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 »

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 »

MCKESSON CORPORATION: Combination Therapy BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) for the Treatment of BRAF-mutant Melanoma, Available for Order at Biologics, Inc.

Biologics, Inc., a McKesson Specialty Health oncology, neurology and complex care pharmacy services company, has been selected by Array BioPharma, Inc. to be in the limited distribution network for the combination therapy BRAFTOVITM (encorafenib) and MEKTOVI®(binimetinib) for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by a U.S. Food and Drug Administration (FDA) approved test. Read More »

PFIZER: Pfizer Announces Overall Survival Results from Phase 3 PALOMA-3 Trial of IBRANCE® (Palbociclib) in HR+, HER2- Metastatic Breast Cancer

Pfizer today announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine therapy. Read More »

PFIZER: Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years

Pfizer Inc. announced that TRUMENBA® (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years. Read More »

MCKESSON, INC.: McKesson Board of Directors Releases Findings and Recommendations of Independent Investigation

The Board of Directors of McKesson today released its response to a request from the International Brotherhood of Teamsters, a McKesson stockholder, that the Board perform an investigation into senior management’s and the Board’s oversight of McKesson’s compliance with its legal and regulatory obligations relating to the distribution of opioids. Read More »

MCKESSON SPECIALTY HEALTH: ERLEADA (Apalutamide), the First FDA-Approved Treatment for Non-Metastatic, Castration-Resistant Prostate Cancer, Available for Order at Biologics, Inc.

Biologics, Inc., a McKesson Specialty Health oncology and complex care pharmacy services company, has been selected by the Janssen Pharmaceutical Companies of Johnson & Johnson1 to be in the limited distribution network for ERLEADA™ (apalutamide), the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer (NM-CRPC). The addition of this critical patient therapy brings the total number of oncology and supportive therapies accessible through Biologics to 115. Read More »

PHIZER: Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis

Pfizer Inc. announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. Read More »