PharmaFocus Today – Page 188 – media

Livanova to close loss-making circulatory support business

Dive Brief Livanova is closing its circulatory support unit to focus on larger, faster-growing cardiopulmonary and neuromodulation opportunities. The advanced circulatory support (ACS) business sells the Lifesparc device, which pumps blood during cardiovascular surgeries, but sales have fallen and then flatlined since peaking in 2021. In a note to investors, Stifel analysts said they supported the decision to wind down the unit by the end of 2024, predicting it will benefit revenue growth and profitability and increase focus at the company. Dive Insight Livanova expanded its circulatory support offering by acquiring Tandemlife for $200 million upfront in 2018 and received 510(k) clearance for Lifesparc the next year. ASC remained a small part of the broader business, though. Over the first nine months of last year, ASC brought in $30.2 million, almost exclusively in the U.S., and accounted for about 4% of total sales. The unit has contracted in recent years. ...
- Source: drugdu
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- January 12, 2024
Multiplexed POC Testing IVD Solution Performs Molecular and Immunoassays from Various Body Fluids on Single Platform

A hybrid in vitro diagnostics (IVD) solution for multiplexed point-of-care testing (xPOCT) can perform both molecular and immunoassays from several body fluids on a single platform. The hybrid and scalable technology aims to deliver lab-comparable test results in a single patient encounter, significantly reducing the diagnostic timeline. Picodya’s B-Matrix diagnostic system is the world’s first POC hybrid solution that can run IVD tests, both immunoassays and molecular assays on the same device at lab-comparable quality, on multiple patient samples, simultaneously within minutes. The B-Matrix is designed to minimize turnaround time, and deliver better outcomes while lowering costs. The B-Matrix is powered by Picodya’s proprietary PicoFluidic technology which enables the system to operate at high capacity testing for a panel of markers simultaneously, using just pico volumes of reagents and controls. This allows for ultra-fast results within as quickly as 15 minutes and at a fraction of the cost for comparable ...
- Source: drugdu
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- January 12, 2024
FDA Fast Tracks SELLAS Life Sciences’ CDK9 Inhibitor for Acute Myeloid Leukemia

Pharmaceutical Executive Editorial Staff SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia. The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The regulatory action was based on safety and efficacy data for the drug, which is being evaluated in an ongoing Phase I/II study (NCT04588922) in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with AML. “Receiving fast track designation for SLS009 for relapsed or refractory AML, following the recent orphan drug designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” ...
- Source: drugdu
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- January 12, 2024
FDA’s Preliminary Review of GLP-1 Meds Finds No Tie to Suicidal Thoughts, Actions

The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing. By FRANK VINLUAN An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced ...
- Source: drugdu
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- January 12, 2024
AcelRx becomes Talphera, adopting new name to reflect pain pivot

AcelRx Pharmaceuticals wants to put a tough few years behind it. After failing to crack the pain market, the biotech has shifted its focus to a pipeline led by a blood thinner and adopted a new name, Talphera, to reflect the revised strategy. The value of AcelRx has fallen sharply in recent memory, dropping 62% over the past year and 98% over the past five years to leave the company with a market cap of below $15 million. The five-year time frame covers the period after the approval of the sublingual pain drug Dsuvia. AcelRx won approval in 2018 but failed to turn the opioid into a major product, generating sales of $1.8 million in 2022. Alora Pharmaceuticals acquired the drug for $1.1 million last year, moving AcelRx away from its earlier focus on pain. Following the transaction, AcelRx’s goals were to win approval tforhe pre-filled ephedrine syringe, Fedsyra, and ...
- Source: drugdu
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- January 12, 2024
GSK

GSK has a lot of experience with its shingles vaccine Shingrix in getting the older population to take their shots; now, with the approval of the world’s first RSV vaccine last year, the U.K. Big Pharma is looking for a slow burn approach for its latest respiratory shot. During GSK’s official J.P. Morgan Healthcare Conference 2024 presentation, CEO Emma Walmsley and Chief Commercial Officer Luke Miels spoke on how the company is looking to carve out a RSV market with its new vax Arexvy. “Creating a market is absolutely fundamental,” Walmsley said during the JPM presentation. “Three years ago, I don’t know how broadly the awareness was of the general public about RSV for older adults, even though it’s a scale disease that hospitalizes tens of thousands of Americans that were on, sadly 15,000 died. “So, we’re at very early stages of penetration of the market. I think competition and ...
- Source: drugdu
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- January 12, 2024
HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority

Review Status Hong Kong, Shanghai & Florham Park, NJ — Thursday, January 11, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”). Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”), being developed for the treatment of hematological malignancies and immune diseases. The NDA is supported by data from ESLIM-01, a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. In August 2023, HUTCHMED announced that the trial had met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib ...
- Source: drugdu
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- January 12, 2024
MHRA sets out regulatory roadmap to support safe access to medical technology

The Medicines and Healthcare products Regulatory Agency (MHRA) has set out a regulatory roadmap to enable safe access to medical technology, including artificial intelligence (AI) and diagnostics. The Roadmap Towards the Future Regulatory Framework for Medical Devices will support the development of new regulations that will prioritise patient safety and help ensure individuals continue to have access to the devices they need without delay, while enhancing the UK’s position as “a world-leading environment for medical technology innovators,” the MHRA said. The roadmap is also set to offer “significant new opportunities for patients and healthcare” by enhancing the UK’s ability to benefit from advancing medical technology such as implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease. Dr Laura Squire, the MHRA’s MedTech regulatory reform lead and chief officer of healthcare, quality and access, said: “Today’s exciting medical technology advances offer important new opportunities for ...
- Source: drugdu
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- January 12, 2024
Nucala® (Mepolizumab Injection) Approved for the Treatment of Severe Eosinophilic Asthma in China

GlaxoSmithKline (“GSK”) announced that NMPA has recently approved Nucala® (Mepolizumab injection) for the maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above. Nucala® is the first targeted human anti-interleukin-5 (IL-5) monoclonal antibody biologic in China for this indication. Asthma is a major health burden in China, where approximately 46 million adults suffer from asthma. About 6% of them have severe asthma, which can cause an increased risk of acute exacerbations requiring hospitalization and even potentially fatal asthma attacks. The daily lives of people with severe asthma are severely affected and treatment is costly. In China, 15.5% of people with asthma have experienced an exacerbation requiring hospitalization in the past 12 months. The Guidelines for the Prevention and Management of Bronchial Asthma (2020 edition), developed by the Chinese Medical Association’s Section of Respiratory Diseases, cites an unmet need for treatment of this disease in ...
- Source: drugdu
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- January 12, 2024
Henlius and Sermonix Announce Strategic Collaboration and Exclusive License Agreements for Novel Endocrine Therapy Lasofoxifene

COLUMBUS, Ohio, & SHANGHAI, Jan. 11, 2024 – Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, and Shanghai Henlius Biotech, Inc. (2696.HK), today announced a strategic collaboration agreement in which Henlius will receive exclusive rights to develop, manufacture and commercialize Sermonix’s lead investigational drug, lasofoxifene, in China. Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights. Sermonix received an upfront payment and is further eligible to receive up to $58 million in certain predetermined milestones, in addition to royalties upon Henlius commercialization in China. Breast cancer is the cancer with the highest incidence rate in the world, according to GLOBOCAN 2020. There were 2.26 million new cases of breast cancer in 2020 ...
- Source: drugdu
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- January 12, 2024

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