Recon: Sanofi Loses Lantus Patent Case Against Mylan; Biogen Ends AGTC Gene Therapy Pact After Failed Study

• Sanofi loses Lantus patent claims against Mylan (Reuters)
• Biogen shrugs off $1B-plus gene therapy pact after PhI/II implosion — AGTC shares crater (Endpoints) (Fierce)
• When pharma companies send checks to patients (Axios) (KHN)
• Opioid maker Insys paid kickbacks to physician assistant, jury hears (Reuters)
• Top HHS official signals more interest in PhRMA’s limited plan for drug ads (STAT)
• FDA hails 2018 as bumper year for drug development successes (Fierce)
• FDA Boss Vows Crackdown On Stem Cell, Supplement Cos. (Law360-$)
• Fetal tissue fight hits Congress today (Politico)
• Failed Startups: Theranos (Forbes)
• Unconfirmed exploratory trials after approvals may cause too much off-label prescribing (STAT)
• A grocery chain launches a discount program for prescription drugs. Will patients save money? (STAT)
• How traditional pharmacies can survive the Amazon threat (STAT)
• A new analysis spotlights the top 20 drugs in the late-stage pipeline (Endpoints)
• Apple now has dozens of doctors on staff, showing it’s serious about health tech (CNBC)

• Vaccines group plots path through conflict, instability, epidemics (Reuters)
• With no antiretrovirals, Venezuela HIV patients rely on leaf remedy (Reuters)
• Brexit contributes to surge in generic drug prices (PMLive)
• Contingency Planning For UK Biopharmas To Continue After May Survives Vote (BioCentury)
• NICE rejects NHS funding for Tegsedi, Onpattro (PharmaTimes)
• EU court upholds EUR 13.96 mn fine on Unichem Lab in Perindopril litigation (Economic Times)
• EU Court Slashes €100M From Servier Pay-For-Delay Fine (Law360-$)
• Sun Pharma faces a new problem as Indian regulator probes whistleblower charges (STAT)
• WuXi AppTec cruises toward a steady debut in Hong Kong stock exchange, ending flat on IPO price (Endpoints)
• Developmental delays persist as Brazil’s Zika babies grow up (STAT)
• Drones set to deliver blood and medical supplies to Ghana’s hospitals (CNBC)

• What to watch in biotech at the JPM Healthcare Conference and beyond in 2019 (STAT)
• ANDA Sponsors Face Tight Controls On Meetings With US FDA After CR Letters (Pink Sheet-$)
• Opioid-Sparing Claims May Be Better Suited For Phase IV Trials Instead Of Phase III (Pink Sheet-$)
• Upstart Akero continues its swoosh into NASH space with $70M windfall round (Endpoints)
• Flagship-backed Foghorn woos Bristol-Myers vet Carl Decicco to direct their ‘gene traffic control’ platform (Endpoints)
• Who needs venture backers? Bill Haney bags new deal cash from Celgene as his biotech upstart Dragonfly explores NK cell tech (Endpoints)
• Third Rock, Takeda-backed Ambys ushers in ex-NGM Bio president Jeff Jonker as CEO (Endpoints)
• Another one of Bob Langer’s MIT postdocs scores a biotech deal, auctioning his startup for up to $415M (Endpoints)
• Warning: The Sex Drug Revolution May Have Side Effects (Forbes)
• Value-Based Pricing And Reimbursement: Still More Promise Than Reality (Forbes)
• AbbVie's latest hep C push highlights Mavyret's time-to-cure advantage (Fierce)
• Could Devices Help Pharma Improve Outcomes? (MDDI)
• Biofrontera cleared of wrongdoing in Nasdaq IPO (Fierce)
• NeuroRx plans pivotal trial after seeing hints of efficacy in suicidal patients (Fierce)
• Polymer–drug conjugate therapeutics: advances, insights and prospects (Nature)
• Determination That IC-GREEN (Indocyanine Green for Injection), 10 Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
• Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications (FDA)

• Sunovion, PsychoGenics nondopamine schizophrenia drug meets phase 2 endpoint (Fierce) (Press)
• Sosei Heptares Starts New Clinical Development Program - First Subject Dosed in Phase I Study of HTL0014242, a Selective mGlu5 Negative Allosteric Modulator in Development to Treat Psychiatric and Neurological Disorders (Press)
• NeuroRx Presents Phase 2 Efficacy & Safety Data for NRX-101, a Breakthrough Therapy Targeting Suicidal Bipolar Depression (Press)
• Health Canada Grants Market Authorization for ORKAMBI® (lumacaftor/ivacaftor) for Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease (Press)
• Generex Biotechnology Receives IND Approval from FDA for Phase II Combination Study using AE37 plus Keytruda® (pembrolizumab) for the Treatment of Triple Negative Breast Cancer (Press)

• Revising FDA 510(k) Poses Challenges For Device Makers (Law360-$)
• Kimberly-Clark recalls Kotex tampons that can unravel inside body (CBS) (FDA)
• FDA Clears First Daily Disposable Silicone Hydrogel Contact Lens Coated with Modified Formula of Tangible Hydra-PEG (Press)

• Government Shutdown Could Hobble FDA (BioCentury)
• Appeals court OKs $248m Stryker win over Zimmer Biomet (MassDevice)
• Newly elected Tennessee Rep. Mark Green says he'll question vaccines (NBC)
• The FTC and FDA May Face New Hurdles in Injunction Actions (FDA Law Blog)
• Hatch-Waxman Reforms Would Have Generics Pick A Lane (FDA News-$)
• No Warnings Causation Equals Summary Judgment In Cook IVC Filter MDL (Drug & Device Law)
• 8th Circ. Won't Revive Express Scripts Breach, Antitrust Suit (Law360-$)
• 'Bundle' Buys Don't Avert FCA Liability, Feds Say In Bayer Suit (Law360-$)
• Synergy Pharma Files Ch. 11, Bausch Health Offers $200M Bid (Law360-$)
• Boston Scientific Wins $35M Verdict In Heart Valve Patent Suit (Law360-$)
• Fed. Circ. OKs Teva's Patent Win Over Allergan Colitis Drug (Law360-$)

• FDA Advisory Committee Calendar

• Teething gels for babies and children to be sold in pharmacies only (MHRA)

• Aging Japan: Dementia puts financial assets of the elderly at risk (Reuters)
• Indonesia will require digital signatures on key device licensing forms (Pacific Bridge Medical)
• Taiwan proposes restrictions to online medical equipment ads (Pacific Bridge Medical)

• India Adds Four Medical Device Types to CDSCO List of Regulated Products (Emergo)
• Delhi High Court denies interim relief to Johnson & Johnson in compensation case (Economic Times)
• Indian drugmakers hit record year for M&A and deal values (Pharmaletter-$)