Recon: Merck’s Keytruda Raises Survival Standard for Advanced Lung Cancer; Amgen KRAS Drug Shows High Response Rate

• Drugs make headway against lung, breast, prostate cancers (AP)
• Who Won and Lost at One of the Year's Biggest Medical Meetings (Bloomberg) (CNBC)
• Moderna makes ASCO debut with an early look at a personalized cancer vaccine (STAT) (Press)
• Amgen drug shows high response rate in small lung and colon cancer trial (Reuters) (STAT) (Endpoints) (Financial Times) (Evaluate)
• Encouraging early data for Amgen’s BiTE therapies (PMLive) (Endpoints) (Press)
• Merck's Keytruda sets new five-year survival standard for advanced lung cancer (Reuters) (Financial Times) (Endpoints) (Press)
• ASCO: Complete response rate in Nektar melanoma trial hits 34% (Fierce) (Endpoints) (Press)
• ASCO: Death in Turning Point NSCLC trial overshadows 82% ORR (Fierce) (Press)
• Janssen presents positive Darzalex results at ASCO (PharmaTimes) (Endpoints) (Press)
• Seattle Genetics, Astellas drug rapidly shrinks tumors in bladder cancer study (Reuters) (Endpoints) (Press)
• At cancer conference, debate over speedy drug approvals in the spotlight (BioPharmaDive)
• US records 41 new cases of measles last week (Reuters)
• FDA Chief of Staff to Step Down This Month (Focus)

• Forget controversy. AstraZeneca’s dynamic duo wants to dominate the market for cancer drugs (STAT) (Reuters) (Press) (Press)
• Novartis hopes Kisqali data will help narrow gap to blockbuster rival (Reuters) (STAT) (Endpoints) (PharmaTimes) (NYTimes)
• He Jiankui tried to protect ‘CRISPR babies’ against HIV. But his attempted fix shortens lives, study shows (STAT) (Financial Times)
• Sanofi's anti-CD38 combo boosts responses, extends lives in advanced multiple myeloma (Fierce) (Endpoints) (Press)
• Hancock says “NHS not for sale” in post-Brexit US trade talks (PMLive)
• NICE Says Vertex Must ‘Engage Fully’ In UK Orkambi Negotiations (Pink Sheet-$)
• NICE recommendation for MSD’s Prevymis after re-evaluation (PharmaTimes)
• Private equity firms circle Bayer’s animal medicine unit (Financial Times) (Fierce)

• #ASCO19 roundup: AstraZeneca, Merck score another Lynparza hit (Endpoints)
• Autophagy: Drugging the yin and yang of the cell (C&EN)
• Trends in Prices of Popular Brand-Name Prescription Drugs in the United States (JAMA)
• ASCO: Pfizer, Astellas' Xtandi racks up more data for new prostate cancer approval (Fierce)
• Blueprint keeps pressure on Lilly with RET-targeted cancer therapy (BioPharmaDive) (Press)
• Biden Cancer Initiative Announces the Oncology Clinical Trial Information Commons (Biden Cancer Initiative)
• ASCO: Ayala's ex-BMS drug shows promise in triple-negative breast cancer (Fierce)
• Continuous Manufacturing: Industry Calls for Changes to FDA’s Draft Guidance (Focus)
• FDA Questions Arizona Stem Cell Company (Focus)
• Quest for safe muscarinic receptor agonists to tackle disaster prone CNS field steers Karuna to $75M IPO (Endpoints)
• Medical Product Safety: Ten Years of the U.S. Sentinel System (FDA)
• Despite last year’s outcry over topless dancers, biotech’s most infamous party is reincarnated (STAT)
• The shortage of haloperidol, an ‘old’ drug, haunts me (STAT)
• ‘Right-to-try’ laws provide little access to investigational drugs. We created a process that does (STAT)
• The Sociology Behind Data Silos In Pharma R&D (Forbes)
• EyeGate surges on FDA nod to start pivotal study; Aldevron to build gene therapy manufacturing campus in Fargus, N.D. (Endpoints)
• GE Healthcare executive jumps ship to lead dermatology biotech LEO (Fierce)
• The Affordable Care Act erased a racial disparity in cancer care, a new study says (STAT)
• 47m medicine doses were diverted in the US last year (Securing Industry)
• BIO conference shines a brighter spotlight on digital health (STAT)
• Vical finds way out of R&D woes via reverse merger with dermatology biotech Brickell (Endpoints)
• Maligned ex-MiMedx chief Petit wants back on the board — wound care company tells shareholders to say no way (Endpoints)
• Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug (FDA)
• Insulin Co-op Urges FDA to Abolish Phase 3 Trials for Insulin Biosimilars (FDA News-$)
• USP General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparations (USP)
• General Chapter <797> Pharmaceutical Compounding – Sterile Preparations (USP)
• USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings (USP)
• USP General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging (USP)

• ASCO: Gilead touts CAR-T franchise with Yescarta analyses, early data on pipeline drug (Fierce) (Press)
• Gilead Presents Data on CAR T Cell Therapy Candidate at ASCO (Press)
• Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the ASCO 2019 Annual Meeting (Press)
• Bristol-Myers Squibb Announces First Presentation of Results for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination in Advanced Hepatocellular Carcinoma at ASCO 2019 (Press)
• Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Press)
• SpringWorks Therapeutics Announces FDA Fast Track Designation for PD-0325901 for the Treatment of a Severe Form of Neurofibromatosis Type 1 (Press)
• Expanded Rubraca® (Rucaparib) Data from Clovis Oncology’s ARIEL3 and TRITON2 Trials in Ovarian and Prostate Cancers to be Presented at 2019 ASCO Annual Meeting (Press)
• Findings from Can-Fite’s Phase II Liver Cancer Study were Presented at ASCO Annual Meeting Late-Breaking Session (Press)
• New Ad-hoc Analysis of Phase 3 HELP Study™ Evaluates Prevention of HAE Attacks with TAKHZYRO® (lanadelumab) During Early Treatment Phase (Press)
• ASCO: With FDA review nearing, Epizyme shares updated sarcoma data (Fierce) (Press)
• Reviva Pharmaceuticals Announces Successful Completion of Pre-IND Meeting with FDA on Brilaroxazine for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) (Press)
• Compugen Presents Update on COM701 Phase 1 Trial at the 2019 ASCO Annual Meeting (Press)
• BerGenBio Presents New Preliminary Clinical and Biomarker Data Showing Durable Response & Median Survival Rates in Phase II Trial With Bemcentinib and KEYTRUDA in Pts With Advanced NSCLC at ASCO 2019 (Press)
• Spectrum Pharmaceuticals Announces Integrated Results from Two Phase 3 ROLONTIS® (eflapegrastim) Trials Being Presented at the ASCO Annual Meeting (Press)
• Five Prime Therapeutics Presents Monotherapy Data From the Phase 1a/1b Trial of FPA150 in Patients With Advanced Solid Tumors at the 2019 ASCO Annual Meeting (Press)
• Celgene Presents Data from a Phase 1/2 Clinical Study of Iberdomide in Combination with Dexamethasone in Patients with Relapsed and Refractory Multiple Myeloma at ASCO 2019 (Press)
• Rakuten Medical Releases Phase 2a Study Data during ASCO Annual Meeting Highlighting Positive Safety Profile and Clinically Meaningful Anti-tumor Activity (Press)
• Clinical Benefit and Safety of LONSURF® (trifluridine/tipiracil) Reinforced by New Data Presented at the 2019 ASCO Annual Meeting (Press)
• IMV Inc. Presents New Positive Data from Phase 2 Monotherapy Arm of Its Decide1 Trial in Advanced Ovarian Cancer and Continued Duration of Clinical Benefits to Patients with Progression Free Survival (Press)
• Celgene Updated Analysis of JAKARTA2 Fedratinib Study Shows Clinically Meaningful Responses in Patients Previously Treated for Myelofibrosis with Ruxolitinib (Press)
• Ironwood Pharmaceuticals and Allergan Initiate Patient Dosing in Phase II Clinical Trial of MD-7246 in Patients with Abdominal Pain Associated with IBS-D (Press)
• Intensity Therapeutics Presents Positive Preliminary Phase 1/2 Results for Intratumoral Injection of INT230-6 at ASCO 2019 (Press)
• New Data from GEOMETRY mono-1 Study Show Clinically Meaningful Results in Patients with Non-Small Cell Lung Cancer with MET exon-14 Skipping Mutation Treated with Capmatinib (Press)
• ALX Oncology Presents New Data from Fully Enrolled ALX148 Clinical Trial Combination Cohorts for the Treatment of Patients with Advanced Solid Tumors (Press)
• Adastra Pharmaceuticals Announces Positive Interim Data from Phase 1b Clinical Trial of Zotiraciclib in the Treatment of Recurrent Malignant Gliomas (Press)
• Xolair (Omalizumab) Significantly Reduced Nasal Polyps and Congestion Symptoms in Adults with Chronic Rhinosinusitis with Nasal Polyps in Two Phase III Studies (Press)
• Xencor Doses First Patient in Phase 1 Study of XmAb®22841 for the Treatment of Patients with Advanced Solid Tumors (Press)
• Pivotal Phase 3 ARTEMIS Trial Data Demonstrates Consistent Safety and Efficacy of AR101 in Children and Adolescents with Peanut Allergy (Press)
• BERG Presents Key Findings From Two Important Clinical Initiatives At The 2019 ASCO Annual Meeting: BERG's Final Phase 1 Results For BPM 31543 In Chemotherapy-Induced Alopecia And A Clinical Study Using BERG's Interrogative Biology® Platform Demonstrating The Importance Of Altruism In Pancreatic Cancer Biomarker Discovery (Press)
• Imbruvica®▼ (ibrutinib) Long-Term Data from Two Pivotal Phase 3 Studies at ASCO and EHA Demonstrate Sustained Efficacy and Safety in Patients with Chronic Lymphocytic Leukaemia (CLL) (Press)
• New Data from Oncopeptides Phase 1/2 O-12-M1 Trial Evaluating Melflufen in RRMM Presented at 2019 ASCO Annual Meeting (Press)
• Takeda Presents Results from Lung Portfolio Including Phase 1/2 Study of TAK-788 in a Rare Form of NSCLC and New Data on Overall Health-Related Quality of Life for ALUNBRIG® (brigatinib) (Press)
• Qurient Announces Positive Phase 2a Data of Novel Antibiotic for the Treatment of Tuberculosis (Press)
• Talaris Therapeutics Presents Data Demonstrating Improved Quality of Life for Patients Treated with FCR001 (Press)
• Adastra Pharmaceuticals Announces Positive Interim Data from Phase 1b Clinical Trial of Zotiraciclib in the Treatment of Recurrent Malignant Gliomas (Press)

• John Oliver Explains FDA Loopholes That Let Faulty Medical Devices Go to Market (Slate)
• Medtronic issues another recall for Endo GIA staplers (MassDevice)
• Smith & Nephew closes Brainlab ortho asset buy (MassDevice)
• Misonix gains FDA clearance for ultrasonic surgical platform (MassDevice)
• TransMedics wins expanded indication for donated lung preservation device (MassDevice)
• Analyst: Mexico tariffs could hit some medical device makers harder (MassDevice)

• The FY 20 Budget and BA Funding for FDA Isn’t Going to Be Easy (Alliance for a Stronger FDA)
• Generic Drugmaker Admits to Price Fixing (Focus)
• FDA’s First Hearing on CBD Opens a Path to Regulation (Focus)
• Johnson & Johnson, Under Fire, Has Track Record Of Weathering Trouble (NPR)
• Fraud Alert: Genetic Testing Scam (HHS OIG)
• America's Largest Retailer Sued For Selling Fake Medicine (Forbes)
• From prison, Martin Shkreli sues ex-colleagues for $30M (Reuters) (Endpoints) (CNBC)
• J&J ordered to pay $300 million in punitive damages in talc baby powder case. Vows to appeal (CNBC)
• Providers say it's time to change anti-fraud laws (Politico)
• Humana: We're Not Merging With Centene (Forbes)
• FDA Focus: What Covington's Practice Chair Is Watching (Law360-$)
• Where Has This Been Hiding? – First Amendment-Based Dismissal of FCA Action (Drug & Device Law)
• The BLOCKING Act: “Oh You Know, Strikes and Gutters, Ups and Downs” (FDA Law Blog)

• FDA Advisory Committee Calendar

• Combination Products and MDR: EMA Offers New Draft Guideline (Focus)
• Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stents (DESs) to the MHRA (MHRA)
• Class 4 Drug Alert, certain Baxter Potassium Chloride containing intravenous infusions (MHRA)

• China: NMPA Drug Traceability Guidance (Drug Channels)

• 70 products in pipeline,Dr Reddy's bullish on China (Economic Times)
• Maharashtra FDA to form society for establishing PMRU to monitor drug price violation (PharmaBiz)

• Share your views in the 2019 TGA stakeholder survey (TGA)
• Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) (TGA)

• Navigating The Regulatory Maze In Emerging Markets – It’s An Art Too (Pink Sheet-$)
• Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America (Springer)