Market News & Trends
Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum
Verrica Pharmaceuticals Inc. recently announced the US FDA has extended the review period for the New Drug Application (NDA) for VP-102 for the treatment of…
uniQure Announces Positive Recommendation to Advance Phase 1/2 Clinical Trial of AMT-130 for the Treatment of Huntington’s Disease
uniQure N.V. recently announced the independent Data Safety Monitoring Board (DSMB) overseeing the Phase 1/2 clinical trial of AMT-130 for the treatment of Huntington’s disease…
Ocugen On Track to Submit EUA Application to US FDA for its COVID-19 Vaccine Candidate
Ocugen, Inc. recently confirmed its plan to submit its Emergency Use Authorization (EUA) application for COVAXIN to the US FDA in June. “Since we have…
Xalud Therapeutics’ Lead Candidate Achieves Multiple Clinical Milestones in Pathologic Inflammation & Neuroimmunology Therapeutic Areas
Xalud Therapeutics recently announced that the Phase 2b study of XT-150 in patients with moderate-to-severe pain due to osteoarthritis (OA) of the knee has completed…
VBL Therapeutics to Provide Update on OVAL Phase 3 Registration Enabling Study of VB-111 in Ovarian Cancer
VBL Therapeutics recently announced that a poster providing an update on the OVAL Phase 3 registration enabling clinical trial of VB-111 in ovarian cancer will…
Onconova Therapeutics Announces Initial Dosing of First Patient in US Phase 1 Clinical Trial
Onconova Therapeutics, Inc. recently announced the first patient has been dosed in the US Phase 1 clinical trial of ON 123300, the company’s proprietary, novel…
The Discovery Labs Signs Foundational Lease With the University of Pennsylvania Gene Therapy Program as Anchor Tenant
The Discovery Labs has recently signed a foundational lease with the University of Pennsylvania Gene Therapy Program (GTP), which will use Discovery Labs’ suburban campus…
CatalYm to Present Initial Data of First-in-Human Trial of GDF-15 Neutralizing Antibody CTL-002
CatalYm GmbH recently announced that their abstract with first interim data from the Phase 1 clinical trial investigation CTL-002 as monotherapy and in combination with…
Ajinomoto Bio-Pharma Services Expands Fill Finish Capacity With New Multi-Purpose Fill Suite
Ajinomoto Bio-Pharma Services recently announced it will soon open a high-speed multi-purpose fill finish line in its state-of-the-art commercial manufacturing facility located in San Diego,…
uniQure Presents HOPE-B Clinical Data Demonstrating Clinical Benefit in Hemophilia B Patients With Pre-existing Antibodies to AAV5 Vector
uniQure N.V. recently presented 26-week clinical data from the pivotal, Phase 3 HOPE-B gene therapy trial of etranacogene dezaparvovec showing clinical benefit in hemophilia B patients…
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Molex Expands European Manufacturing Footprint & Capabilities With State-of-the-Art Campus in Poland
Molex recently announced a major expansion of its global manufacturing footprint with the opening of a new campus in Katowice, Poland. The facility’s initial 23,000-square-meter manufacturing space will….
Kala Pharmaceuticals Completes Sale of EYSUVIS & INVELTYS to Alcon Inc
Kala Pharmaceuticals, Inc. recently announced it has completed the sale of its commercial portfolio and related intellectual property assets to Alcon Inc., a transaction that was….
Insightful Science Acquires Protein Metrics to Expand its R&D Solution to Include Proteomics
Insightful Science recently announced it has completed the transaction to acquire Protein Metrics, Inc. to expand the company’s R&D value chain to widen the biopharmaceutical protein analysis arena….
Acer Therapeutics & Relief Therapeutics Announce NDA Submission for ACER-001 for Treatment of Urea Cycle Disorders
Acer Therapeutics Inc. Relief Therapeutics recently announced the submission of a New Drug Application (NDA) to the US FDA for ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs)….