PharmaFocus Today – Page 294 – media

Roche Expands Into RNAi Through Alnylam Alliance on Hypertension Drug

Photo: Giuseppe Aresu/Bloomberg, via Getty Images Alnylam pioneered RNA interference drugs for rare disease. The biotech aims to bring RNAI to prevalent disorders and its alliance with Roche on the drug zilebesiran for hypertension better positions the company to achieve this goal. Cardiometabolic disease isn’t a big part of Roche’s drug portfolio or pipeline, but the pharmaceutical giant is trying to change that with a deal to share in the development of an experimental Alnylam Pharmaceuticals hypertension drug that could offer patients efficacy and dosing advantages. According to deal terms announced Monday, Roche is paying $310 million for outside-of-the-U.S. rights to the drug, zilebesiran. The companies will share in the development of the RNA therapy for hypertension. Roche has the opportunity to lead future development of the drug for other indications. Cambridge, Massachusetts-based Alnylam is a pioneer among companies developing therapies that leverage RNA interference, a pathway in ...
- Source: drugdu
- 112
- July 26, 2023
Top 5 Foods with the Highest Prebiotic Content

There is growing evidence that consuming prebiotics -; certain types of fiber often found in plants that stimulate beneficial bacteria in your gut -; can help to maintain a healthy gut microbiome. In a new study, scientists estimated the prebiotic content of thousands of food types by using preexisting literature to find out which foods offer the highest prebiotic content. According to the study, foods that pack the greatest prebiotic punch are dandelion greens, Jerusalem artichokes, garlic, leeks, and onions. In addition to supporting gut microbes, prebiotic rich foods contain high amounts of fiber -; something most Americans do not get enough of. “Eating prebiotic dense foods has been indicated by previous research to benefit health,” said Cassandra Boyd, a master’s student at San José State University who conducted the research with Assistant Professor John Gieng, PhD. “Eating in a way to promote microbiome wellness while eating ...
- Source: drugdu
- 228
- July 25, 2023
Majority of Cosmetic Practitioners in the UK are not Qualified Medical Doctors, Study Finds

According to an analysis of the UK’s cosmetic injectables industry by UCL researchers, 68% of cosmetic practitioners who are administering injections such as Botox are not qualified medical doctors. The study, published in the Journal of Plastic, Reconstructive & Aesthetic Surgery, is the first survey of who is providing cosmetic injectable services, such as Botulinum Toxin (Botox) and Dermal Fillers, in the UK. Currently, little is known about the background qualifications, training and experience levels of those who are administering treatments. To fill this knowledge gap, researchers from UCL evaluated 3,000 websites to identify 1,224 independent clinics and 3,667 practitioners who were delivering cosmetic injections such as Botox. Of the professions represented, 32% were doctors, 13% were nurses, 24% were dentists and 8% were dental nurses. Of the 1,163 doctors identified, 41% were on the specialist register and 19% were on the GP register. Among the ...
- Source: drugdu
- 135
- July 25, 2023
ADC Discontinues Zynlonta Trial in DLBCL After Seven Deaths

Pictured: Doctor checking a patient’s neck/iStock, stefanamer ADC Therapeutics is discontinuing the Phase II LOTIS-9 trial testing Zynlonta (loncastuximab tesirine-lpyl) in combination with Genentech and Biogen’s Rituxan (rituximab) for patients with previously untreated diffuse large B-cell lymphoma, the company announced Thursday afternoon. The decision to discontinue comes after the Swiss biotech decided last week to voluntarily halt enrollment in LOTIS-9 after seven patients died of extreme respiratory events. While six of the fatalities were deemed “unlikely or unrelated to the study drug,” the company nevertheless elected to suspend the entry of patients into the study. In connection with the deaths, the FDA has also placed a partial clinical hold on enrollment into LOTIS-9, according to ADC’s Thursday press release. However, the company can continue dosing diffuse large B-cell lymphoma (DLBCL) patients who were seeing clinical benefit from the experimental treatment regimen, as long as these patients have given their consent again. Once ...
- Source: drugdu
- 233
- July 25, 2023
Vir’s GSK-Backed Flu Vaccine Candidate Fails Phase II Trial

Pictured: Flu vaccine vials and syringe/iStock, vchal Topline data from the Phase II PENINSULA study showed that Vir Biotechnology’s investigational flu shot VIR-2482 fell short of its primary and all secondary efficacy endpoints, the biotech announced Thursday. Patients inoculated with the highest 1,200-mg dose of the vaccine candidate saw a 16% drop in influenza A-like illness as compared with placebo, an effect that did not satisfy statistical significance, according to Vir’s news release. PENINSULA defined this primary endpoint as PCR-confirmed influenza A infection with at least one respiratory and one systemic symptom. Phil Pang, Vir’s chief medical officer, called these findings “disappointing” in a statement, but nevertheless said that the company needs to conduct further analysis to “better understand these outcomes.” Vir plans to present these analyses at a future major medical congress. PENINSULA is double-blinded, randomized and placebo-controlled study with approximately 3,000 adult patients enrolled. VIR-2482 was given as a ...
- Source: drugdu
- 149
- July 25, 2023
Sanofi Expects Infant RSV Shot to Roll Out Before Respiratory Virus Season This Fall

Sanofi expects its infant RSV shot to roll out in the U.S. before respiratory virus season this fall, a company spokesperson said Friday. The Food and Drug Administration on Monday approved Beyfortus, a monoclonal antibody that is administered as a single dose to infants before or during their first respiratory syncytial virus season. The Sanofi spokesperson said the company does not expect any challenges with manufacturing or capacity to meet demand this RSV season. The French drugmaker jointly developed Beyfortus with AstraZeneca , which is based in England. A panel of independent advisors to the Centers for Disease Control and Prevention will meet on Aug. 3 to make recommendations about how the shot should be administered. Sanofi is working with the panel to place Beyfortus on the U.S. childhood immunization schedule, the company spokesperson said. The Affordable Care Act requires most private insurance to cover ...
- Source: drugdu
- 124
- July 25, 2023
SN Bioscience’s Nano-Cancer Therapy Wins Orphan Drug Designation

The US Food and Drug Administration (FDA) granted SN Bioscience an orphan drug designation for its small cell lung cancer (SCLC) drug SNB-101, a polymer nanoparticle drug. The South Korea-headquartered company has received approval to run Phase I clinical trials in the US and South Korea, per a 20 July press release. The US trial (NCT04640480) is with solid tumours for any type of cancer. The orphan drug designation programme is an FDA initiative to support the development of new treatments for rare diseases. The classification gives sponsors tax credits from clinical trials, exemption from user fees, and a potential seven years of market exclusivity after approval. SNB-101 is an intravenously or intratumorally administered drug that acts as a topoisomerase I inhibitor. The therapy causes DNA breaks, inhibiting DNA replication and shutting down the cell cycle to prevent tumour growth. The drug uses the active ...
- Source: drugdu
- 101
- July 25, 2023
Mirati’s Flagship KRAS Inhibitor Krazati Gets Rebuffed in Europe

An approval from the U.S. FDA doesn’t guarantee a green light overseas—a lesson Mirati Therapeutics has learned the hard way after European regulators rebuffed the company’s flagship KRAS inhibitor Krazati. Friday, Mirati revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had spurned the company’s conditional marketing authorization application for Krazati, also known as adagrasib, to treat patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). In a release, Mirati said it “disagrees with the opinion” and intends to file for a formal re-examination. Once considered an undruggable target, KRAS now has two FDA-approved therapies competing in a potential blockbuster cancer market in the United States. After Amgen won an accelerated nod for its rival KRAS inhibitor Lumakras in May 2021, Mirati entered the fray with Krazati—the biotech’s first commercial product—in December. While Amgen’s drug has suffered a sequential sales decline in the U.S., Mirati’s med recently surprised ...
- Source: drugdu
- 124
- July 25, 2023
ADC Therapeutics Pulls the Plug on Zynlonta Study After Partial FDA Hold

A week after ADC Therapeutics paused its Zynlonta trial to review seven deaths and five other respiratory events in patients who received the drug, the company has scrapped the study altogether following an FDA partial clinical hold. The trial was testing the drug, combined with Roche’s Rituxan, in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Citing the “challenges of defining the addressable segment” of the difficult-to-treat population, ADC believes the benefit-risk profile “does not support” the continuation of the study, the company said in a release. The call came after a meeting with the FDA, in which the agency slapped a partial hold on enrolling new patients in the trial. However, the agency said patients who are already on the drug and seeing clinical benefits can remain enrolled after reconsenting. After those patients are treated, ADC will take steps to wrap up the trial. ...
- Source: drugdu
- 102
- July 25, 2023
Study Explores the Emergence of Predictive Models in the Hippocampus

Neuroscience studies have found that the brain spontaneously organizes events and life experiences into memories, which can be mentally retrieved and replayed at different points in time. These memories of past events are known to partly shape human perceptions and behavior, for instance highlighting strategies for solving a given problem that have proved to be effective in the past. A key region of the hippocampus, known as the CA1 region, has been hypothesized to support the human ability to retrieve relevant memories to forecast future outcomes, by creating predictive models that roughly represent what could happen in different scenarios. While many neuroscientists have been investigating this hypothesis, the ways in which these models are established and updated over time remain poorly understood. Researchers at The Hospital for Sick Children in Toronto and University of Toronto recently carried out a study aimed at better understanding the formation of these predictive ...
- Source: drugdu
- 144
- July 25, 2023

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