Recon: Merck's Keytruda Gets Full Approval in Non-Squamous NSCLC via FDA Real-Time Oncology Review

• FDA kicks off effort to examine importing drugs (STAT)
• US health secretary says agency can eliminate drug rebates (Reuters)
• What you need to know about the cholesterol trial that could swing billions (STAT)
• FDA gives Merck ‘real-time’ OK for Keytruda, offering a peek at the latest extension of the agency’s data express highway (Endpoints) (Press)
• Alphabet-backed One Medical is in talks to raise more than $200 million (CNBC)
• Amazon hires a star cardiologist to help its push into health (CNBC)
• Walmart and Anthem sign deal to expand access to over-the-counter medicines for seniors (CNBC) (Forbes)
• Oral arguments sped up in Obamacare lawsuit (Politico)
• Jazz hiring 100-plus sales representatives to prep for new narcolepsy and AML launches (Fierce)
• SEC Ends Bribery Probe Into Chinese Vaccine Co. (Law360-$)

• No-deal Brexit could leave hospitals with drug shortage, say NHS chiefs (The Times) (PharmaTimes) (Pharmafile) (Pink Sheet-$) (BBC)
• No-deal Brexit airlift? Sanofi may have to fly flu shots into the U.K. for the 2019-20 season (Fierce)
• AstraZeneca, its new HQ delayed and way over budget, weighs a construction partner swap: report (Fierce)
• Right on the heels of $150M raise, Ascentage files the latest in a rush of HKEX biotech IPOs — but is the market too jittery? (Endpoints) (BioCentury)
• China's Changchun mayor resigns after vaccine scandal: state media (Reuters)
• Consortium Including Gao, GL Capital Bid To Take China Biologic Private (BioCentury) (Law360-$)
• Two Chinese biotechs sign $350M+ PD-L1 inhibitor deal (BioPharmaDive)
• A Chinese Pharmacist Found Out He Had Cancer. Then He Vanished. (NYTimes)
• Japan approves AstraZeneca's Tagrisso in EGFRm non-small cell lung cancer (Pharmafile)
• Pfizer responds to FDA, EMA and Canada after reinspections of plant that makes injected painkillers (Fierce)
• IGAD And WHO Train for Harmonisation of Medicines Registration (IGAD)

• Researchers find potential new gene therapy for blinding disease (NIH)
• Amgen's quick Aimovig launch boosts blockbuster hopes for Lilly, Teva and Alder: analyst (Fierce)
• AstraZeneca spinout Entasis files for $86M IPO to fund antibiotic phase 3 (Fierce) (Xconomy)
• After seeing POC data, Kyowa advances Parkinson’s program despite being dropped by Lundbeck  (Fierce)
• Biotech investment reaches fever pitch, but will it last? (BioPharmaReporter)
• Biotech financing puts pharma M&A in the shade, report finds (PharmaLetter-$)
• Real-World Data Play Rdmd Raises $3m Seed Round (BioCentury)
• Bristol-Myers Squibb-Pfizer Alliance ACROPOLIS™ Real-World Data Program Grows to Sample Size of Nearly One Million Lives Worldwide (Press)
• CROs respond: FDA guidance on expansion cohort use in FIH trials a ‘welcome step’ (Outsourcing Pharma)
• FDA Studying Extent of Risk Information in DTC Print Ads (CHC)
• Many doctors skip meningococcal vaccine talks with teens (Reuters)

• Priority Review For Alexion's Long-Acting PNH Therapy (BioCentury)
• FDA Accepts Priority Review of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the US (Press)
• U.S. FDA Grants Fast Track Designation to Aravive Biologics’ AVB-S6-500 (Press)
• Novo’s new trial results stoke blockbuster hopes, with oral semaglutide scoring again in Phase IIIa (Endpoints) (PharmaTimes)
• Taiwan Liposome OA Therapy Hits Mark In Phase II Trial (BioCentury)
• Q BioMed Inc. Announces FDA Filing for Strontium Chloride Sr89 Injection USP for Relief of Metastatic Cancer Bone Pain (Press)
• MC2 Therapeutics Announces Positive Top-line Results from Phase 3 Clinical Trial Comparing MC2-01 Cream to Taclonex® in Adults with Psoriasis (Press)
• PCSK9 Inhibitor Labeling Parity Is Within Reach As Praluent And Repatha Strive To Make Commercial Case (Pink Sheet-$)
• Under The Radar: Potential Small Cap Takeover Targets (SCRIP-$)

• Fitbit unveils Charge 3, adds SpO2 tracking in preparation for potential sleep apnea, a-fib features (mobihealthnews)
• Tandem launches insulin pump with predictive low glucose suspend feature in US (Drug Delivery)
• Medical devices: The transition to connected devices (Medical Design & Outsourcing)
• Xeris Pharmaceuticals kicks off dual-hormone artificial pancreas trial (Drug Delivery)
• DePuy Launches New Interbody Implant For Degenerative Disc Disease (MDDI)

• Allergan, Tribe Want PTAB Immunity Denial Reheard En Banc (Law360-$)
• Mylan, Pfizer Barely Put Dent In EpiPen Antitrust MDL (Law360-$)
• CVS, Rite Aid Hit AbbVie With Antitrust Suit Over AndroGel (Law360-$)
• Stryker's Coverage Claims Over Knee Implants Deemed Viable (Law360-$)
• New analysis finds 340B medicine sales hit record high in 2017 and continue to grow as a share of total drug spending (PhRMA)
• The Third Cut Is the Deepest: DEA’s Continued Slashing Of Annual Quotas Lacks A Clear Rationale (FDA Law Blog)
• Statute of Limitations in the Context of Prescription Drug Addiction: Case Dismissed in Northern District of New York (Drug & Device Law)
• DOJ's New Policy On FCA Dismissals Highlights Circuit Split (Law360-$)
• Two States Require Industry To Pay For Ongoing Drug Take-Back Programs (Pink Sheet-$)

• FDA Advisory Committee Calendar
• Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control – 19 October 2018
• Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on
• Reducing Barriers to Evidence-Based Care – 20 September 2018

• Pfizer’s lorlatinib clears first hurdle to UK early access scheme (PharmaTimes)

• Price of J&J’s TB drug to drop by more than half (Economic Times)
• Health ministry soon to issue notification to do away with printing of generic name in double the font size than brand name on drug pack (PharmaBiz)

• Orkambi set for reimbursement in Australia despite UK struggle (PharmaLetter-$)

• Selling America on vitamin D — and reaping the profits (NBC)
• Socioeconomic status helps explain U.S. childhood cancer survival rates (Reuters)
• Moderate 'bad cholesterol' levels tied to early death for healthy people (Reuters)