Tag Archives: type-industry &amp; policy

Continue reading “Terns Pharmaceuticals Announces Completion and Positive Results from Phase I Clinical Trial of TERN-201, a SSAO Inhibitor in Development for NASH”

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ORTIKOS^™, the First and Only Once-Daily Dose for Treatment of Mild to Moderate Crohn’s Disease, Now Available in the U.S.

Ferring Pharmaceuticals Inc. announced the launch of ORTIKOS™ in the United States, which was approved as the only once-daily treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years of age and older, and maintenance of clinical remission in adults involving the ileum and/or the ascending colon for up to three months.

[Ferring Pharmaceuticals (Businesswire, Inc.)]

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Veru Receives Positive Input from FDA on Phase III Pivotal Trial to Evaluate VERU-111 in Metastatic Castration Resistant Prostate Cancer

Veru Inc. announced that it has received regulatory clarity from the FDA on the pivotal Phase III trial design for VERU-111—its oral, first-in-class, novel alpha and beta tubulin targeting drug candidate being evaluated for the treatment of metastatic castration and novel androgen-blocking agent resistant prostate cancer.

[Veru Inc.]

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Britta Will, Ph.D., Wins Pershing Square Sohn Prize for Cancer Research

Britta Will, Ph.D., assistant professor of medicine and of cell biology at Albert Einstein College of Medicine, has won a 2020 Pershing Square Sohn Prize for Young Investigators in Cancer Research. Dr. Will is one of seven New York City area-based scientists to receive the prestigious award, which provides $600,000 over three years for innovative basic science cancer research.

[Albert Einstein College of Medicine]

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China’s Coronavirus Vaccines Are Leaping Ahead – But Face Challenges as Virus Wanes

Chinese companies are at the forefront of global efforts to create a vaccine for the coronavirus, with more than half a dozen candidates in clinical development. Last week, Tianjin-based CanSino Biologics published results from an early-stage clinical trial showing that its vaccine is safe and can trigger an immune response. Yet the companies could face difficulty as they try to push vaccines through Phase III trials, a crucial stage of testing that is needed to prove efficacy and secure approval from regulators.

[Nature News]

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European Commission Grants Marketing Authorisation for World’s First Subcutaneous Formulation of Infliximab, Remsima® SC, for an Additional Five Indications including for Use in Inflammatory Bowel Disease and Ankylosing Spondylitis

Celltrion Healthcare announced that the European Commission has granted marketing authorisation for Remsima^® subcutaneous formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.

[Celltrion Healthcare ]

Continue reading “European Commission Grants Marketing Authorisation for World’s First Subcutaneous Formulation of Infliximab, Remsima® SC, for an Additional Five Indications including for Use in Inflammatory Bowel Disease and Ankylosing Spondylitis”

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Emerald Health Pharmaceuticals Begins Enrollment in Phase IIa Study of EHP-101 for the Treatment of Systemic Sclerosis

Emerald Health Pharmaceuticals, Inc. has begun enrollment and has dosed its first patients with diffuse cutaneous systemic sclerosis in its Phase IIa clinical study of its lead product candidate, EHP-101, an oral formulation of a patented new chemical entity derived from cannabidiol.

[Emerald Health Pharmaceuticals, Inc.]

Continue reading “Emerald Health Pharmaceuticals Begins Enrollment in Phase IIa Study of EHP-101 for the Treatment of Systemic Sclerosis”

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China’s Coronavirus Vaccines Are Leaping Ahead – but Face Challenges as Virus Wanes

Chinese companies are at the forefront of global efforts to create a vaccine for the coronavirus, with more than half a dozen candidates in clinical development. Yet the companies could face difficulty as they try to push vaccines through phase III trials, a crucial stage of testing that is needed to prove efficacy and secure approval from regulators.

[Nature News]

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‘A Huge Experiment’: How the World Made So Much Progress on a COVID-19 Vaccine So Fast

The astonishing pace of vaccine progress is also a consequence of the virus itself: It is, scientifically speaking, an easier target for potential vaccines than other pathogens, and a prime candidate for cutting-edge vaccine platforms new to scientists’ toolkits.

[STAT News]

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Henlius and Accord Healthcare Receive EMA Approval for Zercepac^®, Trastuzumab Biosimilar

Shanghai Henlius Biotech, Inc. and Accord Healthcare Limited jointly announced the European Commission has approved Zercepac ^{® for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.}

[Henlius]

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Strategic Alliance a Shot in the Arm for Stem Cell Commercialization Efforts

Several Canadian-made cell therapies will take a major step closer to the clinic thanks to a new collaboration between the Ontario Institute for Regenerative Medicine and the Centre for Commercialization of Cancer Immunotherapy and Regenerative Medicine.

[Ontario Institute for Regenerative Medicine]

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Cleave Therapeutics Announces Commencement of a Phase I Clinical Study of CB-5339, A Valosin-Containing Protein (VCP)/p97 Inhibitor, in Patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Cleave Therapeutics, Inc. announced that the first patient has been dosed with CB-5339 in a Phase I clinical trial of patients with relapsed/refractory AML or relapsed/refractory intermediate or high-risk MDS.

[Cleave Therapeutics, Inc.]

Continue reading “Cleave Therapeutics Announces Commencement of a Phase I Clinical Study of CB-5339, A Valosin-Containing Protein (VCP)/p97 Inhibitor, in Patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)”