Otsuka Pharmaceutical Europe and H. Lundbeck A/S have announced that the European Commission (EC) has approved Abilify Maintena 960 mg (aripiprazole) as a once-every-two-months long-acting injectable (LAI) formulation for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole. The EC decision applies to all European Union (EU) member states, as well as Iceland, Norway and Liechtenstein. Aripiprazole once-every-two-months LAI is a new formulation containing 960 mg aripiprazole provided in a single-chamber prefilled syringe that does not require reconstitution. It is intended for dosing once every two months via intramuscular injection into the gluteal muscle and is the first once-every-two-months LAI antipsychotic licensed…

Viking Therapeutics have announced positive results from the company’s Phase 1 multiple ascending dose (MAD) clinical trial of an oral tablet formulation of VK2735, a dual agonist of the glucagon-like peptide 1(GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, in development for the potential treatment of metabolic disorders such as obesity. Based on these Phase 1 results, the company plans to initiate a Phase 2 trial with the oral formulation of VK2735 in obesity later this year. The 28-day MAD study results highlight positive signs of clinical activity following treatment with oral VK2735. Cohorts receiving VK2735 demonstrated dose-dependent reductions in mean…

Aragen has operationalised the first phase of its biologics manufacturing facility in Bangalore, India through its 100% subsidiary, Aragen Biologics Pvt Ltd. The facility is being set up at an investment of $30 million. It has also executed its first small-scale manufacturing project for a US-based organisation for manufacturing a novel anticancer monoclonal antibody (mAb). The non-GMP facility can undertake batch sizes upto 50 Ltrs and includes process development and analytical labs to support the manufacturing activities.  Commenting on the occasion, Manni Kantipudi, CEO Aragen Life Sciences and Director of Aragen Biologics Pvt Ltd. said, “We are happy to announce the commissioning of the…

BrePco Biopharma (BPCO) have announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a paediatric use marketing authorisation (PUMA) for the use of Neoatricon intended for the treatment of hypotension in neonates, infants and children under 18 years of age. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to issue a Marketing Authorisation for medicines to be supplied in the European Union (EU). Piramal Critical Care (PCC), a global leader in critical care medicines have acquired the EU, UK and Norway…

Akebia Therapeutics have announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo is now approved in 37 countries. “With the approval of Vafseo in the U.S., we’re proud to deliver an alternative treatment option for the hundreds of thousands of Americans on dialysis who are diagnosed with anemia due…

Blackstone have announced a new collaboration with Moderna through a development and commercialisation funding agreement where funds managed by Blackstone Life Sciences and will provide up to $750 million to fund Moderna’s influenza program. “Moderna has demonstrated a remarkable ability to impact human health through mRNA vaccines targeting respiratory illnesses. This landmark collaboration is another example of our long-standing strategy to partner with the world’s leading life science companies to advance their critical path vaccines, medicines and medical technologies to patients,” said Nicholas Galakatos, Ph.D., Global Head of Blackstone Life Sciences. “Moderna is advancing a broad and diverse pipeline at a pace not…

MSD have announced that the U.S. FDA has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. WINREVAIR was previously granted Breakthrough Therapy Designation by the FDA. WINREVAIR is the first FDA-approved activin signalling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. “Pulmonary arterial hypertension is a rare,…

Lonza have announced an expansion of its service offering for spray-drying of proteins for pulmonary delivery. The new offering provides clinical and commercial manufacturing services at a kilogram scale from Lonza’s Bend (US) site, home to Lonza’s Centre of Excellence for respiratory delivery. In the past, the respiratory drug pipeline was primarily dominated by small molecules. Today, approximately 30% of therapies in this pipeline are biologics, with anticipated growth to 50% by 2030. The administration of protein-based therapies to treat respiratory disease has historically been limited to intravenous or subcutaneous injections, which require frequent and costly administration and rely on patient…

Bio-Rad Laboratories have announced the launch of validated antibodies for rare cell and circulating tumour cell (CTC) enumeration. Validated for use with Bio-Rad’s Celselect Slides Enumeration Stain Kits, the antibodies are specific to CTC surface markers to enable the sensitive and specific identification of target cell populations, enhancing the study of tumour heterogeneity and disease progression at various stages.  Bio-Rad’s Genesis Cell Isolation System is a customisable benchtop solution that uses unbiased size-based cell selection to gently and efficiently capture a wide range of CTCs and other rare cells from liquid biopsy samples. After capture, the enriched cells can be recovered for…

Exothera has launched its game-changing nucleic acids service offering, powered by the world’s first continuous-batch RNA production platform, Ntensify. Developed by Exothera sister company Quantoom Biosciences, the Ntensify platform fast-tracks the production of higher quality and more cost-effective RNA therapeutics, delivering significant advantages at both small and large scale. It is also now available to biopharma companies in North America for the first time as Exothera expands its reach beyond Europe. Ntensify is an all-in-one manufacturing platform for RNA production, offering a seamless transition from clinical to commercial-scale manufacturing, without the need for process development or scale-up. Unlike traditional methods, which often require extensive process…

Actylis and Novo Nordisk Pharmatech A/S have entered into an agreement for the distribution of pharmaceutical grade Benzalkonium Chloride (BKC) to the pharmaceutical and medical device markets in Germany, Spain, Portugal, UK and Ireland. Ian Jennings, SVP-President Europe at Actylis explains: ”This new agreement, built on our existing partnership in North America, represents a major opportunity for Actylis Europe to complete our pharmaceutical product portfolio while supporting the development of Novo Nordisk Pharmatech BKC for new applications”. “We are thrilled to strengthen our collaboration with Actylis; this will extend our high standards to these fundamental European markets. We look forward…

Vicore Pharma Holding AB have announced FDA Breakthrough Device Designation status for Almee, a 9-week digital cognitive behavioural therapy (CBT), to be used as an adjunct treatment of anxiety symptoms related to PF. The FDA Breakthrough Devices Program designates those medical devices that are evaluated as providing a more effective treatment for life-threatening or irreversibly debilitating diseases. Breakthrough designation reflects the effectiveness of this new therapy compared to treatment as usual for anxiety associated with pulmonary fibrosis and demonstrates the impactful nature of this digital therapy.  Almee is a patient-facing tool based on CBT principles accessed via a smartphone or tablet.The COMPANION study on Almee demonstrated a 2.7-point…

Roquette have announced an agreement to acquire IFF Pharma Solutions, a worldwide producer of excipients for oral dosage solutions. The combination of the two complementary businesses will rebalance the company’s portfolio around the two pillars of Health and Nutrition. It will expand its pharma product range and accelerate Roquette’s growth. IFF is headquartered in New York (USA). Its pharmaceutical division is a world-class producer of excipients for oral dosage solutions, with revenues of approximately $1B, 10 research and development and/or production sites globally, and around 1,100 employees. It has an extensive range of high-quality products, established brands and a client base…

Lonza have announced it has signed an agreement to acquire the Genentech large-scale biologics manufacturing site in Vacaville, California (US) from Roche for $1.2 billion. The acquisition will significantly increase Lonza’s large-scale biologics manufacturing capacity to meet demand for commercial mammalian contract manufacturing from customers with existing commercial products, and molecules currently on the path to commercialisation within the Lonza network. The Vacaville (US) facility currently has a total bioreactor capacity of around 330,000 liters, making it one of the largest biologics manufacturing sites in the world by volume. Under the agreement, approximately 750 Genentech employees at the Vacaville (US) facility…

Owkin, the first end-to-end TechBio unicorn that provides AI-driven precision drug discovery, development and diagnostics by matching new biology to new populations, has announced the expansion of their collaboration with Sanofi to include immunology. In their work with Sanofi on target identification, the team at Owkin used their AI drug target discovery engine to identify the best candidate gene targets with their associated subpopulations of interest. This enables their partners to understand an individual’s unique biology and design tailored treatments. The next phase of the collaboration will be focused on drug positioning within Sanofi’s immunology therapeutic pipeline. To do this, Owkin…

Hovione and GEA have announced the next stage of their partnership, with new development agreements, the launch of the ConsiGma CDC flex as well as the installation of a new lab-scale R&D Continuous Tableting rig in Hovione´s facilities in Portugal. The two companies’ collective and complementary knowledge of continuous tableting is being applied to streamline the technology and make it more accessible to pharmaceutical customers worldwide. The two expert teams are collaborating to bring continuous tableting to the same level of maturity as batch tableting, thereby capturing the known benefits of continuous manufacturing while reducing the downsides. The ConsiGma CDC flex (patent pending), has…

Novo Nordisk have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Awiqli (the brand name for once-weekly basal insulin icodec) for treatment of diabetes in adults. The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial programme. Once-weekly basal insulin icodec achieved superior blood sugar reduction (measured by a change in HbA1c) and superior Time in Range (time spent within recommended blood sugar range), compared with daily basal insulin in people with type 2 diabetes. In people with type 2 diabetes who have…

It’s long been a concern for scientists and regulators that drugs are intended for use by anyone but are predominantly tested on one group – white men. This could change because of legislation introduced in the U.S. requiring Diversity Action Plans for late-stage trials, reports Richard Staines. While diversity in the workplace is an economic and moral issue, experts argue that diversity in clinical trials is a scientific problem as well as a moral one. The U.S. government-run National Institutes of Health has its own National Institute on Minority Health and Health Disparities, which aims to address this very issue.…