Search Results for “antibody” – Page 46 – media

Novavax’s XBB.1.5-adapted COVID-19 vaccine receives EC approval

Novavax has announced that its updated COVID-19 vaccine, Nuvaxovid XBB.1.5, has been approved by the European Commission (EC) for active immunisation in individuals aged 12 and older. The decision follows a positive opinion for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Developed to target the Omicron XBB sublineage, the updated vaccine prepares the body’s defences against COVID-19 and contains a version of the spike protein of the Omicron XBB.1.5 subvariant, as well as Matrix-M adjuvant to strengthen immune response. The approval was based on non-clinical data which showed that the vaccine induced functional immune responses against the COVID-19 variants XBB.1.5, XBB.1.16 and XBB.2.3. Additionally, the updated vaccine induced neutralising antibody responses to newly emerging subvariants of the SARS-CoV-2 virus, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, as well as strong CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. Based on previous recommendations by ...
- Source: drugdu
- 212
- November 3, 2023
Merck KGaA and Hengrui Pharmaceuticals announce oncology partnership worth over €1.4bn

Merck KGaA has signed a licensing agreement worth over €1.4bn with Jiangsu Hengrui Pharmaceuticals for the rights to its next-generation PARP1 inhibitor HRS-1167 outside of China. The deal also includes an option for an exclusive licence for its Claudin-18.2 antibody drug conjugate (ADC), SHR-A1904. Compared to first-generation PARP inhibitors, HRS-1167 has higher selectivity and affinity for PARP1 and induces DNA trapping, Merck said, adding that the candidate is currently in phase 1 clinical development and “has the potential to be used as a monotherapy and as part of a combination therapy for treating a wider range of patients”. Danny Bar-Zohar, global head of research and development and chief medical officer for the Healthcare business of Merck KGaA, said: “This partnership with Hengrui fully aligns with both our external innovation ambition and our oncology research and development strategy by diversifying our robust internal pipeline in our focus areas of DNA damage ...
- Source: drugdu
- 114
- November 2, 2023
Amid COVID slump, Pfizer turns attention to RSV launch and a potential future in obesity

As COVID revenues dwindle for pandemic stalwart Pfizer, the company is turning attention to its respiratory syncytial virus (RSV) vaccine launch and a potential entry into the hot obesity market. With only five months of sales under its belt, Pfizer’s RSV vaccine Abrysvo is “doing better than we thought,” Chief Commercial Officer Angela Hwang said on the company’s third-quarter earnings call, touting “very fast uptake” for the new shot. After a pair of approvals in late May and August, Abrysvo pulled in revenues of $375 million during the third quarter, Pfizer said Tuesday. Earlier this year, the shot won FDA nods to immunize older adults and then as a maternal vaccination to protect infants. In both settings, the Pfizer offering is facing off against Big Pharma competition. In the adult RSV vaccine marketplace, Pfizer is challenging GSK and its immunization Arexvy. GSK is set to report its third-quarter results Wednesday. ...
- Source: drugdu
- 106
- November 2, 2023
Roche Cuts Pipeline as COVID, Currency Headwinds Impact Q3 Results

Pictured: Roche tower in Switzerland/iStock, olli0815 Roche is eliminating four clinical programs amid drooping sales brought about by a sharp decline in demand for COVID-19 products and a strong Swiss franc, the pharma group announced Thursday morning in its third-quarter earnings results. According to a development pipeline document released alongside the quarterly report, Roche will end a Phase I solid tumor trial for its investigational CEA/CD3 bispecific antibody cibisatamab. The company will also stop Phase II trials of its antipsychotic drug candidate ralmitaront in schizophrenia and the developmental cannabinoid receptor agonist vicasinabin in diabetic retinopathy. Roche discontinued the mid-stage study of ralmitaront after it failed a Phase II trial in May 2023, unable to elicit significant improvements on negative symptoms in a preliminary analysis. The vicasinabin and cibisatamab programs were likewise scrapped following underwhelming reviews of their efficacy in their respective studies. However, in a media call Thursday morning, a Roche spokesperson said that these two ...
- Source: By Tristan Manalac
- 143
- October 31, 2023
CHMP recommends European authorisation for seven new drugs

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new drugs for authorisation. The drugs include Pfizer’s Elrexfio for the treatment of multiple myeloma and Astellas Pharma’s Veozah for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elrexfio (elranatamab) is a subcutaneously administered bispecific B-cell maturation antigen-directed CD3 T-cell engager. The US Food and Drug Administration (FDA) granted accelerated approval for Elrexfio in August for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. According to GlobalData, sales for Elrexfio are expected to reach $536m by 2029. One of its competitors in the market is Talvey (talquetamab-tgvs), marketed by Janssen, which was approved as a fifth-line treatment for relapsed/refractory multiple myeloma in August. Talvey is forecasted to generate $1.9bn in sales by 2029. Astellas Pharma’s Veozah ...
- Source: drugdu
- 111
- October 19, 2023
Birmingham researchers develop nanobodies to understand platelet disorders

Researchers at the University of Birmingham have developed antibody fragments, called nanobodies, in a bid to understand platelet disorders such as thrombosis. The team at the Institute of Cardiovascular Sciences has been able to produce the first binding molecules of defined composition to make platelets clump together in a predictable way. The institute aims to use these nanobodies to develop validated clinical assays for testing patients with platelet disorders such as bleeding or thrombosis, as well as use them as a research tool to study platelet activation. The institute’s work is set to be published in the Journal of Thrombosis and Haemostasis later this week (12 October.) In previous studies carried out by the Birmingham Platelet Group, Professor Steve Watson and Dr Natalie Poulter used novel nanobodies the team had raised to bind to the GPVI (Glycoprotein VI) receptor. This receptor plays a role in thrombosis but only has minor ...
- Source: drugdu
- 112
- October 16, 2023
Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial

By Kate Goodwin Pictured: Eli Lilly world headquarters/iStock, jetcityimage A 52-week study finds Eli Lilly’s mirikizumab to be effective for long-term remission in over half of patients with Crohn’s disease. The company announced Thursday plans to submit a marketing application to the FDA for approval in 2024, followed by submissions to other global regulatory agencies. In the Phase III trial, moderately to severely active Crohn’s disease patients on mirikizumab demonstrated clinical remission as well as endoscopic response at the one-year mark. Over 54% of the patients in the treatment arm achieved clinical remission at week 52, versus 19.6% of those receiving placebo. The endoscopic response was seen in 38% of those on mirikizumab versus 9% on placebo. Safety was consistent with the known profile of the therapy with the frequency of serious adverse events greater in the placebo arm than the treated group, according to Lilly. The interleukin-23p19 antagonist demonstrated ...
- Source: drugdu
- 110
- October 14, 2023
Novartis Wins FDA Approval for Intravenous Cosentyx Formulation

By Tristan Manalac The FDA on Friday approved an intravenous formulation of Novartis’ IL-17A antagonist Cosentyx (secukinumab) for the treatment of rheumatic diseases. This latest approval covers existing indications of Cosentyx, including ankylosing spondylitis (AS), psoriatic arthritis (PsA) and non-radiographic axial spondyloarthritis (nr-axSpA). Previously, Cosentyx was only authorized as a subcutaneous treatment for these conditions. With Friday’s approval, Cosentyx has become the first intravenous (IV) treatment that specifically targets and inhibits IL-17A and currently the only non-TNF-α IV therapy for these indications, according to Novartis’ announcement. The IV route of administration will improve treatment access for “a significant portion of patients” with AS, PsA and nr-axSpA, who are not comfortable with self-injections or simply prefer to receive treatments in their healthcare provider’s office, according to Philip Mease, clinical professor at the University of Washington School of Medicine. “The approval of Cosentyx as an IV formulation is an important milestone for ...
- Source: drugdu
- 178
- October 11, 2023
Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 199
- October 10, 2023
Korean CDMO Lotte Biologics buys land, sets out to build 3 new plants by 2030

Aiming to hit a corporate value of around $15 billion by the end of the decade, Korean CDMO Lotte Biologics has laid out plans to stand up three new manufacturing facilities in the same time frame. Lotte this week unveiled a land purchase agreement with the Incheon Free Economic Zone Authority in Incheon, Korea. With the new real estate, Lotte plans to build out three separate bio plants by 2030. Each plant will be capable of cranking out 120 kiloliters of antibody drugs for a total planned production capacity of 360 kiloliters, Lotte explained in a press release. The company is also weighing whether to add small-scale bioreactors for clinical material production. Plants 1, 2 and 3 are expected to be completed in 2025, 2027 and 2030, respectively. Once full-scale operations kick off around 2034, Lotte will boast 400 kiloliters of total production capacity, the company said. Groundbreaking for the ...
- Source: drugdu
- 111
- October 10, 2023

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