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- Read more about FDA approves first intraocular lens for cataract patients
The U.S. Food and Drug Administration approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances. The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics, Inc. of Santa Ana, California.
- Read more about Zika virus: antibodies identified with therapeutic and diagnostic potential
In red the part that binds to the virus, in grey the “tail” of the antibody (named Fc) that binds the receptors of the antibodies present on the different types of cells, and in yellow the LALA mutation that blocks the binding of the antibody to such receptors.

A team of researchers from the Institute for Research in Biomedicine (IRB, USI Università della Svizzera italiana) and the Swiss biotech company Humabs BioMed SA has identified novel therapeutic monoclonal antibody candidates isolated from Zika-infected patients and new strategies for Zika virus diagnostics. An article published today in the renowned scientific journal Science describes for the first time an in-depth analysis of the human antibody and T cell immune response to the Zika virus infection with important implications for differential diagnostics and for the development of vaccines and new treatments.
- Read more about Oncternal Therapeutics' TK216 get US FDA Orphan Drug status for Ewing sarcoma
Oncternal Therapeutics, Inc., a clinical-stage oncology company developing first-in-class therapies for rare and common malignancies, announced that TK216 has received Orphan Drug designation from the US Food and Drug Administration (FDA) for the treatment of Ewing sarcoma.
- Read more about Amgen & Daiichi Sankyo collaborate to Commercialize Biosimilars In Japan
Amgen and Daiichi Sankyo Company, Limited announced the execution of an exclusive agreement to commercialize nine biosimilars in Japan. The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab.
- Read more about Loxo Oncology Get Breakthrough Therapy Designation from U.S. FDA for LOXO-101
Loxo Oncology, Inc, a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.”
- Read more about Pluristem advances phase I trial of PLX-R18 cells to treat hematologic indication
Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced it has advanced its phase I trial of PLX-R18 cells to treat insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT) by contracting with a leading global clinical research organization (CRO).
- Read more about US FDA advisory committee review Amgen's BLA for ABP 501
Amgen announced that the company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the US Food and Drug Administration's (FDA) Arthritis Advisory Committee. ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumour necrosis factor-alpha (TNF-a) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.
- Read more about Biocon got approval for Insulin Glargine in Japan
Biocon close on the heels of receiving approval for its Insulin Glargine from the Japanese regulator last quarter, its partner FUJIFILM Pharma Co., Ltd. (FFP) has launched the product in Japan today.
- Read more about FDA Approve Cohera Medical Inc to Begin Trials of its Sylys® Surgical Sealant in the U.S.
Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) to begin a prospective, multicenter, randomized clinical trial for its Sylys® Surgical Sealant device.
- Read more about Health Canada grant InVivo Therapeutic’s Investigational Testing Authorization
InVivo Therapeutics Holdings Corp. announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence clinical studies in Canada. The authorization will allow the company to enroll Canadian patients into the ongoing INSPIRE study once a Canadian site is open for enrollment. InVivo currently is in late stage conversation with various Canadian Research Ethics Boards and expects to announce its first Canadian site in the coming weeks.

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