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GSK Awaits Approval for Myelofibrosis Hopeful

The FDA’s final action date this week is for GSK’s investigational drug, momelotinib, which the company is proposing to treat myelofibrosis patients with anemia. The decision is set to be released by June 16. According to GSK, momelotinib works through a differentiated mechanism of action that involves the inhibition of three signaling pathways: the JAK1 and JAK2 cascades, as well as the activin receptor type I (ACVR1) pathway. By disrupting JAK1 and JAK2 signaling, momelotinib induces improvements in patient constitution and symptoms of splenomegaly. Meanwhile, its ACVR1 activity could decrease levels of hepcidin, which contribute to anemia in myelofibrosis. Data from the pivotal Phase III MOMENTUM trial supported momelotinib’s FDA bid. In December 2022, GSK reported 48-week results from MOMENTUM at the 64th American Society of Hematology (ASH) Annual Meeting. Momelotinib achieved its primary efficacy endpoint of an at-least 50% reduction in Total Symptom Score after 24 weeks. GSK’s myelofibrosis ...
- Source: drugdu
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BMS Seeks Another Indication for Camzyos

The FDA will release its verdict on June 16 regarding Bristol Myers Squibb‘s sNDA proposing to use its heart drug Camzyos (mavacamten) to lower the need for septal reduction therapy (SRT) in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Currently, many patients suffering from HCM need to undergo SRT, Roland Chen, senior vice president and head of cardiovascular development, Global Drug Development at BMS, said in a statement upon the FDA’s acceptance of the sNDA. SRT is either an open-heart surgical procedure or a catheter-based operation. BMS supported Camzyos’ sNDA with data from the Phase III VALOR-HCM study, a randomized, double-blinded and placebo-controlled trial that enrolled 112 patients with symptomatic obstructive HCM. All participants were qualified for SRT and had been referred for the operation. VALOR-HCM’s primary endpoint was a composite between the number of patients who decided to push through with SRT by week 16 and the number of ...
- Source: drugdu
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Thyrotropin-releasing hormone neurons play a key role in the response to fasting and weight loss

Regulation of thyroid hormone (TH) levels is a complex multilevel phenomenon. The paraventricular nucleus (PVN) of the hypothalamus (the region of the brain that controls the involuntary nervous system) has been identified as a direct regulator of thyrotropin (a hormone secreted by the pituitary gland that regulates the production of thyroid hormones). The PVN is a key regulator of TH levels, integrating multiple signaling systems. Now for the first time, researchers from Boston University Chobanian & Avedisian School of Medicine, have shown that in addition to being critical for regulating thyroid hormone levels, thyrotropin-releasing hormone (TRH) neurons play a major role in the response to fasting and weight loss. To test this function, the researchers used a chemogenetic approach (engineering of protein receptors to respond to previously unrecognized small molecules) to either stimulate or inhibit specific neuronal populations. They injected an experimental model with an adeno-associated virus (AAV) coding for ...
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Study provides a possible treatment option for prostate cancer resistant to hormone therapy

Prostate cancer is the most-commonly diagnosed malignancy and the second leading cause of cancer death among men in the United States. In its ever-indelicate world, the stubborn disease can continue to grow even when the amount of testosterone in the body is reduced to very low levels, thus earning the clumsy name: castrate-resistant prostate cancer (CRPC). It poses a major clinical challenge as a protein called the androgen receptor (AR) remains behind as a critical player in cancer, changing its behavior in CRPCs. Androgen-deprivation therapy, which is a treatment that reduces the levels of male hormones, is the first-line treatment for locally advanced or metastatic prostate cancer. Despite initial responses to the therapy, nearly all patients eventually develop CRPC within a few years. It is now well recognized that CRPC continues to be dependent on AR signaling. “Understanding the triggers that cause changes in AR’s activity is important for developing ...
- Source: drugdu
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Obesity impairs the brain’s response to nutrients, suggests study

Brain responses to specific nutrients are diminished in individuals with obesity and are not improved after weight loss, according to a study led by Amsterdam UMC and Yale University, published today in Nature Metabolism. “Our findings suggest that long-lasting brain adaptations occur in individuals with obesity, which could affect eating behavior. We found that those with obesity released less dopamine in an area of the brain important for the motivational aspect of food intake compared to people with a healthy bodyweight. Dopamine is involved in the rewarding feelings of food intake,” says Mireille Serlie, lead researcher and Professor of Endocrinology at Amsterdam UMC. “The subjects with obesity also showed reduced responsivity in brain activity upon infusion of nutrients into the stomach. Overall, these findings suggest that sensing of nutrients in the stomach and gut and/or of nutritional signals is reduced in obesity and this might have profound consequences for food ...
- Source: drugdu
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Millions of patients do not have full recovery of smell or taste senses after COVID infection, study finds

During the COVID-19 pandemic, many patients experienced a loss of taste and smell during and after being infected with SARS-CoV-2. A retrospective study by researchers at Massachusetts Eye and Ear, a member of the Mass General Brigham healthcare system, investigated the loss of olfactory and gustatory senses and estimated that about a quarter of Americans who had COVID-19 reported only partial or no recovery of taste or smell. The results are published in The Laryngoscope. “We wanted to quantify the national impact of smell disorders resulting from COVID,” said Neil Bhattacharyya, MD, FACS, Professor of Otolaryngology at Mass Eye and Ear. “With this data we can understand, in big numbers, how many people lost their sense of smell or taste due to COVID infection and how many people never fully recovered those senses.” The retrospective study utilizes data from the 2021 National Health Interview Survey (NHIS), a branch of the ...
- Source: drugdu
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BioNTech to defend itself against COVID-19 vaccine injury claim in Germany

Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against allegations that its shot caused injuries. This lawsuit comes from a German healthcare worker who seeks at least 150,000 euros ($161,500) in damages for alleged bodily harm, plus compensation for unspecified material damage, Reuters reports. The woman claims she suffered from upper-body pain, swollen extremities, fatigue and a sleeping disorder as a result of taking the Comirnaty vaccine. The plaintiff’s attorneys at the firm Rogert & Ulbrich will challenge the vaccine’s positive risk-benefit profile as assessed by European Union regulators and vaccine assessment agencies, according to the news service. Under German drug laws, drugmakers are only liable for side-effect damages if “medical science” can prove their meds have an incorrect label or cause disproportionate harm relative to their benefits, ...
- Source: drugdu
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Johnson & Johnson inks another Stelara patent settlement, this time with Alvotech and Teva

Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement.J&J has signed an agreement granting Alvotech and Teva a license for their proposed Stelara biosimilar, AVT04, in the U.S. The settlement allows the biosimilar makers to launch their version no later than Feb. 21, 2025, the companies said Monday. The new Stelara biosim deal follows another one J&J recently inked with Amgen, which gives the latter a license to launch its copycat no later than Jan. 1, 2025. Like Amgen, Alvotech and Teva haven’t gotten the FDA’s blessing for AVT04. The pair in January said the FDA had accepted its application with a decision targeted for the second half of this year. A verdict for Amgen’s version is expected by the end of the third quarter. Settling those biosimilar entry dates is ...
- Source: drugdu
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Novartis to acquire Chinook Therapeutics for approximately $3.5bn

Novartis has entered into an agreement to acquire Chinook Therapeutics for approximately $3.5bn, marking a notable expansion to the Swiss drugmaker’s renal pipeline. The deal grants Novartis access to the US biopharma’s two late-stage candidates in development for Immunoglobulin A Nephropathy (IgAN), a rare and progressive kidney disease that mostly affects young adults. IgAN, which Novartis says currently lacks targeted treatment options, affects up to 21 people per million per year in the US, with a higher rate among Asian populations. The most advanced of the two assets is atrasentan, an oral endothelin A receptor antagonist that Chinook bought from AbbVie at the beginning of 2020. The candidate is currently in phase 3 development for IgAN, with a readout from the study expected in the fourth quarter of this year. The second candidate, zigakibart (BION-1301), is a subcutaneously administered anti-APRIL monoclonal antibody that is expected to enter phase 3 development ...
- Source: drugdu
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Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says

U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign. The U.S. should use a monovalent vaccine targeting either XBB.1.5, XBB.1.16, or XBB.2.3, collectively the dominant strains nationwide, the staff said in a briefing document. The FDA staff made the conclusion ahead of a meeting on Thursday, when a panel of external advisors to the agency will recommend a strain for new Covid shots to target later this year. There is no set date for when the vaccination campaign will begin. Vaccine manufacturers will be expected to update their shots once that strain is selected. Pfizer, Moderna and Novavax are already developing versions of their respective vaccines targeting XBB.1.5 and other circulating variants. The upcoming strain selection will be crucial to those companies’ abilities to compete in the fall, when the U.S. is expected to ...
- Source: drugdu
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