Recon: Trump Takes Aim at Drug Prices in SOTU; Jury Orders Takeda to Pay Bayer $155M Over Patent Dispute

• Pharma CEOs to Testify at Senate Drug Pricing Hearing (Reuters 1, 2) (BioPharmaDive)
• Pharma execs will testify before Congress 'one way or another,' US senator says (CNBC)
• Trump, claiming progress in lowering drug prices, tells Congress ‘we must do more’ (STAT) (Endpoints) (NBC) (NPR) (KHN) (Politico) (The Hill) (BIO)
• AP Fact Check: Trump on prescription drug pricing (AP)
• Bipartisan group of lawmakers introduces bill to fight high drug prices (Reuters) (Senate Finance)
• How Trump’s Latest Plan to Cut Drug Prices Will Affect You (NYTimes)
• As Trump calls on Congress to lower drug prices, some Democrats cheer. Others scoff (STAT)
• Trump Plan to Stop Spread of HIV Will Target ‘Hot Spot’ Areas (NYTimes) (AP 1, 2)
• US jury orders Takeda to pay Bayer $155 million over hemophilia drug (Reuters)
• Alphabet's Verily is building a high-tech rehab campus to combat opioid addiction (CNBC)
• After a stormy winter, biotech’s IPO hopes hang on a billion-dollar Alzheimer’s company (STAT)
• Making New Drugs With a Dose of Artificial Intelligence (NYTimes)
• CEO of activist hedge fund Starboard: 'We are certainly interested in the story at Bristol-Myers' (CNBC)
• Eli Lilly cuts 2019 outlook after trial failure and Loxo deal (Financial Times)
• Eli Lilly silently walks away from a troubled $690M alliance after BTK drug flounders in PhII (Endpoints)
• Pennsylvania hospital tests patient for possible Ebola exposure (NBC)

• NICE and Canadian counterpart to offer joint advice service (PMLive) (NICE)
• Hal Barron’s GSK team continues to cull respiratory drugs in big shift to oncology R&D (Endpoints) (Fierce)
• Collapse Of Health System Sends Venezuelans Fleeing To Brazil For Basic Meds (NPR)
• Facing crackdown in Canada, drugmakers offered billions in price cuts (Reuters)
• Brexit Won't Impair Pharmacovigilence 'Fundamentals' – DIA Panel (Pink Sheet-$)
• European Commission Requirements for Marketing Medical Devices in a No-deal Brexit Scenario (Emergo)
• Merck KGaA Pens Letter Opposing SPC Waiver Proposal (Merck)
• UK Has Sought Advice On Compulsory Licensing For Vertex’ Orkambi (Pink Sheet-$)
• Eight Weeks Left But Only 27% Of Centrally Authorized Drugs Are Fully Brexit-Ready (Pink Sheet-$)
• Chugai Looks Overseas As Challenges Loom At Home (Scrip-$)

• Allergan is pressured once again by a big hedge fund to split chairman and CEO jobs (STAT)
• A Chicago pharma company raised the price of its skin gel to $7,968. Now it's bankrupt. (Chicago Tribune)
• To tackle superbug scourge and revive R&D, incentivize FDA antibiotic approvals — drugmakers, health groups urge US lawmakers (Endpoints)
• In survey, PhRMA member companies highlight impact of IPI on R&D (PhRMA)
• Blood-Pressure Medicine Will Be First Product for New Generic Drug Venture (WSJ)
• Reopening comment period for Framework for a Real-World Evidence Program (FDA)
• Generic CEOs Need To Act Like Brand Execs, Association Head Says (Pink Sheet-$)
• Alexion runs toward big Ultomiris goals with early Soliris switching success (Fierce)
• Prominent ‘right-to-try’ advocate is getting treatment under the new law (STAT)
• CDER’s Latest Clinical Trial Snapshot Reports Fewer Trial Participants (FDANews-$)
• Genentech pays Xencor $120M for rights to IL-15 cancer pipeline (Fierce)
• Roche, joining rivals, donates hemophilia drug to boost access (Reuters) (Press)
• FDA Psychiatry Product Division Director Joins Allergan (BioCentury)
• Ep. 61 The Ups and Downs of Drug Prices: An Economist’s View (Accad & Koka Report)
• FluMist, HBV Vax Make the 2019 Immunization Schedule (Medpage)
• Former Ablynx exec joins Kiadis as Chief Scientific Officer (Pharmafile)
• Basking in praise and a $4.2B GSK pact, Merck KGaA blueprints expansion plans for Boston-area R&D campus (Endpoints)
• Macrogenics offers major surprise with positive breast cancer data, as shares double (STAT) (Endpoints)
• Bolt Bio Bags $54M for Drugs that Turn the Heat Up on “Cold” Tumors (Xconomy)
• Designing cytokine mimics can optimize cancer therapy potential (Nature)
• With new data, a biotech tries to relieve doubts about the durability of its gene therapy for Fabry disease (STAT)
• Capricor to resume dosing in DMD trial — but scarce resources force company to pause enrollment, cut jobs (Endpoints)
• Amicus presents positive data on Pompe drug, but could wait years for approval (STAT)
• Cancer treatment at home is safe, effective, and closer to happening than you think (STAT)
• Three senior Chimerix execs to hold the fort to replace departing CEO Berrey (Endpoints)
• Avrobio takes a second stab at a good first impression — but durability questions still dog gene therapy (Endpoints)
• The Ultimate Guide to Form FDA 483s (FDAZilla)
• As rebates face the ax, PBMs cast themselves as drug cost cutters in new digital ads (Fierce)

• FDA accepts two of MSD’s new drug applications (PharmaTimes)
• FDA accepts Daiichi Sankyo’s pexidartinib for priority review (PharmaLetter-$)
• Perrigo Announces FDA Final Approval for its AB Rated Generic Version of Zovirax® Cream 5% (Press)
• Takeda Announces Results from First-of-Its-Kind Phase IIIb/IV Trial PROPEL – a Randomized PK-Guided Prophylaxis Study Evaluating Higher Factor VIII Levels in Hemophilia A– at EAHAD 2019 (Press)
• Orphan Technologies Announces First Patients Treated in Phase 1/2 Trial of OT-58 in Homocystinuria (Press)
• AVROBIO, Inc. Announces Updated Clinical Data from Ongoing Phase 1 and Phase 2 Studies for AVR-RD-01 Gene Therapy for Fabry Disease (Press)
• Audion touts Ph1 results for hearing loss drug (Drug Delivery)
• Cytogel Pharma Announces Receipt of FDA Authorization to Commence Phase 2 Development for its Atypical Opioid, CYT-1010 (Press)

• Boston Scientific shares up on Q4, 2018 earnings Beat (MassDevice)
• Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical Devices (Emergo)
• Current Health lands FDA clearance for its remote patient monitoring solution (mobihealthnews) (Press)
• Intuitive Surgical expands Silicon Valley footprint (MassDevice)
• J&J’s Biosense Webster launches IDE-cleared Qdot Micro RF ablation trial (MassDevice)
• Study: Procedures with Abbott’s Mitraclip show sustained low complication, mortality rates (MassDevice)
• AtriCure launches CryoIce persistent AF ablation trial (MassDevice)
• Cellect Biotechnology launches U.S. clinical trial (MassDevice)
• Flowonix wins FDA nod for infusion pump software (MassDevice)

• United Healthcare Services files complaint against Dr Reddy's US arm (Economic Times)
• Trump DOJ Punishes Hedge Fund Manager Who Sued Drug Companies And Shorted Their Stocks (Forbes)
• Trump's border wall won't solve addiction crisis — but finally targeting big pharma can (USA Today)
• Feds warn 180 Wisconsin health care professionals about overprescribing opiates (Journal Sentinel)
• New York City Cracks Down on CBD Edibles, Saying the Cannabis Derivative Is Unsafe (NYTimes)
• California Court Bounces Out-of-State Pradaxa Plaintiffs (Drug & Device Law)
• New Efforts to Expand Access to Laboratory Tests in Maryland (FDA Law Blog)
• Foundation Medicine signs $111M contract with Department of Veterans Affairs (MedCity)
• Cook Medical to pay $3m in damages in IVC bellwether (MassDevice)
• Method-Of-Treatment Patent Eligibility: Step 1 And Done? (Law360-$)
• Fed. Circ. Appears To Side With Eli Lilly Over Cancer Patent (Law360-$)
• Puma Biotech Misled Investors About Cancer Trial, Jury Says (Law360-$)
• Fed. Circ. Revives Sanofi Bid To Amend Cancer Drug Patent (Law360-$)
• Novum Pharma Taps Cash Collateral As It Seeks Ch. 11 Buyer (Law360-$)
• GSK Can't Escape MDL Alleging Zofran Caused Birth Defects (Law360-$)

• FDA Advisory Committee Calendar
• The Cost Of Rising Prescription Drug Prices – 12 February 2019
• Food and Drug Administration – Status of Operations – 12 February 2019
• Managing Pain During the Opioid Crisis – 12 February 2019
• Oncologic Drugs Advisory Committee; Notice of Meeting – 26 February 2019

• Clinical trials for medicines: manage your authorisation, report safety issues (MHRA)
• News from Abroad -- More Pain for Warner-Lambert and Their Pregabalin Patent (Patent Docs)
• CAT monthly report of application procedures, guidelines and related documents on advanced therapies (EMA)
• Recommendations on eligibility to PRIME scheme (EMA)

• Japanese Regulators Approve Promega CDx for Merck's Keytruda (GenomeWeb)

• DCC meet discusses uniform implementation of CDSCO mandated stability studies by pharma companies (PharmaBiz)

• Release for supply of medicines - Technical guidance on the interpretation of the PIC/S Guide to GMP (TGA)
• Releasing medicines manufactured at multiple sites - Technical guidance on the interpretation of the PIC/S Guide to GMP (TGA)

• Chronic pain top reason for medical marijuana use, study says (NBC)