Press Releases
Xellia Pharmaceuticals, a global leader in the manufacturing of specialty anti-infective treatments, announces that its manufacturing site in Cleveland, Ohio is now commercially operational and has released the first anti-infectives manufactured at the site, to be distributed for use by US hospitals. The anti-infective is the first drug product to be manufactured at the Cleveland site since it was bought by Xellia in 2015 and extensively rebuilt. The state-of-the-art facility is now
Read more...18 August 2021
NeuCyte, Inc., an innovative biotech company focused on developing novel treatments for neurological disorders, today announced that it has entered into a research collaboration agreement with KIF1A.ORG. NeuCyte is joining the KIF1A.ORG community in its search for a treatment and cure for KIF1A-Associated Neurological Disorder (KAND). KAND is a progressive and sometimes fatal genetic disorder caused by mutations in the KIF1A gene that usually presents at birth or early in childhood.
Read more...17 August 2021
Germany’s specialty glass company SCHOTT AG has a new partner: Serum Institute of India, the world‘s largest vaccine producer and manufacturer of highly-effective biologics, has bought the 50% stake in the Indian joint venture SCHOTT Kaisha from former co-owners Kairus Dadachanji and Shapoor Mistry. The joint venture is the leading Indian manufacturer of pharma packaging products such as vials, syringes, ampoules and cartridges used to package life-saving medications. With this ac
Read more...Ligand Pharmaceuticals Incorporated announces that its partner Travere Therapeutics, Inc. announced positive topline interim results from the ongoing pivotal Phase 3 PROTECT Study of sparsentan, an investigational product candidate for the treatment of IgA nephropathy (IgAN). The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared
Read more...17 August 2021
Pfizer Inc. and BioNTech SE announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. “Vaccination is our most effective means of preventing COVID-19 infection – especially severe di
Read more...16 August 2021
InxMed (Nanjing) Co., Ltd., a clinical stage biotech company dedicated to developing innovative, individualized medicines with international impact, announced today the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IN10018 for the treatment of platinum-resistant ovarian cancer patients. InxMed owns the global patent and development right of IN10018. The Fast Track designation for IN10018 underscores the urgent need for new treatment options for platinum-resista
Read more...For the past three editions, we have thrived on our unique event format and content. The last year has forced us to re-think how we work, and it helped us identify our potential to innovate during difficult times. At Eminence Business Media, we believe learning should not stop. Hence, after deliberating with the experts with immense experience in the industry, we bring to you the 4th Annual Pharma Project & Portfolio Management Summit, 2021 as a virtual conference, where we are
Read more...13 August 2021
Australian clinical-stage drug development company Noxopharm Limited has reported pre-clinical data confirming a survival benefit of adding Veyonda® to 177lutetium-PSMA-617 (LuPSMA) treatment in prostate cancer. This result validates the survival benefit of the same combination seen in a recently completed Phase I/II trial of Veyonda in men with end-stage metastatic castrate-resistant prostate cancer (mCRPC). Pre-Clinical Data Confirm Survival Benefit of Combination Trea
Read more...Rentschler Biopharma, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced that the company has broken ground at its new production site, adjacent to its existing site in Milford, MA in the greater Boston area. The new Rentschler Biopharma Manufacturing Center US (RBMC US) will add 22,000 square feet of manufacturing cleanroom space and house four new 2,000 L single-use bioreactors. In keeping with Rentschler Biopharma’s commitmen
Read more...Xeris Pharmaceuticals, Inc., a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the Food and Drug Administration (FDA) has allowed the Investigational New Drug Application (IND) for its XeriSol levothyroxine for hypothyroidism to proceed. The active IND enables Xeris to initiate a Phase 1 clinical study for XP-8121 using its novel formulation of levothyroxine
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