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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
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- May 30, 2023
EU regulators recommend yanking authorization for Novartis’ sickle cell med Adakveo after phase 3 miss

After Novartis’ sickle cell disease medicine Adakveo flopped in a phase 3 trial, European regulators promised to take a closer look at its prior approval. Now, the re-examination has come back with a recommendation to revoke authorization. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended snatching back Novartis’ approval after concluding that the med’s benefits did not outweigh the risks. The decision was based on the results of the phase 3 STAND trial, where the drug didn’t outperform placebo. Specifically, Adakveo (crizanlizumab) couldn’t reduce the number of painful crises leading to a healthcare visit. Adakveo-treated patients saw an average of 2.5 painful crises resulting in a healthcare visit over their first year of treatment, while patients in the placebo group had an average of 2.3. Another nail in the coffin was the average number of crises requiring a home healthcare visit or treatment, which ...
- Source: drugdu
- 162
- May 30, 2023
Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP

Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) has been approved by the US Food and Drug Administration (FDA), and Gilead Science’s Veklury (remdesivir) recommended by the European Medicines Agency’s human medicines committee to treat certain COVID-19 patients. Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. The agency’s latest decision is supported by the totality of evidence submitted by Pfizer, the company said, including efficacy data from the phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalisation or death from any cause in patients who took Paxlovid within five days of symptom onset. The drugmaker said in a statement that at this time, the US government will continue to oversee the distribution of Paxlovid, and eligible ...
- Source: drugdu
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
- 262
- 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
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- May 29, 2023

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