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...
Genematrix NeoPlex HPV 29 Detection Gains European CE-IVD
Genematrix, known for their real-time PCR based molecular diagnostics, have announced that NeoPlex HPV29 Detection has gained European Medical Device Certification (CE-IVD). Designed to simultaneously diagnose 29 genotypes of human papillomavirus (HPV - a key...
Medtronic Hugo Robotic Surgery System Granted European CE Mark
A global leader in medical technology, Medtronic, has been granted CE (Conformité Européenne) Mark for the Hugo™ robotic surgery (RAS) system, giving the green light for sales of the system in Europe. The approval has been given for urologic and gynecologic procedures...
Healthcare AI Technology: Beyond Mental Health and Diabetes
For those following our series on AI in communications, or for anyone closely watching developments in the life sciences, it won’t come as news that technology is one of the most promising new tools for solving challenges in health care and developing new treatments....
FDA Approves ChemoCentryx Drug for Rare Autoimmune Disease
ChemoCentryx has received US FDA (Food and Drug Administration) approval for their drug, avacopan, to treat the rare, fatal autoimmune disease, antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV). The oral drug, brand name Tavneos, will help those...
Finland, Sweden & Denmark Limit Moderna COVID-19 Vaccine
Following the release of a Nordic study, Finland joins Sweden and Denmark in pausing the distribution of the Moderna COVID-19 vaccine for young adult males (under 30) after reports of a rare cardiovascular side effect. The unpublished study will be sent to the...
J&J Submits Booster Emergency Use Authorization to FDA
Johnson & Johnson (J&J) has submitted its data to the US FDA (Food and Drug Administration) for emergency use authorization for its booster shot of the J&J COVID-19 vaccination. The submission is based on the Phase 3 ENSEMBLE 2 study that shows that a...
Acute Lymphoblastic Leukemia (ALL): First Approved CAR T-Cell
The US FDA (Food and Drug Administration) has approved the first-ever chimeric antigen receptor (CAR) T-cell therapy, brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company) for adults with relapsed or refractory acute lymphoblastic leukemia (ALL). The approval...