Monoclonal Antibodies Archives - Page 15 of 16

FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis

Approvals, FDA/Regulatory, Interleukin-6 (IL-6), New Formulations, Systemic Juvenile Idiopathic Arthritis (SJIA)

Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

September 13, 2018/by Business Wire

Novartis Receives FDA Approval For New Prescribing Information For Blockbuster PsA Treatment Cosentyx

Active Psoriatic Arthritis (PsA), Clinical Data, FDA/Regulatory, Interleukin-17A (IL-17A), Monoclonal Antibodies, Prescribing Information

FDA approved inclusion of new evidence that Cosentyx significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active psoriatic arthritis (PsA).

June 19, 2018/by PR Newswire

FDA Grants Priority Review for Lanadelumab

Biologics License Application (BLA), FDA/Regulatory, Hereditary Angioedema (HAE), Monoclonal Antibodies, Plasma Kallikrein (pKal) Inhibitors, Priority Review, Rare Diseases

Shire plc announced the U.S. Food and Drug Administration accepted the Biologics License Application and granted priority review for lanadelumab (SHP643).

February 23, 2018/by Administrator

EU Approves Celltrion’s Trastuzumab Biosimilar

Biopharmaceutical, Biosimilars, Blockbusters, Committee for Medicinal Products for Human Use (CHMP), European Commission, FDA/Regulatory, Monoclonal Antibodies, Oncology

The EC approved Herzuma for patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have HER2 overexpression or HER2 gene amplification.

February 13, 2018/by Business Wire

Phase II Data Support Potential for Novel Anti-VEGF/Anti-Angiopoietin-2 Bispecific Antibody, RG7716, for People With Diabetic Macular Edema

Bispecific Antibody, Clinical Trials, Diabetic Macular Edema, Eye Diseases, Monoclonal Antibodies, Ophthalmics, R&D, Retinal eye diseases

Genentech announced encouraging results from the Phase II BOULEVARD study. In people with vision loss from diabetic macular edema, treatment with intravitreal RG7716 resulted in clinically meaningful and statistically significant improvements in visual acuity gains compared with ranibizumab alone.

February 12, 2018/by Business Wire

Chugai’s Hemlibra Gains Positive CHMP Opinion

Committee for Medicinal Products for Human Use (CHMP), Factor VIII Inhibitors, FDA/Regulatory, Hemophilia A, Monoclonal Antibodies

The EU’s CHMP adopted a positive opinion for Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors.

January 28, 2018/by Business Wire

Pfizer Announces Positive Top-Line Results For Potential Biosimilar To Rituxan/MabThera

Pfizer Inc. announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera (rituximab-EU), met its primary endpoint.

January 24, 2018/by Business Wire

Adimab Announces Antibody Discovery Collaboration with Boehringer Ingelheim

Collaboration, Drug Discovery, Monoclonal Antibodies

Adimab will use its proprietary platform to discover and optimize antibodies against targets chosen by BI, who will have the rights to develop and commercialize therapeutic programs resulting from the collaboration.

January 10, 2018/by Business Wire

FDA Approves Actemra for CAR T Cell-Induced CRS

Approvals, Blockbusters, Chimeric Antigen Receptor T Cell Therapy (CART), FDA, FDA/Regulatory, First-of-its kind, Interleukin-6 (IL-6), Oncology, Orphan Drugs, Priority Review

The U.S. FDA approved Genentech’s Actemra (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome in patients 2 years of age and older.

August 30, 2017/by Business Wire

Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab

Chronic Lower Back Pain (cLBP), Chronic Pain, Monoclonal Antibodies, Osteoarthritis

Pfizer Inc. and Eli Lilly and Company announced that the U.S. Food and Drug Administration granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP).

June 13, 2017/by Business Wire