Search Results for “EC” – Page 74 – media

Simcere and Connect sign licensing agreement for anti IL-4Rα AD drug

Simcere has entered a licensing agreement with Connect Biopharma for the development of a monoclonal antibody (MAb) candidate rademikibart (CBP-201) against allergic inflammation in autoimmune conditions such as atopic dermatitis (AD) and asthma. Under the deal, the Nanjing, China-headquartered company will have a licence for the development and commercialisation of rademikibart in mainland China, Macau, Taiwan, and Hong Kong. Connect retains its rights to the MAb outside Greater China. Rademikibart is a humanIgG4 MAb that binds to IL-4Rα, which can be administered as a subcutaneous or intravenous (IV) injection. Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has dominated the AD drug market since it first gained a US Food and Drug Administration (FDA) approval in March 2017. Dupixent had generated $6.4bn in US sales up until 30 September, according to Regeneron’s Q3 2023 report. It is forecast to make over $11bn in global sales for all indications by the end of ...
- Source: drugdu
- 188
- November 26, 2023
Breakthrough decoding of the Y chromosome revolutionizes digestive disease research

A major breakthrough in human genetics has been achieved with the complete decoding of the human Y chromosome, opening up new avenues for research into digestive diseases. This milestone, along with advancements in third-generation sequencing technologies, is poised to revolutionize our understanding of the genetic underpinnings of digestive disorders and pave the way for more personalized and effective treatment strategies. The Y chromosome, the smallest of the human chromosomes, has long been shrouded in mystery due to its complex repetitive structure. However, recent advancements in sequencing technologies have enabled researchers to unravel the intricate details of this genetic region, shedding light on its role in sex determination and its potential impact on various diseases, including those affecting the digestive system. Completing the Y chromosome sequence provides a comprehensive reference for identifying genetic variations that may contribute to digestive diseases. This information is crucial for understanding the “missing heritability” problem, where ...
- Source: drugdu
- 189
- November 25, 2023
Smith+Nephew to buy CartiHeal and its knee cartilage healing tech

Agili-C is a porous, biocompatible, and resorbable scaffold for cartilage regeneration in the knee. [Image courtesy of CartiHeal and Smith+Nephew] Smith+Nephew (LSE:SN, NYSE:SNN) announced today that it has agreed to acquire CartiHeal and its novel sports medicine technology. CartiHeal’s Agili-C is an off-the-shelf, porous, biocompatible, and resorbable scaffold. Approved by the FDA in 2022, it promotes natural regeneration of the articular cartilage — and restoration of its underlying subchondral bone. Under the acquisition agreement, Smith+Nephew will pay an initial $180 million for CartiHeal. There’s also the potential for CartiHeal’s present owners to receive a further $150 million contingent on financial performance. “The acquisition of this disruptive technology supports our strategy to invest behind our successful Sports Medicine business,” S+N CEO Deepak Nath said in a news release. “Agili-C’s superior clinical performance makes it highly complementary to our existing knee repair portfolio, and with our proven commercial expertise in high-growth biologics, ...
- Source: drugdu
- 136
- November 25, 2023
Sunnyside Secures $11.5M To Help People Build Healthier Drinking Habits

Sunnyside, which offers an app to help consumers moderate their drinking, has raised $11.5 million in Series A funding. The round was led by Motley Fool Ventures and will be partially used for product development. By MARISSA PLESCIA About two-thirds of adults in the U.S. drink alcohol, but about one in three are trying to drink less. Sunnyside, which announced it raised $11.5 million in Series A funding last week, aims to help people cut back on their drinking without having to quit altogether. The San Francisco-based startup offers an app for consumers. At $99 a year, users of Sunnyside have access to drink tracking, daily reminders of their goals, personalized recommendations, community support with other users of the app and one-on-one peer support. “This approach provides a much-needed alternative for those looking to change their relationship with alcohol, but who aren’t open to quitting drinking entirely,” said Nick Allen, ...
- Source: drugdu
- 143
- November 25, 2023
Levofloxacin revealed as first effective treatment for multi-drug resistant TB

Two landmark clinical trials involving researchers at University College London (UCL) have demonstrated that levofloxacin is the first effective treatment to prevent multidrug-resistant tuberculosis (MDR-TB). Results from both trials were announced at the Union World Conference on Lung Health in Paris, France. Annually, around 500,000 people develop tuberculosis (TB), an infectious disease caused by a type of bacteria that affects the lungs, that is resistant to multiple antibiotics. Led by Stellenbosch University in South Africa, with the MRC Clinical Trials Unit (CTU) at UCL responsible for trial management and statistical analysis, the TB-CHAMP trial involved 922 children and adolescents exposed to an adult with MDR-TB in their household. Results showed that levofloxacin reduced the risk of MDR-TB disease by 56%, with very few side effects reported. Additionally, after one year, only 1.1% of children developed TB, compared to 2.6% who received a placebo. The second trial, VQUIN, led by the ...
- Source: drugdu
- 125
- November 25, 2023
European Patent Office Declares One of Moderna’s mRNA Patents Invalid

By Tristan Manalac The European Patent Office has decided that a hotly contested mRNA patent held by Moderna pertaining to its COVID-19 vaccine is invalid, Reuters reported on Tuesday. The patent in question covers betacoronavirus vaccines that use at least one RNA polynucleotide with an open reading frame that encodes at least one betacoronavirus antigenic peptide, according to its claims document listed in the European Patent Register. While the patent battle is over the use of this technology to produce COVID-19 vaccines, the claims document also seeks to protect its use for other viral respiratory infections, including MERS and SARS. Several biopharma companies have lodged their opposition to these claims, including BioNTech and Pfizer—Moderna’s chief competitors in the coronavirus vaccine market—as well as Sanofi, according to the patent’s listing on the register. A BioNTech spokesperson in a statement to Fierce Pharma said that the company “welcomes” the European Patent Office’s ...
- Source: drugdu
- 105
- November 24, 2023
Cosmic radiation and microgravity linked to erectile dysfunction in astronauts

During missions into space, astronauts are exposed to high levels of galactic cosmic radiation and weightlessness. Simulation experiments in male rats indicated that these aspects of spaceflight can negatively affect vascular tissues relevant to erectile dysfunction, even after a period of long-term recovery. The research, which is published in The FASEB Journal, indicated that vascular alterations are induced by relatively low doses of galactic cosmic radiation and to a lesser extent simulated weightlessness, primarily through increases in oxidative stress. Treatment with different antioxidants could counter some of these effects. Justin D. La Favor, PhD, corresponding author of Florida State University, said, “With manned missions to outer space planned for the coming years, this work indicates that sexual health should be closely monitored in astronauts upon their return to Earth. While the negative impacts of galactic cosmic radiation were long-lasting, functional improvements induced by acutely targeting the redox and nitric oxide ...
- Source: drugdu
- 95
- November 24, 2023
Another medtech reports a cybersecurity incident

BY JIM HAMMERAND The London-based device developer disclosed the cybersecurity incident in a Securities and Exchange Commission filing this week, saying the incident disrupted portions of its information technology systems and business operations. “Promptly after detecting the issue, the company began an investigation with assistance from external cybersecurity experts and is coordinating with law enforcement,” LivaNova said in the filing. “The company continues to assess what information and systems were impacted and is executing its incident response plan, including implementing remediation measures to mitigate the impact of the incident.” “The company has and will continue to take actions to remediate the issue, such as taking certain systems offline,” the company continued. LivaNova said it expects continued disruption of its operations, and can’t yet determine “the extent of the impact from such event on its business, results of operations, cash flows or financial condition.” Earlier this year, the SEC launched new ...
- Source: drugdu
- 96
- November 24, 2023
EC approves pharmaand’s Rubraca as advanced ovarian cancer maintenance treatment

The European Commission (EC) has approved pharmaand’s (pharma&) Rubraca (rucaparib) as a first-line maintenance treatment for advanced ovarian cancer in patients who have responded to first-line platinum-based chemotherapy. The PARP inhibitor, which has been authorised for use in all advanced ovarian cancer patients regardless of their BRCA mutation status, was previously approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The EC’s latest decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage ATHENAMONO trial. Results showed that, as a first-line maintenance treatment, Rubraca significantly improved investigator- assessed progression-free survival compared with placebo in advanced ovarian cancer patients, regardless of BRCA mutation status. The safety profile observed in the ATHENAMONO trial was also consistent with ...
- Source: drugdu
- 100
- November 24, 2023
Novartis drops subpoena request in trade-secret spat with Takeda

Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade secrets theft. Novartis originally filed the complaint in Massachusetts Superior Court in October. The Swiss pharma wanted to find out whether a former employee in Egypt took sensitive documents to his new job with Takeda. After being “stonewalled” by Takeda, Novartis resorted to legal action, attempting to subpoena the Japanese pharma’s business records and depose an employee. Takeda, on Nov. 10, filed a motion to dismiss the complaint for recovery. According to Novartis, a former employee named Khaled Shams Eldin transferred some 10,000 files to his personal email before departing the company in May. After leaving his post as operations lead for cell and gene therapy at Novartis’ Egyptian unit, Eldin joined Takeda in July in a similar position, the company said. Earlier this week, Novartis dropped the case, according to a court ...
- Source: drugdu
- 108
- November 24, 2023

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