FDA Grants ODD Status to SEL24/MEN1703 for Treatment of AML
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to SEL24/MEN1703, an orally available, dual PIM/FLT3 inhibitor designed for the treatment of Acute Myeloid Leukemia (AML). Licensed by the Menarini group from Ryvu Therapeutics,...
Expanding AI Healthcare Capabilities Driving Global Growth
Considering estimations predict that AI in the global healthcare market will reach $194.4 billion by 2030, it is clear that AI (artificial intelligence) is an increasingly crucial tool for the future of healthcare. CSOFT has written extensively on AI in our AI...
HPV Vaccinations: UK Cervical Cancer Program Shows Success
The results of an England-based national program to vaccinate females against human papillomavirus (HPV) to protect against cervical cancer has shown significant success, new data from England shows. Among this success is a reported 87% decrease in cervical cancer...
FDA Grants Memgen IND Application Clearance
The US FDA (Food and Drug Administration) has granted IND (investigational new drug) application clearance for Memgen’s MEM-288, their cancer immunotherapy treatment for patients with multiple solid tumors. Following this announcement, Memgen, a clinical-stage...
Eli Lilly Retracts From EU, While US Buys Antibody Doses
While Eli Lilly has withdrawn its request for European Union (EU) approval of its COVID-19 antibody-based treatment as the EU pivots its focus on other suppliers, the US has agreed to buy 614,000 additional doses of Lilly's antibody combo for $1.29 billion. The...
Positive Data for Aquestive Therapeutics Sublingual Film
Aquestive Therapeutics, (previously MonoSolRX), known for specializing in the development and commercialization of products that meet unmet needs for patients, has announced positive topline data from its first-in-human Phase 1 PK study of AQST-109 sublingual film for...
Breast Implants: FDA Issues Stronger Risk Warning Labels
The US FDA (Food and Drug Administration) has announced new labels for boxed warnings, to further warn and inform consumer decision-making when considering the risks around breast implants. Included in this announcement, the FDA will also be limiting the sale and...
Daytime Sleepiness (EDS): EMA Approves Bioprojet Ozawade
Bioproject has received approval from the European Medicines Agency (EMA) for their Ozawade (pitolisant) to treat adult excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA). The approval is based on two Phase III clinical studies to study...
Novavax Files for UK Authorization for its COVID-19 Vaccine
Novavax, a biotechnology company committed to development and bringing to market next-generation vaccines for critical infectious diseases, announced that it has finalized its ongoing regulatory submission to the U.K. Medicines and Healthcare products Regulatory...
Solasia & Nippon Kayaku File for Darinaparsin License Agreement
Solasia Pharma K.K (Salasia) and Nippon Kayaku (Nippon) have announced their joint license agreement for marketing rights for darinaparsin (SP-02) in Japan. Drug candidate developed by Salasia, darinaparsin, aims to treat relapsed or refractory peripheral T-cell...
Resilia Solace Eczema Cream Granted US Commercialization
Resilia Pharmaceuticals has been granted the rights to manufacture, commercialize and sell Solace™ Eczema Cream, a medical device, as an OTC (over the counter) product in the United States. Signing the agreement with Pelle Ventures, the deal will make the cream more...
Chemo Side Effects: A Global Challenge for Cancer Treatments
Advancements in global medicine and specialist care are essential to improving quality of life, treatment options, and survival rates for those with a cancer diagnosis, as well as mitigating the side effects that come with receiving those treatments. Recently, the US...
Ultimovacs Receives Fast Track Designation for Cancer Drug
The US Food and Drug Administration (FDA) has given Norwegian pharmaceutical company Ultimovacs ASA Fast Track designation for its experimental product, UV1, as a supplementary therapy to either pembrolizumab or ipilimumab for the treatment of unresectable or...
Ok to ‘Mix and Match’ Moderna and J&J Boosters, FDA Says
The US Food and Drug administration (FDA) has given approvals to Moderna and Johnson & Johnson (J&J) to authorize boosters. By using a mix and match approach, the FDA has authorized the boosters for all populations eligible to receive one under the emergency...
Successful Pig Kidney Transplant, A First for US Surgeons
In a first for the industry, New York Surgeons at NYU Langone Health have successful transplanted a pig kidney into a human without an immediate immune system rejection. The successful transplant is a major breakthrough which has the potential to alleviate a stark...
Post-operative Pain: Hyloris Maxigesic IV Gains UK/IRL Approval
Hyloris Pharmaceuticals SA, known for reinventing exciting medications for unmet medical needs, has announced the approval of Maxigesic® IV, in the UK and Ireland. Maxigesic IV is a unique concoction of of 1000mg paracetamol and 300mg ibuprofen solution for infusion...
FDA Approves Oyster Point First Nasal Spray for Dry Eyes
Oyster Point announced that its nasal spray will become available next month for patients with a prescription, making it the first FDA-approved nasal spray in the US for chronic dry eye disease. The drug is aimed at filling the unmet medical need for people who suffer...
Long COVID-19 Survivors Report Effects Following Recovery
According to a systematic review consisting of 57 studies and including 250,000+ patients, more than 50% patients with long COVID (persistent postacute sequelae of COVID-19 or PASC) described feeling effects of COVID beyond six months after recovery. The results...
Migraines: Canada Gives Regulatory Approval for ElectroCore
electroCore, a leading bioelectronic medicine company, have received a revised Medical Device License (MDL) from Health Canada to extend its labelling of electroCore’s gammaCore nVNS to include the acute and preventive treatment of migraine in adolescents (aged 12 -...
Breast Cancer: FDA Approves Eli Lilly Verzenio Inhibitor
Eli Lilly and Company has received FDA approval from the US FDA (Food and Drug Administration) for the first and only CDK4/6 inhibitor for a specific group of people with Breast Cancer. Verzenio, abemaciclib, aims to treat adult patients with hormone receptor-positive...