Recon: Bayer Signs Deal With US Biotech Arvinas to Develop Protein Degradation Drugs

• Bayer teams up with biotech firm Arvinas in deal worth up to $750 million (Reuters) (Endpoints) (Fierce) (Press)
• What you missed at ASCO? A lot, as cancer research hastens on (STAT)
• Congress weighs dropping ban on altering the DNA of human embryos used for pregnancies (STAT)
• Updated Apple Watch will track your menstrual period and aim to protect your hearing (STAT) (CNBC)
• Merck wins FDA approval for expanded use of antibiotic (Reuters) (Fierce) (Endpoints) (FDA) (Press)
• Without older subjects, cancer drugs trials rely on atypical patients (Reuters)
• DEA to ask Congress to classify illicit fentanyl like heroin (Reuters) (Senate Judiciary)
• More states sue opioid maker alleging deceptive marketing (AP)
• Emerging Biopharma’s Contribution to Innovation (IQVIA)
• Drugmakers Want AGs' Generics Price-Fixing Claims Tossed (Law360-$)
• How cheaper drugs are kept off the market (Axios)

• Sanofi loses German patent case against Amgen over cholesterol drug (Reuters)
• Eli Lilly, BMS among 77 drugmakers targeted in Chinese financial probe (Fierce) (The Business Times)
• AstraZeneca plots search for next chairman (SkyNews) (Fierce)
• EU Gets a Leg Up on US With First New Gene Therapy for Blood Disorder (Focus)
• Lonza to carve out Specialty Ingredients unit, cut 130 jobs in restructuring push (Fierce) (Press)
• Congo Ebola infections exceed 2,000 as new case rate triples (Reuters)
• Nipah virus resurfaces in India's Kerala after killing 17 last year (Reuters)
• Fifth PD-1, Zavicefta, Novel Psoriasis Ointment Among Latest China Approvals (Pink Sheet-$)
• WHO Outlines Process to Designate Regulators as WHO-Listed Authorities (Focus)
• The top 10 pharma R&D budgets in 2018 (Fierce)

• Could we nationalize insulin to make it a ‘public good’? (STAT)
• ‘Anchoring’ was at work in setting the price of Novartis’ new gene therapy (STAT)
• Jazz Pharma nabs Immunomedics' Iannone as R&D chief (Fierce)
• How do drug companies arrive at the names they give their products? (The Guardian)
• On The Toxicity Of Humira And Other Rheumatoid Arthritis Drugs (Forbes)
• FDA Launches Expanded Access Pilot ‘Project Facilitate’ (Focus)
• Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies (JCE)
• Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature (Drug Safety)
• BIO Elects Dr. Jeremy Levin as New Board Chair (BIO)
• ASCO's hot marketing topics: Real world data, competition and differentiation, analyst says (Fierce)
• #Rival Novartis, Merck drugs square up on rare lung cancer at ASCO (PMLive) (Endpoints)
• ASCO: Viracta's HDAC-inhibitor combination garners high response in EBV-linked lymphoma (Fierce)
• BIO 2019 Notebook: Merck; RMAT; Out-Licensing Deals (Pink Sheet-$)
• Weeks after raising $40M, Celgene-partnered Inhibrx lays groundwork for nearly $75M public debut (Endpoints) (Fierce)
• Lawmakers Urge FDA to Get Moving on Drug Supply Chain Securityc (FDANews-$)
• NIH-supported study reveals a novel indicator of influenza immunity (NIH)
• Tempus, a well-funded company run by a Groupon billionaire, wants to get patients into clinical trials (STAT)
• Neil Woodfood forcefully stems investor outflow by suspending his beleaguered main fund (Endpoints)
• CEPI Awards up to US$21 Million to Themis Bioscience for Phase 3 Chikungunya Vaccine Development (Press)
• NORD and Trio Health Publish New Book To Provide Critical Patient Insights Into The Burden of Living With and Treating Rare Diseases (Press)

• Puma Biotechnology Presents Results from Phase III NALA Trial of Neratinib in Patients with HER2-Positive Metastatic Breast Cancer at the ASCO 2019 Annual Meeting (Press)
• In a much-needed positive for BMS, Celgene gains FDA review for blockbuster hopeful (Fierce) (Press)
• Celgene Announces Data from Ongoing Studies of Liso-Cel in Patients with Difficult-to-Treat Blood Cancers at ASCO 2019 (Press)
• Pivotal phase III CLL14 results for Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for chronic lymphocytic leukaemia presented at ASCO 2019 and published in the New England Journal of Medicine (Press)
• New Data from Phase 3 PALISADE Follow-on Study of AR101 for Peanut Allergy Show Continued Immunomodulation Through Daily Dosing Beyond One Year (Press)
• Five-Year Survival Observed in Longest Follow-up to Date of Advanced Melanoma Patients Treated with the Combination of Opdivo (nivolumab) and Yervoy (ipilimumab) (Press)
• Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Pemigatinib as a First-Line Therapy for Cholangiocarcinoma (Press)
• Dance Biopharm to Present Data from Phase 2 Clinical Trial of Dance 501 Inhaled Insulin Therapy at American Diabetes Association Meeting (Press)
• Cellenkos, Inc. Initiates Phase 1 Clinical Trial of CK0801 for Treatment of Bone Marrow Failure Syndromes (Press)
• Bristol-Myers Squibb Announces First Presentation of Results for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination in Advanced Hepatocellular Carcinoma at ASCO 2019 (Press)
• Allegro Ophthalmics Announces Positive Topline Vision Results of Phase 2 Study Evaluating Risuteganib in Patients with Intermediate Dry Age-Related Macular Degeneration (Press)
• New data on Vitrakvi® (larotrectinib) in TRK fusion cancer patients with brain metastases or primary central nervous system (CNS) tumors (Press)
• LYNPARZA® (olaparib) Phase 3 SOLO3 Trial Demonstrated a 72% Objective Response Rate in Patients with Platinum-Sensitive Relapsed Germline BRCA-mutated Advanced Ovarian Cancer Compared to 51% of Patients Receiving Chemotherapy (Press)
• NantKwest Launches First-in-Human Targeted NK Phase I Clinical Trial of CD19 T-haNK Cell Therapy in Lymphoma Patients (Press)
• Phase III Study Showed XOFLUZA (Baloxavir Marboxil) is Effective at Preventing Influenza Infection (Press)
• Astellas and Seattle Genetics Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer (Press)
• Proteostasis Therapeutics Receives Orphan Drug Designation in the EU for PTI-428 for the Treatment of Cystic Fibrosis (Press)

• We’re not far from using blood tests to detect early-stage cancer, says CEO of Silicon Valley oncology firm (CNBC)
• Hospital Must Face Suit For Using Recalled Medtronic Device (Law360-$)

• Battle Begins Over Legislation To Expand What Inventions May Be Patented (Pink Sheet-$) (Law360-$)
• FDA Warns Pregnant Women Not to Take Vinpocetine (Focus) (FDA)
• Supreme Court rules against Obama-era provision on Medicare reimbursements (The Hill)
• Era of soaring ACA rate hikes appears to be over (Politico)
• Foreign Threats to Taxpayer – Funded Research: Oversight Opportunities and Policy Solutions (Senate Finance)
• Meet The Judge Overseeing The First Opioid Trial (Law360-$)
• PTAB Takes Up Dr. Reddy's Suboxone Patent Challenge (Law360-$)
• J&J Unit Urges ITC To Investigate Intuitive Surgical's Imports (Law360-$)
• Nevada adopts a law requiring drug makers to disclose costs for asthma meds, but to what end? (STAT)
• Quest Diagnostics says 11.9M patients' information may have been exposed in data breach (CNBC) (MedCity)
• In states with most overdose deaths, poor patients struggle to find treatment (Reuters)
• Analysis: Why Alexa’s Bedside Manner Is Bad For Health Care (KHN)
• You Can’t Always Get What You Want (Drug & Device Law)

• FDA Advisory Committee Calendar
• June 6, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement – 6 June 2019

• Combination Products and MDR: EMA Offers New Draft Guideline (Focus) (Pink Sheet-$)
• Recommendations for ongoing use of paclitaxel drug coated balloons (DCBs) and implantable drug eluting stents (DESs) in the treatment of patients with peripheral artery disease (PAD) (MDA/2019/023) (MHRA)

• Four Cs to determine the course for Indian pharma (Economic Times)
• Two-thirds of AIDS treatment drugs supplied globally by India (Economic Times)

• The TGA seize SARMs and Nootropics during search warrants in the Sutherland Shire, NSW (TGA)
• Webinar: The GMP Clearance Framework - an overview (TGA)