Pfizer has reported positive top-line results from its Phase III MONeT study (NCT05842967) evaluating the efficacy of single-dose Abrysvo for adults at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). As per the 9 April press release, Abrysvo met its co-primary immunogenicity and safety endpoints, with patients demonstrating non-inferior RSV-A and RSV-B neutralising responses compared to the Phase III RENOIR study (NCT05842967) where the vaccine previously showed efficacy. Compared to pre-vaccination, the vaccinated patients also demonstrated a minimum of a four-fold increase in serum-neutralising titers for RSV-A and RSV-B a month after being vaccinated. The MONeT trial did not identify any new safety signals for Abrysvo. The pharma giant plans to publish the findings in a peer-reviewed journal and submit the results to regulatory agencies in a bid to expand the vaccine’s label from its current indication to include adults 18 years and older, the ...
Kanabo Group has linked up with City Dock Pharmacy in London, to introduce a walk-in pain clinic offering specialised medicines, including medicinal cannabis. The partnership will cater for patients who are eligible for alternative therapies, as traditional treatments have not delivered improvements. The facility, which will be situated at City Dock Pharmacy in Wapping, will deliver both walk-in and appointment-related services, and becomes the UK’s first walk-in clinic for pain management. The clinic will represent an extension of Kanabo’s ‘Treat It’ online platform, allowing onsite pharmacists will also be able to guide patients through the medicinal cannabis treatment options. Meanwhile, the clinic will also support the unrolling of personalised plans for the growing number of chronic pain sufferers across the UK. At present, such individuals often face difficulties accessing medical treatments due to long waiting times and affordability. The latest development is part of Kanabo’s wider ambition to extend its ...
Alebund Pharmaceuticals has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its investigational drug AP303. This designation is intended for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a genetic disorder that causes the growth of numerous cysts in the kidneys. AP303 is an internally developed drug candidate that has shown promise in improving renal survival in an ADPKD mice model. The drug has successfully completed a first-in-human study in healthy subjects in Australia and is poised to enter Phase II trials. ADPKD has a prevalence of between one in 400 and one in 1,000 live births and is a significant cause of end-stage kidney disease (ESKD), which often necessitates renal replacement therapy. Alebund co-founder, chairman, and CEO Dr Gavin Xia said: “We are very excited that AP303 has been granted orphan drug designation by the FDA. “It is an important milestone for Alebund ...
WHO has released new Guidelines on prevention, diagnosis and treatment of chronic hepatitis B (HBV) infection at the 2024 Asian Pacific Conference for the Study of Liver Disease (APASL) in Kyoto, Japan. These guidelines provide a substantial simplification and expansion of eligibility for treatment to overcome barriers in access to HBV testing and treatment. More than 250 million people live with chronic hepatitis B infection, leading to increasing deaths each year. Most of the global burden of chronic hepatitis B (CHB) is due to mother-to-child transmission at or shortly after birth. WHO’s Global health sector strategy sets actions and targets to eliminate viral hepatitis by 2030 by driving new infections and deaths down to half a million each globally – a reduction of 90% and 65%, respectively. Considerable progress has been made towards eliminating mother-to-child transmission of HBV through universal infant HBV immunization, including the timely hepatitis B birth dose. ...
SHANGHAI, March 29, 2024 /PRNewswire/ — Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD). “We are very excited that AP303 has been granted Orphan Drug Designation by the FDA”, Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented. “It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with ADPKD. We look forward to advancing AP303 to improve future treatment options for patients in need.” AP303, a novel drug candidate developed in-house by Alebund, has demonstrated a meaningful improvement of renal survival in an ADPKD mice model. AP303 has completed its first-in-human study in healthy ...
Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of medical device company Shockwave Medical, as first reported by the Wall Street Journal (WSJ) on 26 March. The WSJ cited people familiar with the matter who claimed that a finalised deal could be around the corner pending successful acquisition talks. However, the report also noted that another suitor could emerge to merge with Santa Clara, a California-based medical device manufacturer. WSJ did not mention the valuation of the potential acquisition. This is not the first time Shockwave has been involved in acquisition rumours, as Bloomberg reported that Boston Scientific was eyeing Shockwave for a takeover in April 2023. Since the publication of the WSJ report, Shockwave’s stock price has increased by 3.8%. Shockwave has a market cap of $12.3bn. As per a 15 February press release, Shockwave has commenced the ...
Today (March 29), according to the official website of CDE, Guangdong Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as “Hengrui Pharmaceutical”) class 1 new drug SHR-1139 injection indicated for psoriasis application obtained approval. Psoriasis is a chronic inflammatory skin disease that is stimulated by environmental factors, genetic control, and immune media. According to relevant data, there are more than 7 million psoriasis patients in China. Fhstrilin predicts that China’s psoriasis market will increase to US $ 9.5 billion in 2030, with a compound annual growth rate of 27.1%. Globally, the number of patients with psoriasis is on the rise. At present, biopharmaceuticals have gradually become one of the mainstream therapies of psoriasis in China. Related drugs are mainly focused on targets such as TNF-α and IL families. Hengrui Pharmaceutical also deployed psoriasis therapy drugs, of which Fu Niqizumab (SHR-1314) targets IL-17A targets. Following the CDE acceptance of the listing of ...
The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure Novo Nordisk and Cardior Pharmaceuticals has announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. Martin Holst Lange, executive vice president for Development at Novo Nordisk said, “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development. We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to ...
Don Tracy, Associate Editor Deal includes the novel treatment CDR132L, which is currently in Phase II clinical trials for heart failure. Novo Nordisk announced that it has acquired Cardior Pharmaceuticals in hopes of improving its pipeline in cardiovascular disease management. The acquisition includes Cardior’s top drug candidate, CDR132L, which is currently in Phase II of clinical development for treating heart failure. Under terms of the agreement, Cardor has the potential to earn up to $1.112 billion, including an upfront payment and the opportunity for more payments pending the completion of certain development and commercial milestones.1 “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programs across all phases of clinical development,” said Martin Holst Lange, EVP, development, Novo Nordisk, in a press release. “We have been impressed by the scientific work carried out by the ...
Novo Nordisk has announced that the European Medicine Agency’s advisory committee has recommended Awiqli (once-weekly basal insulin icodec) to treat diabetes in adults. The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was based on positive results from the phase 3a ONWARDS clinical trial programme. Estimated to affect 415 million people worldwide, diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, a hormone that regulates glucose, or when the body cannot effectively use the insulin it produces. Awiqli works to cover the basal insulin requirements for a week with a single subcutaneous injection. Comprising six phase 3a global clinical trials involving more than 4,000 adults with type 1 or type 2 diabetes, the ONWARDS clinical development programme investigated the efficacy and safety of Awiqli. Results from the programme showed that Awiqli achieved a superior blood sugar reduction and superior time in ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.