Search Results for “mental health” – Page 31 – media

WuXi Biologics Successfully Completes First 1,6000L Manufacturing Run in Ireland

DUNDALK, Ireland, Jan. 31, 2024 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has successfully completed the first manufacturing run at its drug substance facility MFG7, paving the way for large-scale commercial manufacturing projects at this Ireland site. The manufacturing run reached 16,000-liter scale by combining four 4,000-liter single-use bioreactors. This pioneering paradigm marks not only the first successful manufacturing run for the MFG7 facility, but also the largest manufacturing scale for WuXi Biologics to date. The Cost of Goods (COGS) from this run is comparable to that of a 16,000-liter traditional stainless-steel bioreactor, reinforcing the comparable cost seen in over 100 runs at 12,000-liter scale single-use bioreactors (6×2,000-liter in MFG2 and MFG5 facilities; 3×4,000-liter in MFG5 and MFG8 facilities) compared with a traditional 12,000-liter stainless steel bioreactor. Dr. Chris Chen, CEO of WuXi Biologics, commented, “We ...
- Source: drugdu
- 156
- February 2, 2024
Genetic Medicines Biotech Dyne Pulls In $345M for Clinical Tests of Muscle Drugs

Dyne Therapeutics recently reported encouraging Phase 1/2 clinical data in myotonic dystrophy type 1 and Duchenne muscular dystrophy. At the J.P. Morgan Healthcare Conference, CEO Joshua Brumm said Dyne’s existing cash combined with the new capital is expected to last through 2025—well beyond the next key milestones for both therapeutic candidates. By FRANK VINLUAN Dyne Therapeutics started the new year with proof-of-concept clinical data for experimental genetic medicines addressing two rare muscle diseases—one of which has no FDA-approved treatments. Now the biotech has $345 million as it looks toward key tests for both therapies. Ahead of the Martin Luther King Jr. holiday weekend, Dyne closed a stock offering of 19.7 million shares priced at $17.50 each. In the prospectus, Dyne said the net proceeds of the stock offering will be combined with its existing capital to fund ongoing clinical development of the two clinical-stage programs, DYNE-101 and DYNE-251. Dyne CEO ...
- Source: drugdu
- 140
- January 17, 2024
CAR-T drug launches pay-per-therapeutic-value program with up to 600,000 yuan drug rebate

On January 11, Fosun Kate and Chenshi Health, a health management and comprehensive patient service platform under Sinopharm Holdings, jointly launched the first lymphoma pay-per-therapeutic value plan for Ekeda in China. Eligible patients who fail to achieve complete remission (CR) after treatment with Ekeda, a CAR-T treatment that originally cost $1.2 million, will receive a rebate of up to RMB600,000. The program will be China’s first innovative payment model for lymphoma drugs paid by the value of efficacy, and Ekeda will be China’s first bioinnovative drug paid by the value of efficacy. “If the complete remission indicator is not reached at three months, even if there is efficacy but the efficacy is not as good as complete remission, half of their out-of-pocket drug purchase price will still be refunded under the program. If this patient’s medication is completely self-funded, then the maximum return is 600,000 RMB for the medication. If ...
- Source: drugdu
- 199
- January 16, 2024
BioMarin’s new CEO Hardy says top priority is expansion of dwarfism drug Voxzogo

In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist. The top priority for the former Genentech CEO is to accelerate and maximize the commercial potential of dwarfism drug Voxzogo, Hardy said Tuesday at the J.P. Morgan Healthcare Conference. His second objective is to ramp up the commercialization of Roctavian, a newly approved gene therapy for hemophilia A. Thirdly, it is up to Hardy to identify BioMarin’s most promising R&D projects and make tough decisions about what to cut. Given his experience heading up Roche subsidiary Genentech for the last five years, Hardy is equipped to take on these challenges. During his time in charge, Genentech launched 10 medicines, including blockbuster macular degeneration drug Vabysmo. The company’s revenue jumped 24% and did so efficiently as profit-per-employee grew by 69%. “Why did I choose BioMarin? I ...
- Source: drugdu
- 101
- January 15, 2024
GSK

GSK has a lot of experience with its shingles vaccine Shingrix in getting the older population to take their shots; now, with the approval of the world’s first RSV vaccine last year, the U.K. Big Pharma is looking for a slow burn approach for its latest respiratory shot. During GSK’s official J.P. Morgan Healthcare Conference 2024 presentation, CEO Emma Walmsley and Chief Commercial Officer Luke Miels spoke on how the company is looking to carve out a RSV market with its new vax Arexvy. “Creating a market is absolutely fundamental,” Walmsley said during the JPM presentation. “Three years ago, I don’t know how broadly the awareness was of the general public about RSV for older adults, even though it’s a scale disease that hospitalizes tens of thousands of Americans that were on, sadly 15,000 died. “So, we’re at very early stages of penetration of the market. I think competition and ...
- Source: drugdu
- 168
- January 12, 2024
BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod

By PharmaCompass BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod This week’s Phispers is a double bill with news from last week and the first days of the New Year. Bristol Myers Squibb (BMS) and AstraZeneca have been on year-end shopping sprees with the former picking up Karuna Therapeutics for a whopping US$ 14 billion and the latter expanding its already dominant presence in China through an acquisition and a deal. Novo Nordisk is investing over US$ 2 billion, this time in Ireland, to meet the skyrocketing demand for its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy. In drug approvals, AstraZeneca and Ionis Pharmaceuticals’ drug Wainua became the first self-administered treatment in the United States for a rare nerve damage disease. In trial news, a potential first-in-class small molecule that was on course to becoming the first new drug approved in 20 years ...
- Source: drugdu
- 123
- January 8, 2024
Making the Most of Real-World Data in Clinical Trials

Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies. By DAVID BLACKMAN Clinical research is in the midst of a data explosion, and that’s a good thing. Technological advances are enabling access to secure and de-identified data sources for researchers, and the optimization of this data holds enormous potential for conducting clinical trials more efficiently, both from a cost and timeline perspective. The incorporation of real-world data (RWD), data gathered from actual patient experiences, in many ways represents an important step toward a fundamentally better understanding of states of disease and health. Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for ...
- Source: drugdu
- 177
- January 3, 2024
SINOPHARM Releases 2022 Environment, Social and Governance Report

The Environment, Social and Governance Report 2022 is the first ESG report released by SINOPHARM. The report focuses on the three themes of “Sinopharm – Navigating New High-Quality Development”, “Green Sinopharm – Building a Green and Safe Home” and “Warm Sinopharm – Guarding the People’s Good Life”, and comprehensively demonstrates the economic, social and governance achievements of Sinopharm in 2022. SINOPHARM’s comprehensive economic, social and environmental values in 2022 were comprehensively demonstrated, and SINOPHARM, as the national team and main force of the central pharmaceutical enterprises, was strongly demonstrated through the two responsibility themes of “Comprehensively Deepening Reform” and “Empowering Rural Revitalization” and the performance of the sustainable development (SDG) actions. As the national team, main force and pillar of the central pharmaceutical enterprise, Sinopharm actively serves the national strategy, improves its core competitiveness, enhances its core functions, and contributes Sinopharm’s power and wisdom to build a safe, green, harmonious ...
- Source: drugdu
- 93
- January 3, 2024
Insulet applauds NICE guidance on hybrid closed loop insulin delivery

BY SEAN WHOOLEY The Omnipod 5 hybrid closed-loop insulin delivery system worn on the back of an arm. [Image courtesy of Insulet] Insulet (Nasdaq:PODD) supports new National Institute for Health and Care Excellence (NICE) guidance supporting automated insulin delivery for type 1 diabetes. NICE published guidance recommending hybrid closed-loop systems for eligible people with type 1 diabetes in England and Wales. Hybrid closed-loop systems, like the Insulet Omnipod 5, deliver insulin automatically based on calculations from glucose monitors. Medtronic, Tandem Diabetes Care and Beta Bionics also compete with Insulet in the automated insulin delivery space. Medtronic applauded automated insulin delivery recommendations from NICE last month. NICE’s guidance, published this week, outlines that the systems require less input from the user, but manual insulin dosing is still needed sometimes, for example, around mealtimes. So, they may reduce the mental burden and improve people’s quality of life. In a LinkedIn post from ...
- Source: drugdu
- 99
- January 1, 2024
Shanghai RAAS’s New Drug ‘SR604 Injection’ Clinical Trial Application Accepted

On December 21, 2023, Shanghai RAAS received the ‘Acceptance Notification’ from the National Medical Products Administration regarding the clinical trial application for ‘SR604 Injection.’ SR604 Injection is a humanized monoclonal antibody that combines with human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. It is intended for the prophylactic treatment of bleeding in patients with hemophilia A/B and congenital coagulation factor deficiency. Currently, routine prophylactic treatment for hemophilia worldwide involves intravenous injection of blood-derived or recombinant coagulation factors 2-3 times a week. SR604 is intended to undergo a Phase I clinical trial for subcutaneous injection prophylactic treatment every 4 weeks. Some preclinical research findings from this project have already been published in the international hematology research journal Blood in the form of a cover article. As of the disclosed information, there are no products on the global market targeting the same ...
- Source: drugdu
- 147
- January 1, 2024

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