PharmaFocus Today – Page 233 – media

Takeda’s enzyme replacement therapy approved by FDA for rare blood clotting disorder

Takeda’s Adzynma (ADAMTS13, recombinant-krhn) has been approved by the US Food and Drug Administration (FDA) as the first therapeutic option for congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare inherited blood clotting disorder. Estimated to affect fewer than 1,000 people in the US, cTTP is caused by a deficiency in the ADAMTS13 enzyme that regulates blood clotting. Patients with cTTP can experience severe bleeding episodes, strokes and damage to vital organs, and mortality rates are high if left untreated. “Without treatment, cTTP is ultimately fatal,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He continued: “[The] approval reflects important progress in the development of much-needed treatment options for patients affected by this life-threatening disorder.” Until now, cTTP treatment has typically involved plasma therapy, which Takeda has previously described as “insufficient in restoring ADAMTS13, time-consuming and costly”. Adzynma, which has been authorised for use as a preventative ...
- Source: drugdu
- 96
- November 16, 2023
Henry Schein says customer data breached in cyber incident

Dive Brief Henry Schein, a medical and dental supplies company, is still recovering from a cybersecurity incident last month that took some of its systems offline. In a letter to its customers, the company disclosed on Monday that a data breach occurred, but “we do not have all the details of what data may have been compromised.” Customer bank accounts and credit card numbers may have been affected. Henry Shein also issued a letter to its suppliers, writing that the company is “aware that the bank account information for a limited number of suppliers was misused.” CEO Stanley Bergman told investors on a Monday earnings call that the company is working to bring its e-commerce platform back online this week, and that the incident primarily affected its dental and medical distribution operations in North America and Europe. Dive Insight Henry Schein lowered its sales expectations for its 2023 fiscal year, ...
- Source: drugdu
- 99
- November 15, 2023
Major trial finds apixaban reduces stroke risk in patients with device-detected atrial fibrillation

The widely available blood thinner apixaban substantially reduced stroke in at-risk patients with a type of atrial fibrillation only detectable by a pacemaker or other implanted cardiac electronic device, a global study has found. The oral anticoagulant medication, which helps to prevent dangerous blood clots by thinning the blood, reduced the risk of stroke and blood clotting by 37% and reduced fatal or disabling stroke by 49% in individuals with device-detected atrial fibrillation, also known as sub-clinical atrial fibrillation (SCAF). This condition is not easily detectable through standard tests like electrocardiograms, unlike clinical atrial fibrillation. The study was published on Nov. 12 in the New England Journal of Medicine (NEJM) and simultaneously presented at the American Heart Association Scientific Sessions by lead researcher Jeff Healey, a senior scientist at the Population Health Research Institute (PHRI), a joint research institute of McMaster University and Hamilton Health Sciences. Healey and a global ...
- Source: drugdu
- 108
- November 15, 2023
Novartis Enters into Deal with Legend Biotech for $100 Million Upfront

By Tyler Patchen Legend Biotech has secured an exclusive global license deal with Novartis giving the Swiss pharma access to Legend’s CAR-T cell therapies. The deal announced on Monday will give Novartis access to CAR-Ts that target the delta-like ligand protein (DLL3) candidate LB2102, which Legend has been investigating to treat adults with certain small cell lung cancers. Novartis will pay Legend $100 million upfront, and the New Jersey–based biotech “will be eligible to receive up to $1.01 billion in clinical, regulatory and commercial milestone payments and tiered royalties,” according to the company’s announcement. The deal has Legend taking the lead on the Phase I trials for LB2102 in the U.S., while Novartis will handle all other development. No hard date has been given as to when the deal will close. For its part, Novartis will receive exclusive worldwide rights to develop, produce and eventually commercialize the therapies. The company ...
- Source: drugdu
- 106
- November 15, 2023
Lilly Notches Second Cholesterol Win with RNA Silencer

By Tristan Manalac Data from an early-stage study showed that Eli Lilly’s investigational RNA silencing therapeutic lepodisiran can induce sharp and durable reductions in serum lipoprotein(a) levels, the company revealed in a read-out presented over the weekend at the 2023 Scientific Sessions of the American Heart Association. These findings come nearly three months after the Indianapolis-based pharma notched another Phase I victory, this time for its oral drug candidate muvalaplin, which strongly decreased lipoprotein(a) levels in healthy participants within 24 hours. Lipoprotein(a), also known as Lp(a), is a form of cholesterol that can cause plaques to form in arteries and block blood flow and is often tied to the risk of developing cardiovascular diseases. The first-in-human trial of lepodisiran enrolled 48 patients who were given ascending doses of the investigational therapy—from 4 mg up to 608 mg—or a placebo. At the highest dose level, lepodisiran was able to elicit a ...
- Source: drugdu
- 114
- November 15, 2023
Collections, Aggressive Tactics, and Consequences

Don Tracy, Associate Editor The growing issue of medical debt has caused stakeholders to reevaluate tactics as the cost of pharmaceutical healthcare continues to rise. In modern times, hospitals have continuously employed aggressive tactics to collect debts from patients, especially those in low-income situations. A recent study published by The New England Journal of Medicine (NEJM) notes that these tactics include wage garnishments, selling debts to third party buyers, reporting of delinquent debts to credit bureaus, lawsuits, seizures of bank accounts, property liens, foreclosures, refusals of care, and even arrests. Politicians on both sides of the spectrum have criticized these tactics, citing the lack of charity care. Since the 1980s, hospitals have shifted away from this in favor of incessant debt collection tactics, according to the investigators. In a recent episode of the An Arm and a Leg podcast, Luke Messac, MD, PhD, discussed his experience in this area. In ...
- Source: drugdu
- 98
- November 15, 2023
FDA deems stolen Medtronic scopes problem a Class I recall

BY SEAN WHOOLEY Conforming devices can be identified by their serial number. The FDA today issued a notice saying the recall of Medtronic (NYSE: MDT)+ McGrath Mac video laryngoscopes is Class I, the most serious kind. Medtronic in October warned on stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties. The company initiated a recall as a result of the stolen, defective products. The company informed the public of the illegal offering of the devices by third parties through various social media platforms. Affected products failed to pass Medtronic’s rigorous tests established for the product. The company did not release them for sale, distribution or importation. Potential adverse effects from defective scopes include hypoxia, hypercapnia, tissue damage/trauma and/or a delay to treatment. More details on the Medtronic recall The recall affects 5,709 devices in the U.S., distributed between July 5, 2019, and July 14, 2022. Medtronic’s ...
- Source: drugdu
- 98
- November 15, 2023
Victoria Atkins MP takes over UK’s department of Health and Social Care

The UK Prime Minister, Rishi Sunak, has confirmed that Victoria Atkins has been appointed Secretary of State for Health and Social Care amid a cabinet shake-up. The Conservative MP for Louth & Horncastle was appointed to the position today (13 November) during a cabinet reshuffle that saw the previous incumbent, Steve Barclay, removed from his position. From 2017 to 2021 Victoria Atkins was the Parliamentary Under Secretary of State for Crime, Safeguarding and Vulnerability at the Home Office, and then moved on to become Financial Secretary to the Treasury between 27 October and 13 November 2022. Initially a barrister by trade and with no formal background in the healthcare trade, her husband Paul Kenward is Managing Director of British Sugar, a firm licensed to grow cannabis for use in children’s epilepsy medication. Now, Atkins will have to helm the government department as it navigates a winter of disruption and potential ...
- Source: drugdu
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- November 15, 2023
Merck’s Keytruda combination receives CHMP recommendation for biliary tract cancer

Merck & Co – known as MSD outside the US and Canada – has announced that the European Medicines Agency’s human medicines committee has recommended its Keytruda (pembrolizumab) in combination with chemotherapy to treat biliary tract cancer (BTC). The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended that the anti-PD-1 therapy be used alongside gemcitabine and cisplatin for the first-line treatment of adults with locally advanced unresectable or metastatic BTC. BTC is a group of rare and highly aggressive cancers in the liver, gallbladder and bile ducts. Approximately 211,000 people are diagnosed with the disease each year globally and about 70% of BTC patients are diagnosed at an advanced stage, at which point the prognosis is poor. The CHMP’s positive opinion was supported by results from the late-stage KEYNOTE-966 trial, in which the Keytruda/chemotherapy combination demonstrated a significant overall survival benefit in these patients versus chemotherapy alone. ...
- Source: drugdu
- 94
- November 15, 2023
GSK’s momelotinib recommended by CHMP to treat myelofibrosis patients with anaemia

GSK’s momelotinib has been recommended for approval by the European Medicines Agency’s human medicines committee as the first treatment option specifically indicated for myelofibrosis patients with moderate-to-severe anaemia. The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be used to treat disease-related splenomegaly or symptoms in adult patients with moderate-to-severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Eligible patients will also have either not been treated with JAK inhibitors before or have been treated with Novartis’ Jakavi (ruxolitinib), GSK said. Myelofibrosis is a rare blood cancer that can lead to severely low blood counts, with about 40% of patients having moderate-to-severe anaemia at the time of diagnosis and nearly all patients developing anaemia at some point in the course of their disease. Transfusions are often required by myelofibrosis patients with anaemia and more than 30% will discontinue treatment ...
- Source: drugdu
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- November 15, 2023

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