PFIZER: U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (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 (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. Read More »

GENENTECH, INC: Genentech Announces Submission of Supplemental New Drug Application for Venclexta for People With Previously Untreated Acute Myeloid Leukemia who are Ineligible for Intensive Chemotherapy

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Venclexta® (venetoclax), in combination with a hypomethylating agent or in combination with low dose cytarabine (LDAC), for treatment of people with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Read More »

MERCK: FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Advanced Hepatocellular Carcinoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with advanced hepatocellular carcinoma (HCC). Read More »

ASTELLAS PHARMA US, INC.: Seattle Genetics and Astellas Announce Progress in Enfortumab Vedotin Urothelial Cancer Clinical Development Program

Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced completion of enrollment for the enfortumab vedotin EV-201 pivotal phase 2 clinical trial cohort of patients with locally advanced or metastatic urothelial cancer who have been previously treated with both platinum chemotherapy and a checkpoint inhibitor (PD-L1 or PD-1). Read More »

ABBVIE: AbbVie Announces Submission of Supplemental New Drug Application to US FDA for Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for venetoclax in combination with a hypomethylating agent (HMA) or in combination with low-dose cytarabine (LDAC) for the treatment of newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Read More »

ABBVIE: AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Blood Cancer Diffuse Large B-Cell Lymphoma (DLBCL) and Ongoing Ibrutinib Clinical Program

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced an update on a Phase 3 study (DBL3001) of ibrutinib (IMBRUVICA®) in untreated (treatment-naïve) diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma (NHL). Read More »

MERCK: FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy in Advanced Melanoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S Food and Drug Administration (FDA) has accepted for standard review a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act (PDUFA), or target action, date of February 16, 2019. Read More »

CENTERS FOR MEDICARE AND MEDICAID SERVICES: CMS Approves State Proposal to Advance Specific Medicaid Value-Based Arrangements with Drug Makers

Today, the Centers for Medicare & Medicaid Services (CMS) issued the first-ever approval of a state plan amendment proposal to allow the state of Oklahoma to negotiate supplemental rebate agreements involving value-based purchasing arrangements with drug manufacturers that could produce extra rebates for the state if clinical outcomes are not achieved Read More »

PURDUE PHARMA L.P: Eisai and Purdue Pharma Announce Oral Presentation of Latest Clinical and Non-Clinical Data on Lemborexant at 43rd Annual Meeting of the Japanese Society of Sleep Research

Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD “Purdue Pharma”) today announced that they will present data on their investigational sleep-wake regulation agent lemborexant (development code: E2006), in an oral presentation at the 43rd Annual Meeting of the Japanese Society of Sleep Research (JSSR), July 11-13, Sapporo, Japan Read More »

MERCK: FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy as First-Line Treatment for Metastatic Squamous Non-Small Cell Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. Read More »

BRISTOL-MYERS SQUIBB: Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended expanded approval of the current indications for Opdivo (nivolumab) to include the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Read More »

AMGEN: Amgen And Novartis Present New Data Demonstrating Long-Term Efficacy, Safety And Tolerability Of Aimovig™ (erenumab-aooe) In Patients With Chronic And Episodic Migraine

Amgen (NASDAQ:AMGN) today announced that the results of two open-label extension (OLE) studies of Aimovig™ (erenumab-aooe) in patients with chronic and episodic migraine, respectively, will be presented at the 60th Annual Scientific Meeting of the American Headache Society (AHS) in San Francisco. Read More »

PFIZER INC: U.S. FDA Grants Priority Review for Pfizer’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia

Pfizer Inc. (NYSE:PFE) today announced that the U.S.Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO) inhibitor, being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC), a type of chemotherapy. Read More »