Search Results for “FDA” – Page 104 – media

Depression Trial Win Moves Intra-Cellular Drug Closer to Label Expansion & Blockbuster Status

Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression. By Frank Vinluan High placebo responses common in tests of neuropsychiatric drugs makes any clinical trial in major depressive disorder risky. Intra-Cellular Therapies now has data showing its drug met key goals of a pivotal clinical trial, beating a placebo in this indication. The results build the case for expanding the product’s label, which could push its sales into blockbuster territory. According to the preliminary results reported Tuesday, the drug, lumateperone, led to statistically significant and clinically meaningful reductions in scores measured on a widely used rating scale for assessing depression episodes, which was the main clnical trial goal. The drug also met a key secondary ...
- Source: drugdu
- 88
- April 18, 2024
Jardiance and Ofev propel Boehringer’s human pharma sales

Boehringer Ingelheim reported robust sales in 2023, with a 10.3% increase in human pharma sales that was strongly driven by Jardiance (empagliflozin) and Ofev (nintedanib). The German company announced that it had reached €20.8bn ($22.1bn) in human pharma sales in 2023, also achieving a 14.2% boost in research and development (R&D) investments that reached €5.8bn. Boehringer’s R&D investments accounted for 22.5% of net sales, as per a 16 April press release. In the press release, Michael Schmelmer, a member of Boehringer’s board of managing directors with responsibility for finance and group functions, said, “We are committed to upholding these high investment levels to ensure that we bring innovation to patients as fast as possible across our entire pipeline. Our more than 53,500 employees know that every day that we gain can make a real difference in patients’ lives.” Last year, Jardiance propelled the company’s growth with a 31% sales jump, ...
- Source: drugdu
- 80
- April 18, 2024
Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths

Dive Brief Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday. Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type. Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company. Dive Insight Heartmate devices take over the pumping function of the left ventricle, the ...
- Source: drugdu
- 110
- April 17, 2024
A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. By Frank VinluanWhen it comes to evaluating the health of a patient, each therapeutic area has its own data-gathering tools. Think glucose monitors in diabetes and heart monitors for cardiovascular disease. But in mental health, a clinician relies on what a patient says. Self-reporting is incomplete and lacks objectivity, says George Eleftheriou, CEO and co-founder of Feel Therapeutics. Feel is trying to bring more complete and objective data collection to the field of mental health. The San Francisco-based startup does it with wearable technology that continuously collects data and provides recommendations. “One of the things we hear is how poor storytellers people are and [how they] cannot truly depict what happened over the past ...
- Source: drugdu
- 126
- April 16, 2024
Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment

Cancer treatment typically adheres to a standard of care—established, statistically validated regimens that are effective for the majority of patients. However, the disease’s inherent variability means that a one-size-fits-all approach often falls short. Individual responses to the same drug can vary dramatically. Personalized cancer treatment, which outperforms traditional treatment methods, increasingly relies on genomics—DNA profiling of a patient’s cancer—to tailor therapy. Current genomic profiling processes can analyze thousands of genes but might take weeks to deliver results and still fail to provide complete clarity on the optimal treatment strategy. For the first time, researchers have combined genetic testing with personalized drug screening directly on tumor samples to identify the right treatment for children with relapsed cancers, offering a timelier and effective approach. The functional precision medicine approach to target cancer has been developed by researchers at Florida International University (Miami, FL, USA) combines genetic testing with a new method of ...
- Source: drugdu
- 98
- April 16, 2024
YuanSong Bio-technology Receives Another Clinical Trial Approval, Its Innovative Lysoma Virus Product Receives Implied Clinical Trial Approval from China CDE

On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd (“Yuansong Biotechnology”) announced that its self-developed lysosomal virus Class I new drug “Recombinant L-IFN Adenovirus Injection (YSCH-01)” has received implied clinical trial approval from the Center for Drug Evaluation of the State Drug Administration (CDE) and has been approved to conduct Class I clinical trials in China. The Center for Drug Evaluation (CDE) of the State Drug Administration has granted implied consent for clinical trials and approved to conduct Phase I clinical trials in China for the indication of advanced solid tumors. The approval of this IND filing by the CDE in China is another important progress made by YuanSong Biotech in exploring the clinical study of YSCH-01, in addition to the clinical approval by the US FDA in December 2023 for two original IIT programs under development, including capsular delivery for recurrent gliomas and lysosomal viral nebulized delivery for the ...
- Source: drugdu
- 143
- April 16, 2024
GlobalData

The pharma industry has experienced a notable uptick in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology over the past five years. These agreements, primarily concentrated in oncology, immunology, and central nervous system therapeutics, have collectively accumulated an impressive $21 billion in deal value. Furthermore, the period from 2020 to 2022 witnessed a remarkable surge in deal worth, particularly in the domain of hematological disorders, reaching a substantial total deal value of $1.8 billion, reveals GlobalData. Ophelia Chan, Business Fundamentals Analyst at GlobalData, comments: “This underscores the increasing significance of CRISPR advancements in the development of therapies for hematological disorders.” The FDA’s approval of Casgevy in December 2023 marked a significant breakthrough in gene therapy. Developed jointly by Vertex Pharmaceuticals and CRISPR Therapeutics, Casgevy is the first CRISPR and CRISPR-associated protein 9 (Cas9) genome editing therapy for sickle cell disease and beta thalassemia. This ...
- Source: drugdu
- 121
- April 15, 2024
Dr Reddy’s launches drug-free migraine management device Nerivio in Europe

Dr Reddy’s Laboratories announced the launch of the drug-free non-invasive migraine management wearable device Nerivio in Germany through its step-down subsidiary betapharm. The launch marks the company’s entry into digital therapeutics in Europe. Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Nerivio was presented in 2023 by Dr Reddy’s at the DGN Kongress organised by the German Association of Neurology in Berlin, and the 17th European Headache Congress held in Barcelona, Spain. Dr Reddy’s will present and launch Nerivio during the Neurological Association of South Africa annual congress on April 17, 2024, in the presence of Dr Stewart Tepper, Professor of Neurology at the Geisel School of Medicine – Dartmouth, and Vice President, New England Institute for Neurology and Headache. In May 2024, Nerivio will also be presented at International Headache Society 2024 iHEAD meeting in Berlin, Germany. In subsequent ...
- Source: drugdu
- 117
- April 15, 2024
MMI receives de novo nod for microsurgery robot

Dive Brief Medical Microinstruments (MMI) has received de novo authorization for a robotic system that enables surgeons to reconnect tiny blood vessels, the company said Monday. The Food and Drug Administration authorized the device, called the Symani Surgical System, for soft tissue manipulation to perform microsurgery, a way to restore blood flow and redirect fluid during reconstruction or repair. CEO Mark Toland said the commercial availability of Symani could increase the number of physicians who can perform complicated microsurgical procedures. MMI plans to immediately launch the system in the U.S. Dive Insight Microsurgery and supermicrosurgery, a technique for 0.3mm to 0.8mm vessels, are microscope-assisted operations that enable physicians to take a piece of tissue from one part of the body and use it to reconstruct another area. By reconnecting blood vessels, surgeons can restore form and function to parts of the body damaged by trauma or disease. The potential for ...
- Source: drugdu
- 67
- April 15, 2024
UK’s NICE recommends AbbVie’s Aquipta to treat migraines

The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
- Source: drugdu
- 145
- April 13, 2024

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