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Monthly Archives: July 2017

LabCorp to Acquire Specialty CRO Chiltern for $1.2 Billion in Cash

BURLINGTON, N.C. & WILMINGTON, N.C. & LONDON–(BUSINESS WIRE)–LabCorp® (NYSE:LH), a leading global life sciences company, and Chiltern, a specialty CRO, announced today that LabCorp will acquire Chiltern pursuant to a definitive agreement with Chiltern’s shareholders in an all-cash transaction valued at approximately $1.2 billion. Once the transaction is complete, Chiltern …

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FDA Grants Breakthrough Therapy Designation to Imfinzi for Non-Small Cell Lung Cancer

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. Sean Bohen, …

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FDA to Review Teva and Celltrion’s BLA for Proposed Biosimilar to Herceptin

INCHEON, Republic of Korea & JERUSALEM–(BUSINESS WIRE)–Jul. 31, 2017– Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P6, a proposed Monoclonal Antibody (mAb) biosimilar to Herceptin®1 (INN: trastuzumab) which is used for the treatment of Human Epidermal …

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AstraZeneca’s Imfinzi Fails to Meet Primary Endpoint in Late-Stage Lung Cancer Trial

AstraZeneca and MedImmune, its global biologics research and development arm, today announced progression-free survival (PFS) results for the Phase III MYSTIC trial, a randomized, open-label, multi-center, global trial of Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung …

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Study Finds Breast Cancer Driver, HER2, in 3 Percent of Lung Cancers

The Lung Cancer Mutation Consortium at the University of Colorado Cancer Center reports this week in the journal Cancer that 24 of 920 patients (3 percent) with advanced-stage lung cancer had mutations in the gene HER2. Seventy-one percent of these patients were never-smokers, with a median age of 62. The gene HER2 …

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FDA Grants Breakthrough Therapy Designation for Roche’s Venclexta in Acute Myeloid Leukemia

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Venclexta® (venetoclax) in combination with low dose cytarabine (LDAC) for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy. FDA breakthrough therapy designation is intended …

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Flex Pharma’s FLX-787 Granted FDA Fast Track Status for Treatment of Severe Muscle Cramps Associated with ALS

Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology company that is developing innovative and proprietary treatments for cramps and spasticity associated with serious neurological diseases including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Charcot-Marie-Tooth (CMT), today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for …

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Merck and AstraZeneca Enter Strategic Oncology Collaboration

ENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s LYNPARZA (olaparib) for multiple cancer types. LYNPARZA is an innovative, first-in-class oral poly ADP …

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Astellas Announces Wind-Down of Agensys Research Operations

TOKYO, July 26, 2017 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that it is winding down its Agensys research operations in Santa Monica, California, USA, to further refine its oncology strategy by expanding its investment in the research in new technologies and modalities and reducing its focus …

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Servier Licenses GLPG1972 in Osteoarthritis from Galapagos

28 July 2017 – As a result of their research collaboration, Servier announces today that it has exercised its option to develop novel osteoarthritis molecule GLPG1972/S201086 from Galapagos NV (Euronext/NASDAQ: GLPG), thus obtaining global commercial rights outside the U.S. Osteoarthritis (OA) is a highly prevalent and disabling pathology, considered as …

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