Search Results for “FDA” – Page 98 – media

Osteal raises $50m to bring joint infection drug/device combo to market

Osteal Therapeutics has raised $50m in Series D financing, as the orthopaedic infection treatment specialist turns its eyes to a regulatory submission for its lead candidate VT-X7. Medtech giant Zimmer Biomet led the round with participation from existing investors, including Johnson & Johnson Innovation, among others. The funds, which follow $23m raised in Series C financing in late 2023, will be used for a new drug application (NDA) to the US Food and Drug Administration (FDA) for VT-X7. Proceeds will also go towards advancing the US-based company’s musculoskeletal portfolio, according to a 5 June press release. Osteal has designed VT-X7 for the treatment of periprosthetic joint infection. The condition is a complication of joint replacement surgery in which bacteria infiltrate the joint implant. This causes biofilms, a layer of microorganisms that are hard to treat. VT-X7 is a drug/device combination product, consisting of antibiotic drugs vancomycin hydrochloride and tobramycin sulfate ...
- Source: drugdu
- 72
- June 11, 2024
RINVOQ® (upadacitinib) Now Available in the U.S. for the Treatment of Pediatric Patients Two Years of Age and Older with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis

On June 4, AbbVie announced that the U.S. FDA approved the use of RINVOQ® (upadacitinib) for the treatment of pediatric patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who have had an insufficient response to, or are intolerant of, one or more tumor necrosis factor (TNF) inhibitors. In addition, a new dosage form of RINVOQ® LQ (upadacitinib) oral solution, based on weight-based dosing, is now available in the U.S. for the pediatric population. Dr. Roopal Thakkar, Senior Vice President, Global Therapeutic Areas and Chief Medical Officer of AbbVie, said: “RINVOQ has always been an important addition to the treatment of a wide range of rheumatic diseases, helping adult patients achieve meaningful disease control. Now, AbbVie is proud to offer RINVOQ in tablets and oral solution for our younger patients. Nearly 300,000 children and adolescents in the U.S. have some form ...
- Source: drugdu
- 103
- June 11, 2024
Q&A with Bobby Azamian

Mike Hollan The Tarsus Pharmaceuticals CEO discusses the ways that his company is finding solutions that may have been overlooked. Bobby Azamian, CEO and chairman at Tarsus Pharmaceuticals, is focused on finding new treatments for diseases that he believes have been overlooked. He spoke with Pharmaceutical Executive about his approach to finding ways to treat the root causes of chronic diseases. Pharmaceutical Executive: Can you explain your mission at Tarsus? Bobby Azamian: My career mission has been to try and unlock solutions to big chronic diseases. I started as a scientist and then became a physician internist, where I saw a lot of big chronic diseases and realized that we don’t have many definitive therapies for those. We don’t have treatments that really address the root causes for a lot of those big diseases. That really motivated me to become an entrepreneur, so I started out investing in early-stage venture ...
- Source: drugdu
- 87
- June 7, 2024
Virtual Therapeutics, Akili Interactive Strike Definitive Merger Agreement Seeking to Improve Mental Health Through Immersive Video Games

Don Tracy, Associate Editor Under terms of the deal, Akili will become a wholly owned subsidiary of Virtual Therapeutics, with Akili shareholders receiving $0.4340 per share of common stock in cash.Virtual Therapeutics and Akili, Inc. announced that they have agreed to terms on a definitive merger agreement, aiming to establish a digital health company that creates engaging and immersive games to improve mental health. Under terms of the merger, Akili will now work as a wholly owned company of Virtual Therapeutics, Akili shareholders will receive $0.4340 per share of common stock in cash, representing a 4% premium to the closing stock price.1 “In today’s global mental health crisis, patients deserve access to clinically validated solutions that address their specific needs. We have been able to advance multiple solutions on our platform since founding Virtual Therapeutics, and we look forward to taking a significant step forward through this merger,” said Dan ...
- Source: drugdu
- 91
- June 5, 2024
Novartis Pivotal Phase III ASC4FIRST Study Provides Efficacy and Safety Data for Scemblix in Newly Diagnosed CML Patients

Novartis recently presented positive results from the pivotal Phase III ASC4FIRST study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting: the treatment of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) with Scemblix® at Week 48 demonstrated greater efficacy and safety than the investigator’s choice of tyrosine kinase inhibitors (TKIs) (imatibe Scemblix demonstrated a superior major molecular response (MMR) rate at week 48 than both investigator-selected tyrosine kinase inhibitors (TKIs) (imatinib, nilotinib, dasatinib, and bosutinib) and imatinib alone.Scemblix demonstrated a higher MMR rate at week 48 than the second-generation TKIs (nilotinib, dasatinib, and bosutinib) with higher rate values.The MMR rate was higher than that of the second-generation TKIs. In addition, Scemblix demonstrated a favorable safety and tolerability profile, with fewer adverse events (AEs) and treatment interruptions relative to imatinib and second-generation TKIs. Tim Hughes, M.D., professor at the South Australian ...
- Source: drugdu
- 91
- June 5, 2024
GSK’s Quest to Bring Myeloma Drug Back to the Market Stops for a Data Drop at ASCO

GSK’s Blenrep has pivotal clinical trial results showing the multiple myeloma therapy reduced the risk of disease progression or death by nearly 50%. The results were presented Sunday during the annual meeting of the America Society of Clinical Oncology.A GSK multiple myeloma drug that was withdrawn from the market is accumulating new clinical data that could support its return — perhaps as an earlier line of therapy. With the latest results, clinicians and GSK executives say they may have figured out how to address a lingering question about how to safely dose the drug, Blenrep. The new data were presented Sunday during the annual meeting of the American Society of Clinical Oncology in Chicago. Blenrep is an antibody drug conjugate (ADC) that targets the BCMA protein on multiple myeloma cells, delivering to them a payload of toxic chemotherapy. There are many multiple myeloma drugs available, but frequent relapse in this ...
- Source: drugdu
- 104
- June 4, 2024
Scemblix Shows Improved Major Molecular Response Treating Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

Don Tracy, Associate Editor Results of a Phase III trial indicated that Scemblix was more effective than standard-of-care tyrosine kinase inhibitors in treating newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Novartis announced promising results from the Phase III ASC4FIRST trial of Scemblix (asciminib), which showed superiority over standard-of-care tyrosine kinase inhibitors (TKIs) in treating newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). “Patients living with CML need efficacious and well-tolerated treatment options that help them achieve meaningful outcomes as they manage their chronic condition,” said Shreeram Aradhye, MD, president, development, chief medical officer, Novartis, in a press release. “The compelling ASC4FIRST data highlight the potential of Scemblix to achieve better results than standard-of-care in newly diagnosed adults, while maintaining a favorable safety and tolerability profile. These results reinforce Scemblix as a proven treatment in Ph+CML-CP, as we continue to build on ...
- Source: drugdu
- 107
- June 4, 2024
EMA endorses AbbVie’s Skyrizi for ulcerative colitis

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has granted AbbVie’s ulcerative colitis (UC) drug Skyrizi (risankizumab) a positive recommendation for approval. The committee’s recommendation was based on results from two Phase III studies. In the INSPIRE trial (NCT03398148), 20.3% of patients in the Skyrizi treatment group achieved clinical remission, compared to 6.2% in the placebo group. Furthermore, in the Phase III COMMAND study (NCT03398135), 51% of patients treated with Skyrizi 180 mg and 48% of patients treated with Skyrizi 360mg demonstrated endoscopic improvement in week 52. Skyrizi is a monoclonal antibody therapy that inhibits interleukin-23 (IL-23). This reduces anti-inflammatory processes. In the 31 May press release, Dr Edouard Louis, the head of gastroenterology at University Hospital CHU of Liège Belgium said: “These results suggest that risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and ...
- Source: drugdu
- 106
- June 4, 2024
Merck Sees Pipeline Diversification Opportunity in $1.3B EyeBio Acquisition

Merck’s EyeBio acquisition brings a lead program ready for pivotal testing in diabetic macular edema. The therapy could pose competition to Eylea, the blockbuster Regeneron Pharmaceuticals eye drug. By Frank VinluanMerck is on the hunt for drugs with blockbuster potential to make up for declining revenue when its top product, the cancer immunotherapy Keytruda, loses patent protection in the next few years. The pharmaceutical giant is getting a contender through the acquisition of a clinical-stage startup whose lead program is on track to begin pivotal testing in diabetic macular edema. According to deal terms announced Wednesday, Merck is acquiring Eyebiotech Limited, or EyeBio, for $1.3 billion in cash up front. Shareholders of the New York-based company could receive up to $1.7 billion more in milestone payments. EyeBio develops drug for retinal conditions in which inflammation leads to the breakdown of the inner blood-retinal barrier. This breakdown leads to vascular leakage, ...
- Source: drugdu
- 93
- June 1, 2024
New Assay Detects Heart Failure Biomarker in Less than 11 Minutes

According to the Heart Failure Society of America, nearly 6.5 million Americans over the age of 20 suffer from heart failure, which accounts for about 8.5% of all heart disease deaths in the United States. A new assay now aids in diagnosing individuals who are suspected of having acute heart failure in emergency departments, as well as in evaluating the severity and risk stratification of patients with heart failure and acute coronary syndrome. The Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay from Beckman Coulter (Brea, CA, USA) measures the levels of N-terminal pro B-type natriuretic peptide in serum or plasma that is released in the heart. Elevated levels of these peptides may indicate heart failure. As per the latest heart failure guidelines issued by the American College of Cardiology and the American Heart Association, the Access NT-proBNP assay includes age-based cutoffs to aid in the accurate diagnosis of heart ...
- Source: drugdu
- 103
- June 1, 2024

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