Industry News

- Read more about European Commission award orphan drug status to Cytori Therapeutics' cell therapy formulations
The European Commission has granted orphan drug status to Cytori Therapeutics' broad range of Cytori Cell Therapy formulations when used for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma.
- Read more about US FDA grants orphan drug status to selumetinib
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc. in 2003.
- Read more about Aurinia initiate clinical study of voclosporin in Japanese volunteers
Aurinia Pharmaceuticals Inc, a clinical stage pharmaceutical company announced that after constructive interactions with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the company will initiate a study of voclosporin in healthy Japanese volunteers. With positive results from the pending phase 2b AURA-LV study in lupus nephritis (LN) and supportive safety, tolerability, pharmacokinetic and pharmacodynamic data from this clinical study, the company hopes to be able to incorporate Japanese patients into future global voclosporin studies, eliminating the need to conduct a stand-alone Japanese trial.
- Read more about FDA Finalize rule for data collection of antimicrobial sales and distribution by animal species
The U.S. Food and Drug Administration finalize rule that revises its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human consumption or food-producing animals. The new sales data will improve the agency’s understanding of how antimicrobials are sold and distributed for use in major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials.
- Read more about X4 Pharma start phase 1/2 study of X4P-001
X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking and increase the ability for T-cells to track and destroy cancer, announced dosing of the first patient in a phase 1/2 study of X4P-001, the company’s lead CXCR4 inhibitor, in patients with advanced clear cell renal cell carcinoma (ccRCC).
- Read more about JHL Biotech Opens Innovative Biosimilars Manufacturing Facility in China
JHL Biotech (JHL), a biopharmaceutical company,opened the world’s first KUBio™ biopharmaceutical manufacturing facility with single-use bioprocessing technology at a ribbon-cutting ceremony in Wuhan, China today.
- Read more about Morepen Laboratories Scores No. 1 Position Globally for its Bulk Drug Montelukast
Morepen Laboratories Ltd. has established a leadership position for its anti-asthmatic bulk drug Montelukast in the global market. As per the latest report published by a global research firm - QYR Research, Morepen is the No.1 supplier globally in terms of total quantity sold, followed by Mylan and TAPI (Teva) who appear on the second and third position respectively.
- Read more about Abbott Announces Positive Results From Pivotal Study Of Tecnis® Symfony IOL
Abbott announced that its pivotal clinical trial of the company's Tecnis® Symfony 1-Piece Acrylic Intraocular Lens (IOL) met its primary endpoint of improved intermediate vision. Data from this study showed that people who received the Tecnis Symfony lens achieved significantly improved intermediate, as well as near, vision compared to those who received a monofocal IOL. The data were presented at the American Society of Cataract and Refractive Surgery (ASCRS) in New Orleans by Jason Jones, M.D., Jones Eye Clinic, Sioux City, Iowa.
- Read more about Epizyme collaborate with Lymphoma Study Association to Evaluate Tazemetostat with R-CHOP
Epizyme, Inc. announced that it has entered into a collaboration agreement with the Lymphoma Study Association (LYSA) to investigate the combination of tazemetostat with R-CHOP as a front-line treatment in patients with diffuse large B-cell lymphoma (DLBCL). LYSA is a premier cooperative group in France dedicated to clinical and translational research for lymphoma, and is certified by the French National Cancer Institute. Under the agreement, the phase 1b/2 trial will be jointly conducted with the Lymphoma Academic Research Organisation (LYSARC), the operational arm of LYSA.
- Read more about Theravance Biopharma get FDA Approval of Expanded Label for VIBATIV(R) (telavancin)
Theravance Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for VIBATIV® (telavancin) to expand the product's label to include data describing the treatment of patients with concurrent Staphylococcus aureus (S. aureus) bacteremia in both of the antibiotic's currently approved indications in the United States.