Recon: Supreme Court Hands Teva a Victory in Patent Dispute Against Helsinn

• US top court rejects Helsinn over anti-nausea drug patent in win for Teva (Reuters)
• US insulin costs per patient nearly doubled from 2012 to 2016: study (Reuters)
• Cancer survivors face stress from steep medical bills (Reuters)
• Trump Proposals Could Increase Health Costs for Consumers (NYTimes)
• Johnson & Johnson tops fourth-quarter expectations but signals sales to slow this year (CNBC) (MassDevice)
• Johnson & Johnson’s Litigation Costs Double in Fourth Quarter (WSJ)
• Opioid-addicted patients continue to search for help (Politico)
• FDA Places Clinical Hold on Translate Bio’s mRNA Drug Study (Xconomy) (Endpoints)
• Are we ready for a flu pandemic? (Boston Globe)
• Analysis: Can States Fix The Disaster Of American Health Care? (KHN)
• Celgene, sold for $74 billion, leaves a legacy of chutzpah in science and drug pricing (STAT)
• In oversight inquiry, key Democrat seeking 10 years’ worth of pricing, sales, research data from drug companies (STAT)

• Pharma Tycoon Dilip Shanghvi Once Again In The Hot Seat (Forbes)
• There is no diversion of funds at all: Sudhir Valia, director, Sun Pharma (Economic Times)
• Sun Pharma replaces domestic formulations distributor with its own subsidiary (Economic Times)
• China Says Claim Of Gene-Edited Babies 'Seriously Violated' Regulations (NPR)
• One Family’s Struggle to Get Their Daughter Lifesaving Medication (WSJ)
• Court cuts Samsung BioLogics a break during probe of its accounting for Biogen deal (Fierce)
• Canada Consults On Disclosing Names Of Generic Drug Applicants (Pink Sheet-$)
• Russian government to force foreign drugmakers to reduce prices for local market (PharmaLetter-$)
• Vertex gains EU approval for earlier Orkambi use (PMLive)
• AbbVie's case against the NHS thrown out of court (Pharmafile)
• Boehringer expands manufacturing facility in Shanghai (Pharmafile)
• Financial Penalties Scope Widened Under New EU Regulation (Pink Sheet-$)
• Pharmacists To Get New Substitution Powers To Tackle Brexit Shortage Risk (Pink Sheet-$)
• Singapore Reveals Phase-In Plans For eCTD (Pink Sheet-$)
• A spot of good news in an Ebola crisis: Vaccine supplies are expected to last (STAT)

• Scientists Are Teaching the Body to Accept New Organs (NYTimes)
• Editas founder Katrine Bosley abruptly steps aside from the helm, just ahead of historic CRISPR move (Endpoints) (Fierce)
• New breast cancer gene tests don't faze women (Reuters)
• Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review (Nature)
• Three things that pharma executives must do to keep pace with the healthcare evolution (BioPharmaDive)
• Novartis picks hackathon challengers, preps for final showdown at SXSW (Fierce)
• Novo infuses cash into 4 biotechs, adding to their arsenal for the superbugs battle to come (Endpoints)
• CBER's Regulatory Activity in 2018: A Reading List (Pink Sheet-$)
• US FDA’s Biologics Center Faces Exciting 2019 After Quiet Year For Novel Approvals (Pink Sheet-$)
• Gene Therapy’s Next Big Challenge: Manufacturing (Pink Sheet-$)
• Alvotech raises $300 million; will further develop biosimilars (PharmaLetter-$)
• For HIV, Treatment is Prevention (NIH Director's Blog)
• Wren raises £18M to drug protein-misfolding diseases (Fierce) (Endpoints)
• Immunochina raises $20M for blood cancer CAR-T (Fierce)
• Gamida Cell teams up with Be The Match to help develop its bone marrow transplant alternative (Fierce)
• Scientists Discover New Potential Way To Stop Breast Cancer Spreading (Forbes)
• TC BioPharm creates allogeneic cell banks for CAR-T cancer therapy products (Press)

• Aurinia posts mixed midphase data on would-be Restasis rival (Fierce) (Endpoints) (STAT) (Press)
• TG Therapeutics’ shares jump as umbralisib wins FDA’s breakthrough status (Endpoints)
• Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease (Press)
• Neoantigen player Achilles gets OK for first clinical trial (PMLive)
• Sorrento shows fast, durable arthritis pain relief with ‘spicy’ injection in early study (Fierce)
• Faulty molecular master switch may contribute to AMD (NIH)
• TaiwanJ Pharmaceuticals Announces Positive Results from Phase 2 Orphan Drug Designation Study of JKB-122 on Autoimmune Hepatitis (AIH) (Press)
• TWi Biotechnology Announces Last Patient Enrolled in Phase 2 Proof-of-Concept Study of AC-203 for Treatment of Epidermolysis Bullosa (Press)
• Concert Pharmaceuticals Completes Enrollment of 12 mg Cohort in Phase 2a Trial of CTP-543 in Alopecia Areata (Press)
• Rainier Therapeutics Announces Oral Abstract Presentation on Fierce 21 Phase 2 Trial of Vofatamab in Metastatic Urothelial Cell Carcinoma (Bladder Cancer) at the 2019 ASCO Genitourinary Cancers Symposium (Press)
• Bio-Thera Solutions Announces Initiation of Phase III Clinical Trial for BAT1806, a Proposed Biosimilar of Actemra® (Tocilizumab) (Press)
• Albireo Granted Orphan Drug Designation by FDA For Lead Product Candidate A4250 for Treatment of Biliary Atresia (Nasdaq)

• Vaginal mesh has caused health problems in many women, even as some surgeons vouch for its safety and efficacy (Washington Post)
• Patient-Level Survival Analysis Demonstrates No Link Between Paclitaxel Dose and Mortality in Patients Treated with IN.PACT Admiral DCB (Press)
• New app may improve ability to focus (Reuters)
• FDA clears Abbott’s TactiCath Sensor Enabled AF contact force ablation cath (MassDevice)
• Boston Scientific’s Vici venous stent meets primary endpoints at 1 year (MassDevice)
• Circuit error prompts Medtronic to recall 157k dual-chamber pacers (MassDevice)
• Baxter acquires software developer True Process (MassDevice)

• The NIH needs to become leaner and more innovative. Here’s how to do that (STAT)
• Supply Agreement Not Enough for Personal Jurisdiction (as if BMS hadn’t taught us that already) (Drug & Device Law)
• Amerigen Pharmaceuticals Ltd. v. UCB Pharma GmbH (Fed. Cir. 2019) (Patent Docs)
• AHIP Insurance Lobby Adds Seven New Members As Medicare Battles Loom (Forbes)

• FDA Advisory Committee Calendar

• Are Wearables Medical Devices Requiring a CE-Mark in the EU? (Inside Medical Devices)
• R&D veteran joins Denmark’s Lundbeck (PharmaLetter-$)
• Medicines: reclassify your product (MHRA)
• Takeda UK boss retains role after Shire acquisition (PharmaLetter-$)
• MHRA grants approval for RXC004 trial restart (PharmaTimes)
• Superdrug to offer stricter mental health checks for Botox users (PharmaTimes)

• Meiji pays for Thai and Indonesian rights to pruritus drug (PharmaLetter-$)

• A Rising Threat to Pregnant Women: Syphilis (NYTimes)