PharmaFocus Today – Page 326 – media

BeiGene Signs $1.3bn Deal with DualityBio for Investigational Solid Tumour ADC

BeiGene has acquired an exclusive option for a global licence to one of DualityBio’s investigational, preclinical antibody-drug conjugates (ADC) for solid tumours. Though few details of the agreement were disclosed, it has been confirmed that DualityBio will receive undisclosed upfront payments from BeiGene and will be eligible to receive certain development, regulatory, and commercial milestone payments totalling up to $1.3bn. ADCs are a class of cancer therapies that combine the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy cells. BeiGene’s global head of research and development, Lai Wang, said: “Through this strategic partnership with DualityBio, we are well positioned to advance this asset globally alongside our initial internally discovered ADC assets with our ...
- Source: drugdu
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- July 14, 2023
EMA Concern Stirs over Suicide Risk with Weight Loss GLP-1RA Drugs

The European Medicines Agency (EMA) is reviewing data on the potential effects of high-profile glucagon-like peptide-1 receptor agonists (GLP-1RAs), including Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) in causing suicidal thoughts and thoughts of self-harm. The EMA has previously approved these drugs for weight loss and/or as treatments for type 2 diabetes. The EMA investigation comes after the Icelandic Medicines Agency flagged reports of suicidal thoughts and self-injury in patients taking Ozempic and Saxenda. Authorities are so far investigating 150 reports of possible cases of self-injury and suicidal thoughts. Led by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA evaluation aims to find if these symptoms are linked to the medicines themselves, are unrelated or caused by other underlying factors. The EMA reports that more than 20 million patients in the EU have so far used liraglutide and semaglutide. GLP-1RAs are a rapidly growing ...
- Source: drugdu
- 112
- July 14, 2023
FDA Clears More Chemotherapy Imports from China’s Qilu Amid Shortage of Key Cancer Meds

As a shortage of key chemotherapy drugs continues to upend cancer treatment across the country, the FDA has resorted to securing some of the meds from China.After approving the importation of four lots back in May, the agency has now cleared 10 more lots of cisplatin for shipment to the U.S. from Chinese company Qilu Pharmaceuticals. Canada’s Apotex will distribute the drugs, which are expected to arrive this week, a company spokesperson told Fierce Pharma. Apotex is “very pleased” to aid in addressing the shortage, the spokesperson added. Cisplatin, along with fellow platinum-based chemotherapy carboplatin, are commonly used as a standard of care across many types of cancer. The newest import was first reported by Bloomberg. After the FDA flagged quality issues at a facility that produced the drug, a “ripple effect” ensued across the supply chain, the FDA’s Oncology Center of Excellence chief Richard Pazdur, M.D., told The Cancer ...
- Source: drugdu
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- July 14, 2023
J&J Megadyne Unit’s Electrode Pad Recall Labeled Class I over Burn Risk

Dive Brief Megadyne’s recall of electrode pads was classified by the U.S. Food and Drug Administration as a Class I event due to the risk of serious burn injuries, the agency said in a Tuesday notice. Megadyne contacted customers last month after receiving reports of burns linked to its reusable electrode pads. The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths. The Class I recall covers 21,200 MEGA 2000 and MEGA Soft reusable electrodes sold in the U.S. In an emailed statement, a spokesperson for J&J wrote that the notification was not a product removal, and Mega Soft pads may continue to be used. Dive Insight Megadyne is a subsidiary of Johnson & Johnson’s Ethicon segment that makes tools used in electrosurgery, procedures that involve the use of electric current to heat or cut tissue or to stop bleeding. The ...
- Source: drugdu
- 141
- July 14, 2023
New Talking Therapy Shows Promise in Treating Depression

A new talking therapy for depression has shown encouraging early signs of being more effective and cheaper to deliver than the current best practice of Cognitive Behavioural Therapy (CBT). A pilot trial from the University of Exeter, funded by the National Institute of Health and Care Research (NIHR) and published in Lancet EClinical Medicine, has found Augmented Depression Therapy (ADepT) could be a significant advance in depression care. A core feature of depression is anhedonia (reduced interest or pleasure) and wellbeing deficits, but current depression psychotherapies like CBT fail to adequately target these components. ADepT has been developed to pay just as much attention to building wellbeing as it does reducing depressive symptoms. Professor of Clinical Psychology, Barney Dunn, from the University of Exeter led the trial and said: “Depression is widespread and a significant contributor to global disability, resulting in extensive social and economic costs. Only ...
- Source: drugdu
- 131
- July 14, 2023
Anti-inflammatory Drugs Do Not Lead to a Swifter Hospital Exit

Anti-inflammatory drugs may reduce deaths due to Covid-19, but they do not help speed up the recovery for those in hospital, according to a recent study. Results from s study, published in The Journal of the American Medical Association, demonstrated that giving abatacept, cenicriviroc, or Johnson and Johnson’s Remicade (infliximab) in addition to standard of care did not decrease time to recovery for patients hospitalised with Covid-19 pneumonia. The standard of care included in this study involved Gilead Sciences’ Veklury (remdesivir) and the corticosteroid dexamethasone. Patients who took either one of the three drugs recovered after a similar number of days compared to those who were on placebo. The investigators also measured mortality across the sub-studies by day 28 – which did show slight differences, though not statistically significant. Abatacept and Remicade led to a narrow decrease in patient deaths – a 4.1% and 4.4% difference respectively, whilst ...
- Source: drugdu
- 141
- July 13, 2023
GSK’s Jemperli Made Available to Endometrial Cancer Patients via UK’s Early Access Scheme

GSK has announced that eligible endometrial cancer patients in the UK will be granted early access to its anti-PD-1 therapy Jemperli (dostarlimab) in combination with platinum-containing chemotherapy via the Early Access to Medicines Scheme (EAMS). The EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. The combination has been specifically indicated to treat adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. Endometrial cancer is the most common gynaecological cancer in the UK, with approximately 10,000 new cases reported each year. While it often has a better prognosis than other womb cancers if diagnosed early, patients with advanced or recurrent disease face limited treatment options and a poor prognosis. The positive scientific opinion from the Medicines and ...
- Source: drugdu
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- July 13, 2023
FDA Rejects Xspray’s Would-Be Rival to Bristol Myers’ Sprycel on Dosing, Manufacturing Concerns

With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel. Swedish drugmaker Xspray has received an FDA complete response letter on its application for its first product Dasynoc. In issuing the rejection, the FDA requested additional information on the drug’s dosing plus greater clarity around a third-party manufacturing facility. Xspray is seeking an FDA nod for Dasynoc to treat chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). Despite issuing the rejection, Xspray said the FDA signed off on “critical aspects” of the application and did not identify any deficiencies pertaining to the drug’s stability or clinical data, the company said in a release Tuesday. Xspray is positioning its drug as a rival to BMS’ Sprycel, which clinched its first approval in CML back ...
- Source: drugdu
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- July 13, 2023
Moderna Mounts 2 New Patent Lawsuits Against mRNA Rivals Pfizer, BioNTech

Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech.Seeking damages from Pfizer and BioNTech for alleged infringement, Moderna has lodged new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, European intellectual property outlet Juve Patent reported Tuesday. The Irish court, where Moderna is claiming infringement by Pfizer-BioNTech on a pair of Spikevax patents, is set to hear the case in early 2024, according to the publication. Less is known about the status of Moderna’s Belgian lawsuit, Juve points out. A spokesperson for Moderna didn’t immediately respond to a request for comment. The new lawsuits add to a complex web of ongoing mRNA patent litigation. The legal melee began last August when Moderna filed patent infringement lawsuits in the U.S. and Germany. Separately, Moderna has also sued Pfizer and its German partner BioNTech in the Netherlands, plus ...
- Source: drugdu
- 135
- July 13, 2023
UAE, Saudi Arabia Serve as Gateway to International Markets for Biopharma

Biopharma companies, including Sanofi, AbbVie and Virax Biolabs, are finding significant business opportunities in the Middle East, particularly in the United Arab Emirates and Saudi Arabia. These countries have emerged as attractive markets for novel therapies, driven by growing populations with increasing incidences of chronic diseases such as diabetes and cardiovascular diseases. The Middle East is emerging as a key healthcare market, with an increasing demand for innovative healthcare solutions, particularly after the region struggled to meet the challenges brought on by the pandemic, said Cameron Shaw, chief operating officer for Virax Biolabs, which recently made a deal to set up a regional headquarters in the Dubai Science Park in the UAE. “The UAE was hit very hard by the COVID pandemic, similarly to how everyone in the world was affected,” Shaw told BioSpace. This is partly due to the high prevalence of diabetes and obesity in Dubai and Saudi Arabia, he ...
- Source: drugdu
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- July 13, 2023

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