Patients can access their record through a code for their iPhone. The idea is to help patients better understand their medical history, improve the quality of interactions with their physicians and family members, and make more informed decisions about their care.
First and only subcutaneous immunoglobulin (SCIg) approved for the treatment of CIDP based on the largest controlled clinical study in CIDP
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
Pregnant women today are more likely to have chronic conditions that could cause life-threatening complications than at any other time in the past decade - particularly poor women and those living in rural communities, a new Michigan Medicine study suggests.
The chronic brain disease that causes seizures currently affects around 600,000 people living in the UK The NHS has announced that it will be rolling out a new laser beam therapy this June to help prevent seizures in patients living with epilepsy. The new fibre optic laser therapy called laser interstitial thermal therapy (LITT) works to target the part of the brain that causes seizures without the need for invasive surgery. Affecting around 600,000 people in the UK, epilepsy is a chronic brain disease that causes seizures, which lead to involuntary movement. Around one in three people living with the condition are unable to control their seizures using anti-seizure drugs and may need invasive neurosurgery to remove the epilepsy-causing part of the brain. Being offered at King’s College Hospital NHS Foundation Trust and the Walton Centre in Liverpool, the treatment involves drilling a small hole to allow a 1.5mm-wide probe ...
Dive Brief Outset Medical received 510(k) clearance for TabloCart with prefiltration, an accessory that filters sediment and minerals out of water before it enters the company’s dialysis machines. Outset stopped distributing the accessory last year after receiving a warning letter in July 2023 from the Food and Drug Administration stating that it needed 510(k) clearance. BTIG analyst Marie Thibault wrote in a research note that the clearance is a “big win” for Outset, adding that she expects the company to now be able to work through a customer backlog. Dive Insight San Jose, California-based Outset is competing in the market for dialysis equipment. Its Tablo hemodialysis system can be used in acute or chronic care facilities and was cleared for home use in 2020. The company also makes an accessory for the system, called TabloCart, which includes wheels, storage drawers, and water prefiltration to remove sediment and minerals from supply ...
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,” ...
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 ...
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, ...
Strategic collaboration to leverage BigHat’s AI/ML (Artificial Intelligence / Machine Learning) guided Milliner platform to design high-quality next-generation protein therapeutics BigHat Biosciences, a biotechnology company with an artificial intelligence/machine learning-guided antibody discovery and development platform announced a collaboration with Janssen Biotech Inc., a Johnson & Johnson company. This strategic collaboration combines the drug discovery, clinical development and data science expertise from Johnson & Johnson with BigHat’s Milliner platform, a suite of machine learning technologies integrated with a high-speed wet lab, to guide the design and selection for high-quality antibodies for multiple Neuroscience therapeutic targets. The agreement was facilitated by Johnson & Johnson Innovation. BigHat’s antibody design platform, Milliner, integrates a synthetic biology-based high-speed wet lab with machine learning technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins ...
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