PharmaFocus Today – Page 318 – media

Researchers discover new weapon against antibiotic resistance—it also fights malaria

Florida International University scientists discovered the first and only known natural arsenic-containing antibiotic to fight antibiotic resistance. Now, research reveals it can stop transmission of a deadly disease spreading in the U.S. for the first time in 20 years: malaria. A team from FIU’s Herbert Wertheim College of Medicine developed arsinothricin (AST) to combat the rise of antibiotic-resistant bacteria. Lab tests proved AST effectively defeated the most notorious, including E. coli and Mycobacteria, which cause tuberculosis. Collaborating with malaria researchers in the College of Arts, Sciences & Education, they’ve recently also found AST prevents Plasmodium falciparum, the parasite that causes malaria, from infecting mosquitoes—unlike other current antimalarial drugs. The discovery, recently published in Microorganisms, paves the way for AST to one day be developed into a more effective antimalarial drug for humans. “Current antimalarials don’t completely stop transmission, meaning patients can continue to infect mosquitoes before they recover,” said lead ...
- Source: drugdu
- 119
- July 4, 2023
New technology to capture and release cfDNA on nanowire surfaces from urine

by Danielle Ellis, B.Sc. A group led by researchers at Nagoya University in Japan has developed a technology to capture and release cell-free DNA (cfDNA) on nanowire surfaces from urine. By extracting this DNA, they were able to successfully detect IDH1 mutation, a characteristic genetic mutation of gliomas, a type of brain tumor. Their findings increase the effectiveness of cancer detection tests using urine. They published their results in the journal Biosensors and Bioelectronics. Brain tumors are often examined only after the appearance of symptoms, such as paralysis of the limbs. But even when they are detected, they are often so advanced that it is difficult to remove them by surgery. Among these tumors, some of the deadliest are gliomas. These tumors have an average survival time as low as 12-18 months. Therefore, for the patient to have a chance of survival, early detection is necessary. As many patients have ...
- Source: drugdu
- 106
- July 4, 2023
BioMarin Wins FDA Approval for First Gene Therapy for Hemophilia A

By Tristan Manalac Pictured: BioMarin headquarters/iStock, Michael Vi The FDA has approved BioMarin Pharmaceutical’s valoctocogene roxaparvovec-rvox, to be marketed as Roctavian in the U.S., for the treatment of adult patients with severe hemophilia A, the company announced Thursday. Roctavian, a one-time single-dose infusion, is authorized for use only in adults without antibodies against the adeno-associated virus serotype 5 (AAV5), as determined by an FDA-approved test. It is also the first gene therapy approved for hemophilia A, according to BioMarin’s news release. In an investor call Thursday afternoon, BioMarin Chief Commercial Officer Jeff Ajer said that “the product profile of Roctavian presents tremendous value to patients, including bleed control, good safety profile and freedom from the burden of chronic therapy.” Roctavian is “priced at a wholesale acquisition cost, or WAC, that equates to $2.9 million for the typical patient for this one-time, single-dose treatment,” Ajer said. Hemophilia A is an inherited ...
- Source: drugdu
- 111
- July 4, 2023
The first fully A.I.-generated drug enters clinical trials in human patients

The first drug fully generated by artificial intelligence entered clinical trials with human patients this week. Insilico Medicine, a Hong Kong-based biotech startup with more than $400 million in funding, created the drug, INS018_055, as a treatment for idiopathic pulmonary fibrosis, a chronic disease that causes scarring in the lungs. The condition, which has increased in prevalence in recent decades, currently affects about 100,000 people in the U.S. and can lead to death within two to five years if untreated, according to the National Institutes of Health. “It is the first fully generative AI drug to reach human clinical trials, and specifically Phase II trials with patients,” Alex Zhavoronkov, founder and CEO of Insilico Medicine, told CNBC. “While there are other AI-designed drugs in trials, ours is the first drug with both a novel AI-discovered target and a novel AI-generated design.” The discovery process for the new drug began in ...
- Source: drugdu
- 178
- July 3, 2023
FDA approves CellTrans’ Lantidra as first cellular therapy to treat type 1 diabetes

The US Food and Drug Administration (FDA) has approved CellTrans’ Lantidra (donislecel) as the first cellular therapy to treat patients with type 1 diabetes. The authorisation specifically applies to adults who are unable to meet their target blood glucose levels because they have repeated episodes of severe low blood sugar (hypoglycaemia), despite intensive disease management and education. Almost 1.9 million people in the US have type 1 diabetes, according to the American Diabetes Association. The condition requires lifelong care, including the regular administration of insulin, either through multiple daily injections or continuous infusion using a pump. However, some patients have trouble managing the amount of insulin needed every day, and dosing becomes difficult. These patients may also develop hypoglycaemia unawareness, where they are unable to detect that their blood glucose is dropping and may not have a chance to treat themselves. Lantidra, which is administered initially as a single infusion, ...
- Source: drugdu
- 129
- July 3, 2023
Lantidra wins FDA approval as first-ever type 1 diabetes cell therapy

The US Food and Drug Administration (FDA) has announced that Lantidra, a cellular therapy for type 1 diabetes (T1D), has become the first treatment of its kind to be approved. Lantidra is an allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells. The approval applies to adults with ‘brittle’ T1D – those unable to reach target glycated haemoglobin (average blood glucose levels) due to repeated severe hypoglycaemic episodes, despite intensive diabetes management and education. T1D accounts for roughly 5%-10% of all diabetes cases. Within this population, an even smaller group, approximately three out of every 1,000 people with T1D, suffer from ‘brittle’ disease. The therapy works by essentially replacing the body’s insulin-producing beta cells in the pancreas. This is achieved through allogeneic islet beta cells that secrete insulin, administered as a single infusion into the hepatic (liver) portal vein. While this is generally sufficient, an additional infusion ...
- Source: drugdu
- 207
- July 3, 2023
Sanofi outlines five-pronged approach to reel in €10B in vaccine sales by 2030

While Dupixent often steals the show, Sanofi isn’t sleeping on its vaccine franchise. Boasting prophylactic prospects in respiratory syncytial virus (RSV), pneumococcal disease and flu—including a clutch of promising mRNA candidates—the French pharma feels confident its shots can deliver billions of dollars by the end of the decade. By 2030, Sanofi figures its immunizations could generate more than €10 billion in annual sales, the company said during a vaccines R&D event Thursday. Much of that momentum hinges on Sanofi’s pipeline, where the company is targeting an “accelerated pace of innovation” in a bid to launch at least five innovative phase 3 vaccine programs by 2025. “When developing new vaccines, our scientists can now choose from nine distinct platforms—probably the largest number in the industry,” Thomas Triomphe, Sanofi’s executive vice president of vaccines, said of the company’s future immunization prospects. And despite big things on the horizon—principally in the form of ...
- Source: drugdu
- 112
- July 3, 2023
Missed trial protocols, fabricated emails and failed endpoint mar BioXCel’s Alzheimer’s agitation readout

A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. As BioXCel unveiled its phase 3 data for its orally dissolving dexmedetomidine (originally Pfizer’s Precedex) formulation in Alzheimer’s-related agitation, the company also disclosed some serious trial missteps in an Securities and Exchange Commission (SEC) filing. After the FDA in December inspected a trial site that enrolled about 40% of study participants, the agency found three big red flags relating to adherence of the trial’s framework, the filing says. For one, the investigator failed to follow the informed consent plan for four trial subjects, chief medical officer Robert Risinger, M.D., told investors on a conference call. In “certain instances” the investigative plan wasn’t followed and sufficient case histories weren’t maintained for some patients. For example, the site reported a serious adverse event for one patient outside of ...
- Source: drugdu
- 106
- July 2, 2023
Gates Foundation and Wellcome to fund late-stage trial of tuberculosis vaccine candidate

The Bill & Melinda Gates Foundation and Wellcome have joined forces to fund the late-stage development of what could be the first tuberculosis (TB) vaccine in over a century. TB is a bacterial infection spread by inhaling tiny droplets from the coughs or sneezes of an infected person. Despite being both curable and preventable, the disease continues to affect around ten million people every year, and 1.6 million people died from it in 2021, almost entirely in low and middle-income countries. The only TB vaccine in use today, bacille Calmette-Guérin (BCG), was first used in 1921. It helps protect babies and young children against severe systemic forms of TB, but offers limited protection against pulmonary TB – a form of active TB – among adolescents and adults. The Gates Foundation and Wellcome will invest around $550m to support the phase 3 trial of the M72/AS01E (M72) vaccine, which will be ...
- Source: drugdu
- 122
- July 2, 2023
CDC recommends RSV vaccines from Pfizer, GSK for adults 60 and older

The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors. Outgoing CDC Director Rochelle Walensky signed off on the recommendation, which an advisory panel of outside experts made last week. That endorsement says seniors should work with their health-care providers to decide if taking a shot is right for them. The CDC said the shots are expected to be available to the public this fall, when respiratory syncytial virus – along with Covid and the flu – typically begins to spread at higher levels. “These vaccines provide an opportunity to help protect older adults against severe RSV illness at a time when multiple respiratory infections are likely to circulate,” the CDC said in a statement. The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but ...
- Source: drugdu
- 111
- July 2, 2023

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