Search Results for “EC” – Page 351 – media

Salipro partners with Icosagen to develop monoclonal antibody therapies

Swedish company Salipro Biotech has entered into a multi-target antibody research agreement with biotech company Icosagen. The agreement leverages Salipro’s proprietary platform technology for membrane proteins to identify drugs that target specific G protein-coupled receptors (GPCRs) and solute carrier (SLC) transporters, as per a 10 October announcement. These membrane proteins play a role in different areas such as oncology and autoimmune diseases. Estonian company Icosagen has CRO [contract research organisation] and CDMO [contract development and manufacturing organisation] capabilities, with expertise in protein production and analytics, which contributes to the drug development of monoclonal antibodies. Icosagen will utilise its QMCF technology to advance the project, based on the 10 October press release. The company’s QMCF technology is based on a proprietary mammalian expression system for producing recombinant proteins. Monoclonal antibodies have been identified by GlobalData as a key innovation area for cancer therapy, with Johnson & Johnson being the leading patent ...
- Source: drugdu
- 103
- October 12, 2023
Q&A With David Klein, Co-Founder and CEO of Click Therapeutics

Mike Hollan Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry. David Klein CEO and co-founder Click Therapeutics FDA recently released draft guidelines regarding the use of software as a medical device (SaMD), which determines when the software should be included on the drug’s label. David Klein, CEO of Click Therapeutics, spoke with Pharmaceutical Executive about the impact these guidelines could have on the industry. Pharmaceutical Executive: What work are you doing with SaMD? David Klein: We are a science led biotech and tech company developing SaMD to be prescription treatments. That includes prescription digital therapeutics and discovering developing them in a way where they could potentially work independently or in conjunction with pharmacotherapies in order to lead to better clinical and economic outcomes. PE: The FDA just issued some updated guidelines regarding SaMD, how do you think the industry will ...
- Source: drugdu
- 176
- October 12, 2023
Akero’s Phase IIb NASH Data Disappoints, Sends Stock Plummeting

By Tristan Manalac Pictured: Illustration of a damaged liver/iStock, Mohammed Haneefa Nizamudeen Results from the Phase IIb SYMMETRY study showed that Akero Therapeutics’ lead candidate efruxifermin failed to significantly reduce liver fibrosis without worsening non-alcoholic steatohepatitis, the company announced on Tuesday. In the 36-week analysis, 22% of patients treated with the 28-mg dose of efruxifermin (EFX) saw at least a one-stage improvement in liver fibrosis with no non-alcoholic steatohepatitis (NASH) worsening, whereas 24% of those given the higher 50-mg dose met this endpoint. Neither dose level was statistically better than placebo, in which group 14% of participants demonstrated at least a one-stage fibrosis improvement without disease worsening. In addition, 21% and 14% of patients in the lower and higher EFX dose groups—respectively— demonstrated NASH resolution alongside fibrosis improvement of at least one stage. These were not significantly better than the 9% rate in the placebo arm, according to Akero. Despite ...
- Source: drugdu
- 202
- October 12, 2023
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 ...
- Source: drugdu
- 136
- 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 ...
- Source: drugdu
- 106
- 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 ...
- Source: drugdu
- 216
- 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 ...
- Source: drugdu
- 157
- 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 ...
- Source: drugdu
- 174
- 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 ...
- Source: drugdu
- 107
- 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
- 108
- October 11, 2023

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