Recon: Gilead Partners With Nurix for Protein Degradation Drugs; NICE Backs Blincyto for Acute Lymphoblastic Leukemia

• Merck Seeks More Deals as It Expands Its Cancer Treatments Portfolio (WSJ)
• Low prices of some lifesaving drugs make them impossible to get (Washington Post)
• Key senators release bipartisan package to lower health care costs (The Hill)
• Combatting misinformation on biosimilars and preparing the market for them can save the U.S. billions (STAT)
• Drug Industry Notches Win as Senator Rethinks Patent Measure (Bloomberg)
• ‘They’re all fighting him’: Trump aides spar with health secretary (Politico) (Politico)
• German patients get the latest drugs for just $11. Can such a model work in the US? (LA Times)
• One-quarter of people with diabetes in the U.S. are rationing their insulin (STAT) (1A)
• “We Didn’t Cause The Crisis”: David Sackler Pleads His Case On The Opioid Epidemic (Vanity Fair)
• Gilead baits new alliance with $45M upfront, diving into the busy protein degradation field (Endpoints) (Press)
• A new number 1 drug? Keytruda tapped to top the 10 biggest blockbusters on the world stage by 2024 (Endpoints)
• Allergan says ‘sense of urgency' could prompt move within 60 days (BioPharmaDive) (Fierce)
• ‘Missing protein’ biotech Stoke raises $142m in IPO (PMLive)
• California Vaccine Bill Amended To Appease Governor (KHN)
• Florida Wants To Import Medicine From Canada. But How Would That Work? (NPR)

• 'It's a growth play': Catalent acquires Bristol-Myers' European launch pad, expanding global CDMO ops (Endpoints) (BioPharmaDive) (Fierce) (Press)
• NICE recommends Amgen's Blincyto in rare acute lymphoblastic leukaemia sub-population (Pharmafile)
• Woodford braces political storm as UK financial regulators scrutinize fund suspension (Endpoints)
• What Bluebird Bio Gets Wrong In Pricing For Its $1.8 Million Drug (Forbes)
• Iran Joins Global Drug Regulators Group (Pink Sheet-$)
• Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’ (Focus)
• UK MHRA Starts Internal Review Over Stolen Drug Revelations (Pink Sheet-$)
• Lynparza bags EU approval for RCA-mutated advanced ovarian cancer (PharmaTimes)
• Japan Approves AZ and Merck’s Lynparza for BRCA-Mutated Advanced Ovarian Cancer (Press)
• Threat of no-deal damaging life sciences, says UK biotech leader (PMLive)
• Vital medicine supplies at risk if UK crashes out of EU, MPs warned (The Guardian)
• NHS and life sciences sector failing to work together (Financial Times) (Fierce) (ABPI)
• France leads the world in mistrust of vaccines (Reuters)
• Poorer countries have more confidence in vaccines (Financial Times) (Reuters) (BBC)

• 5 questions facing companies developing liquid biopsies for cancer screening (STAT)
• FDA Releases New Data to Help Generic Drug Competitors (Focus)
• Woodcock Offers 180-Day Exclusivity Tweaks as Senate Committee Preps for Vote (Focus)
• FDA expand Paragraph IV Patent Certifications List for generic drugmakers (Pharmafile)
• Drug research: hits and miss (Financial Times)
• Bob Langer's first port of call — Polaris Partners — maps $400M for ninth fund (Endpoints)
• The US Zolgensma Review: Full Speed Ahead Despite Dose, Stability, Method Uncertainties (Pink Sheet-$)
• Add 6 to the First Generic Approval List (Lachman)
• Opinion: FDA’s overreach will harm compounding pharmacies and the patients they serve (STAT)
• Schrödinger hires ex-Eisai, Merck staff for push into clinic (Fierce)
• Preclinical antisense biotech, led by former Sarepta CEO Kaye, vaults on to Nasdaq with upsized IPO (Endpoints)
• Cell/Gene Therapy Manufacturing Readiness Urged As A Condition For US Expedited Designation (Pink Sheet-$)
• Kymera rolls out new animal data on its lead protein-degradation drug to treat lymphoma (Fierce)
• Technology can propel healthcare out of the Middle Ages (Financial Times)
• Seres Therapeutics Issues Statement Regarding U.S. Food and Drug Administration Safety Alert Related to Use of Fecal Microbiota Transplantation (Press)
• Contract manufacturing services industry set to grow at CAGR of 10.6% between 2017-2027 (Pharmafile)
• Arcturus expands collaboration, adding $30M cash; Kura shoots for $100M raise (Endpoints)
• Chicago biotech argues Bluebird, Third Rock 'killed' its rival, pioneering thalassemia gene therapy in lawsuit (Endpoints)
• David de Graaf now has his $28.5M launch round in place, building a coenzyme A platform in his latest startup (Endpoints)
• Looking to grow some trust, GW Pharma takes physicians on VR 'voyage' to marijuana greenhouse (Fierce)
• Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance (FDA)
• Scientific Data and Information About Products Containing Cannabis or Cannabis Derived Compounds; Extension of Comment Period (FDA)

• Bayer's Stivarga® (regorafenib) becomes first compound used in clinical trial platform to investigate new therapies for brain cancer (Press)
• Ironwood, Allergan add a slate of PhIIIb data to its Linzess pitch for physicians, patients (Endpoints) (Press)
• Medimetriks Pharmaceuticals Focuses on Advancing MM36 (difamilast) Through Phase 3 Trials; Extinguishes Debt Owed to Knight Therapeutics (Press)

• FDA clears J&J and Grifols’ blood-stopping protein spray for surgical bleeds (Fierce) (Press)
• Philips wins PMAs for OTC automated external defibs (MassDevice)
• FDA clears Life Spine’s surgical spacer system (MassDevice)
• FDA: More data needed on paclitaxel devices (MassDevice)

• Momenta Pharmaceuticals Announces Settlement Agreement with Amphastar Resolving Enoxaparin Sodium Injection Litigation (Press)
• USTR Pledges Close Work With Congress To Pass NAFTA 2.0 (Law360-$)
• A Guide To FCA Cooperation Credit For Life Sciences Cos. (Law360-$)
• Go for It! (Connect) Paragraph IV! FDA Revamps ANDA Paragraph IV Certifications List (FDA Law Blog)
• Court Strikes Down NECC Convictions for Vagueness (Drug & Device Law)

• FDA Advisory Committee Calendar

• Oral evidence: The progress of the UK's negotiations on EU withdrawal, HC 372 (House of Commons)
• UK Says Illumina's $1B Genomic Sequencing Deal Problematic (Law360-$)
• EU pharmaceutical industry lost €16.5B in sales as staff shift to patent infringing firms (Pharmafile) (InPharmaTechnologist)
• Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome (MHRA)
• GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued (MHRA)
• Lartruvo▼ (olaratumab): withdrawal of the EU marketing authorisation due to lack of efficacy (MHRA)
• Oral retinoid medicines▼: revised and simplified pregnancy prevention educational materials for healthcare professionals and women (MHRA)
• Letters and drug alerts sent to healthcare professionals in May 2019 (MHRA)
• The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019 (MHRA)
• Medical Device Alerts issued in May 2019 (MHRA)

• Asia Regulatory Roundup: Australia Extends GMP Clearance Filing Review Timelines to up to 120 Days (Focus)
• Japan’s MHLW Approves Invivoscribe’s LeukoStrat CDx FLT3 Mutation Assay as the CDx for Daiichi Sankyo’s Quizartinib for Treatment of Relapsed/Refractory FLT3-ITD AML. Expands Use to Include Specimens Collected in EDTA (Press)

• DCGI cancels registration certificate of Mumbai-based firm for violation of labelling norms (PharmaBiz)

• Health Canada Consults on New Proposed Device Regulations (Focus)

• Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 (TGA)