FDA grants regenerative medicine advanced therapy designation to AlloVir’s posoleucel
January 6, 2022Business Services
The FDA has granted AlloVir’s posoleucel Regenerative Medicine Advanced Therapy Designation (RMAT), for the treatment of adenovirus infections in adults …
Jazz Pharmeuticals announces Phase III data of idiopathic hypersomnia treatment
January 6, 2022Business Services
Jazz Pharmaceuticals have announced that positive data, from the Phase III of Xywav oral solution for the treatment of adults …
Bharat Biotech receives approval to test nasal COVID-19 shot as booster
January 5, 2022Research and Development
India’s drug regulator has granted approval to Bharat Biotech, for late stage trials of its nasal COVID-19 vaccine to be …
FDA grants breakthrough therapy designation to novel EGFR inhibitor
January 5, 2022Research and Development
The FDA has granted a breakthrough therapy designation to Cullian Oncology’s CLN-081, in certain patients with locally advanced or metastatic …
NaNotics and Mayo Clinic to collaborate on nanomedicine cancer treatment
January 5, 2022Research and Development
Nanomedical company NaNotics have announced a research collaboration with Mayo Clinic, to develop a NaNot that targets the soluble form …
NICE recommends PONVORY for the treatment of relapsing forms of multiple sclerosis
January 5, 2022Research and Development
NICE has issued a positive Final Appraisal Document (FAD) recommending PONVORY® (ponesimod) as an option in England and Wales for …
Further evidence shows Omicron causes milder symptoms
January 4, 2022A WHO official has said more evidence is emerging to support that the Omicron variant causes milder symptoms than previous …
Theranos founder Elizabeth Holmes found guilty of fraud
January 4, 2022Manufacturing and Production
Elizabeth Holmes, founder of Theranos, has been found guilty on four of 11 charges of fraud, including one count of …
FDA expands Pfizer COVID-19 booster shot EUA for children aged 12-15
January 4, 2022Manufacturing and Production
The FDA has bypassed its advisory panel and extended its Emergency Use Authorisation (EUA) for Pfizer BioNTech’s COVID-19 booster vaccine …
Santhera enters exclusive license agreement with Sperogenix for Vamorolone in rare diseases
January 4, 2022Manufacturing and Production
Santhera Pharmaceuticals has announced that it has entered into an exclusive license agreement with China-based company, Sperogenix Therapeutics, specialising in …
NICE recommends combination treatment for patients with multiple myeloma
December 24, 2021Medical Communications
NICE has recommended the use of Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) as induction and …
MHRA approves license extension for Novartis’ breast cancer targeted therapy
December 24, 2021Medical Communications
The MHRA has approved the marketing authorisation to extend Novartis’ licence in Great Britain for Piqray (alpelisib), for use in …
Veklury demonstrates reduced risk of hospitalisation in high-risk patients with COVID-19
December 23, 2021Business Services
Gilead Sciences have announced full results from a Phase III investigational study, evaluating the efficacy and safety of a three-day …
FDA approves Novartis’ Cosentyx for psoriatic arthritis patients
December 23, 2021The FDA has approved Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in children four years and older, …
Avacta lateral flow test receives CE mark for consumer self-testing
December 22, 2021Research and Development
Avacta Group plc, a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® …
South African study suggests Omicron has a lower risk of hospitalisation than Delta
December 22, 2021Research and Development
A new South African study suggests that there are reduced risks of hospitalisation and severe disease in people infected with …
FDA places clinical hold on use of injectable lenacapavir for HIV treatment
December 22, 2021Research and Development
The FDA has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials, in all ongoing clinical …
EMA recommends Nuvaxovid for authorisation, as WHO grants second Emergency Use Listing
December 22, 2021Research and Development
Nuvaxovid™, the COVID-19 vaccine manufactured by the biotechnology company Novavax, has been listed for emergency use by WHO. The news …
FDA approves first injectable treatment for HIV pre-exposure prevention
December 21, 2021Manufacturing and Production
The FDA have approved Apretude (cabotegravir extended-release injectable suspension), for use in at-risk adults and adolescents weighing at least 35 …
Moderna CEO says Omicron booster could begin development within weeks
December 21, 2021Medical Communications
Stephane Bancel, CEO of Moderna, said that the company could begin work on a booster shot against the Omicron variant …
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