PharmaFocus Today – Page 287 – media

Kinnate Biopharma announces 70% layoffs and pipeline restructuring

Kinnate Biopharma plans to sack around 70% of its workforce and stop the development of three programmes as a result of its strategic review. The company expects to retain 28 full-time employees after the layoffs are concluded, per the 18 September press release. The US-based oncology company has also decided to consider strategic alternatives for the exarafenib monotherapy programme and the asset KIN-3248, which is designed for use in cancers with FGFR2 and FGFR3 alterations. Despite the clearing of KIN-7136’s investigational new drug application (IND), Kinnate will also not be going ahead with its Phase I trial. The strategic review reflects multiple factors that include its cash runway and the commercial potential of its programmes, based on the 18 September update. Although exarafenib was well tolerated by patients in a Phase I trial (NCT04913285), it displayed limited anti-tumour activity in subjects with Class II alterations. The company has decided to ...
- Source: drugdu
- 114
- September 21, 2023
BeiGene and Nona Biosciences expand collaboration for antibody discovery

BeiGene will utilise Nona’s Harbour Mice platform as part of the agreement BeiGene and Nona Biosciences have announced an agreement to expand their strategic collaboration for antibody discovery. The collaboration will allow BeiGene to utilise Nona’s Harbour Mice platform – a fully human transgenic mouse platform – to further improve therapeutic antibody discovery efficiency and flexibility. BeiGene first obtained the rights to use the proprietary Harbour Mice H2L2 platform for multiple antibody programmes in 2018 as part of the now expanded collaboration. Harbour Mice works to generate fully human monoclonal antibodies in classical two light and two heavy chain (H2L) formats and heavy chain only (HCAb) formats. The H2L platform allows mice to bear fully human immunoglobulin genes with robust B cell development and antibody maturation. The HCAb platform is the world’s first human HCAb transgenic mouse platform that works to generate fully human heavy chain-only antibodies. It allows the ...
- Source: drugdu
- 216
- September 21, 2023
CSL Seqirus highlights impact of flu vaccines on reducing strain on healthcare resources

CSL Seqirus has unveiled new data highlighting the potential impact of influenza vaccines on reducing the burden seasonal flu has on hospitals and broader healthcare systems. The analyses were presented at this year’s European Scientific Working Group on Influenza (ESWI) Conference. Seasonal flu is an acute respiratory infection caused by influenza viruses, which circulate in all parts of the world. Although most people can recover within a week without requiring medical attention, the flu can cause severe illness among high-risk groups such as young children, older adults, pregnant individuals and those with serious medical conditions. In France, approximately 2 to 6 million people are affected by influenza every year, leading to over 20,000 hospitalisations and 10,000 excess deaths, 90% of which occur in older adults. According to findings from a dynamic transmission model, standard-dose quadrivalent flu vaccines for older adults could reduce hospitalisations by 11.1% to 30.0% and cut ICU ...
- Source: drugdu
- 122
- September 21, 2023
Sanofi Sells 11 CNS Assets to Pharmanovia including Frisium and Gardenal

By Tristan Manalac Pictured: Sanofi’s Germany office at night/iStock, Panama7 Sanofi on Monday offloaded 11 brands in its central nervous system portfolio to U.K-based company Pharmanovia, including epilepsy drugs Frisium and Gardenal. The companies did not disclose specific terms of the agreement, but revealed that the medicines span four therapeutic areas—all with ongoing unmet need: psycholeptics, anxiolytics, anti-epileptics and anti-psychotics. Though not all these drugs are approved in every market, they still have “clear synergy” with Pharmanovia’s existing portfolio and will fit well with the company’s “core sub-therapy focuses of mental health and epilepsy, where there continues to be significant unmet need,” CEO James Burt said in a statement. Among the divested drugs are several brands of the benzodiazepine clobazam, including Sentil, Urbanol, Noiafren, Castilium and Frisium. All of these are for the treatment of anxiety in certain patient subgroups; Frisium can also be used as an adjunctive treatment in ...
- Source: drugdu
- 195
- September 21, 2023
Novartis Returns Cancer Asset Tislelizumab to BeiGene

By Tristan Manalac Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto Novartis on Tuesday gave back the investigational monoclonal antibody tislelizumab to BeiGene, returning worldwide rights to develop, manufacture and commercialize the anti-PD-1 candidate to the cancer-focused biotech. Also on Tuesday, BeiGene announced that the European Commission had approved tislelizumab for patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had previously failed platinum-based chemotherapy. The treatment will be marketed under the brand name Tevimbra. After more than a year of regulatory delay, the FDA has also accepted BeiGene’s Biologics License Application (BLA) for tislelizumab as a first-line treatment option in this indication, according to Tuesday’s announcement. Novartis and BeiGene first entered into a collaboration and license agreement over tislelizumab in January 2021 to develop tislelizumab in ESCC, as well as other malignant diseases such as non-small cell lung cancer and hepatocellular carcinoma. In July 2022, however, ...
- Source: drugdu
- 123
- September 21, 2023
FDA finalizes breakthrough device changes to target health inequities

Dive Brief The Food and Drug Administration has finalized changes to its breakthrough devices guidance, adopting revisions that could accelerate development of products that address health inequities. Eleven months ago, the FDA proposed updating its breakthrough guidance to clarify that devices that improve accessibility, and thereby tackle health inequities, can qualify for the program. The proposals received broadly positive feedback, including from industry trade group AdvaMed, leading the FDA to finalize the changes with only minor revisions and schedule a webinar to discuss its new policy. Dive Insight The FDA designed the breakthrough program to support development of devices that could better treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. Originally, the guidance lacked a specific reference to accessibility as a way that devices can improve care. In October, the FDA proposed updating the guidance to explain that it considers the “totality of information regarding the proposed device, ...
- Source: drugdu
- 227
- September 20, 2023
Meridian Bioscience announces FDA clearance for innovative Curian® Shiga Toxin Assay

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) had granted clearance for the company’s new Curian® Shiga Toxin assay. This assay joins Curian HpSA® and Curian Campy as Meridian expands its Curian diagnostic platform to maintain leadership in the gastrointestinal disease testing market. Foodborne illness is a severe global public health problem that causes 48 million people to get sick yearly and 128,000 hospitalizations from common bacterial agents like Campylobacter and E. coli.1 Meridian is expanding its foodborne immunofluorescent testing capabilities beyond Campylobacter by adding Shiga toxin to the Curian platform. Speedy diagnosis is essential with patients suspected of having a Shiga toxin-producing E. coli infection because the use of antibiotics for treatment can increase Shiga toxin release, leading to hemolytic uremic syndrome (HUS), a potentially life-threatening complication. The Curian Shiga ...
- Source: drugdu
- 248
- September 20, 2023
FDA Approves GSK’s Momelotinib for Myelofibrosis Patients with Anemia

By Tristan Manalac Pictured: GSK building in Poland/iStock, Wirestock The FDA on Friday approved GSK’s oral drug momelotinib, now to be marketed under the brand name Ojjaara, for the treatment of myelofibrosis in adults with anemia. Myelofibrosis patients often develop anemia, which forces them to discontinue treatment and raise the need for transfusions. Ojjaara’s approval will help address this “significant medical need in the community” and lead to better outcomes in these patients, Nina Mojas, GSK senior vice president for oncology global product strategy, said in a statement. With Friday’s approval, Ojjaara becomes the first authorized treatment for both newly diagnosed and previously treated myelofibrosis patients with anemia that also targets the key symptoms of the condition, according to the company’s press release. The approval comes after a three-month delay in June 2023, which the FDA said was to give it more time to review additional data supporting the application. ...
- Source: drugdu
- 254
- September 20, 2023
Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

By Tristan Manalac Pictured: Illustration of a blood clot in a blood vessel/iStock, libre de droit Anthos Therapeutics is ending the Phase II AZALEA-TIMI 71 study ahead of schedule after its investigational monoclonal antibody abelacimab demonstrated an “overwhelming reduction” in bleeding compared to Bayer and Johnson & Johnson’s Xarelto (rivaroxaban), the company announced Monday. Patients treated with abelacimab saw a sharp reduction in the composite endpoint of major and clinically relevant non-major bleeding events compared with counterparts given rivaroxaban, the current standard-of-care oral anticoagulant. The Massachusetts-based biopharma did not provide specific data in Monday’s announcement but said that the Data Monitoring Committee stopped the study early following these data. Anthos will share the full results and analysis of the trial in an upcoming medical meeting. Due to the “overwhelming reduction in bleeding” reported in AZALEA-TIMI 71, abelacimab may represent a “paradigm shift” in atrial fibrillation care particularly in the prevention ...
- Source: drugdu
- 115
- September 20, 2023
FDA revises biosimilar guidelines for clearer drug labelling

The US Food and Drug Administration (FDA) released a draft guidance giving drug manufacturers recommendations for biosimilar and interchangeable biosimilar products, detailing tips for drafting label prescription information, on 15 September. In the “Labeling for Biosimilar and Interchangeable Biosimilar Products” document, the agency said that “the biosimilar or interchangeable biosimilar label should only be used in labelling text that is specific to the biosimilar or interchangeable biosimilar product or refers solely to it.” The FDA defines an interchangeable biosimilar as a “biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy, depending on state pharmacy laws.” The agency guided drug manufacturers to only include the drug product’s proprietary name in the following sections: indications and usage, dosage and administration, dosage forms and strengths, description and how supplied/storage and handling. The FDA also recommended its use in recommendations for preventing, monitoring, managing, or mitigating risks. ...
- Source: drugdu
- 118
- September 20, 2023

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