Market News & Trends
Sharp Acquires Berkshire Sterile Manufacturing
Sharp recently announced the acquisition of Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO) for….
Bio-Rad Extends Range of Anti-Idiotypic Antibodies for Use in Preclinical & Clinical Drug Development
Range of highly selective anti-idiotypic antibodies now includes six antibodies specific to dupilumab and its biosimilars for bioanalysis and drug monitoring….
Ocular Therapeutix Announces Initiation of its First Pivotal Clinical Trial of OTX-TKI in Wet AMD
Ocular Therapeutix, Inc. recently announced the initiation of its first pivotal clinical trial to evaluate OTX-TKI, the company’s axitinib intravitreal implant, for the treatment of…
Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone
Eton Pharmaceuticals recently announced it has entered into an agreement to acquire an abbreviated new drug application for Nitisinone Capsules via Oakrum Pharma, LLC’s Chapter…
BioXcel Therapeutics Provides Update on Recent Developments for Late-Stage Clinical Programs & Expansion of IP Portfolio for Sublingual Film
BioXcel Therapeutics, Inc. recently provided an update on recent developments with its late-stage clinical programs as well as its patent portfolio for IGALMI (dexmedetomidine) sublingual…
Advent International & Warburg Pincus Complete Acquisition of Baxter’s BioPharma Solutions Business
Advent International, one of the largest and most experienced global private equity investors, and Warburg Pincus, a leading global growth investor, recently announced the completion of their previously announced acquisition of Baxter International Inc.’s BioPharma Solutions (BPS) business….
Oxford BioTherapeutics Announces Partner Boehringer Ingelheim Received US FDA Fast Track Designation for the Treatment of Extensive Stage Small Cell Lung Cancer & Extrapulmonary Neuroendocrine Cancers
Oxford BioTherapeutics (OBT) recently announced the US FDA has granted Fast Track designation to BI 764532 for the treatment of extensive stage small cell lung…
Ocean Biomedical Announces Newly Published Findings Demonstrating Ability to Restore Treatment Sensitivity to AstraZeneca’s Leading Lung Cancer Drug After Resistance Has Formed
Ocean Biomedical, Inc. recently announced its cancer-targeting immunotherapy antibody candidate has demonstrated effective tumor reduction against an aggressive subset of Non-Small Cell Lung Cancer (NSCLC)…
Apellis Announces US FDA Approval of the EMPAVELI Injector, a Device to Streamline Self-Administration
Apellis Pharmaceuticals, Inc. recently announced the US FDA has approved the EMPAVELI Injector, a compact, single-use, on-body device designed to enhance self-administration of….
Zevra Therapeutics Announces Interim Data From Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia
Zevra Therapeutics, Inc. recently announced interim data from the open-label dose titration phase of the Phase 2 clinical trial evaluating KP1077 in patients with idiopathic…
Assembly Biosciences Nominates Development Candidate ABI-6250, an Orally Bioavailable HDV Entry Inhibitor
Assembly Biosciences, Inc. recently announced the selection of development candidate ABI-6250 to progress to IND-enabling studies. ABI-6250, an orally bioavailable small molecule entry inhibitor, is…
Evonik Strengthens Portfolio of Nanoparticle Technologies & Services for Parenteral Drug Delivery
Evonik is strengthening its platform of parenteral drug delivery solutions with three new standard PLA-PEG di-block copolymers and a new nanoparticle formulation service using….
Bio-Rad Launches PTC Tempo 48/48 & PTC Tempo 384 Thermal Cyclers
Bio-Rad Laboratories, Inc.recently announced the launch of its PTC Tempo 48/48 and PTC Tempo 384 Thermal Cyclers, designed to support PCR applications in basic and…
Investigational Treatment for Fragile X Syndrome Receives Rare Pediatric Disease Designation From FDA
Shionogi & Co., Ltd. recently announced the US FDA has granted Tetra Therapeutics Inc. Rare Pediatric Disease Designation for zatolmilast (BPN14770), an investigational treatment being…
Omega Therapeutics Announces Promising Preliminary Clinical Data for OTX-2002 From Ongoing MYCHELANGELO I Trial
Omega Therapeutics, Inc. recently announced encouraging preliminary safety, tolerability, pharmacokinetic, and translational data from the initial two dose level cohorts (n=8) from Part 1 of its ongoing Phase 1/2 MYCHELANGELO I study evaluating….
Phathom Pharmaceuticals Announces Vonoprazan NDA Submission for Non-Erosive GERD
Phathom Pharmaceuticals, Inc. recently announced the submission of an NDA to the FDA for vonoprazan as a daily treatment for Non-Erosive gastroesophageal reflux disease (GERD)…
bYoRNA & Dyadic Announce a Collaboration Targeting the Production of Abundant, Low-Cost mRNA From C1-Cells
bYoRNA SAS and Dyadic International, Inc. recently announced they entered into a development and commercialization agreement to work on disruptive bioproduction technologies that will help…
SOHM Announces Acquisition of ABBIE, a World-Class Gene-Editing Platform That Can Deliver Genetic Payloads Using Non-Viral Vectors
With this acquisition, SOHM is well-positioned as a competitive player in the $5.3 billion gene-editing market in 2023. The gene-editing market is expected to grow….
MilliporeSigma to Become First Provider to Offer Fully Integrated mRNA Services
MilliporeSigma is the first CTDMO to offer integrated services for all critical stages of mRNA development, manufacturing, and commercialization, including products and….
AcuraStem Enters Into License Agreement With Takeda to Advance PIKFYVE Therapeutics
AcuraStem recently announced it has entered into a license agreement with Takeda to develop and commercialize AcuraStem’s PIKFYVE targeted therapeutics including AS-202, an innovative antisense oligonucleotide…
