Search Results for “immune” – Page 53 – media

EMA CHMP recommends approval for Moderna’s updated Covid-19 vaccine

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorisation for Moderna’s Spikevax, an updated Covid-19 vaccine targeting the SARS-CoV-2’s XBB.1.5 sublineage. The vaccine is intended for active immunisation for the prevention of Covid-19 in those aged six months and above. The latest development comes after the company filed a regulatory application seeking approval for the updated vaccine in July 2023. Based on the positive opinion from the committee, the European Commission will adopt a decision on the vaccine approval for autumn/winter 2023. Moderna has obtained clinical results for the monovalent XBB.1.5 vaccine candidate which offered an immune response against sublineages of XBB, XBB.1.5, XBB.1.16, and XBB.2.3.2, apart from BA.2.86, EG.5 and FL.1.5.1 variants. Injection site pain was reported to be the most frequently solicited local adverse event for the updated vaccine. Fatigue, myalgia, headache, chills and arthralgia were the ...
- Source: drugdu
- 149
- September 18, 2023
ICON partners with US Government for clinical trials of Covid-19 vaccines

US Biomedical Advanced Research and Development Authority (BARDA) has partnered with Ireland-based ICON to conduct clinical trials of Covid-19 vaccine candidates selected as part of “Project NextGen”. A part of the US Government’s Strategic Preparedness and Response division, BARDA has launched Project NextGen to develop Covid-19 vaccines and therapies for current and future strains. To achieve this, BARDA plans to leverage its public-private partnerships. The government has plans to invest more than $5bn in the Project NextGen programme. In June, the European Medicines Agency (EMA) identified the need to update the Covid-19 vaccines to include the XBB Omicron variant. The US Government seconded that sentiment, and last month, BARDA partnered with Regeneron to develop a Covid-19 monoclonal antibody vaccine candidate. ICON’s government and public health solutions team will conduct a Phase IIb active comparator clinical trial to evaluate the efficacy of the next-generation Covid-19 vaccine, selected by BARDA, compared to ...
- Source: drugdu
- 123
- September 18, 2023
BMS Culls Two Mid-Stage, Four Early-Stage Clinical Programs

By Connor Lynch Pictured: Bristol Myers Squibb in New Jersey/iStock, arlutz73 Bristol Myers Squibb has trimmed its development pipeline, announcing at an R&D Day on Thursday that the company would be cutting two mid-stage and four early-stage clinical programs for efficacy and safety reasons. Two Phase II clinical programs were on the BMS chopping block, including an investigational asset targeting heat shock protein 47 (HSP47), a small interfering RNA (siRNA) for nonalcoholic steatohepatitis (NASH), which was licensed from Nitto Denko for an upfront payment of $100 million in 2016. The compound inhibits expression of the heat shock protein, which is associated with excessive collagen buildup such as occurs in NASH, which is the most severe form of fatty liver disease. In 2019, BMS completed a Phase II trial investigating two different doses of the siRNA in 61 patients with scar tissue buildup post-hepatitis C infection. Neither dose performed better than ...
- Source: drugdu
- 206
- September 16, 2023
Avalo drops three rare disease assets amid ongoing challenges

Avalo Therapeutics will divest three compounds in its rare disease AVTX-800 series to AUG Therapeutics, marking a further development in the company’s tumultuous past months that included a negative trial readout and a default. The divestment is expected to be completed in Q4 2023, according to a 12 September press release. AUG will make an upfront payment of $150,000 for each of the three compounds bought from Avalo. This includes AVTX-801 (D-galactose), AVTX-802 (D-mannose) and AVTX-803 (L-fucose). In addition to the upfront payment, AUG will make a contingent payment of $15m if the first US Food and Drug Administration (FDA) approval is for an indication that is not a rare paediatric disease. AUG will also assume up to $150,000 of certain liabilities incurred before the agreement, based on the 12 September press release. Avalo’s AVTX-801 is a therapeutic dose of D-galactose that was developed for the treatment of the rare ...
- Source: drugdu
- 105
- September 15, 2023
Moderna, Pfizer-BioNTech’s Updated COVID-19 Vaccines Approved by FDA

By Hayley Shasteen Pictured: Syringe drawing up vaccine/iStock, Diy13 The FDA approved two updated COVID-19 booster shots from Pfizer-BioNTech and Moderna Monday afternoon, just in time for the fall vaccination season. The reformulated mRNA vaccines are specifically tailored to provide protection against circulating Omicron-related variants, including subvariant XBB.1.5, which the FDA had recommended vaccines be updated to cover in June 2023. The CDC is anticipated to release its recommendation guidance on the boosters Tuesday. A positive endorsement by the agency could see boosters available at pharmacies and doctors’ offices by the end of the week, The New York Times reported. CDC Director Mandy Cohen is expected to recommend the updated vaccines and sign off on their use, having previously made remarks favoring an updated booster. The approval for both boosters covers individuals ages 12 years and up, with Emergency Use Authorization granted for individuals ages six months to 11 years. ...
- Source: drugdu
- 233
- September 13, 2023
Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Out with the old and in with the new: Monday, the U.S. FDA approved retooled mRNA shots against COVID-19 from Pfizer-BioNTech and Moderna, simultaneously bidding adieu to the companies’ bivalent shots in the U.S.The FDA has approved Pfizer-BioNTech and Moderna’s separate vaccine formulations that are more closely targeted to current variants of the disease, the agency said in a release. Specifically, each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. The vaccines have been updated to include a monovalent component aimed at omicron variant XBB.1.5, according to the companies and the FDA. Meanwhile, Novavax’s revised shot is still pending regulatory approval. Moderna noted the COVID is “on the rise again” and warned of a “’tripledemic’” of COVID, flu and respiratory syncytial virus this winter and fall. Vaccines should remain “top of mind,” the company said. Following ...
- Source: drugdu
- 109
- September 13, 2023
Coherus acquires immuno-oncology company Surface

Coherus BioSciences has concluded the acquisition of clinical-stage immuno-oncology (I-O) company Surface Oncology in a deal totalling nearly $66.9m. The deal value comprises $40m, along with Surface’s net cash at deal closing of $26.9m. Surface Oncology focuses on the development of immunotherapies that act on the microenvironment of the tumour. With the deal closing, Surface became a completely owned Coherus subsidiary. Following the takeover, Coherus expanded its I-O pipeline by adding clinical-stage antibody immunotherapy candidates of Surface, Casdozokitug (SRF388 / casdozo) and CHS-114 (SRF114). These product candidates can boost the innate and adaptive immune responses to facilitate a strong immunologic response and disease outcomes in cancer patients. Casdozokitug is a new antibody targeting IL-27 and is presently being analysed in Phase I/II clinical trials for lung and liver cancer. An anti-CCR8 antibody, CHS-114 is being evaluated in Phase I/II study as a single agent in advanced solid tumour patients. Coherus ...
- Source: drugdu
- 207
- September 13, 2023
FDA fast tracks Mendus’s acute myeloid leukaemia vaccine vividencel

The US Food and Drug Administration (FDA) has granted fast track designation to Mendus’s cancer vaccine vividencel for the treatment of acute myeloid leukaemia (AML). The FDA’s decision was based on results from the Phase II ADVANCE II trial (NCT03697707), which investigated the vaccine’s use as a maintenance monotherapy in patients with AML in complete remission. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews. In June, the Swedish company, which was previously known as Immunicum, presented comprehensive immunomonitoring data at the European Hematology Association’s 2023 hybrid congress. According to Mendus, the vaccine led to increased levels of activated, cancer-killing T cells and reduced levels of immune-suppressive T cells in the majority of the patients in the Phase II ADVANCE II study. Prior to this, the company published data on the drug’s effects on measurable residual ...
- Source: drugdu
- 167
- September 12, 2023
Veracyte and Gustave Roussy announce partnership for cancer therapies

Veracyte has announced a multi-year partnership with Gustave Roussy to support biopharmaceutical companies in expediting the development of new cancer therapies. They will combine their abilities to offer new insights into the biology of metastatic tumours, helping to develop new cancer treatments. The collaboration will utilise Gustave Roussy’s extensive collection of tumour samples and related data, along with Veracyte’s Biopharma Atlas, a machine learning-powered, multi-omic solution aimed at enhancing the effectiveness and efficacy of clinical studies. Gustave Roussy’s department of therapeutic innovation and early clinical trials will deliver metastatic tumour samples and information for several cancer indications. These are derived from research projects, specifically for new immunotherapies. Veracyte intends to combine these resources with its multi-omics testing and machine learning capabilities, resulting in the development of a Veracyte Biopharma Atlas reference database for genomic and immunomic biomarkers. Using the comprehensive understanding of each tumour’s biology, especially its immune context, the ...
- Source: drugdu
- 145
- September 11, 2023
CymaBay’s Liver Disease Candidate Hits Phase III Primary, Secondary Endpoints

By Connor Lynch Pictured: Illustration of a human body with the liver highlighted/iStock, magicmine CymaBay Therapeutics’ liver disease candidate, seladelpar, hit its primary and key secondary endpoints in the Phase III RESPONSE trial, the company announced Thursday. The clinical-stage biopharma was testing its selective PPARδ agonist in adult patients with primary biliary cholangitis (PBC), a disease in which the bile ducts in the liver are slowly destroyed. The year-long, double-blind study was looking at 193 PBC patients that either had an inadequate response or an intolerance to the main treatment for PBC, ursodeoxycholic acid. The study’s primary composite endpoint was related to serum alkaline phosphatase (ALP), a key indicator of liver damage and/or bone disorders. CymaBay said in Thursday’s announcement that 61.7% of patients met this endpoint, versus 20% of patients taking a placebo. The study also met a second primary endpoint of ALP normalization and another related to itching. ...
- Source: drugdu
- 115
- September 11, 2023

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