Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
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...
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