Recon: GSK Teams up With CRISPR Pioneers for New Drug Discovery Lab

• GSK signs up gene-editing pioneers in drug discovery alliance (Reuters) (Financial Times) (Endpoints)
• Trump Offers to Negotiate Price of J&J Anti-Depressant for VA (Bloomberg) (Endpoints)
• Nebraska’s AG is lone holdout in pursuing opioid cases (AP)
• A CRISPR startup is testing pig organs in monkeys to see if they’re safe for us (MIT Technology Review)
• Pelosi to change drug-pricing plan after progressive complaints (The Hill) (Politico)
• Senate Judiciary Committee plans markup of drug pricing bill this month (The Hill)
• As Amazon seeks to win over health care consumers, its PillPack is accused of violating privacy (STAT)
• The US Is Purging Chinese Cancer Researchers From Top Institutions (Bloomberg)
• ‘If We Do This Right’ Maybe HIV Will Be Forgotten (NYTimes)
• Depo-Provera, an Injectable Contraceptive, Does Not Raise HIV Risk (NYTimes)
• Gilead, AbCellera ink infectious disease antibody discovery pact (Fierce)
• Moody's: Amgen, Biogen, Gilead have 'high capacity' to do M&A (BioPharmaDive)
• Gene therapies top the list of the most expensive drugs on the planet (Endpoints) (Fierce)

• Ebola vaccine for pregnant women: one step closer but still more to go (STAT)
• Ebola: EU releases additional €3.5 million to tackle epidemic (EC)
• Canadian panel calls for universal public drug coverage (Reuters)
• Canada will move on new drug price rules in 'very near future': minister (Reuters)
• UK NB Will Not Apply for EU MDR/IVDR (Focus)
• Family sent back to DR Congo after two die of Ebola in Uganda (Reuters)
• Following CAR-T pioneers' footsteps, Tessa launches China JV in $120M deal (Endpoints)
• UK Pharma Sector ‘Not Ready’ For No-Deal Brexit (Pink Sheet-$)
• Iranian drugmaker opens $100M plant in Turkey, will make Humira biosimilar (Fierce)
• Pharmaceutical industry launches new guidance on working with patients (ABPI)

• FDA Approves 20th Biosimilar, 5th for Roche’s Herceptin (Focus)
• FDA, USP Clash Over Biologics Monographs (Focus)
• Researchers recruit more than 20,000 people for Facebook-based genomics project (STAT)
• AbbVie touts new data for Humira successor; Gilead inks discovery deal (Endpoints)
• As another antibiotics biotech sinks into a crisis, warnings of a sector ‘collapse’ (Endpoints)
• The BCMA bonanza (Nature)
• Official Approval, Receipt, and Complete Response Numbers for May and June Slow Out of the Box for ANDA Approvals (Lachman)
• Turns out, Rudy Tanzi didn't see much of a story about a hidden link between Enbrel and Alzheimer's either (Endpoints)
• Savara shares are crushed as PhIII trial flunks primary, key secondaries — but they can’t stop believing (Endpoints) (Press)
• GlaxoSmithKline steps into the myeloma game at European hematology conference (MedCity)
• FDA dermatology advisors found to accept payments after drug approvals (EPR)
• A CRISPR alternative for editing genes without cutting (Fierce)
• Adding marquee investors, BlackThorn bags $76M to back an AI-driven strategy for precision neuro medicine (Endpoints) (Xconomy)
• Clinical Trials in Plain English: TrialAssure Translates for Patients (Xconomy)
• Allergan reportedly hires Spark Foundry as US advertising agency (BioPharmaDive)
• FDA Signals Willingness To Grant Regulatory Flexibility For Cell and Gene Therapy Products In CMC Reviews (Pink Sheet-$)
• Real-World Evidence: Sponsors Will Need Prospective Process Early In Development (Pink Sheet-$)
• Now It Really Is Personal: US FDA 'Rushing' To Develop Policy For 'Bespoke Therapies' (Pink Sheet-$)
• New Trial With Longer Liver Elevation Needed For Iclaprim, US FDA Tells Motif Bio (Pink Sheet-$)
• Request for Nominations from Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee (FDA)
• Request for Nominations for Individuals and Consumer Organizations for Advisory Committees (FDA)

• New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR (Press)
• Resolve Therapeutics Announces RSLV-132 Significantly Reduces Fatigue in Phase II Study of Patients with Sjögren’s Syndrome (Press)
• Noveome Biotherapeutics, Inc. Announces the First Patient Dosed in Phase 2 Open Label Clinical Trial Evaluating Topical Ocular Delivery of ST266 For the Treatment of Persistent Corneal Epithelial Defects (Press)
• First-in-Human Data Presented from Phase 1a Study of NKTR-358, a Novel T Regulatory Cell Stimulator, at Annual European Congress of Rheumatology (Press)
• New data from Janssen presented at the Annual European Congress of Rheumatology (EULAR 2019) shows sustained clinical benefit and reduction in severe flares with Stelara® (ustekinumab) in patients with systemic lupus erythematosus (SLE) (Press)
• Corvidia Therapeutics Initiates Phase 2b Dose-Finding Study for Ziltivekimab (Press)
• Phase III PEMPHIX Study Showed That Genentech’s Rituxan (Rituximab) is Superior to Standard of Care in Achieving Sustained Remission in Patients with Pemphigus Vulgaris (Press)
• Terns Pharmaceuticals Initiates a Phase 1 Clinical Trial of TERN-101 (Press)

• The road ahead for FDA’s Pre-Cert program (MedCity)
• FDA approved vs. FDA cleared: Why you need to know the difference (CNET)
• FDA Clears Roche Extraction Platform For Use With Applied BioCode GI Pathogen Panel, System (GenomeWeb)

• Bipartisan E&C Leaders Request Briefings On Ongoing Threat Posed By Fentanyl From Six Federal Agencies (House E&C)
• NIH director will no longer participate in all-male panels (The Hill)
• Federal Grants Restricted To Fighting Opioids Miss The Mark, States Say (NPR)
• ACell Pays $15M to Resolve Probe Into Failing to Notify FDA of a Market Withdrawal (Focus)
• Bastion of Anti-Vaccine Fervor: Progressive Waldorf Schools (NYTimes)
• New Bill Would Make It Easier To Invalidate Drug Patents (Law360-$)
• Even More Ill-Conceived Remedies from Congress Regarding Prescription Drug Costs (Patent Docs)
• Biotech Co. Illumina Inks $14M Deal To End Stock-Drop Suit (Law360-$)
• J&J and Colgate pay $4.8 million each to woman in California (Pharmafile)
• House panel demands internal documents from Juul in teen vaping probe (CNBC)
• This Is Why Board Presentations Are Privileged And Protected (Drug & Device Law)

• FDA Advisory Committee Calendar
• Arthritis Advisory Committee; Notice of Meeting – 25 July 2019
• Psychopharmacologic Drugs Advisory Committee; Notice of Meeting – 31 July 2019

• Persistent Sexual Dysfunction Warning For Anti-Depressants In EU (Pink Sheet-$)
• EU Regulatory Roundup: MHRA Offers Advice on use of Brand Names to Prescribe Drugs (Focus)
• UK MHRA Inspectors Gear Up For AI Challenges (Pink Sheet-$)
• Digital division NHSX looks to improve experience for doctors as well as patients (PMLive)
• GSK tech exec joins Institute of Cancer Research (Pharmafile)
• Class 2 Medicines Recall: Paracetamol 500mg Tablets, 1 x 1000 PL 04077/0001 (MDR 13-04/19) (MHRA)

• Revisions of PRECAUTIONS (PMDA)

• Maharashtra FDA files FIR against e-commerce major Amazon for online sale of prescription drugs (PharmaBiz)

• Statement from the Government of Canada on the Final Report  from the Advisory Council on the Implementation of National Pharmacare (Health Canada)