AstraZeneca Finalizes Equity Investment, Research Collaboration with Cellectis

Don Tracy, Associate Editor Joint venture aims to develop up to 10 new cell and gene therapy products targeting areas with high unmet medical needs. AstraZeneca announced that it has officially completed its equity investment and research collaboration agreement with Cellectis, a biotechnology company specializing in gene editing technologies. According to the company, the agreement is expected to result in a collaboration to develop up to 10 different cell and gene therapy (CGT) products in areas such as oncology, immunology, and rare diseases. Regarding terms of the deal, Cellectis earned an upfront payment of $105 million, which included $25 million in cash and $80 million in an equity investment. Cellectis will have the opportunity to profit further through an investigational new drug (IND) option fee, and additional payments based on development, regulatory, and sales milestones that could range from $70 million to $220 million.1 The collaboration, which was first announced ...

• Source: drugdu
• 182
• May 9, 2024

TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar launched for sale in the U.S.

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is committed to developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company today announced that its partner, Bojian (NASDAQ: BIIB), has recently begun marketing and selling TOFIDENCE™ (tocilizumab-bavi) tocilizumab biosimilar in the United States. TOFIDENCE™, a biosimilar developed by BIO-THERA with reference to Amero® (tocilizumab), was approved by the U.S. FDA in September 2023 for the treatment of moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.TOFIDENCE™ is currently available in the U.S. as an intravenous infusion of 80 mg/4 ml, and is sold as an intravenous injection of 80 mg/4 ml. sales, 80 mg/4 mL, 200 ...

• Source: drugdu
• 131
• May 9, 2024

Lantern Pharma and Oregon partner to develop cancer treatment

Lantern Pharma has entered into a partnership with Oregon Therapeutics for optimising the development of the cancer drug candidate, XCE853, through an AI-driven approach. XCE853 is an inhibitor of protein disulfide isomerase (PDI). The partnership will utilise RADR AI platform of Lantern to identify biomarkers and efficacy-linked signatures of XCE853 for precision development across solid tumours. Furthermore, this alliance will identify biomarker signatures that can aid in stratifying tumours that are most responsive to the drug and facilitate in the clinical development and patient selection in the future. Oregon focuses on developing XCE853 for a range of cancer indications, including drug-resistant ovarian and pancreatic cancers, certain haematological cancers, and several paediatric cancers, such as central nervous system (CNS) cancers. The collaboration aims to harness computational tools, including machine learning and large-scale molecular analysis, to streamline the development process. The partnership will integrate and interrogate a vast array of molecular, genetic, ...

• Source: drugdu
• 131
• May 9, 2024

International phase 3 clinical trial for new melanoma treatment recruits first patients

A phase 3 international trial evaluating a new personalised immunotherapy treatment for melanoma has recruited its first patients at University College London Hospitals (UCLH) NHS Foundation Trust. Results from the phase 2 study evaluating Moderna and Merck & Co’s – known as MSD outside the US and Canada – mRNA-based technology treatment were published in the Lancet. Currently the fifth most common type of cancer, melanoma is a serious form of skin cancer that is responsible for over 8,000 new cases every year. The condition is characterised by the uncontrolled growth of pigment-producing cells. The new trial, INTerpath-001, is evaluating mRNA-4157 (V940) in combination with Merck’s PD-1 inhibitor, Keytruda (pembrolizumab), versus Keytruda on its own – the current standard of care – as a risk-reducing treatment option for patients with resected, high-risk, stage 2b to 4 melanomas following surgical removal of the cancer, with primary outcomes of recurrence-free survival and ...

• Source: drugdu
• 193
• May 9, 2024

Cambridge researchers develop robotic nerve devices for neurological conditions

Neurological disorders, such as epilepsy or chronic pain, affect over three billion people worldwide Researchers at the University of Cambridge have developed small, flexible devices, combining electronics and soft robotics, to help treat a range of neurological conditions, including epilepsy and chronic pain. Published in Nature Materials, the nerve cuff implant has the ability to change shape through electrical activation, opening up a variety of avenues for new, highly targeted treatment options. Affecting more than three billion people worldwide, neurological disorders are conditions that affect the brain as well as the nerves found throughout the human body and spinal cord. Currently, the tools for interfacing peripheral nerves are outdated, bulky and carry a high risk of nerve injury, according to the University of Cambridge. “Nerves are small and highly delicate, so anytime you put something large, like an electrode, in contact with them, it represents a danger to the nerves,” ...

• Source: drugdu
• 191
• May 9, 2024

New Blood Test Device Modeled on Leeches to Help Diagnose Malaria

Many individuals have a fear of needles, making the experience of having blood drawn from their arm particularly distressing. An alternative method involves taking blood from the fingertip or earlobe, but this often yields insufficient blood for many tests and can result in inaccurate laboratory values that vary between measurements. Now, researchers have developed an innovative device that uses microneedles and a suction cup instead of a large needle, which could be especially beneficial for those with needle phobia. This device can collect more blood than the traditional finger prick, enhancing the reliability of diagnostic measurements. Additionally, its low production cost makes it feasible for use in developing countries. The new device for taking blood samples developed by researchers at ETH Zurich (Zurich, Switzerland) operates on a principle similar to that of a leech and is less invasive than traditional arm blood draws. It is user-friendly and can be operated ...

• Source: drugdu
• 170
• May 8, 2024

The BCR::ABL1 fusion gene plays a key role in the pathogenesis of several blood cancers, particularly chronic myeloid leukemia (CML). This gene results from a chromosomal translocation that causes constitutive activation of the ABL1 tyrosine kinase domain, triggering unchecked cell growth. Testing for the BCR::ABL1 fusion gene is crucial in managing leukemia, as it helps identify patients with Philadelphia chromosome-positive leukemia who might benefit from targeted therapies such as tyrosine kinase inhibitors (TKIs). While Sanger sequencing has been the standard method for this analysis, it has its limitations in sensitivity. Next-generation sequencing (NGS) offers a more comprehensive approach to detecting, quantifying, and analyzing the genetic alterations associated with leukemia, including minor BCR::ABL1 transcripts and mutations. NGS thus provides detailed insights into disease progression, treatment response, and potential resistance mutations, enabling personalized treatment plans. BioVendor MDx (Brno, Czech Republic) has introduced the first commercial NGS assay specifically for the BCR::ABL1 fusion ...

• Source: drugdu
• 109
• May 8, 2024

FTC Seeks More Information on the $16.5B Novo-Catalent Deal, Leading to Another Delay

Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.Novo Holdings’ planned acquisition of Catalent is facing another delay. Just weeks after Novo Holdings decided to resubmit its application to the Federal Trade Commission, the agency is seeking more information about the deal. The transaction was originally expected to close by the end of this year, but this timeline may not be as solid given the repeated delays in the FTC’s review process. The acquisition was announced in early February when Novo Holdings — the investment arm of the foundation that owns a controlling stake in Danish pharma giant Novo Nordisk — disclosed its plans to acquire New Jersey-based contract development manufacturing organization Catalent ...

• Source: drugdu
• 193
• May 8, 2024

FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients

Don Tracy, Associate Editor Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients. Axurity Pharmaceuticals announced that the FDA has officially approved Myhibbin as a ready-to-use mycophenolate mofetil oral suspension for organ transplant patients. Myhibbin is the first FDA-approved liquid formulation of mycophenolate, which is used to avoid organ rejection in transplant recipients, according to Azurity. The company stated that this approval provides a significant new option for both pediatric patients above the age of three months and adults who have undergone kidney, heart, or liver transplants.1 “We are very pleased that adult and pediatric organ transplant recipients will soon have access to the only FDA-approved ready-to-use oral liquid formulation of mycophenolate,” said Richard Blackburn, CEO, Azurity Pharmaceuticals, in a press release. “Patients are our priority, and our purpose is to bring them new formulations that help them ...

• Source: drugdu
• 127
• May 8, 2024

Cipla and Glenmark initiate recall of certain products in the US

Cipla and Glenmark Pharmaceuticals are recalling specific products from the US market due to distinct manufacturing issues, the latest Enforcement Report issued by the US Food and Drug Administration (USFDA) noted. The recalls involve inhalation solutions and extended-release capsules used for treating respiratory conditions and high blood pressure, respectively. New Jersey-based subsidiary of Cipla, Cipla USA is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. This product is manufactured at Indore SEZ plant of the company in India. It is prescribed for controlling the symptoms of lung diseases such as chronic bronchitis, asthma, and emphysema. The recall of the affected inhalation solution lot is claimed to be due to complaints of “short fill”. The US regulator detailed that the affected lot was recalled after reports of less fill volume in respules and the presence of a few drops of liquid in the intact pouch. Simultaneously, Glenmark Pharmaceuticals, ...

• Source: drugdu
• 283
• May 8, 2024