Search Results for “Clinical Trial” – Page 102 – media

Moderna says it expects up to $15 billion in sales of Covid, RSV, flu vaccines in 2027

Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially available product. ...
- Source: drugdu
- 120
- May 2, 2023
Medicare will cover Leqembi for all patients if FDA approves drug, CMS chief says

Medicare will cover the new Alzheimer’s treatment Leqembi for all patients eligible under the medication’s label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday. The official, Chiquita Brooks-LaSure testified before Congress Wednesday for the first time since her confirmation as administrator of the Centers for Medicare and Medicaid Services. Brooks-LaSure faced pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare’s controversial coverage policy for new Alzheimer’s treatments. The Food and Drug Administration approved Leqembi, which is a collaboration by Biogen and Eisai antibody treatment, on an expedited basis in January. Twice-monthly intravenous infusions of the drug, generically known as lecanemab, have shown promise in slowing the progression of early Alzheimer’s disease. But Medicare, which primarily provides health coverage to senior citizens, currently will only cover the ...
- Source: drugdu
- 116
- May 1, 2023
Moderna says it expects up to $15 billion in sales of Covid, RSV, flu vaccines in 2027

Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially ...
- Source: drugdu
- 136
- April 30, 2023
Hansa Biopharma enters into collaboration with Genethon

Swedish biotech company Hansa Biopharma has entered a research and development collaboration with Genethon. The partnership will assess the efficacy and safety of imlifidase, Hansa Biopharma’s antibody cleaving enzyme, in a clinical trial. Imlifidase will be developed as a pre-treatment for patients with Crigler-Najjar syndrome and pre-existing neutralising antibodies (NAbs) to adeno-associated virus serotype 8 (AAV8), before administering GNT-0003, Genethon’s gene therapy product candidate. The company stated that patients with circulating NAbs will be excluded from the clinical trial of potentially curative gene therapies as well as from access to approved gene therapies. Hansa Biopharma president and CEO Søren Tulstrup said: “Genethon is a pioneer at the cutting-edge of research and development of gene therapies for rare diseases and we are thrilled to be collaborating with them. “This research collaboration further validates Hansa’s commitment in gene therapy and underscores the important role that our antibody-cleaving ...
- Source: drugdu
- 124
- April 30, 2023
BrainStorm files ALS drug application over FDA protest

Ned Pagliarulo Lead Editor A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Sarah Silbiger via Getty Images A yearslong disagreement between the Food and Drug Administration and a developer of an experimental medicine for ALS will get a public hearing sometime in the future, setting up another high-profile debate of what amount of evidence merits an approval for the progressive and fatal disease. On Monday, BrainStorm Cell Therapeutics said the agency will convene a panel of outside experts to review its medicine, a personalized stem cell treatment called NurOwn. The planned meeting, which has not yet been scheduled, is the result of BrainStorm taking the rare step of requesting its approval application be filed over the FDA’s protest. Last November, the regulator refused to review BrainStorm’s application, which was based on a late-stage clinical trial that failed to meet its main goal. ...
- Source: drugdu
- 169
- April 28, 2023
Biogen’s new strategy brings more pipeline cuts, but leaves deal options open

Biogen has stopped or paused several drug programs as part of a larger effort to cut costs and prioritize certain research. The decision, disclosed Tuesday in the company’s latest earnings report, comes as sales of its marketed medicines for brain and nervous system disorders continue to fall. Biogen recorded $2.46 billion in total revenue between January and March, a 3% decline from the same period a year prior. Revenue was down across most business segments, with the company’s flagship multiple sclerosis franchise taking the biggest hit, decreasing by 19%. Christopher Viehbacher, the former chief executive at Sanofi and the recently minted CEO of Biogen, is now trying to reshape a research and development organization that, for many years, revolved around high-risk, high-reward neuroscience programs. ““Having a few of those projects in our pipeline is good,” he said in February, “having 100% … is challenging.” On Tuesday, Biogen ...
- Source: drugdu
- 177
- April 27, 2023
Arterial stiffness may be a novel risk factor for childhood and adolescent metabolic disease

Arterial stiffness may be a novel risk factor for metabolic syndrome in teens, a paper published in the American Journal of Physiology-Heart and Circulatory Physiology concludes. The study was conducted in collaboration between the University of Bristol in the UK, the University of Exeter in the UK, and the University of Eastern Finland. The presence of any three of high blood pressure, high trunk fat mass, high fasting glucose, high fasting triglyceride and low fasting high-density lipoprotein cholesterol describes metabolic syndrome. Arterial stiffness in adolescents measured with carotid-femoral pulse wave velocity may potentially cause metabolic syndrome in young adulthood via an increase in fasting insulin resistance and low-density lipoprotein cholesterol. Image Credit: Andrew Agbaje. The World Health Organization describes metabolic syndrome as the constellation of three or more of the following: abdominal obesity, insulin resistance, hypertension, and hyperlipidemia. The prevalence of metabolic syndrome in US middle-aged adults is 30%, ...
- Source: drugdu
- 102
- April 27, 2023
Study shows no significant cognitive benefit of adhering to Mediterranean diets regardless of calorie intake

In a recent study published in Preventive Medicine Reports Journal, researchers performed a randomized clinical trial (RCT) to investigate whether adhering to the Mediterranean diet (MedDiet) with or without limiting calorie intake could improve cognition. Background Obesity, lifestyle choices including diet and exercise, and cardiometabolic comorbidities elevate the risk of cognitive decline. To date, there are no efficient pharmaceutical therapeutics available to prevent, retard, or manage cognitive deficits. However, studies have shown that MedDiet and weight loss benefit cognition, and combining the two may enhance cognitive function. However, RCTs have shown inconsistent results, with either a favorable or negligible impact of nutrition on cognition, warranting further research. About the study In the present three-arm RCT, researchers evaluated the potential cognitive benefit of adhering to MedDiet with or without limiting calorie intake. The Building Research in Diet and Cognition study was conducted between January 2017 and ...
- Source: drugdu
- 126
- April 27, 2023
After delay, Bluebird submits sickle cell gene therapy for FDA approval

Bluebird bio said Monday it has submitted its lovo-cel gene therapy for sickle cell disease for Food and Drug Administration approval, ending a brief delay as it awaited feedback from the agency on manufacturing. The Massachusetts-based drugmaker missed its goal to submit an application by the end of March, allowing Vertex Pharmaceuticals and CRISPR Therapeutics to jump ahead with an approval application for a competing therapy. The agency now has until late June to decide whether to accept Bluebird’s application. The company is seeking a “priority,” or expedited, review, which if granted would shorten the review from 10 months to six. Bluebird is planning for an expedited review and, should an approval be granted, an early 2024 commercial launch. Lovo-cel is viewed by analysts as Bluebird’s best chance for business success because many more people in the U.S. have sickle cell disease than the rarer conditions ...
- Source: drugdu
- 163
- April 26, 2023
Apellis’ immune system drug hits a setback in ALS

Jacob Bell Senior Reporter In the latest setback for ALS research, Apellis Pharmaceuticals, a Massachusetts-based drug company, has discontinued a portion of a key clinical trial testing one of its medicines as a treatment for the nerve-destroying disease. The “MERIDIAN” trial began in the fall of 2020, ultimately enrolling around 250 participants who were given either a placebo or Apellis’ medicine, known as pegcetacoplan, over a two-year period. Following that period, participants could join a so-called “open-label extension” study, in which everyone would have access to the drug. But Apellis has chosen to stop that latter study, based on feedback from an external group of advisers who reviewed the data available and concluded further treatment with the drug was unwarranted. Analysts at the investment bank Mizuho Securities were the first to report this development. According to the analyst Graig Suvannavejh, Apellis announced the study discontinuation through a “company communication” that clarified that the ...
- Source: drugdu
- 162
- April 25, 2023

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