Pharma News

Novavax, Inc announced the Phase 3 trial of its RSV F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization will continue. Novavax also provided an update on its nanoparticle influenza vaccine candidate with proprietary Matrix-M™ adjuvant (NanoFlu™).

Vedanta Biosciences, an affiliate of PureTech Health developing a new category of therapies for immune-mediated and infectious diseases based on rationally defined consortium of human microbiome-derived bacteria, announced that the United States Patent and Trademark Office (USPTO) has issued four new patents, US 9,801,933, US 9,808,519, US 9,827,276, and US 9,833,483. The new patents broadly cover pharmaceutical compositions including Clostridium bacterial strains and methods of use for therapeutic products, including consortia of bacterial strains and spore-forming fractions based on beneficial bacteria. The newly issued patents are exclusively licensed to Vedanta under an agreement with the University of Tokyo and provide coverage through at least 2031. These issuances further strengthen Vedanta’s leading intellectual property position in the microbiome field, which includes previous issuances US 9,415,079, US 9,421,230, US 9,433,652, US 9,642,882, US 9,662,381, EP2575835, JP5592958, JP5853063, and JP6115971.

MacroGenics, Inc a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, announced the presentation of clinical data from its ongoing Phase 1 study of flotetuzumab in an oral session at the 59th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia. John E. Godwin, M.D., Program Leader, Hematologic Malignancies at Earle A. Chiles Research Institute at Providence Cancer Center in Portland, Oregon presented "Preliminary Results of a Phase 1 Study of Flotetuzumab, a CD123 x CD3 Bispecific DART Protein, in Patients with Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome."

Myriad Genetics, Inc. a leader in molecular diagnostics and personalized medicine, announced that data from the EMBRACA trial showed Myriad’s BRACAnalysis CDx®  test successfully identified patients with metastatic breast cancer (MBC) who responded to Pfizer’s investigational PARP inhibitor, talazoparib. 

People with either type 1 or type 2 diabetes treated with Tresiba® had fewer episodes of low blood sugar (hypoglycaemia) compared with people on insulin glargine U100 regardless of whether they had achieved blood sugar targets.These new post-hoc analyses from the SWITCH 1 and 2 trials were presented at the International Diabetes Federation (IDF) Annual Congress in Abu Dhabi.

Sandoz, a division of Novartis  and the global leader in biosimilars, announced data demonstrating the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta®*. The Phase I study, conducted in healthy volunteers, confirmed that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of PK, PD, safety and immunogenicity profiles. The data were presented during the 2017 San Antonio Breast Cancer Symposium.

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Mylan N.V.and Biocon Ltd.  announced that the U.S. Food and Drug Administration (FDA) has approved Mylan´s Ogivri^TM (trastuzumab­dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. OgivriTM has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).