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Merck Touts Keytruda Phase III NSCLC Survival Data Ahead of FDA Decision  

By Kate Goodwin Pictured: Merck headquarters/iStock, JHVEPhoto Phase III results released Tuesday showed Merck’s anti-PD-1 therapy Keytruda is the first to improve overall survival when used as a neoadjuvant and adjuvant treatment versus pre-operative chemotherapy for patients with non-small cell lung cancer, according to the company’s announcement.  In the KEYNOTE-671 trial, Keytruda plus chemotherapy was given to patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) prior to surgery. After resection, Keytruda was administered as a single agent.   While the data was not provided in Tuesday’s announcement, Merck called the trial the first Phase III to “show a statistically significant overall survival benefit for these patients with stage II, IIIA or IIIB” NSCLC.  The company said results from the analysis of KEYNOTE-671 will be presented later this month at the European Society for Medical Oncology (ESMO) Congress and shared with global regulatory authorities.  Previous interim results ...
- Source: drugdu
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Merck shares positive results for Keytruda in phase 3 bladder cancer study

Merck & Co – known as MSD outside the US and Canada – has shared positive results from a late-stage trial of its anti-PD-1 therapy Keytruda (pembrolizumab) in certain bladder cancer patients. The phase 3 AMBASSADOR trial has been evaluating Keytruda versus observation as an adjuvant treatment for patients with localised muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma. At a pre-specified interim analysis, Keytruda demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of disease-free survival versus observation in these patients after surgery. The safety profile of Keytruda was consistent with that observed in previously reported studies, Merck said, adding that the National Cancer Institute-sponsored study will continue to evaluate its second dual primary endpoint of overall survival. More than 82,000 people in the US are expected to be diagnosed with bladder cancer this year, and approximately 7% of bladder cancer cases are locally advanced ...
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- October 11, 2023
In cutting sales guidance, EuroAPI cites CDMO industry struggles and customers’ inventory reductions

Flush with business during the COVID pandemic, the CDMO industry is struggling to adjust in the aftermath. Case in point is EuroAPI, which has slashed its projected revenue growth in 2023 from a range of 7% to 8% to a new window of 3% to 5%. The Sanofi drug ingredients spinoff also has dropped its estimated earnings growth from between 12.5% and 13.5% to range of 9% to 11%. During a conference call on Monday, CEO Karl Rotthier chalked the changes up to pricing pressures resulting from lower inflation, coupled with “inventory reduction programs implemented by some of our customers.” Rotthier also mentioned the “biotech funding crisis.” He said that more than 20 of the company’s projects have been delayed, reduced in scope or halted altogether. The board of EuroAPI has begun to conduct a strategic review of its operating model. The company’s midterm view of its prospects from 2023 ...
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- October 11, 2023
Gates Foundation announces $40m for mRNA vaccine platform

The Bill & Melinda Gates Foundation is providing $40m in funding to advance the accessibility of Quantoom Biosciences’ affordable mRNA vaccine research and manufacturing platform. The platform was developed with an early-research Grand Challenges grant awarded to its parent company, Univercells. The new investments will advance access to mRNA research and vaccine manufacturing technology that will support the capacity of low and middle-income countries (LMICs) to develop vaccines at scale. Senegal’s Institut Pasteur de Dakar and South Africa’s Biovac, both experienced in vaccine manufacturing, will each receive a $5m grant to acquire the technology to develop locally relevant vaccines. Quantoom Biosciences will receive $20m to further advance the technology and reduce commercialisation costs. The foundation will grant a further $10m to other LMIC vaccine manufacturers. The new funding builds on its earlier $55m investment in mRNA manufacturing technology. Biovac CEO Morena Makhoana stated: “This collaboration will help close critical gaps ...
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- October 11, 2023
ABVC BioPharma obtains patent for MDD treatment in Taiwan

ABVC BioPharma has obtained a patent in Taiwan for the use of PDC-1421 in ABV-1504, an asset that treats major depressive disorder (MDD). PDC-1421 is an extract of Radix Polygala. In April 2023, the company received a patent for the same treatment in the US. Data from the latest studies showed that PDC-1421 should be given orally as a capsule for a minimum of 25 days. Doses ranged from once to three times per day. ABVC CEO Dr Uttam Patil stated: “These patents grant ABVC the right to exclude others from using, offering or selling PDC-1421 throughout the US and Taiwan until the year 2040. “As our patent map steps into global coverage, we eagerly await the results of patent applications in the European Union, China, Japan and more.” ABV-1504 is an inhibitor of norepinephrine transporter. The company has concluded Phase II clinical trials of ABV-1504 containing PDC-1421 and intends ...
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- October 11, 2023
Novartis Wins FDA Approval for Intravenous Cosentyx Formulation

By Tristan Manalac The FDA on Friday approved an intravenous formulation of Novartis’ IL-17A antagonist Cosentyx (secukinumab) for the treatment of rheumatic diseases. This latest approval covers existing indications of Cosentyx, including ankylosing spondylitis (AS), psoriatic arthritis (PsA) and non-radiographic axial spondyloarthritis (nr-axSpA). Previously, Cosentyx was only authorized as a subcutaneous treatment for these conditions. With Friday’s approval, Cosentyx has become the first intravenous (IV) treatment that specifically targets and inhibits IL-17A and currently the only non-TNF-α IV therapy for these indications, according to Novartis’ announcement. The IV route of administration will improve treatment access for “a significant portion of patients” with AS, PsA and nr-axSpA, who are not comfortable with self-injections or simply prefer to receive treatments in their healthcare provider’s office, according to Philip Mease, clinical professor at the University of Washington School of Medicine. “The approval of Cosentyx as an IV formulation is an important milestone for ...
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- October 11, 2023
FDA Blocks Alnylam’s Bid to Expand Onpattro Label

By Tristan Manalac Pictured: Alnylam headquarters in Cambridge, Massachusetts/iStock, hapabapa The FDA on Monday denied approval of Alnylam Pharmaceuticals’ siRNA therapy Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated amyloidosis. In its Complete Response Letter (CRL), the regulator said that Alnylam had not provided enough evidence of the therapy’s benefit in the proposed indication. At the same time, the FDA did not flag any problems with patisiran’s clinical safety, drug quality, manufacturing processes or study conduct. “The CRL indicated that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established,” according to the company’s announcement. In light of the rejection, Alnylam will no long work toward an expanded label for Onpattro in the U.S. Monday’s CRL runs counter to the recommendations of the FDA’s own panel of external advisers. In September 2023, the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in ...
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- October 11, 2023
FDA Approves Novartis’ New Rheumatic Disease Treatment

Cosentyx is the first intravenous formulation interleukin-17A antagonist to focus on disease. Image Credit: Adobe Stock Images/Seventyfour Novartis officially announced that the FDA approved n intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Currently, Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. “At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience,” said Christy Siegel, ...
- Source: drugdu
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- October 11, 2023
FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024. By FRANK VINLUAN An Alnylam Pharmaceuticals drug developed to treat a rare disease’s potentially fatal effects on the heart has fallen short in its bid for FDA approval, costing the company a chance to immediately challenge a Pfizer product that has become a blockbuster seller in the indication. But the biotech still has another chance with a different drug in late-stage development that could offer patients a better alternative. Alnylam was seeking approval of its drug, Onpattro, as a treatment for cardiomyopathy caused by hereditary transthyretin amyloidosis (hATTR). According to the Cambridge, Massachusetts-based company, the FDA’s complete response letter said ...
- Source: drugdu
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- October 11, 2023
analysts

Dive Brief Johnson & Johnson’s spinoff of its consumer health business has positioned the company to achieve top-tier medtech growth and profitability, according to analysts at RBC Capital Markets. J&J recently split off its consumer health unit to make a standalone company, turning itself into the only global healthcare company with pharma and medtech in a single portfolio. RBC analysts expect the new structure to support the growth of a “bellwether” healthcare stock. On the medtech side, the analysts identified J&J’s leadership position in 11 categories, shift to fast-growing markets, investment in robotics and capacity for M&A as factors that position it to outperform its peers. Dive Insight The RBC analysts praised J&J’s current medtech portfolio, noting that the company is a leader in 11 categories and has 12 platforms with sales of more than $1 billion. The portfolio is the result of a “clear winning strategy,” they wrote in ...
- Source: drugdu
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- October 11, 2023

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