Sunovion Announces Health Canada Approval of KYNMOBI (Apomorphine Hydrochloride) Soluble Film for the Treatment of Parkinson’s Disease OFF Episodes

Sunovion Pharmaceuticals, Inc. announced that Health Canada has approved apomorphine HCI soluble film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease.
[Sunovion Pharmaceuticals, Inc.]
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TG Therapeutics Completes Rolling Submission of New Drug Application to the US Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma

TG Therapeutics, Inc. announced the completion of the rolling submission of a New Drug Application (NDA) to the FDA requesting accelerated approval of umbralisib, the company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma and follicular lymphoma.
[TG Therapeutics]
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PharmaCyte Biotech Successfully Accelerates Development of Container Closure Integrity Test for Pancreatic Cancer Clinical Trial Product

PharmaCyte Biotech, Inc. announced that it has successfully accelerated the development of its Container Closure Integrity test– an essential component of the Stability Test required by the FDA.
[PharmaCyte Biotech Inc.]
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AgeX Therapeutics and Pluristyx Announce Manufacturing, Marketing, and Distribution Agreement to Expand Access to Clinical-Grade Human Pluripotent Stem Cells for Therapeutic Applications

AgeX Therapeutics, Inc. and Pluristyx, Inc. have announced they have entered into a manufacturing, marketing, and distribution agreement through which Pluristyx will undertake these activities on behalf of AgeX with respect to AgeX’s research- and clinical-grade ESI brand human ESCs.
[AgeX Therapeutics Inc.]
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Inventiva’s Lanifibranor Meets the Primary and Key Secondary Endpoints in the Phase IIb NATIVE Clinical Trial in Non-Alcoholic Steatohepatitis (NASH)

Inventiva are developing oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses and other diseases with significant unmet medical need. They have announced positive topline results from the Phase IIb NAsh Trial to Validate IVA337 Efficacy (NATIVE) clinical trial evaluating lanifibranor for the treatment of NASH.
[Inventiva]
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Verzenio® (abemaciclib) Significantly Reduced the Risk of Cancer Returning in People with High Risk HR+, HER2- Early Breast Cancer

Eli Lilly and Company announced Verzenio® in combination with standard adjuvant endocrine therapy has met the primary endpoint of invasive disease-free survival, significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant endocrine therapy alone.
[Lilly]
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Devonian Health Group Announces Notice of Allowance for a US Patent Application Covering Use of Thykamine for the Treatment of Ulcerative Colitis

Devonian Health Group, Inc. announced today that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S patent application titled, “Thylakoid Extract Composition and Formulation for the Treatment of Inflammatory Bowel Disease,” covering the use of Thykamine for the treatment of ulcerative colitis.
[Devonian]
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CyMedica Orthopedics Completes e-vive Parent Clinical Trial for Management of Knee Osteoarthritis Pain

CyMedica Orthopedics announced that it completed early enrollment of 159 patients in the FDA-regulated clinical trial of their e-vive technology for pain relief in patients with knee osteoarthritis.
[CyMedica Orthopedics]
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Huge Open-Access Journal Deal Inked by University of California and Springer Nature

The University of California (UC) system announced it has signed the biggest open-access deal in North America with one of the largest commercial scientific publishers. The agreement with Springer Nature includes a commitment by the publisher to explore making all articles that UC corresponding authors publish in the Nature family of journals immediately free to read on publication starting in 2022.
[ScienceInsider]
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UCLA Receives Nearly $14 Million from NIH to Investigate Gene Therapy to Combat HIV

UCLA researchers and colleagues have received a $13.65 million grant from the National Institutes of Health (NIH) to investigate and further develop an immunotherapy known as CAR T, which uses genetically modified stem cells to target and destroy HIV.
[University of California, Los Angeles]
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Partner Therapeutics Announces Initiation of Clinical Trial Evaluating Leukine® in T Cell Replete HLA-mismatched Haploidentical Stem Cell Transplant

Partner Therapeutics announced the enrollment of the first patient dosed in a Phase II investigator-initiated study evaluating the efficacy and safety of Leukine® in T cell replete HLA-mismatched haploidentical stem cell transplant recipients who are receiving post-transplant cyclophosphamide.
[Partner Therapeutics, Inc.]
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