PharmaFocus Today – Page 95 – media

Datopotamab deruxtecan demonstrates positive results in TROPION-Lung01 Phase III trial

High-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favoured datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Survival results did not reach statistical significance in the overall trial population. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy. The final analysis of OS builds on the positive progression-free survival (PFS) results presented at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC. In TROPION-Lung01, patient enrolment by tumour histology ...
- Source: drugdu
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- May 29, 2024
GlobalData

The total prevalent cases of osteoporosis in the seven major markets (7MM*) are projected to increase from 51.17 million in 2023 to 58.05 million in 2033, with an annual growth rate (AGR) of 1.34 per cent, forecasts GlobalData. GlobalData’s latest report, “Osteoporosis – Epidemiology Analysis and Forecast to 2033,” reveals that in 2033, the US is predicted to have the highest number of total prevalent cases of osteoporosis in the 7MM at 19.91 million, whereas Spain, with nearly 4.24 million cases, will have the lowest number. Osteoporosis is a systemic bone disease characterised by low bone mass, deterioration of bone tissue, and disruption of bone microarchitecture; it can lead to compromised bone strength and an increase in the risk of fractures. It can be further characterised as either primary or secondary. Primary osteoporosis can occur in both sexes at all ages, but often follows menopause in women and occurs later ...
- Source: drugdu
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- May 29, 2024
GlobalData

Great progress has been made in the management of female infertility since the introduction of assisted reproductive technology, predominantly in vitro fertilisation (IVF). However, despite the improvements made in the space, challenges associated with the treatment remain. The development of non-injectable fertility medications represents a significant unmet need, according to key opinion leaders (KOLs) interviewed by GlobalData. Dr Shireen Mohammad, Senior Cardiovascular & Metabolic Disorders Analyst at GlobalData, comments, “KOLs have described the level of unmet need in this market as moderate. While injectable gonadotropins are commonly used in IVF, they require subcutaneous or intramuscular injections, which can be inconvenient, painful, and stressful for patients. Therefore, the development of non-injectable alternatives could offer significant benefits in terms of patient convenience, compliance, and the overall treatment experience.” Linzagolix choline, developed by Kissei Pharmaceutical, is an orally administered gonadotropin-releasing hormone (GnRH) receptor antagonist currently in Phase III clinical trials in the US, ...
- Source: drugdu
- 95
- May 28, 2024
HOF Pharma targets global expansion

With an aim to enhance its global presence and deliver high-quality medicines to a broader market, the Ahmedabad based, HOF Pharmaceuticals has shared its plans for growth. In two years, HOF Pharma has established itself as a manufacturer and exporter of tablets, capsules, and oral liquids. Reportedly, the company’s plant at Sanand, Ahmedabad meets stringent international standards. “Currently we are exporting to 12 countries across Latin America, Africa, and Southeast Asia. With twenty more specialty products in the pipeline, which will augment HOF’s export performance, we are now aiming to double our reach to 25 countries within the next year” commented Pravin Patel, Chairman, HOF Pharma. “Towards this year end, we are gearing up our Quality Management Systems (QMS) and formulation development initiatives towards regulated markets,” added Patel. HOF Pharma comprises over 150 products across various therapeutic categories. These include treatments for diabetes, cardiovascular, central nervous system disorders, immunosuppressant, anticoagulants, ...
- Source: drugdu
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- May 28, 2024
Andelyn Biosciences selected to manufacture AAV therapies under CIRM

Andelyn Biosciences, a patient-focused cell and gene therapy Contract Development and Manufacturing Organisation (CDMO), has been selected to manufacture adeno-associated vectors (AAV) therapies using its suspension AAV Curator Platform under the California Institute for Regenerative Medicine (CIRM) Accelerating Medicines Partnership (AMP) Bespoke Gene Therapy Consortium (BGTC). The CIRM partnership with Andelyn aims to advance BGTC’s mission to develop platforms and standards to propel the development and delivery of customised or ‘bespoke’ gene therapies for millions of people affected with rare diseases. BGTC is focusing on development of cures for eight such diseases, with Andelyn selected to optimise and scale the AAV therapy processes for the treatment of Congenital Hereditary Endothelial Dystrophy – Type 1. With scalable end-to-end development and manufacturing capabilities across its three Columbus, Ohio facilities, Andelyn aims to work towards the progression of life-altering gene therapies for rare and prevalent diseases. https://andelynbio.com/news-and-media/andelyn-biosciences-selected-as-viral-vector-manufacturing-partner-for-the-cirm-amp-bgtc/
- Source: drugdu
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- May 28, 2024
Asahi Kasei Medical completes new assembly plant for Planova virus removal filters

Asahi Kasei Medical has completed the construction of its third assembly plant for Planova virus removal filters in Nobeoka, Miyazaki, Japan, and held its completion ceremony on May 24, 2024. The bioprocess business of Asahi Kasei Medical comprises Planova virus removal filters and equipment used in the manufacturing process of biotherapeutic products such as biopharmaceuticals and plasma derivatives, biosafety testing services, and biopharmaceutical Contract Development and Manufacturing (CDMO) operations. It is one of the Asahi Kasei Group’s businesses to drive future growth. Planova cellulose hollow-fibre membrane filters, developed specifically for removing viruses from biotherapeutic products, were launched in 1989, followed by Planova BioEX hydrophilic PVDF hollow-fibre membrane filters in 2009. A next-generation line of cellulose hollow-fibre membrane filters, Planova S20N, was launched in 2022 featuring robust virus removal capability and simplified operation. To further ensure stable supply, Asahi Kasei Medical has been proactively expanding production capacity for Planova including the ...
- Source: drugdu
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- May 28, 2024
Lipoprotein Blood Test Detects Hereditary Cardiovascular Risk

Lipoprotein (a), or Lp(a), is increasingly recognized as a critical but under-acknowledged potential risk factor for cardiovascular diseases, which are a significant public health concern. Around 20% of the global population has high levels of Lp(a), which heightens their risk of conditions such as myocardial infarction and stroke. Elevated Lp(a) levels contribute to the accumulation of lipids within artery walls, facilitating plaque formation and heightening the risk of cardiovascular events. While factors such as menopause, and kidney or liver diseases, as well as hyperthyroidism can affect Lp(a) levels, over 90% of the variability in Lp(a) levels is due to genetic differences in the lipoprotein (a) (LPA) gene. Consequently, testing for Lp(a) is a crucial diagnostic tool that helps clinicians accurately evaluate cardiovascular risk, and its integration into routine diagnostics is anticipated soon. Roche’s (Basel, Switzerland) Tina-quant lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and ...
- Source: drugdu
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- May 28, 2024
Blood Test Measures Immune Response to Epstein-Barr Virus in MS Patients

Multiple sclerosis (MS) is a chronic neurological condition for which there is currently no cure. It affects around three million people globally and ranks as the second most common cause of disability among young adults. The urgent need for improved treatments has led to extensive research into various viruses associated with MS, with the Epstein-Barr Virus (EBV) emerging as a significant risk factor for the disease. It remains unclear why certain individuals with MS exhibit an abnormal immune response to EBV, which typically causes no symptoms in most people. Now, a novel blood test has been developed that measures the immune response to EBV, providing new avenues for basic research into EBV’s role in MS and potential applications in clinical trials aimed at targeting the virus. Researchers at Trinity College Dublin (Dublin, Ireland) conducted studies measuring the immune response of MS patients to EBNA-1, a component of EBV that resembles ...
- Source: drugdu
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- May 28, 2024
Degron Therapeutics, Takeda Ink Exclusive License and Collaboration Agreement to Develop Molecule Degraders Targeting Multiple Indications

Don Tracy, Associate Editor Joint venture expected to utilize Degron’s GlueXplorer platform to identify, validate, and optimize molecular glue degraders. Degron Therapeutics announced that it has agreed to terms on a collaboration with Takeda, which will utilize its GlueXplorer to develop molecular glue degraders targeting oncology, neuroscience, and inflammation. Upon completion of the initial stages, Takeda will take over for further development and commercialization. Under terms of the deal, Degron will receive an upfront payment, with the opportunity to receive up to $1.2 billion in milestone payments and tiered royalties on sales. The deal also includes an equity investment by Takeda in Degron and the option to expand to additional targets.1 “We are excited to collaborate with Takeda, expanding the use of our platform into new therapeutic areas,” said Lily Zou, PhD, co-founder, CEO, Degron Therapeutics, in a press release. “Degron’s differentiated and powerful GlueXplorer platform has been validated by ...
- Source: drugdu
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- May 28, 2024
Eli Lilly Pumps $5.3B More Into Site for Making Metabolic Meds Zepbound & Mounjaro

Eli Lilly says its capital commitment to its new Indiana site is the largest manufacturing investment in the company’s history. The site will make tirzepatide, the active pharmaceutical ingredient in both Zepbound and Mounjaro. By Frank VinluaEli Lilly is boosting its ability to meet growing demand for the metabolic disorder drugs Zepbound and Mounjaro, committing $5.3 billion toward the expansion of a site that will produce the main pharmaceutical ingredient in both medications. Lilly broke ground on the Lebanon, Indiana, site in 2023. The expansion announced Friday brings Lilly’s total investment in the site to $9 billion. The company expects this facility will begin making medicines in late 2026. Mounjaro, approved in 2022 for treating type 2 diabetes, has become a blockbuster seller with 2023 revenue totaling $5.1 billion. Zepbound was approved late last year for chronic weight management. Both medications are incretins, drugs that mimic a gut hormone to ...
- Source: drugdu
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- May 28, 2024

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