Search Results for “Clinical Trial” – Page 87 – media

Kezar and Everest enter lupus nephritis therapy development deal

Kezar Life Sciences and Everest Medicines have signed a partnership and licence agreement for the development and commercialisation of zetomipzomib for lupus nephritis (LN) in select territories. The territories covered under the agreement include Greater China, South Korea and South East Asia. As per the deal terms, Kezar is eligible to receive up to $132.5m in initial upfront and milestone payments contingent on meeting development, regulatory and commercialisation goals in the future. Kezar will also receive tiered royalty payments on net product sales from Everest. Everest will obtain sole rights for developing and marketing zetomipzomib in regions such as Greater China, Indonesia, Malaysia, the Philippines, Singapore, South Korea, Thailand and Vietnam. Everest will also collaborate with Kezar for the Phase IIb PALIZADE clinical trial of zetomipzomib, an immunoproteasome inhibitor of Kezar, in active LN patients in Greater China, South Korea and South East Asia. In the licensed territories, Everest will ...
- Source: drugdu
- 153
- October 1, 2023
Evaxion partners with Afrigen Biologics to develop mRNA gonorrhea vaccine

The Danish artificial intelligence (AI) biotech Evaxion has announced plans to develop an mRNA vaccine against gonorrhea in partnership with Afrigen Biologics. Gonorrhea antigens identified through Evaxion’s EDEN platform have shown strong protective effects in preclinical trials, as per the company. The partnership will investigate the function of these antigens when presented in the mRNA form. After the validation phase, the partners will discuss an agreement for clinical development and commercialisation, with the opportunity to involve additional collaborators. Cape Town, South Africa-based Afrigen Biologics is set up as a specialised centre to support mRNA vaccine development and technology transfer, will take charge of developing the mRNA vaccine in low and middle-income countries and African territories. Gonorrhea is a sexually transmitted infection, caused by the bacteria Neisseria gonorrhoeae. It heightens the vulnerability to HIV, a prevalent health concern in many low and middle-income countries (LMICs). Birgitte Rønø, Evaxion’s Chief Scientific Officer ...
- Source: drugdu
- 101
- September 30, 2023
Study finds mixed results for mobile health app in cardiac rehabilitation

Nearly one in three Americans wear a wearable device, like a smartwatch, to track their health and fitness. Studies have shown positive effects of increasing movement in ways that can be measured by these devices, especially for people who recently had a heart attack or other cardiovascular event. But a Michigan Medicine-led report shows that adding a mobile health application to such devices yields mixed results. Tailored text messages to encourage high-risk people to move more may improve some short-term outcomes but doesn’t always improve physical activity levels for everyone. The randomized clinical trial, called the Virtual AppLication-supported Environment To Increase Exercise Study, or VALENTINE, compared the physical activity levels of patients enrolled in cardiac rehabilitation who received the mobile health intervention to those who did not. Cardiac rehabilitation is a medically supervised program is recommended after cardiovascular events, such as heart attack or surgery. Of the more than 200 ...
- Source: drugdu
- 104
- September 28, 2023
Merck KGaA’s MilliporeSigma pumps €28M into 2 new mRNA production plants

On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization.Tuesday, MilliporeSigma christened two new mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. The company has invested €28 million in the sites, where it plans to hire 75 new staffers, MilliporeSigma said in a release. The new facilities will be able to tackle a full range of mRNA services, from pre-clinical to commercial-scale projects, MilliporeSigma said. Those offerings will include analytical development and biosafety testing specifically designed for mRNA technologies, the company added. The facilities fall under the umbrella of MilliporeSigma’s €1 billion investment to advance mRNA technologies and build its global mRNA network. Employing 27,000 worldwide, MilliporeSigma sells life sciences companies the tools and tech needed for testing and manufacturing. It also operates a contract testing, development ...
- Source: drugdu
- 189
- September 28, 2023
Boston Scientific expects ‘dramatic shift’ to pulsed field ablation to fuel fast growth through 2026

Dive Brief Boston Scientific has set bullish growth targets for 2024 to 2026, according to analysts. The company is forecasting that a “dramatic shift” to pulsed field ablation will increase its organic revenues by 8% to 10% over the period. Analysts went into Boston Scientific’s investor day expecting 7% to 9% growth. Some analysts left the event speculating that Boston Scientific can exceed its 10% target after being convinced that PFA and left atrial appendage closure can power the company toward its goal. Boston Scientific forecast that the global atrial fibrillation ablation market will grow from $5 billion today to $8 billion in 2026 and $11 billion by 2028. PFA’s share of the market is predicted to rise from less than 5% today to 40% to 60% in 2026 and 60% to 80% in 2028. Dive Insight Boston Scientific forecast an 8% to 10% organic sales compound annual growth rate ...
- Source: drugdu
- 239
- September 25, 2023
Novartis Returns Cancer Asset Tislelizumab to BeiGene

By Tristan Manalac Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto Novartis on Tuesday gave back the investigational monoclonal antibody tislelizumab to BeiGene, returning worldwide rights to develop, manufacture and commercialize the anti-PD-1 candidate to the cancer-focused biotech. Also on Tuesday, BeiGene announced that the European Commission had approved tislelizumab for patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had previously failed platinum-based chemotherapy. The treatment will be marketed under the brand name Tevimbra. After more than a year of regulatory delay, the FDA has also accepted BeiGene’s Biologics License Application (BLA) for tislelizumab as a first-line treatment option in this indication, according to Tuesday’s announcement. Novartis and BeiGene first entered into a collaboration and license agreement over tislelizumab in January 2021 to develop tislelizumab in ESCC, as well as other malignant diseases such as non-small cell lung cancer and hepatocellular carcinoma. In July 2022, however, ...
- Source: drugdu
- 113
- September 21, 2023
Pfizer’s Vydura recommended by NICE for acute migraines

The treatment is the first oral GPCR receptor antagonist class recommended for NHS use The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines in adults. The recommendation marks Vydura as the first drug in the oral GPCR receptor antagonist class to be recommended for routine NHS use as treatment for the condition. Published in NICE’s draft guidance, Vydura is recommended for adults who have previously tried at least two triptant-based therapies that were ineffective, not tolerated, or contraindicated. It is also recommended after prior use of nonsteroidal anti-inflammatory drugs, such as ibruprofen and aspirin, and paracetamol didn’t work well enough. Triptants are a group of medicines used to treat a migraine or headache. The recommendation was based on clinical trial evidence, which showed that Vydura is more likely to reduce pain in patients within 2 ...
- Source: drugdu
- 128
- September 20, 2023
FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class

Myelofibrosis can already be treated with several drugs from a class of medicines that address a pathway driving this type of blood cancer. A drug from GSK is now the latest entrant into the class, but with an additional component that specifically treats the anemia complication affecting myelofibrosis patients. FDA approval of GSK’s momelotinib covers the treatment of adult myelofibrosis patients regardless of whether or not they have been previously treated with another drug for the cancer. The regulatory decision announced late Friday marks the payoff for the pharmaceutical giant’s bet on a molecule it acquired in a $1.9 billion deal. The GSK drug, known in development as momelotinib, will be marketed under the brand name Ojjaara. In myelofibrosis, inflammation and scar tissue (fibrosis) impair the bone marrow’s ability to normally produce red blood cells. The disease leads to anemia, which must be treated with regular blood transfusions. Other complications ...
- Source: drugdu
- 177
- September 19, 2023
Iovance’s PDUFA date for lifileucel pushed due to FDA backlog

The US Food and Drug Administration (FDA) is feeling the strain on its resources and has had to delay the priority review of Iovance Biotherapeutics’s lifileucel to 2024. The Prescription Drug User Fee Act (PDUFA) action date for the priority review of the Biologics License Application (BLA) for lifileucel has been postponed from 25 November 2023 to 24 February 2024. However, Iovance was quick to add that the reason for pushing the date was the FDA’s “insufficient resources” and that it was working with the agency to expedite the review for a potentially earlier approval date. The company also added that the FDA reported no major review issues, no concerns regarding the status of the confirmatory trial, and had no plans to hold an advisory committee meeting. The markets viewed the news favourably, as Iovance’s stock rose by more than 15% in pre-market trading. The company’s market cap stands at ...
- Source: drugdu
- 99
- September 19, 2023
First Wave plans to repurpose Sanofi’s capeserod as GI therapy

First Wave BioPharma has acquired Sanofi’s capeserod with plans to repurpose it as a gastrointestinal (GI) disease therapy. Following the news, First Wave’s stock skyrocketed by over 80% in pre-market trading. The US-based company has a market cap of $3.112m. The agreement includes a $500,000 upfront payment, with developmental and commercial milestone payments of up to $46m and $235m, respectively. Additionally, Sanofi would have the right of first refusal on any capeserod sublicensing agreement and would be entitled to a percentage of any licensing payments. Sanofi also reserves the first refusal right to reacquire capeserod during development. Capeserod is a selective partial agonist of the serotonin type 4 (5-HT4) receptor. In the GI tract, these receptors perform various functions, including gastric emptying, decreasing oesophageal reflux, and promoting intestinal peristalsis. Sanofi had previously evaluated capeserod in Alzheimer’s disease and urinary incontinence but had since terminated the drug development. However, Fist Wave ...
- Source: drugdu
- 211
- September 18, 2023

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