News

Hovione announced that it will soon initiate recruitment for its Phase 1 clinical trial of HY02. This first in human study is a double-blinded, randomized trial, which will include…
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Lysogene has completed the enrollment in its “Sanfilippo A Multi-national Observational Study” (SAMOS). Sanfilippo A is also known as Mucopolysaccharidosis Type IIIA (MPS IIIA).…
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Lysogene and Brammer Bio has entered into manufacturing agreement. Brammer Bio will produce an AAVrh10-based gene therapy, LYS-GM101 for clinical testing of the therapeutic candidate in…
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US Patent and Trade Office (USPTO) has issued Notice of Allowance to Neurana Pharmaceuticals for two new tolperisone patents, including a second Composition of Matter patent for a novel…
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US FDA has granted Orphan Drug Designation (ODD) for Abeona’s EB-101 gene therapy program for patients with dystrophic epidermolysis bullosa (DEB), including recessive dystrophic…
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Optibrium has entered into a collaboration with Imperial College London for developing new treatments for neglected diseases as part of a collaborative project with DNDi (Drugs for…
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The US FDA Oncologic Drugs Advisory Committee (ODAC) recommended the approval of the Pizer’s proposed epoetin alfa biosimilar across all indications. The Committee’s favorable…
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X4 Pharmaceuticals announced dosing of the first patient in the Phase 2 portion of the ongoing Phase 1/2 study evaluating X4P-001, the CXCR4 inhibitor, in combination with Inlyta…
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The US FDA accepted Bristol-Myers Squibb supplemental BLA to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The FDA…
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Constellation Pharmaceuticals has appointed Jigar Raythatha as president and CEO. He will lead the company focused on harnessing its deep scientific expertise in cancer epigenetics, to…
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Optum announced that they will collaborate with Merck to explore value-based and pay-for-performance models, known as Outcomes-Based Risk Sharing Agreements (OBRSAs), and their…
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PharmaMar has signed agreement with Eczacibasi Group to commercialize the marine-derived anticancer drug Aplidin (plitidepsin) in Turkey. Aplidin is PharmaMar´s second most advanced…
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The U.S. Patent and Trademark Office has issued a Notice of Allowance in favour of Ammonett Pharma for Patent Application No: 15/271,542, entitled “DETECTING AND TREATING GROWTH HORMONE…
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Akebia Therapeutics has appointed Rita Jain, M.D. as Senior VP and CMO. She will be responsible for leading the clinical development of the Company's HIF pipeline, including the global…
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miRagen Therapeutics announced that  MRG-106 has received orphan medicinal product designation from European Commission (EC) for the treatment of cutaneous T-cell lymphoma (CTCL). CTCL…
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Sun Pharmaceutical Industries announced that USFDA has accepted BLA for tildrakizumab submitted by Merck & Co., USA. The FDA filing acceptance follows acceptance of the regulatory…
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KBI Biopharma announced that they have planned to invest $30M for expanding its biopharmaceutical manufacturing capacity at both its Durham, NC, and Boulder, CO, facilities. KBI is…
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Selexis SA and OSE Immunotherapeutics announced that they have signed a commercial license agreement that provides OSE Immunotherapeutics with access to high performance research cell…
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Pierre Fabre announced that they signed a definitive purchase agreement with Igenica Biotherapeutics to acquire several of Igenica assets. The agreement includes innovative…
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LSNE Contract Manufacturing announced that it has signed a manufacturing supply agreement with Selecta Biosciences to support the development of biologic therapies for rare and serious…
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