Market News & Trends
Thermo Fisher Scientific Announces FDA Approval of Oncomine Dx Target Test as the First NGS-Based Companion Diagnostic to Aid in Therapy Selection for Patients with RET Mutations/Fusions in Thyroid Cancers
The US FDA has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selection of patients…
NJIT Researchers Unlock a New Method for Testing Protein-Based Drugs
New Jersey Institute of Technology researchers have unveiled a new lab technique they say represents a “paradigm shift” in how pharmaceutical laboratories test and produce…
Cornerstone Pharmaceuticals Initiates Phase 1 Trial of CPI-613 in Combination With Chemoradiation for the Treatment of Advanced Pancreatic Cancer
Cornerstone Pharmaceuticals, Inc. recently announced the initiation of a Phase 1 clinical trial evaluating CPI-613 (devimistat) in combination with chemoradiation for the treatment of advanced…
Cara Therapeutics Announces Difelikefalin Injection NDA Has Been Submitted in Japan
Cara Therapeutics, Inc. recently announced its licensing partner Maruishi Pharmaceutical Co., Ltd. submitted a New Drug Application (NDA) in Japan for approval of difelikefalin for…
KemPharm Announces Positive Topline Data from Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate
KemPharm, Inc. recently announced topline data from its exploratory Phase 1 clinical trial confirming the relative cardiovascular effects and pharmacokinetics of serdexmethylphenidate (SDX) compared to…
SCHOTT Pharma Expands Cartridge Production in China & Hungary
SCHOTT Pharma is again announcing plans to expand its manufacturing facilities: With a double-digit million Euro investment, the company aims to significantly increase its production…
Clearmind Applies for Patent to Treat Obesity & Metabolic Syndrome
Clearmind Medicine Inc. recently announced it has filed a provisional patent application related to metabolic syndromes including obesity. The patent application is another result of…
Mapi Pharma Announces Positive Top-Line Results from GA Depot Phase 3 Trial for Relapsing Forms of Multiple Sclerosis
Mapi Pharma Ltd. recently announced positive top-line results from the GA Depot (a long acting glatiramer acetate) Phase 3 clinical trial assessing the efficacy, safety,…
Genelux Corporation Initiates Pivotal Phase 3 Trial Evaluating Olvi-Vec for the Treatment of Platinum-Resistant/Refractory Ovarian Cancer
Genelux Corporation recently announced it has initiated OnPrime, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination…
Immunic Announces Positive Results from Single & Multiple Ascending Dose Parts of its Phase 1 Clinical Trial
Immunic, Inc. recently announced positive unblinded safety, tolerability and pharmacokinetic (PK) results from Part A (single ascending doses, SAD) and Part B (multiple ascending doses, MAD)…
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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)….