Search Results for “EC” – Page 418 – media

VarmX raises funds to seek IND approval for VMX-C001

Biotechnology company VarmX has raised an additional €30m in a Series B2 financing round to obtain investigational new drug (IND) approval for its lead compound VMX-C001. VMX-C001 is a modified recombinant human blood clotting factor X that enables patients taking direct oral anticoagulant blood thinners to undergo emergency surgery without the risk of bleeding. It also enables blood to clot normally in the presence of factor Xa blood clotting inhibitors. VarmX also intends to use the financing to complete preparations for the pivotal clinical trial including large scale manufacturing. The company’s first-in-human study will demonstrate the safety of VMX-C001 and provide clinical proof of concept. Enrolment for this study is completed. Full study results are expected to be announced later this year. Led by Sound Bioventures, the Series B2 financing round has also seen participation from another new investor, the European Innovation Council (EIC) Fund. Existing investors include EQT Life ...
- Source: drugdu
- 109
- May 30, 2023
Merck’s Keytruda, Novartis’ Kisqali face their moment of truth in early-stage cancers

Two cancers studies are slated to grab significant attention at the upcoming American Society of Clinical Oncology 2023 annual meeting, and each could lead to a major label expansion for the companies involved. With KEYNOTE-671, Merck is looking to shake up how nonmetastatic non-small cell lung cancer (NSCLC) is treated by testing Keytruda both before and after surgery. For its part, Novartis will elaborate on the postsurgery data for Kisqali in early breast cancer from the NATALEE trial. When the company said the trial met its endpoint, investors sent the Big Pharma’s stock price up by 8% in a single day. Before the official data revelations on June 2 for NATALEE and June 3 for KEYNOTE-671, Fierce Pharma gathered expectations for the two studies from oncology leaders at Penn Medicine and MD Anderson Cancer Center plus market analysts at multiple firms. The NATALEE study could open a market that’s worth ...
- Source: drugdu
- 116
- May 30, 2023
Medical row in France over unauthorised COVID trial

French medical bodies on Sunday called on authorities to punish researcher Didier Raoult for “the largest ‘unauthorized’ clinical trial ever seen” into the use of hydroxychloroquine to treat COVID-19. Raoult, the former head of the IHU Mediterranee research hospital, and his subordinates engaged in “systematic prescription of medications as varied as hydroxychloroquine, zinc, ivermectin and azithromycin to patients suffering from COVID-19… without a solid pharmacological basis and lacking any proof of their effectiveness,” a group of 16 research bodies wrote in an op-ed piece on daily Le Monde’s website. The drugs continued to be prescribed “for more than a year after their ineffectiveness had been absolutely demonstrated,” they added. Endorsement from respected tropical disease specialist Raoult helped push anti-malaria drug hydroxychloroquine into the public consciousness in the early days of the coronavirus pandemic, feeding into its promotion by former US President Donald Trump and Brazil’s then-leader Jair Bolosonaro. In April, ...
- Source: drugdu
- 100
- May 30, 2023
FDA approves Lexicon’s heart-failure drug after defeat in diabetes

Nicole DeFeudis Editor The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi. The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday. The company did not release Inpefa’s price but said it will be “comparable to existing branded heart failure medications.” Lexicon CEO Lonnel Coats expects the drug to hit the market by the end ...
- Source: drugdu
- 106
- May 30, 2023
Centre for Genomic Regulation and Almirall join forces on skin cancer treatments

The collaboration aims to develop novel preclinical models with a view to identifying new treatments Almirall – a company which concentrates on medical dermatology – has linked up with the Centre for Genomic Regulation. The collaboration aims to develop novel preclinical models with a view to identifying new treatments for non-melanoma skin cancer (NMSC). The condition poses a considerable health challenge, with basal cell carcinoma and squamous cell carcinoma representing 70% and 25% of NMSC cases, respectively. The partnership – led by Almirall’s investigators Dr Cristina Gutiérrez and Dr Amadeu Gavaldà – will also incorporate CRG group leader and ICREA research professor Luciano Di Croce and his team. In partnership, they will establish experimental models that enable the validation of new therapeutic approaches and therapies for these diseases. The collaboration has emerged following the request for proposals from AlmirallShare – the company’s open innovation platform dedicated to discovering treatments for ...
- Source: drugdu
- 119
- May 29, 2023
FDA approves Blueprint Medicines’ Ayvakit for indolent systemic mastocytosis

The US Food and Drug Administration (FDA) has approved Blueprint Medicines’ Ayvakit (avapritinib) as the first and only medicine designed to treat indolent systemic mastocytosis (ISM). Systemic mastocytosis (SM) is a rare haematologic disorder that can lead to a range of debilitating symptoms across multiple organ systems. ISM accounts for the vast majority of SM cases and, despite the availability of multiple supportive care treatments, a number of ISM patients continue to experience a substantial disease burden. Ayvakit, which has been approved in the US to treat advanced SM since June 2021, works by targeting the primary underlying cause of the disease – a mutation known as KIT D816V. Blueprint’s chief medical officer, Becker Hewes, said the approval marked “a shift in the treatment paradigm from supportive care to disease modifying therapy” for ISM patients. “With a broad indication for ISM and a strong label, we are now engaging healthcare ...
- Source: drugdu
- 110
- May 29, 2023
Bristol Myers’ $4B plan for Reblozyl takes shape in blood cancer anemia—with one caveat

Bristol Myers Squibb’s Reblozyl could be an effective initial treatment for anemia patients who are suffering from a group of blood cancers called myelodysplastic syndromes (MDS) and are at a relatively lower risk of progression. That’s the conclusion reached by Olatoyosi Odenike, M.D., from the University of Chicago Medical Center, after she reviewed data from the phase 3 COMMANDS trial that are slated to be presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Odenike is an invited ASCO expert and an opinion leader in the MDS field. The COMMANDS trial is the first study in decades that has shown a benefit for a new agent against erythropoiesis-stimulating agents (ESAs) in low- to intermediate-risk MDS, Noah Berkowitz, M.D., Ph.D., senior vice president of hematology development at BMS, said in an interview with Fierce Pharma. If the FDA eventually agrees with Odenike’s finding, Reblozyl could move from behind ...
- Source: drugdu
- 257
- May 29, 2023
Epilepsy groups, lawmakers demand better education, funding and government action for the condition

A whole host of epilepsy organizations and several members of Congress have come together to call for more governmental help to treat and educate those with epilepsy. The groups, which include the Epilepsy Foundation, the Epilepsies Action Network, CURE Epilepsy, the Rare Epilepsy Network and DEE-P Connections, along with Reps. Greg Murphy, M.D., R-North Carolina, and Jim Costa, D-California, took to Capitol Hill this month to speak about their personal connections to epilepsy. “My son developed epilepsy when he was 14, and it took us months to get the right treatment for him,” said Murphy in a press release. “While he is now 28 and his seizures are controlled, there are still millions of Americans who continue to struggle with seizures. “My sister is one of those people,” he added. “I am committed to elevating the community’s voice in Washington to bring much-needed education and awareness about this very common ...
- Source: drugdu
- 114
- May 29, 2023
Elon Musk’s brain chip firm says US approval won for human study

By James FitzGerald BBC News Elon Musk’s brain-chip firm says it has received approval from the US Food and Drugs Administration (FDA) to conduct its first tests on humans. The billionaire’s Neuralink implant company wants to help restore people’s vision and mobility by connecting brains with computers. It says it does not have immediate plans to start recruiting participants. Mr Musk’s previous ambitions to begin tests came to nothing. The regulator itself is yet to comment. An earlier bid by Neuralink to win FDA approval was rejected on safety grounds, according to a report in March by the Reuters news agency that cited multiple current and former employees. • What is Neuralink? Neuralink hopes to use its microchips to treat conditions such as paralysis and blindness, and to help certain disabled people use computers and mobile technology. The chips – which have been tested in monkeys – are designed to ...
- Source: drugdu
- 109
- May 29, 2023
Binge-eating disorders

My niece is living in my home while she is attending college. I’ve invited her to eat meals with our family, but she typically declines, desiring to eat alone in her room. I’m concerned because she often seems to eat a lot of food at one time, like two sandwiches with two bags of chips or a quart of ice cream. Could this be a sign of an eating disorder? If so, what can I do to help her? ANSWER: Most people eat too much occasionally. They may fill up an extra plate with seconds at a special event, enjoy another piece of pie at a holiday gathering or eat popcorn until stuffed at the movies. There’s no reason to be concerned if this happens occasionally. But, for some people, overeating can become excessive. It is possible that your niece is suffering from a binge-eating disorder if her excessive eating ...
- Source: drugdu
- 109
- May 29, 2023

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