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 new supplemental Biologics License Application (sBLA) for GARDASIL ® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. Read More »

The Eighth Circuit Court of Appeals, in a unanimous three judge decision, today ruled in favor of the Pharmaceutical Care Management Association’s (PCMA) challenge (PCMA vs. Rutledge) to Arkansas law, Act 900, which restricted pharmacy benefit management (PBM) tools, and required employers and consumers to pay higher rates to independent drugstores for prescription drugs. Read More »

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.1 Read More »

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. Read More »

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved, under priority review, VENCLEXTA® (venetoclax tablets) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy Read More »

Celgene Corporation (NASDAQ:CELG) today announced updated six-month safety and efficacy data from the TRANSCEND (NHL-001) study of lisocabtagene maraleucel (liso-cel; JCAR017), an investigational CD19-directed CAR T cell therapy, in patients with relapsed/refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL) in a presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Read More »

Hookipa Biotech AG ("Hookipa"), a clinical-stage biotech company pioneering an innovative class of active immunization therapies for oncology and infectious diseases and Gilead Sciences, Inc., ("Gilead"), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need, today announced that they have entered into a research collaboration and license agreement that grants Gilead exclusive rights to Hookipa's TheraT® and Vaxwave® arenavirus vector-based immunization technologies for two major chronic infectious disease indications, hepatitis B virus (HBV) and human immunodeficiency virus (HIV). Read More »

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S.Food and Drug Administration (FDA) has approved Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.1 Read More »

Eli Lilly and Company (NYSE: LLY) today announced that the U.S Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA® (pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. . Read More »

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with Lynparza (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a standard of care, in metastatic castration-resistant prostate cancer (mCRPC). Read More »

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (Nasdaq: SGEN) today announced the presentation of updated phase 1 data of enfortumab vedotin, an investigational antibody-drug conjugate (ADC), at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting in Chicago. Read More »

Takeda Pharmaceutical Company Limited [TSE:4502] (“Takeda”) today announced a new analysis of real-world data comparing the safety data of the gut-selective biologic Entyvio® (vedolizumab) and tumor necrosis factor-alpha (TNFα)-antagonist therapy. Read More »

Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, “Purdue Pharma”) today presented the results of two key Phase 1 clinical studies of their investigational sleep/wake regulation agent lemborexant at the 32nd Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2018), June 2-6, Baltimore, MD. Lemborexant is currently being studied for the potential treatment of multiple sleep disorders. Read More »

Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced new interim results from the Company’s ongoing Phase 2a study of cerdulatinib, an investigational, oral SYK/JAK inhibitor, in patients with specific subtypes of B-cell and T-cell Non-Hodgkin Lymphoma (NHL), including relapsed/refractory follicular lymphoma (FL) and peripheral T-cell lymphoma (PTCL), and chronic lymphocytic lymphoma/small lymphocytic lymphoma (CLL/SLL). Read More »

Celgene Corporation (NASDAQ:CELG) today announced additional results from RELEVANCE, a phase III, randomized, open-label, international clinical study conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC), were presented at the 54th Annual American Society of Clinical Oncology Scientific Sessions (ASCO) in Chicago, Illinois on June 1-5, 2018. Read More »

CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S.Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug Application (IND) for CTX001 for the treatment of sickle cell disease pending the resolution of certain questions that will be provided by the FDA as part of its review of the IND. Read More »

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that preliminary data from the dose escalation part of an ongoing phase 1/2 study with investigational U3-1402 in heavily pretreated patients with HER3-positive metastatic breast cancer will be presented during a Poster Discussion Session on Monday, June 4 at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL (Abstract 2512; 3:00 – 4:15 PM CDT). Read More »

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S.Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT® (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. Read More »

Global biotherapeutics leader CSL Behring today announced that the US Food and Drug Administration (FDA) has approved a 3500 IU (international unit) vial size for IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)], its novel, long-acting recombinant albumin fusion protein for treating hemophilia B. Read More »

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a randomized, open-label Phase 3 study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Read More »