug (Fierce) (PharmaLetter) (Endpoints) (Press)
• Meet EU Safety Feature Deadline Or Face Penalties, Firms Warned (Pink Sheet-$)
• Accelerated Access Collaborative announces first Rapid Uptake Products for NHS (PharmaTimes)
• With vaccine in hand, Ebola response teams are struggling to track those who need it (STAT)

• Editor’s letter: The precision medicine issue (MIT Technology Review)
• Finally, the drug that keeps you young (MIT Technology Review)
• Profiles in precision medicine (MIT Technology Review)
• The skeptic: What precision medicine revolution? (MIT Technology Review)
• Your genome, on demand (MIT Technology Review)
• Foreign Inventory Completion, Faster Inspection Follow-up Among CDER Compliance Office 2018 Achievements; API, OTC Process Findings Spotlighted (IPQ)
• FDA approves expansion of antidepressant Trintellix’ label (PharmaLetter-$)
• Ultragenyx gains exclusive rights for Regenxbio’s NAV vectors (PharmaLetter-$)
• BsUFA III: Industry Eyes Streamlined Review Of New Indications, Phased Review Process (Pink Sheet-$)
• US FDA Panel Will Reckon With Need For Diabetes Drug CV Risk Assessments (Pink Sheet-$)
• First Amendment takes center stage in DTC price fight (BioPharmaDive)
• Purdue Pharma takes exclusive option to acquire SpineThera (PharmaLetter)
• On College Campuses, Making Overdose Medication Readily Available (NPR)
• QIDP Program Heads Into Uncomplicated Territory: Iterum, Paratek Eye uUTI Indications (Pink Sheet-$)
• Antisense startup Stoke Therapeutics secures another $90M in series B funding (Endpoints)
• AstraZeneca and Ionis target diabetes with antisense approach to regenerating pancreatic cells (Fierce)
• Amid pipeline woes, Celgene brings on Keytruda and Bavencio R&D executive in shake-up (Fierce)
• What's next for pharma in the advancing battle over drug prices in TV ads? (Fierce)
• CRISPR toolmaker Synthego raises $110M Series C led by Peter Thiel’s VC fund (MedCityNews)
• Novo Nordisk and Sanofi brands rank best for the digital type 2 diabetes patient experience, study finds (PharmaLetter)
• New Stem Cell Research Aims To Stop Boys Losing Fertility After Childhood Cancer Treatment (Forbes)
• Don't Believe The Headline Hype When It Comes To Genomics Research (Forbes)
• Centrexion Plans IPO to Bankroll Non-Opioid Pain Drugs (Xconomy)
• Obesity drugs: fat chance (Financial Times)
• GlaxoSmithKline expands API production for COPD inhalers as Advair sales wither (Fierce)
• Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution (FDA)

• Spectrum Pharmaceuticals Receives FDA Approval of KHAPZORY™ (levoleucovorin) for injection (Press)
• UCB, Biogen admit defeat in PhII lupus trial, adding to a string of late-stage failures in the field (Endpoints)
• FDA Grants Orphan Drug Designation to Omeros’ OMS721 for Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (Press)
• Xeris Pharmaceuticals Announces FDA Acceptance for Review of NDA for Its Ready-to-Use Glucagon Rescue Pen (Press)
• Roche’s Alecensa (alectinib) significantly reduced the risk of disease worsening or death as a first-line treatment in Asian patients with ALK-positive advanced or metastatic non-small cell lung cancer (Press)
• ACR 2018: Lilly Announces Positive Results for Two Phase 3 Studies of Taltz® (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis) (Press)
• Forbius Announces First Patient Dosed in Phase 2 Trial of anti-EGFR ADC AVID100 in EGFR-Overexpressing Squamous NSCLC (Press)
• Deciphera Pharmaceuticals Initiates a Phase 1b/2 Clinical Trial of Rebastinib in Combination with Paclitaxel to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced or Metastatic Solid Tumors (Press)
• Provention Bio Announces Completion of Enrollment of Phase 1b Clinical Trial of PRV-300 in Moderate-to-Severe Ulcerative Colitis (Press)
• Enanta Pharmaceuticals Announces Positive Phase 1 Results and Initiation of Phase 2a Clinical Study of EDP-938 for Respiratory Syncytial Virus (Press)
• New Phase 2 Data Show Stelara® (Ustekinumab) Sustained Improvement In Disease Activity In Adults With Systemic Lupus Erythematosus Through One Year (Press)

• US FDA Preparing For New 'Combination Product Agreement Meetings' (Pink Sheet-$)
• Common Combo Product Designation Mistakes To Be Outlined In Upcoming Guidance (Pink Sheet-$)
• Medtronic Receives FDA Approval for Valiant Navion(TM) Thoracic Stent Graft System (Press)
• Is your Company’s IP a Cybersecurity Risk? (MDDI)
• UDI: 5 Opportunities You May Not Have Considered (MDDI)
• FDA Modifies List of Recognized Standards for Medical Device Premarket Reviews (Emergo)
• Siemens Healthineers partners with Healthy.io for smartphone-based urine testing (Reuters)
• 3M slides on Q3 misses; sales, income down for healthcare business (MassDevice)
• K2M settles investor suits with updated financials on $1.4B Stryker merger (MassDevice)
• US military to adopt Adaptiiv’s 3D bolus cancer software (Medical Design & Outsourcing)
• LivaNova updates on 3T Heater-Cooler infection prevention corrections (MassDevice)

• Azar is empowering anti-fetal tissue research ideologues at the expense of science (STAT)
• Trump Officials Make It Easier for States to Skirt Health Law’s Protections (NYTimes)
• US Judge Affirms Monsanto Weed-Killer Verdict, Slashes Damages (NYTimes) (Law360-$)
• Gov'ts Must Link Patient Data To Prescriptions In Opioid MDL (Law360-$)
• Allergan Fights For Ropes & Gray Docs In Compounder IP Suit (Law360-$)
• Fed. Circ. Rejects Bid For PTAB Tribal Immunity Rehearing (Law360-$)
• Uninjured Class Members Means No Class Certification (Drug & Device Law)
• California Cuts Manufacturers Some Slack; Amends Slack Fill Law (FDA Law Blog)
• ResMed touts German win in continued Fisher & Paykel patent spat (MassDevice)
• Boston Scientific claims win over Edwards Lifesciences in German TAVR spat (MassDevice)

• FDA Advisory Committee Calendar

• Valproate use by women and girls (MHRA)
• MRC Holland Gets CE-IVD Mark for Spinal Muscular Atrophy Assay (GenomeWeb)

• Zeesan Biotech Wins China FDA Approval for HPV Genotyping Assay (GenomeWeb)
• Japanese firms file for safinamide approval in Japan (PharmaLetter)

• PIL filed in Bombay High Court seeking curbs on antibiotics sale without prescription (Economic Times)
• Daiichi alleges fraudulent siphoning of over Rs 2,000 crore by Singh brothers (Economic Times)
• Johnson and Johnson asked to cut down price of new TB drug (Economic Times)

• Application for conformity assessment certificates (medical devices) (TGA)
• Consultation: Proposal for the regulation of IVD companion diagnostics (TGA)
• Australian regulatory guidelines for medical devices (ARGMD) (TGA)
• Consultation: Transition to eCTD only for prescription medicines (TGA)