Researchers have demonstrated a reverse phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous determination of Amlodipine and Irbesartan using analytical quality by design (AQbD). Amlodipine and Irbesartan are compounds use to treat patients with hypertension, they explained. Irbepex-AM tablets containing 150mg of Irbesartan and 2.5mg Amlodipine were assessed in the study. Benefits of the proposed RP-HPLC method Currently there is no working RP-HPLC technique for Amlodipine and Irbesartan that uses the AQbD methodology, according to the paper. The RP-HPLC techniq ..read more

The first treatment approved in the EU to target a genetic cause of amyotrophic lateral sclerosis (ALS), has been authorised by the European Commission (EC). QALSODY ® (tofersen) is indicated for adults with ALS associated with a mutation in the superoxide dismutase 1 gene (SOD1-ALS). The treatment is an antisense oligonucleotide (ASO) designed to bind to SOD1 mRNA to reduce SOD1 protein production, Biogen shared. This authorisation is subject to approval under exceptional circumstances and orphan designation of QALSODY. Biogen stated that it licensed the treatme ..read more

A novel drug delivery method combining proline and metal such as palladium, could enable chemotherapy drugs to be transported in the body via nano-sized cages. Practically, this could enable delivering the structure “more directly” to a tumour, while “shielding healthy cells”. Chemotherapy drugs, antibiotics, as well as antivirals could be transported using this delivery system, the authors theorised. Harnessing the properties of proline This innovative delivery approach, which utilises proline, an amino acid found in chicken feathers and skin tissue, could help to mitigate side effects assoc ..read more

Merck (known as MSD outside of the US and Canada) plans to acquire Eyebiotech Limited, with the aim to advance development of novel treatments for vision disorders. The deal has a potential value of $3 billion. Under the terms of the acquisition, Merck, through a subsidiary, will acquire all outstanding shares of EyeBio. The total sum comprises of a $1.3 billion upfront payment and up to $1.7 billion in future milestone payments. the acquisition significantly expands Merck/MSD’s presence in ophthalmology” In addition to augmenting MSD’s pipeline, this new acquisition “significantly exp ..read more

The safety and tolerability of rationally-designed live bacterial product (LBP) BMC128 combined with nivolumab has shown initial positive trends in non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC), new data from an ongoing Phase I clinical trial suggests. Biomica’s microbiome-based immuno-oncology candidate and the anti-PD1 immune checkpoint inhibitor is being evaluated in eleven participants. All of whom had experienced disease progression in prior immunotherapy treatment before enrolling in the study. Key initial results from the anti-cancer treatment As of t ..read more

The European Commission (EC) has granted the first approval for an omalizumab biosimilar in Europe. Omlyclo® (CT-P39) is authorised as a biosimilar referencing Xolair®. CT-P39 is indicated for allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP).  The authorisation is based on clinical data, including findings from a Phase III clinical trial comparing Omlyclo® to the reference product in patients with chronic spontaneous urticaria up to Week 40, according to Celltrion. “For more than two decades, omalizumab, a blockbuster m ..read more

A report by The Brainy Insights has predicted that the ampoules packaging market will value $9.83 billion by 2033. This is expected to be largely driven by increasing demand for this packaging type. A higher incidence of chronic diseases will propel growth of the market between 2024 and 2033, according to the data. Prospects of the ampoules packaging market On the other hand, advancements in ampoule packaging, as well as sustainability measures and manufacturing innovations such as automation and robotics, were highlighted as promising contributing factors for growth of the market. packaging ..read more

Repurposing cyclophosphamide may enable more patients with high-risk blood cancers to receive transplanted stem cells from unrelated, partially matched donors, new research suggests. These new findings, which are part of an ongoing Phase II study, will be presented at the 2024 American Society of Clinical Oncology (ASCO) meeting and the European Hematology Association (Abstract #6503). The study is assessing patients treated with cyclophosphamide and peripheral blood stem cell (PBSC) transplantation. Expanding the donor pool Finding a matched donor has been a major obstacle for patients ..read more

A new $5.3 billion investment for Eli Lilly and Company’s manufacturing site in Lebanon, Indiana, US, increases the firm’s total investment there from $3.7 billion to $9 billion. This expansion will expand manufacturing capacity of active pharmaceutical ingredients (APIs) for Zepbound® (tirzepatide) injection and Mounjaro® (tirzepatide) injection. These treatments are indicated for obesity and type 2 diabetes. This new $5.3 billion investment tops the largest manufacturing investment in [Eli Lilly’s] history” This new $5.3 billion investment “tops the largest manufacturing in ..read more

UCB has announced positive results from the first Phase III trials evaluating the efficacy and safety of an IL-17A and IL–17F inhibitor to treat adults with moderate-to-severe hidradenitis suppurativa. Humanised IgG1 monoclonal antibody (mAb) BIMZELX® (bimekizumab-bkzx) selectively binds to IL-17A, IL-17F, and IL-17AF cytokines. This inhibits their interaction with the IL-17RA/IL-17RC receptor complex, UCB explained. The biologic enabled a “significantly higher” number of individuals to obtain a 50 percent or greater improvement in hidradenitis suppurativa signs and symptoms at Week 16 ..read more