European Medicines Agency Adopts Positive Opinion for KEYTRUDA® (pembrolizumab) Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

European Medicines Agency Adopts Positive Opinion for KEYTRUDA® (pembrolizumab) Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

July 30, 2018 KEYTRUDA Combination Improved Overall Survival Compared with Pemetrexed and Platinum Chemotherapy Alone in Pivotal Phase 3 Trial (KEYNOTE-189) Positive Opinion for KEYTRUDA Also Adopted for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-040)

FDA grants Breakthrough Therapy Designation for Roche’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma (HCC)

FDA grants Breakthrough Therapy Designation for Roche’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma (HCC)

19 July 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced

Lilly’s Once-Weekly Trulicity® (dulaglutide) Label Updated to Include Data Showing Benefits for Adults with Type 2 Diabetes and Chronic Kidney Disease

Lilly’s Once-Weekly Trulicity® (dulaglutide) Label Updated to Include Data Showing Benefits for Adults with Type 2 Diabetes and Chronic Kidney Disease

July 19, 2018 Lilly’s Once-Weekly Trulicity® (dulaglutide) Label Updated to Include Data Showing Benefits for Adults with Type 2 Diabetes and Chronic Kidney Disease INDIANAPOLIS, July 19, 2018 /PRNewswire/ — The U.S. label for Eli Lilly and Company’s (NYSE: LLY) once-weekly

U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

July 13, 2018 First and Only Oral Treatment FDA-Approved for Both Non-Metastatic and Metastatic CRPC Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration

Amgen And UCB Resubmit Biologics License Application (BLA) For EVENITY™ (romosozumab) To The US FDA

Amgen And UCB Resubmit Biologics License Application (BLA) For EVENITY™ (romosozumab) To The US FDA

July 12, 2018 BLA Includes Data From Pivotal Phase 3 Studies of More Than 11,000 Patients THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics

Bristol-Myers Squibb’s Opdivo® (nivolumab) + Low-Dose Yervoy® (ipilimumab) is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin and…

Bristol-Myers Squibb’s Opdivo® (nivolumab) + Low-Dose Yervoy® (ipilimumab) is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin and…

July 11, 2018 Bristol-Myers Squibb’s Opdivo ® (nivolumab) + Low-Dose Yervoy ® (ipilimumab) is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin and Irinotecan In the CheckMate -142 trial, Opdivo +

Anti-PD-L1 Immunotherapy Plus ABRAXANE® Significantly Reduced the Risk of Disease Worsening or Death in Patients with Metastatic or Locally Advanced Triple Negative Breast Cancer in Phase III IMpassion130 Study

Anti-PD-L1 Immunotherapy Plus ABRAXANE® Significantly Reduced the Risk of Disease Worsening or Death in Patients with Metastatic or Locally Advanced Triple Negative Breast Cancer in Phase III IMpassion130 Study

Jul 10, 2018 First Phase III study to demonstrate a statistically significant progression-free survival improvement in first-line metastatic triple negative breast cancer (TNBC)  IMpassion130 is the third positive Phase III study to demonstrate a clinical benefit with the investigational combination

Lynparza approved in Japan for BRCA-mutated metastatic breast cancer

Lynparza approved in Japan for BRCA-mutated metastatic breast cancer

02 July 2018 Lynparza is the first and only PARP inhibitor approved for use beyond ovarian cancer Second approval in Japan for AstraZeneca and MSD’s Lynparza AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside

Imfinzi approved in Japan for unresectable Stage III non-small cell lung cancer

Imfinzi approved in Japan for unresectable Stage III non-small cell lung cancer

02 July 2018 Imfinzi is the only immunotherapy approved for unresectable Stage III NSCLC Approval is based on the Phase III PACIFIC trial AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the Japanese Ministry of