Regulatory Focus™ > News Articles > 2019 > 2 > Recon: Trump Takes Aim at Drug Prices in SOTU; Jury Orders Takeda to Pay Bayer $155M Over Patent Dis

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

Posted 06 February 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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 $690M alliance after BTK drug flounders in PhII (Endpoints)
  • Pennsylvania hospital tests patient for possible Ebola exposure (NBC)
In Focus: International
  • NICE and Canadian counterpart to offer joint advice service (PMLive) (NICE)
  • Hal Barron’s GSK team continues to cull respiratory drugs in big shift to oncology R&D (Endpoints) (Fierce)
  • Collapse Of Health System Sends Venezuelans Fleeing To Brazil For Basic Meds (NPR)
  • Facing crackdown in Canada, drugmakers offered billions in price cuts (Reuters)
  • Brexit Won't Impair Pharmacovigilence 'Fundamentals' – DIA Panel (Pink Sheet-$)
  • 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-$)
Pharmaceuticals & Biotechnology
  • 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 $54M for Drugs that Turn the Heat Up on “Cold” Tumors (Xconomy)
  • Designing cytokine mimics can optimize cancer therapy potential (Nature)
  • With new data, a biotech tries to relieve doubts about the durability of its gene therapy for Fabry disease (STAT)
  • Capricor to resume dosing in DMD trial — but scarce resources force company to pause enrollment, cut jobs (Endpoints)
  • Amicus presents positive data on Pompe drug, but could wait years for approval (STAT)
  • Cancer treatment at home is safe, effective, and closer to happening than you think (STAT)
  • Three senior Chimerix execs to hold the fort to replace departing CEO Berrey (Endpoints)
  • Avrobio takes a second stab at a good first impression — but durability questions still dog gene therapy (Endpoints)
  • The Ultimate Guide to Form FDA 483s (FDAZilla)
  • As rebates face the ax, PBMs cast themselves as drug cost cutters in new digital ads (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • FDA accepts two of MSD’s new drug applications (PharmaTimes)
  • FDA accepts Daiichi Sankyo’s pexidartinib for priority review (PharmaLetter-$)
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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-$)
Upcoming Meetings & Events Europe
  • 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)
General Health & Other Interesting Articles
  • Chronic pain top reason for medical marijuana use, study says (NBC)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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