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Definitive Agreement to Acquire Exelead Will Strengthen the CDMO Offering for mRNA of the Life Science Business of Merck KGaA, Darmstadt, Germany January 11, 2022
Merck KGaA, Darmstadt, Germany recently announced the signing of a definitive agreement to acquire Exelead, a biopharmaceutical contract development and...Adare Pharma Solutions Announces Appointment of Tom Sellig as Chief Executive Officer January 6, 2022
Adare Pharma Solutions recently announced the appointment of Tom Sellig as Chief Executive Officer (CEO). Sellig, a 30-year veteran of the pharmaceutical and life sciences industries, will lead the….
Metrics Contract Services Appoints Commercial Manufacturing BD Lead January 4, 2022
Metrics Contract Services, a full-service contract development and manufacturing organization (CDMO) in novel oral solid dose (OSD) products, has appointed...Allarity Therapeutics Submits NDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma December 22, 2021
Allarity Therapeutics, Inc. recently announced the submission of a new drug application (NDA) with the US FDA seeking marketing approval...Intensity Therapeutics Reports Promising Early Efficacy Results Using INT230-6 as a Monotherapy or in Combination With Pembrolizumab in Metastatic Breast Cancer December 10, 2021
Intensity Therapeutics, Inc. recently reported safety, pharmacokinetic, biomarker, and efficacy data using INT230-6, with and without pembrolizumab, in heavily pretreated refractory breast cancer patients as part of the….
Fortress Biotech, Cyprium Therapeutics & Sentynl Therapeutics Announce the Initiation of Rolling Submission of an NDA for Treatment of Menkes Disease December 7, 2021
Cyprium Therapeutics, Inc., a Fortress Biotech, Inc. partner company, with support from its licensing partner Sentynl Therapeutics, Inc., a wholly owned subsidiary of Cadila Healthcare Limited, recently announced the initiation of a rolling submission of a New Drug Application….
SCYNEXIS Announces Agreement With FDA on Innovative Strategy for Approval of Oral Ibrexafungerp for Treatment of Invasive Candidiasis December 6, 2021
SCYNEXIS, Inc. recently announced initiation of a global Phase 3 study to evaluate the efficacy, safety, and tolerability of oral...Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings December 1, 2021
Adare Pharma Solutions recently announced the acquisition of Frontida BioPharm, a vertically integrated CDMO focused on oral formulations. The acquisition reinforces….
ImmunityBio Expands Vaccine Program to Accelerate Use of “Mix-and-Match” Technologies in Developing & Manufacturing Next-Generation COVID-19 Vaccines November 18, 2021
ImmunityBio, Inc. recently announced the expansion of the company’s cancer and infectious disease vaccine programs to include self-amplifying self-adjuvating RNA (SASA-RNA), recombinant protein vaccine candidates, and potent adjuvant formulations that….
Oculis Announces Patient Dosing in its First Phase 3 Study for Investigational Topical Eye Drop Treatment for Diabetic Macular Edema November 12, 2021
Oculis S.A. recently announced the first patients have been dosed in its Phase 3 DIAMOND trial evaluating the efficacy and...Intensity Therapeutics Reports Use of INT230-6 Alone or in Combination With Ipilimumab Shows Evidence of Direct Tumor Necrosis & Promising Overall Survival Results in Adult Subjects With Metastatic Sarcomas November 12, 2021
Intensity Therapeutics, Inc. recently announced that data from its open-label Phase 1/2 study of novel lead asset, INT230-6, as a monotherapy or...Zealand Pharma Announces First Subject Dosed in Phase 1 Trial of Amylin Analogue ZP8396 for the Treatment of Obesity November 4, 2021
Zealand Pharma A/S recently announced the first patient has been dosed in a Phase 1 clinical trial evaluating the amylin...Pfizer & BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine October 21, 2021
Pfizer Inc. and BioNTech SE recently announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of...Evelo Biosciences Announces Positive Phase 2 Clinical Data With EDP1815 in Psoriasis September 28, 2021
Evelo Biosciences, Inc. recently announced positive data from its Phase 2 study evaluating EDP1815 versus placebo for the treatment of mild and moderate psoriasis. A statistically significant reduction in the….
Soligenix Announces Accelerated Publication Demonstrating Efficacy & Broad Neutralizing Activity of its COVID-19 Vaccine in Non-Human Primates September 28, 2021
Soligenix, Inc. recently announced publication of preclinical immunogenicity studies for CiVax (heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing...Evelo Biosciences Announces Issuance of US Patent for Pharmaceutical Compositions of Single Strains of Naturally Occurring Bacteria as Medicines September 15, 2021
Evelo Biosciences, Inc. recently announced the US Patent and Trademark Office has issued a new composition of matter patent (No....Celsion Reports T-cell & B-cell Response From In Vivo Studies With its PLACCINE DNA Vaccine Platform September 8, 2021
Celsion Corporation recently announced results from preclinical in vivo studies showing production of antibodies and cytotoxic T-cell response specific to...SPECIAL FEATURE – Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System August 26, 2021
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
DIGITAL CUSTOM PLATFORM – PCI Pharma’s Digital Transformation: Reaching New Levels of Customer Experience August 26, 2021
Wayne Hull and Rebecca Coutts, PhD, explain how incorporating digital transformation as core to their company’s business strategy was a decision based on increasing evidence that investment in digital solutions provides real and measurable returns.
HOT MELT EXTRUSION – API Bioavailability: Suspending Hydrophobic Drugs in a Solid Solution August 26, 2021
Ameya Deshpande, MS, says for APIs that are compatible with HME, careful attention to the formulation quality attributes that include excipient selection, dosage form design, analytical testing, and stability are required to maximize the efficacy and quality of the final product.