Recon: Trump’s Canada Drug Import Plan Needs Pharma’s Cooperation; Top HHS Drug Pricing Advisor to Depart

• Deciphera shares skyrocket as cancer drug improves progression-free survival (Reuters) (Endpoints) (Press)
• Trump’s Canada Drug Import Plan Can’t Happen Without Big Pharma (Bloomberg)
• Trump's key drug pricing advisor O'Brien makes HHS exit (Endpoints)
• Senator Grassley seeks info on Novartis's Zolgensma data issues (Reuters) (Endpoints) (Letter)
• Questions Pile up for Novartis as Senators Call on FDA to Take Action (Focus)
• DNA Data Shared in Ways Patients May Find Surprising (WSJ)
• Hepatitis A Races Across The Country (KHN)
• Ads Pitching CBD as a Cure-All Are Everywhere. Oversight Hasn’t Kept Up. (NYTimes)
• Vertex, known for cystic fibrosis drugs, sets its sights on taming pain (STAT)
• Humana lawsuit targets Mallinckrodt's 'billion-dollar golden goose' (PMLive)
• Eli Lilly's Taltz bests J&J rival Tremfya in head-to-head psoriasis tilt (Fierce)

• At BSI's full-day EU Medical Device Roadshow, learn the challenges in meeting European CE-marking regulatory and compliance expectations for the new MDR/IVDR requirements. BSI will be sharing our current experiences, best practice and expectations from the perspective of the first notified body designated under the MDR (EU 2017/745).

• Novartis offloads a late-stage PI3Kẟ rare disease program in a discount deal (Endpoints) (Fierce)
• Boehringer Ingelheim forms ‘virtual research’ alliance with MD Anderson (PMLive)
• UK Seeks Cargo Planes To Fly In Post-Brexit Medicines Supplies (Pink Sheet-$)
• Embattled Sun Pharma’s Dilip Shanghvi, with Rs 1 salary, ranks among lowest-paid pharma CEOs (Fierce)
• Excessive Drug Pricing: Biogen’s Spinraza Referred To Italian And Belgian Competition Authorities (Pink Sheet-$)
• Janssen Announces EC Approval of Imbruvica for Expanded Use in Two Indications (Press)
• ICH Hires Trainers As Emerging Authorities Strive To Harmonize (Pink Sheet-$)
• Daiichi-Sankyo, Bayer, Otsuka and Others Called Out for UK Advertisement Breaches (Focus)

• Ground rules for embryo edits (Politico)
• It's The Go-To Drug To Treat Opioid Addiction. Why Won't More Pharmacies Stock It? (NPR)
• To Find The Next Antibiotic, Scientists Give Old Drugs A New Purpose (NPR)
• New Research Questions FDA’s Reliance on and Inability to Enforce Postmarketing Requirements (Focus)
• Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity (Focus)
• First chlamydia vaccine tested in humans shows early promise (NBC)
• Toddler denied $2.1m gene therapy will now get it for free (STAT)
• Intensive blood pressure control may slow age-related brain damage (NIH)
• FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo) (FDA)
• Enterovirus antibodies detected in acute flaccid myelitis patients (NIH)
• Regeneron's pre-filled Eylea syringe makes the FDA cut; CureVac inks pact with Yale (Endpoints) (Fierce)
• Plugging in the last piece to its gene therapy puzzle, AskBio acquires Scottish synthetic promoter company (Endpoints)
• Gilead, US FDA Ponder Innovative Designs For Descovy HIV Prevention Study In Women (Pink Sheet-$)
• Combination Product Reporting Rule Set For 2020 Enforcement (Pink Sheet-$)
• Do Black Boxes Work? US FDA Survey Would Test Impact On Prescribers (Pink Sheet-$)
• Biosimilars Sponsors Seek Changes In US FDA Guidance On Comparative Analytical Assessments (Pink Sheet-$)
• MSD teams up with Harvard University to discover novel immune system pathways to fight cancer (Pharmafile)
• Few Americans took obesity drugs thanks to doctor doubts and spotty insurance (STAT)
• Making things personal: Roche and personalised medicine (Pharmafile)
• Make that 2 new US Big Pharma chiefs today, as Novartis remakes top team (Endpoints)
• IBD startup Landos lands $60M Series B in first test case of Chris Garabedian's lean and mean model at Xontogeny (Endpoints)

• Terns Pharmaceuticals Announces Positive Interim Results From Ongoing Phase 1 Clinical Trial of TERN-201, a SSAO Inhibitor in Development for NASH (Press)

• FDA grants breakthrough nod to Concept Medical for below-the-knee use of MagicTouch DCB (MassDevice) (Press)
• Misonix lands CE Mark for Nexus ultrasonic platform (MassDevice)
• Novocure’s Optune wins innovative medical device designation from China (MassDevice)
• FDA slaps Class I label on Fresenius Kabi USA infusion pump recall (MassDevice)
• Class 1 Device Recall Centurion Primary Set Pack Convenience Kit, Centurion Primary Warmer Pack Convenience Kit (FDA)
• Class 1 Device Recall Medline Primary Warmer Pack (FDA)
• Class 1 Device Recall Vigilant Agilia, Vigilant Drug'Lib (FDA)
• Class 1 Device Recall VOLUMAT MC AGILIA US (FDA)

• Amgen Wins Enbrel Patent Suit Preventing Sandoz Biosimilar Launch (Focus)
• Grassley Calls for More Unannounced Foreign Drug Inspections From FDA (Focus)
• Seema Verma warns on individual insurance market (Politico)
• Drinking bleach will not cure cancer or autism, FDA warns (NBC) (FDA)
• Screen All Adult Patients for Drug Abuse, National Panel Urges (NYTimes)
• Bringing transparency to the notion of price transparency (STAT)
• Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019) (Patent Docs)
• Clean Sweep of Plaintiffs’ Causation Experts in Gadolinium Litigation (Drug & Device Law)
• Akorn Seeks OK On $30M Deal Over Failed Merger (Law360-$)

• FDA Advisory Committee Calendar

• Romanian Agency Reorganizes To Boost Performance & Face Brexit Challenge (Pink Sheet-$)

• Asia Regulatory Roundup: China Approves Gilead HIV Drug Within 18 Months of EMA and FDA (Focus)

• Health ministry asks medical device manufacturers to register at information sharing portal as part of MvPI (Pharmabiz)
• Exporters ask govt to reduce timeline for granting manufacturing license for pharma producers (Pharmabiz)