Tag Archives: monoclonal antibody

July, 2018

13 July
Amgen and UCB Resubmit BLA for Evenity to the FDA for the Treatment of Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY increases bone …
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29 September
Prothena Discontinues Development of PRX003 in Psoriasis Following Negative Trial Results

DUBLIN, Ireland, Sept. 28, 2017 (GLOBE NEWSWIRE) — Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, today announced clinical results of a Phase 1b multiple ascending dose (MAD) study of PRX003 in patients with psoriasis. PRX003 is a …
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9 August
Dermira Enters into Agreement for Global Rights to Roche’s IL-13 Drug Lebrikizumab

MENLO PARK, Calif., Aug. 08, 2017 (GLOBE NEWSWIRE) — Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today announced that it has entered into a licensing agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc., a …
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29 June
Celltrion and Teva Announce FDA Acceptance of BLA for Proposed Biosimilar to Rituxan

INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE)–Celltrion, Inc., a global biopharmaceutical company, 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-P10, a proposed Monoclonal Antibody (mAb) biosimilar to Rituxan®1 (rituximab), …
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8 May
Horizon Acquires River Vision and its Late-Stage Rare Eye Disease Drug for $145 Million

DUBLIN, Ireland, May 08, 2017 (GLOBE NEWSWIRE) — Horizon Pharma plc (NASDAQ:HZNP), a biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that it has agreed to acquire River Vision Development Corp. (“River Vision”) and …
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10 February
FDA Panel Backs Pfizer and Celltrion’s Proposed Biosimilar Infliximab

Pfizer Inc. commends today’s recommendation by the United States (U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory Committee to approve the investigational biosimilar infliximab (CT-P13) across all eligible indications by a vote of 21 to three. Celltrion’s proposed biosimilar infliximab, to which Pfizer holds exclusive U.S. commercialization rights, is the …
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