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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. ...
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- April 28, 2023
Pfizer, BioNTech enlist Marvel’s Avengers in latest COVID-19 vaccine booster push

Just like how the Avengers have repeatedly kept the world safe from Ultron, people need to protect themselves by updating their COVID-19 vaccination with the latest booster. That’s the message Pfizer and BioNTech are trying to get across in a new custom comic book partnered with Marvel. The companies unveiled the project Tuesday. “We are proud to work with Marvel, which is so firmly entrenched in global culture and entertainment, to help remind people of the actions they can each take to help protect themselves, similarly to how the Avengers protect their community,” Pfizer said in a statement shared with Fierce Pharma Marketing. The new comic, titled “Everyday Heroes,” represents Pfizer flexing its marketing muscle. COVID vaccines are slated to switch to the private commercial market after the U.S. government failed to secure additional funding from Congress. As Pfizer CEO Albert Bourla, Ph.D., has said, Pfizer can be “even more competitive” and ...
- Source: drugdu
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- April 28, 2023
FDA awards Biogen’s ALS drug Qalsody an accelerated approval, following its experts’ feedback this time

The FDA has approved another Biogen drug for a neurological disorder. And, unlike the controversial go-ahead for Aduhelm, the agency’s neuroscience division didn’t go against its external advisers’ advice this time. Tuesday, the FDA granted an accelerated approval to Biogen and Ionis’ tofersen to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the SOD1 gene. The drug will be sold under the brand name Qalsody. The move follows the recommendation from an FDA advisory committee in March. At that time, nine experts agreed that Qalsody’s ability to reduce plasma neurofilament light (NfL), a biomarker of nerve injury and neurodegeneration, provides enough basis for a conditional approval. However, thanks to a phase 3 trial flop, the panel voted against full approval. SOD1-ALS is a small subset of ALS, affecting fewer than 500 patients in the U.S. and about 2% of all 168,000 ALS patients ...
- Source: drugdu
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- April 27, 2023
Novartis trims 10% of drug pipeline in research cutback

The company discontinued about 20 early-stage projects after reviewing their strategic fit and commercial potential. Novartis said Tuesday it will discontinue or license out 10% of its clinical development projects after reviewing their strategic fit and sales potential. The Swiss drugmaker has trimmed its drug pipeline to 136 projects, down by 16 from the 152 disclosed in its fourth quarter earnings report, according to a presentation Tuesday. The biggest cutbacks came to its early-stage projects, with 19 programs cut. Half of those were early-stage programs testing drugs for solid tumors. The move comes one year after Novartis resized its business and narrowed its research focus to five core therapeutic areas — cardiovascular, immunology, neuroscience, solid tumors and hematology. It expects to save at least $1 billion annually by 2024 as a result. “We systematically looked at the pipeline, identified projects that were outside the scope ...
- Source: drugdu
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- April 27, 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 ...
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Implications for public health

The rapid global transmission of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) led to a pandemic commonly known as Coronavirus Disease 2019 (COVID-19). To date, this pandemic has affected approximately 686 million people and claimed more than 6.8 million lives worldwide. Even though this virus is primarily transmitted through respiratory droplets or direct contact with an infected person, SARS-CoV-2 has also been detected in feces. It is, therefore, possible that SARS-CoV-2 may be excreted in human feces and other bodily secretions, such as saliva and urine, and be transported subsequently to wastewater treatment plants. Study: Survival of SARS-CoV-2 in wastewater. Image Credit: Avigator Fortuner / Shutterstock Background The recent identification of SARS-CoV-2 in feces has raised the concern that it could be an additional route of viral transmission. A similar occurrence was recorded in 2003, during the first SARS pandemic. During this period, SARS cases increased due to aerosolized fecal matter, which resulted from faulty ...
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- April 27, 2023
High-protein diet counters adaptive thermogenesis in prediabetic individuals

The high rate of obesity has become a growing problem in the modern world. Obesity is associated with the incidence of several comorbidities, such as cardiovascular diseases and type 2 diabetes. Despite weight loss being considered the most important remedy for obesity, long-term weight maintenance is also important. Background Metabolic adaptation, i.e., adaptive thermogenesis (AT), could be the key factor preventing long-term weight-loss maintenance. AT causes a decrease in energy expenditure, which is significantly more than the predictions based on reductions in fat mass (FM) or fat-free mass (FFM). Energy expenditure adaptations have been found to last multiple years after a weight loss period. Therefore, after weight loss, a reduction in AT is extremely important for long-term weight loss maintenance. Some factors have been identified to reduce AT, such as physical activity, cold-induced brown adipose tissue activation, tea catechins, and capsaicinoids. Furthermore, high protein (HP) intake was also ...
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- April 27, 2023
Language impairment in autism associated with gray matter volume

Researchers from Russia and the U.S. have found language impairment in children with Autism Spectrum Disorder (ASD) to be associated with a lower volume of gray matter and greater gyrification in the temporal and frontal lobes of the cerebral cortex. These regions play a critical role in language functioning. Understanding the structural characteristics that underlie behavioral deficits can aid in designing special education programs for children with autism. A paper with the study’s findings has been published in Scientific Reports. Autism Spectrum Disorder is typically characterized by issues with social interaction and communication skills, and by stereotypical behaviors. These symptoms are often attributed to genetic factors that impact the development of the nervous system. Children with ASD frequently experience language difficulties, ranging from mild speech disorders to a complete inability to communicate verbally. These difficulties can become obstacles to effective communication and social interaction. But the neurobiological underpinnings of these disorders remain poorly ...
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- April 27, 2023
Laser speckle imaging can identify hearts suitable for transplantation

In the majority of cases, graft failure after heart transplantation is attributable to abnormalities like severe coronary artery disease. As donors with extended criteria like advanced age and pre-existing heart conditions become eligible for heart transplantation, careful screening for congenital abnormalities has become crucial. Invasive coronary angiography is an essential screening tool that can detect coronary artery disease (CAD), a condition characterized by cholesterol deposits in the heart’s arteries. However, logistical challenges limit utility so it’s used for fewer than a third of donors who are at risk of developing CAD. To overcome this limitation, a new heart preservation procedure called “ex situ heart perfusion” (ESHP) has been developed. By allowing the supply of oxygenated nutrients to the heart via blood vessels, ESHP allows doctors to monitor the performance of the heart and screen it for any defects outside the body. However, coronary angiography conducted during ESHP is known to damage ...
- Source: drugdu
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- April 27, 2023
survey

The FDA approval of AbbVie’s oral CGRP inhibitor Qulipta in chronic migraine could unleash a fresh phase of growth for the drug. That is the conclusion of survey data gathered by Spherix Global Insights, which found most physicians are very willing to prescribe the drug to patients with chronic migraine. Prior to the FDA approval, Spherix spoke to 74 neurologists and 101 primary care physicians about the migraine market, including their interest in prescribing Qulipta for the treatment of patients who have headaches at least 15 days per month. The survey suggests that AbbVie’s work to drum up interest in Qulipta since winning approval in episodic migraine in 2021 has primed the product for growth. Almost two-thirds of the surveyed neurologists said they would be very willing to prescribe Qulipta to chronic migraine patients, up from half earlier in the launch. Similarly, more than 50% of primary ...
- Source: drugdu
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- April 27, 2023

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