Recon: Minnesota AG Sues Insulin Makers; Express Scripts Covers Amgen, Lilly Migrane Drugs, Excludes Teva’s Ajovy

• Drug giant Pfizer offers early retirement ahead of layoffs in memo to employees (CNBC)
• Express Scripts covers Amgen, Lilly migraine therapies, excludes Teva drug (Reuters)
• Researchers behind Biogen’s breakthrough drug win big at ‘Oscars of science’ (STAT) (Forbes)
• Minnesota becomes first state to sue major insulin makers over price-gouging (STAT) (Reuters)
• Cost of blood pressure drug surges in U.S. after recall (Reuters)
• The list price is not right: Trump’s plan to force pharma to advertise prices is misguided (STAT)
• J&J takes a $630M asset hit on the books, shuttering PhIIb trials as its $1.75B RSV drug teeters on the brink (Endpoints)
• Six years after a spectacular debut, Warp Drive Bio is powering down and handing its ‘undruggable’ ambitions over to Revolution (Endpoints) (Fierce)
• 2018’s Biotech IPO Bonanza: View From the After Market (LifeSciVC)
• Mysterious paralyzing illness found among kids in 22 states (AP) (NBC)
• We can now customize cancer cures, tumor by tumor (MIT Technology Review)
• Fueling an Epidemic: Inside the Insys Strategy for Boosting Fentanyl Sales (Senate HSGAC)

• China hands record fine to manufacturer of faulty vaccines (Financial Times) (NYTimes)
• Roche torches a mountain of biobucks, sweeping out a roster of drugs in the latest pipeline cleanup (Endpoints) (Fierce)
• Roche reports very strong growth in the first nine months of 2018 (Press) (Financial Times)
• Roche’s Old-Guard Cancer Drugs Get Boost from Sales in China (Bloomberg)
• Samsung BioLogics slides after reports of watchdog action (Financial Times)
• Samsung and Bioepis launch third Humira biosimilar in Europe (Pharmafile) (Press)
• Regulator seizes almost 10,000 unsafe STI + HIV test kits (MHRA)
• Merck KGaA looks to boost drug R&D alliances as the CFO crunches the numbers on development costs (Endpoints)
• Submit Your Brexit-Related Changes Before We Move: EMA Plea To Industry (Pink Sheet-$)
• EU Policymakers Under Industry Pressure To 'Neuter' SPC Waiver Plan (Pink Sheet-$)
• Foundation Medicine, Novartis partner up on companion diagnostics in oncology (MedCity)
• A New Surge Of Ebola Cases Suspected In Congo (NPR)
• Zika in Africa: Rare birth defect on the rise in Angola (Reuters)
• Why it's so hard to diagnose Zika (Reuters)

• Nobel laureate James Allison looks to the future of cancer immunotherapy (STAT)
• Most older adults would willingly take fewer medicines (Reuters)
• Flu Vax at Pharmacies Could Save the Day During Epidemic (Medpage)
• Teva, Eagle Fight To Block Generic Versions Of Chemo Drug (Law360-$)
• Fewer patents being filed for novel infectious diseases and AMR diagnostic technologies; US leads, UK follows (Pharmafile)
• Cold-and-flu beverage to go? GSK launches Theraflu pods for coffee makers, backed by ad campaign (Fierce)
• Shire’s Prucalopride Brings Real-World CV Safety Data To US FDA Panel, But Will It Be Enough? (Pink Sheet-$)
• FDA approves five-year hormonal contraceptive (Drug Delivery)
• Merck joins Novartis, GlaxoSmithKline in grabbing a consumer executive to beef up digital (Fierce)
• Improving Drug Price Transparency: From Removing Pharmacy Gag Clauses To Reforming The Rebate System (Fobres)
• Allergan set to make headway in crowded CGRP migraine market, as the battle for formulary coverage begins (Endpoints)
• Bristol-Myers Squibb to Showcase Immunoscience Research and Biomarker-Guided Treatment Approaches at the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting (Press)
• FDA needs best and brightest to advance a new era of medicine with America’s biopharmaceutical companies (PhRMA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; TREMFYA (FDA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; DUPIXENT (FDA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; BRINEURA (FDA)

• Eiger chalks up one win, one loss between a pair of PhII rare disease drugs, reshuffling priorities (Endpoints) (Press)
• Pharnext muscle wasting phase 3 hits primary endpoint (Fierce)
• Immusoft Receives Rare Pediatric Disease Designation for Treatment of MPS I (Press)
• Oragenics, Inc. Receives Clearance to Enroll Patients in Belgium into Its Phase 2 Clinical Trial of AG013 for Oral Mucositis (Press)
• JHL Biotech Announces China Approves Phase I and Phase III Clinical Trial Application for Bevacizumab Biosimilar to Treat Cancer (Press)

• What's Next for Bioresorbable Scaffolds? (MDDI)
• Abbott slips on narrowed earnings guidance (MassDevice)
• Boston Scientific closes $600m Augmenix buyout (MassDevice)
• MITA Commends New Research Paper Demonstrating The Many Flaws Of The Medical Device Tax (MITA)
• Smith & Nephew launches portable negative pressure wound therapy system (Medical Design & Outsourcing)
• Phillips-Medisize inks deal to develop connected health platform for drugs (Drug Delivery)
• Teleflex, Arcis enter agreement for cancer diagnostics (MassDevice)
• Where medtech is putting its money this November (Medical Design & Outsourcing)
• Si-Bone prices upsized $108m IPO (MassDevice)
• Medical Devices; Neurological Devices; Classification of the External Upper Limb Tremor Stimulator (FDA)
• Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel (FDA)

• Medicare Advantage plans proliferate (Politico)
• Quick Chancery Appeal Sought For Rocky $4.8B Akorn Merger (Law360-$)
• Pfizer Can't Derail EpiPen Pay-For-Delay Discovery: 2nd Circ. (Law360-$)
• UnitedHealth Bought Pharmacy Company Avella to Build Optum Unit (Bloomberg)
• Appeals court overturns Stryker win in retaliatory filing case (MassDevice)
• Dead Men Tell No Tales . . . and They Don’t Violate the FTC Act, Either (FDA Law Blog)
• Clinical Trial Liability Revisited, Briefly (Drug & Device Law)
• Pa. Justices Snub Preemption Fight Over Actiq Labeling (Law360-$)

• FDA Advisory Committee Calendar

• BD Obtains CE Mark for Molecular TB, MDR-TB Assay (GenomeWeb)
• Prescription painkillers reclassified in UK amid addiction concerns (Pharmafile)
• Thermo Fisher Scientific Gets CE-IVD Mark for NGS Cancer Test (GenomeWeb)
• MSD adds vaccine and biologics facility next to Keytruda site, creates 170 jobs (BioPharmaReporter)
• UK Pharmacists have good understanding of biosimilars but concerns over switching, study results show (Pharmaceutical Journal)
• Proposal to make Colourstart Test 65mcg Cutaneous Patch available from general sales outlets without prescription (MHRA)

• Jiao Hong meets with the Former Prime Minister of Czech,Bohuslav Sobotka (CNDA)
• Daiichi Sankyo files for Japanese approval of quizartinib (PharmaLetter-$)

• DCGI asks company to recall Ozurdex Intravitreal implants (Economic Times)

• Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 (Health Canada)

• Untreated hearing loss tied to cognitive decline in older adults (Reuters)
• A Device That Makes Running Faster and Easier (NYTimes)