Recon: GSK’s Dovato Hits Main Goal in Phase III Study; Trump Signs Executive Order to Boost Home Dialysis, Kidney Transplants

• The FDA's Janet Woodcock talks about some big changes she's pushing for in drug development, and agency reviews (Endpoints) (Fierce)
• 23andMe’s chief scientific officer, a star in drug development, is leaving role (STAT) (Endpoints)
• DNA-Testing Service Exposed Thousands of Customer Records Online (Bloomberg)
• CDC made a synthetic Ebola virus to test treatments. It worked (STAT)
• Top Trump advisers hint at support for progressive proposal to cap drug price hikes (STAT)
• US aims to cut dialysis in centers, increase transplants by 2025 (Reuters)
• Trump officials seek plan B on drug pricing rule (The Hill)
• A Supreme Court ruling may have made it harder to get some info from the FDA (STAT)
• Trump executive order on organ transplants will fuel a little-known biotech company, Raymond James says (CNBC) (NYTimes)
• Novartis to sell epinephrine shot in U.S. pharmacies amid EpiPen shortage (Reuters)
• ICER Lists Potential Topics for Assessments in 2020 (ICER)

• Pharmaceutical mergers and megamergers stifle innovation (STAT)
• GSK's two-drug HIV Dovato treatment meets main goal in study (Reuters) (Endpoints) (Press)
• Need quick medical advice in Britain? Ask Alexa (Reuters) (PMLive)
• Pharma industry invests £377m in UK R&D collabs (PharmaTimes)
• Merck’s Ebola vaccine helps combat deadly outbreak in the Congo as the virus spreads (CNBC)
• Genmab steps up for a $500M IPO haul, with its sights on a record-setting market cap (Endpoints)
• Pharma continues to get poor grades when it comes to sharing clinical trial data (STAT)
• Score! 'Good Pharma' ranking finds uptick in new drug data sharing and clinical trial transparency (Fierce) (Press)
• Bayer floats animal health merger with Lilly spinoff Elanco: report (Fierce)
• France will end healthcare refunds for homeopathic drugs (Reuters)

• Charles River plots 2020 opening of South San Francisco lab (Fierce)
• Supply constraints push EpiPen rival maker Amneal to restructure, shares fall (Endpoints) (BioPharmaDive)
• KRAS G12C is the hot new play in cancer R&D, and Novartis jumps in with a combo deal (Endpoints) (BioPharmaDive)
• FDA Finalizes Revised REMS Modifications Guidance (Focus)
• Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs (Focus)
• FDA Warns Akorn for Repeat Violations (Focus)
• Trust, But Verify (AJA Journals)
• Pharma Money And Physician Prescribing Of Painkillers (Forbes)
• When Patients Need Opioids to Ease the Pain (NYTimes)
• New MaPP Fully Outlines Process for FDA Safety Label Changes (Lachman)
• GSK hires computational drug design expert Dr Kim Branson as new head of machine learning and AI (Pharmafile)
• Large pharmas set up screening library data-sharing experiment (Nature)
• Building on bispecifics (Nature)
• New funding needed for late-stage vaccine work? (Nature)
• How To Get A Cheaper Prescription Before Leaving The Doctor’s Office (KHN)
• Watch: High Cost Of Insulin Sends Americans To Canada To Stock Up (KHN)
• After exiting troubled Merrimack, former CEO becomes new chief at Yumanity (Fierce)
• Osivax raises €8M for universal flu vaccine clinical trials (Fierce)
• Sanofi begins countdown for FDA isatuximab review; Cirrhosis-focused biotech presents another mini IPO (Endpoints)
• New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food (FDA)

• FDA accepts BLA filing for Sanofi's rival to J&J's Darzalex  (Fierce) (Press)
• Horizon Therapeutics plc Submits Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED) (Press)
• Metavant/Poxel prep phase 3 for imeglimin in diabetic kidney disease (PMLive)
• Moleculin Files for New Patents for Annamycin After Receiving FDA Approval of Fast Track Designation (Press)
• FDA Approves Katerzia™, the First and Only Amlodipine Oral Suspension, 1 mg/mL, for Pediatric Patients 6 Years of Age and Older (Press)
• Akebia Therapeutics Announces Collaboration Partner’s Positive Top-line Results of Phase 3 Clinical Study of Riona® (ferric citrate hydrate) in Adult Patients with Iron Deficiency Anemia in Japan (Press)
• Teva to Present New Data on AJOVY® (fremanezumab-vfrm) Injection at the American Headache Society’s 61st Annual Scientific Meeting (Press)
• Ligand Announces Positive Top Line Results from Phase 1 Clinical Trial of Captisol-enabled Iohexol  (Press)
• Peanut Allergy: Final Evidence Report and Meeting Summary (ICER)
• Warning Letter - Abington Memorial Hospital, IRC (FDA)
• Warning Letter - AllerQuest LLC (FDA)

• USTR exempts some medical devices from 25% China tariffs (MedtechDive)
• Medtech VC and the billion-dollar era (Evaluate)
• AdvaMed Calls for Tweaks to FDA Draft Guidance on Inspections (Focus)
• Medtronic debt offers draw nearly $9B in tenders (MassDevice) (Press)
• DHS warns on GE Aestiva and Aespire anesthesia devices (MassDevice)
• ‘Pathways Picks’ July 10: The News this Week (MedTechStrategist)
• Human factors studies: Considerations for recruiting rare and complex user populations (Emergo)
• FDA Clears Koios DS™ Breast 2.0 to Assist Physicians with AI-Based Software (Press)

• Obamacare on the ropes … again (Politico)
• U.S. appeals court signals sympathy to bid to strike down Obamacare (Reuters)
• So You Want to Overturn Obamacare. Here Are Some Things That Would Be Headaches. (NYTimes)
• Sununu To Sign Bill To Protect Health Coverage for Those With Pre-existing Conditions (NHPR)
• Okla. Says J&J Addiction Expert Is Just A 'Book Reviewer' (Law360-$)
• GSK Says Reed Smith Widow Can't Ignore 'Final Judgment' (Law360-$)
• Bio-Rad's $24M DNA Patent Win Backed By Evidence: Judge (Law360-$)
• 3rd Circ. Suggests Remicade Fight May Require Arbitration (Law360-$)
• Rule to Require Drug Prices in TV Ads Found Invalid (FDA Law Blog)
• Opioid Use Decreased in Medicare Part D, While Medication-Assisted Treatment Increased (HHS OIG)
• Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019) (Patent Docs)
• E.D. Missouri Dismisses Non-Missouri Mesh Claims for Lack of Personal Jurisdiction (Drug & Device Law)

• FDA Advisory Committee Calendar
• Hearing On "Oversight Of Federal Efforts To Combat The Spread Of Illicit Fentanyl" – 16 July 2019
• Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA) – 2 October 2019
• Federal Listening Session on Interoperability of Medical Devices, Data, and Platforms to Enhance Patient Care – 17 July 2019
• Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems – 11 July 2019
• Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes – 11 July 2019

• EU MDR/IVDR: EC Calls for Observers to Sit on Nomenclature Subgroup (Focus)
• German, Danish Regulators Explain Dos And Don'ts Of Master Protocols (Pink Sheet-$)
• New European Commission guidance covers responsible person requirements under MDR, IVDR (Emergo)
• Healthcare regulators to gain autonomy (PharmaTimes)
• Biocon founders donate £6 million to Glasgow University for new research hub (Pharmafile)
• UK Pilot To Generate Real World Data On Medicinal Cannabis Use (Pink Sheet-$)
• Transgene Receives MHRA Approval for Lead myvac™ Individualized Immunotherapy, TG4050, to Commence Clinical Development in HPV Negative Head and Neck Cancers in the UK (Press)
• Adaptation of the Guidance document Formal requirements HMV4 (SwissMedic)

• Astellas Launchs Smyraf Tablets for rheumatoid arthritis in Japan (Press)
• Chinese drug packaging industry set to be worth RMB200 billion (EPR)
• USFDA issues 12 observations for three units of Biocon in Malaysia (Business Standard) (BSE)

• Will India Figure In First-Wave Markets For Sun's Ilumya? (Scrip-$)

• Updates to variations to prescription medicines guidance and e-form (TGA)
• Everything you ever wanted to know about sunscreens (but were afraid to ask) (TGA)

• WHO Updates Lists of Essential Medicines, Diagnostics (Focus)

• First baby in the U.S. born from transplanted womb of dead donor (NBC)
• C.D.C. Investigates Rare Type of Paralysis in Children (NYTimes)