Recon: Senate Finance Reaches Deal on Drug Pricing Legislation, Markup Set for Thursday

• Drugmaker Group Boosts Lobbying as Push to Lower Prices Stalls (Bloomberg)
• Grassley, Wyden reach deal to lower drug prices (The Hill) (Politico) (Reuters) (STAT) (Senate Finance) (PDPRA)
• Pelosi aide: Major bill to lower drug prices coming in September (The Hill)
• How Alex Azar sees Trump’s health strategy now (Politico)
• Frequency Therapeutics raises another $62 million (STAT) (Endpoints)
• Merck unveils early data on HIV drug it says could be ‘game changer’ (STAT) (Pharmafile) (NYTimes)
• Biotech group Biogen boosted by sales of key drugs (Financial Times) (Endpoints)
• Sanofi signs US rights deal with Roche for flu treatment Tamiflu (Reuters) (Endpoints) (Fierce)
• Acadia's schizophrenia treatment misses late-stage main goal; shares fall 16% (Reuters) (STAT) (Endpoints) (Press)
• Bayer recalls mislabeled vials of hemophilia A treatment (Fierce) (FDA)
• Vertex files cystic fibrosis triple therapy with FDA (PMLive)
• For all his tough talk, can Donald Trump lower drug prices? (Financial Times)
• Many Americans mistakenly use aspirin to prevent heart disease (Reuters) (AP)

• 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).

• Boris Johnson is new PM – but opposition to his Brexit plans mount (PMLive)
• NICE unveils long-awaited review of methodologies (PMLive) (NICE)
• Congo minister's resignation over Ebola snub could unblock new vaccine (Reuters)
• Myovant’s uterine fibroid drug meets goals in trial, setting up competition with AbbVie (STAT) (Endpoints)
• Chinese CDMO GenScript takes steps to be player in China's gene and cell therapy market (Fierce)
• Changes Encourage Celltrion And Nan Fung To Bet On China Biosimilars Opportunity (Scrip-$)
• Multidrug-resistant malaria spreading in Southeast Asia: study (Reuters)

• Medicaid Coverage Criteria For CAR-T Often More Restrictive Than Label (Pink Sheet-$)
• Antibiotic use without prescription common in US (Reuters)
• The superbug Candida auris is giving rise to warnings — and big questions (STAT)
• 3 years after the FDA forced Chiasma back into PhIII, they’re back with positive data — but now they have a rival (Endpoints)
• State: Doctor’s wife mishandled vaccines, caused outbreak (AP)
• Nonprofit US generics company secures supplier in Hikma (BioPharmaDive)
• Designing an agile transformation in pharma R&D (McKinsey)
• US FDA Invites Randomized Trial Designs With Real-World Elements (Pink Sheet-$)
• Randomized Study Objectives Should Drive Choice Of Real-World Data Sources, Experts Say (Pink Sheet-$)
• Rethinking What To Call The ‘Real World’ (Pink Sheet-$)
• Risk of neural tube defects slightly higher for babies of women on HIV therapy containing dolutegravir (NIH)
• Little Marinus sees its shares eclipsed as the Sage rival fails to compare on PPD in PhII (Endpoints)
• How Ocular Therapeutix Recovered From US FDA’s Second Dextenza CRL (Pink Sheet-$)
• PACT Pharma says it's perfected the tech to select neoantigens for personalized therapy — now onto the clinic (Endpoints)
• OPDP’s Aikin Highlights Role of Social Science Research in FDA Promotional Policymaking (CHC)
• Proteostasis shakes up medical team; Novo funds antibiotics efforts out of Curza, Spero (Endpoints) (Fierce)
• Our STAT Op-Ed: Drug Importation Can’t Coexist with US Track-and-Trace Law (Drug Channels)
• City-wide electronic health records reveal gender and age biases in administration of known drug–drug interactions (Nature)
• WuXi STA Shanghai & Changzhou Facilities Pass US FDA Inspections (Press)
• German Drugmaker Cited for Inadequate CAPAs (FDA News-$)
• Disarm Therapeutics hires Dr Alvin Shih as new President and CEO (Pharmafile)

• Merck and Eisai Receive Third Breakthrough Therapy Designation from FDA for KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment (Press)
• Akebia Therapeutics Announces Submission of Vadadustat New Drug Application in Japan for Anemia Due to Chronic Kidney Disease by Collaboration Partner, MTPC (Press)
• PolyActiva Completes Recruitment in Key Phase I Glaucoma Implant Safety Study. Six-month Treatment Period Demonstrated. (Press)

• Report: Ethylene oxide levels high near Georgia medtech sterilization plants (MassDevice)
• Hamilton Medical, Draeger win DoD deals (MassDevice)
• Medtronic bids for expanded FDA indication for Guardian Sensor 3 (MassDevice)
• Medtronic Requests Approval of Non-Adjunctive Labeling from FDA (Press)
• Curetis Submits Lower Respiratory Tract Infection Test for FDA Clearance (GenomeWeb)

• Patent reform is needed to protect patients’ access to lifesaving drugs (STAT)
• Senate panel looks at easing cannabis laws that restrict the industry’s access to mainstream banking services (CNBC)
• FTC Asks 3rd Circ. To Revive Claims In AbbVie Antitrust Case (Law360-$)
• Fed. Circ. Leaves Open Questions On Patent Eligibility (Law360-$)
• Actavis Infringed Constipation Drug Patent, Judge Rules (Law360-$)
• DOJ Errors Doom Suboxone Film Fraud Case, Indivior Says (Law360-$)
• Purdue Wants Fed. Circ. To Rehear OxyContin Patent Claims (Law360-$)
• Conn. Denies Leaking Heritage Doc In Generic-Drug Case (Law360-$)
• A $100B settlement? Or much less? Opioid payouts a mystery until J&J judge rules (Fierce)
• Remand Court Forces Plaintiff’s Counsel Out of the Shadows (Drug & Device Law)

• FDA Advisory Committee Calendar

• ABPI responds to launch of Government’s Prevention Green Paper (ABPI)
• Good laboratory practice (GLP) for safety tests on chemicals (MHRA)
• Field Safety Notice: 15 to 19 July 2019 (MHRA)
• MHRA has taken action against companies on FMD compliance (Pharmaceutical Journal)
• International Conference for the publication of the 10th edition of the European Pharmacopoeia (Swissmedic)

• Symposium for the draft revision on the ICH E8 “General Considerations for Clinical Trials”: Update on the ICH and Overview of the ICH E8(R1) Draft Guideline (PMDA)
• IPEC Pressure Continues on China to Align with Global Science-Based Excipient Standards (IPQ)
• China's NMPA Extends Approval for Roche Cobas EGFR Mutation Test v2 to Plasma Samples (GenomeWeb)

• Novartis Ceritinib India Case: Court Rebuke Amid Wait For Patent Decision (Scrip-$)
• Vaccine deaths in India have not been evaluated: Uppsala Monitoring Center (PhamaBiz)
• Alembic Pharma gets tentative nod from USFDA for glycemic control drug (Economic Times)

• Civil penalties ordered against Peptide Clinics Pty Ltd for advertising breaches (TGA)
• Submissions received: Remaking Therapeutic Goods Order No. 78 (TGA)
• Presentation: Software as a Medical Device: Regulatory insights and Q&A (TGA)

• Rabies Kills Tens of Thousands Yearly. Vaccinating Dogs Could Stop It. (NYTimes)