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
• 125
• 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 Currently, the tools for interfacing peripheral nerves are outdated, bulky and carry a high risk of nerve injury, according to the University of Cambridge.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
• 97
• May 9, 2024

VIETNAM MEDIPHARM EXPO 2024

Organiser: MINISTRY OF HEALTH Time:9 – 12 May 2024 address：91 Tran Hung Dao St. ,Hoàn Kiêm, Hanoi, Vietnam Exhibition hall:  Cultural Friendship Palace   Product range: Medical products: medical equipment and instruments, medical consumables, medical dressings, surgical equipment, rescue equipment, diagnostic medical equipment and supplies, ENT equipment, dental products and supplies, medical health products and equipment, medical institutions and laboratory technical equipment, medical information and technical exchange, beauty equipment, etc Pharmaceutical equipment: pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning and disinfection configuration system, etc Laboratory equipment: optical instrument equipment, microscope, optical image processing, electronic measuring instrument, multimeter, electronic probe, electronic simulation system, single-chip microcomputer development system, image analysis and processing system, etc Analytical instruments: optical analytical instruments, mass spectrometers, spectrometers, chromatographs, spectrometers, various portable instruments, surface analysis instruments, nuclear analysis instruments, elemental analysis instruments, process analysis instruments, composition analysis instruments, injection analysis instruments and other ...

• Source: drugdu
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• 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
• 107
• 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
• 80
• 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
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• 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
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• 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
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• May 8, 2024

Henlius Dual HER2 Blockade Therapy Receives Phase 3 MRCT IND Approval from U.S. FDA

Shanghai, China, May 6, 2024-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved by the United States Food and Drug Administration (FDA). As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally. Until now, gastric/gastroesophageal junction (G/GEJ) cancer still constitutes a major global health problem. Globally, there were around 1 million cases in 2022. G/GEJ cancer generally carries a poor prognosis since it is often diagnosed at an advanced stage, with a 5-year relative survival rate of only 6%. The reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%, and the prognosis for patients with HER2-positive disease ...

• Source: drugdu
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• May 8, 2024

Nova’s Xromi approved in UK and EU for vaso-occlusive complications of SCD

Nova Laboratories’ Xromi (hydroxycarbamide) has received approval from the Medicines and Healthcare products Regulatory Agency and the European Commission to extend the indication for vaso-occlusive complications of sickle cell disease (SCD) to infants from nine months of age. SCD is a group of inherited red blood cell disorders that are caused by a genetic mutation that affects the production of haemoglobin, the protein in red blood cells that carries oxygen. The regulatory decisions were based on data from the pharmacokinetic, efficacy and safety study, HUPK, which showed that Xromi is expected to work in the same way in children from nine months of age as it does in older children. Furthermore, additional data from the phase 3 BABY HUG study suggests that the benefits and safety of Xromi in children as young as nine months of age are similar to those in older children. Dr James White, deputy managing director, ...

• Source: drugdu
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• May 8, 2024