News and Trends 28 Jul 2022 Biogen’s New Drug Application for first treatment of rare form of neurological disease accepted by FDA A drug to target a rare genetic form of a neurological disease that affects the nerve cells, leading to the loss of everyday functions, could be the first of its kind available if approved. The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Massachusetts-based Biogen Inc. for tofersen, an […] July 28, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 28 Jul 2022 Step Pharma moves into oncology clinical trials Step Pharma, which works on CTPS1 inhibition for the targeted treatment of cancer, has announced its lead asset STP938 has cleared both an Investigational New Drug (IND) application by the Food and Drug Administration (FDA), and a clinical trial application (CTA) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This means Step Pharma […] July 28, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 28 Jul 2022 Kelun-Biotech announces joint license agreement with MSD for drug targeting solid tumors Kelun-Biotech and MSD (Merck & Co.) have announced they are entering in a joint license agreement to develop a drug to treat solid tumors. The announcement was made yesterday (July 27) for the partnership to create the investigational antibody drug conjugate (ADC). Under the terms of the agreement, Kelun-Biotech, a clinical-stage biotech company focused on […] July 28, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 28 Jul 2022 First of a kind multiple sclerosis biosimilar natalizumab accepted by US Food and Drug Association Sandoz, a global pharmaceutical company working in generic and biosimilar medicines, announced this week that the US Food and Drug Administration (FDA) has accepted its biologics application (BLA) for treatment for people with multiple sclerosis (MS). The application is for a biosimilar natalizumab developed by Polpharma Biologics and includes all indications covered by the reference […] July 28, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 28 Jul 2022 Commercial launch of Monkeypox PCR test announced for research A PCR test to pick up the monkeypox virus is now available outside the US for use in research applications by laboratories. Becton, Dickinson and Company (BD) a global medical technology company and CerTesy Biotec made the announcement today (July 27). The BD MAX System used to leverage the test is a fully integrated, automated […] July 28, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jul 2022 AbbVie seeks nod from FDA and EMA for Crohn’s disease drug U.S. biopharma company AbbVie has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ) for the treatment of adult patients with moderately to severely active Crohn’s disease. “Crohn’s disease can be debilitating and have a significant impact on a person’s daily life,” […] July 27, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jul 2022 T-cell therapy company AlloVir set to raise $126.6M AlloVir, Inc., a late clinical-stage allogeneic T-cell immunotherapy company, has entered into a securities purchase agreement with a group of institutional and strategic investors to sell 27,458,095 shares of common stock in a registered direct offering at a purchase price of $4.61 per share. Gross proceeds from the offering will equal approximately $126.6 million. The […] July 27, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jul 2022 Diffusion Pharmaceuticals to start brain tumor clinical trial U.S. biopharma company Diffusion Pharmaceuticals Inc. is set to start a new phase 2 clinical trial. Entitled “Open-Label, Dose-Escalation, Phase 2 Safety and Efficacy Study of TSC in Newly Diagnosed Glioblastoma (GBM) Patients when Administered with Standard of Care (“SOC”),” the company said the trial is a result of a collaboration with the United States […] July 27, 2022 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jul 2022 SOTIO Biotech starts solid tumor trial SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group is starting its phase 2 trial on patients with selected advanced/refractory solid tumors. The company has dosed its first patient in the AURELIO-04 combination trial of SOT101 and MSD’s (Merck & Co., Inc., Rahway, NJ) anti-PD-1 therapy KEYTRUDA (pembrolizumab). “The initiation of this phase […] July 27, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jul 2022 Oryzon collaborating with CMT Research Foundation in the US Spanish biopharma company Oryzon Genomics, S.A. is starting a preclinical collaboration with the CMT Research Foundation (CMTRF), a U.S.-based patient-led, non-profit organization focused on delivering treatments and cures for Charcot-Marie-Tooth (CMT) disease, to explore Oryzon’s histone deacetylase 6 (HDAC6) inhibitors. HDAC6 inhibitors have been previously described as potentially effective treatments for CMT. Oryzon has recently […] July 27, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jul 2022 SomaLogic acquires DNA nanotechnology company Palamedrix Colorado-based AI data-driven proteomics technology company SomaLogic has entered into an agreement to acquire Palamedrix, Inc., which is involved in DNA nanotechnology. Palamedrix provides scientific and engineering expertise and miniaturization technology, which SomaLogic intends to leverage as it develops the next generation of the SomaScan assay. Proteomic tool The SomaScan assay is a multiplexed, sensitive, quantitative, […] July 27, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 26 Jul 2022 Pleco Therapeutics expands into U.S. and names president Pleco Therapeutics BV, a biopharmaceutical company based in the Netherlands, has expanded, with the incorporation of a U.S. subsidiary, Pleco Therapeutics USA. Pleco Therapeutics, which develops novel treatments designed to detoxify the cancer promoting cellular micro-environment, also named Michael Stalhamer as the US subsidiary’s president and first employee. Stalhamer also serves on the global leadership […] July 26, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email