Drugs

One year after the initial request by a journalist, the EU Commission (EC) has still not clarified whether messages between its president, Ursula von der Leyen and Pfizer CEO, Albert Bourla, reportedly about the COVID-19 vaccine procurement deal exist and whether the public is entitled to see them, according to the independent body. The Ombudsman

Of the top six bacterial pathogens responsible for AMR deaths, only one, Pnuemoccocal disease (Streptococcus pneumoniae​), has a vaccine. The report identifies 61 vaccine candidates in clinical development, including several in late stages, and 94 in active pre-clinical development. But while the report says late-stage vaccine candidates have a high development feasibility, it cautions that

This Phase 1 dose-escalation, open-label clinical trial is the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability, and immunogenicity of a Nipah mRNA vaccine. “Our partnership with NIAID to advance mRNA-1215 for Nipah virus reflects our commitment to advance a portfolio of 15 vaccine programs by 2025, targeting emerging or neglected

Trial and error is a necessary part of successful drug manufacturing and development efforts. However, the sooner an operation can get through that stage (especially the error part of the phase), the more quickly it can reach success. To learn more about how the cleanroom-on-demand concept can help accelerate the process of trial and error,

The contract development and manufacturing organization (CDMO) published its second annual ESG Report earlier this week. That publication, according to the organization, addresses a wide range of environmental, social, and governance (ESG) activities related to its business, including a reduction of greenhouse gas (GHG) emissions. “The publication of our annual ESG report reinforces the progress

The pharma giant said it intends to submit concizumab for regulatory approval in the second half of 2022 in the US and Japan, and in 2023 in the EU and the UK. Concizumab is an anti-TFPI monoclonal antibody, designed to block TFPI, the protein that stops blood from clotting. It is given as a once-daily

Vertex’s VX-880, an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy for T1D, has already achieved proof-of-concept with ‘highly promising’ safety and efficacy results from an ongoing Phase 1/2 study which continues to enroll and dose patients. The acquisition of ViaCyte provides Boston-headquartered Vertex – whose approved medicines to date are for cystic fibrosis – with

A groundbreaking ceremony took place last week. Four new production lines are to be built, which, among other things, will produce mRNA vaccines for customers. As previously announced, part of the new capacity will be available to the German federal government as and when required as part of its pandemic preparedness contracts. Melanie Käsmarker, managing

In April 2022, the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) suggested that people over 80 years of age be considered for a second booster. However, the agencies noted, at the time, that it might be necessary to consider second boosters in people between 60 and 79 years

Under the license agreement, the pharma giant gains rights to Touchlight’s dbDNA patent portfolio for worldwide use in the manufacture and commercialization of its messenger RNA-based vaccines, therapeutics, and gene therapies. The deal includes upfront payment, potential development and commercial milestone payments, as well as royalties upon commercialization, said Touchlight. Alternative to plasmid DNA​ The

The project will cover proof-of-concept at small scale to drug substance and drug product manufacturing, including DSP process development, analytical toolkit assays set-up, quality control validation and CMC support, said the parties. It will leverage Exothera’s services such as plasmid supply, full upstream and downstream process development, and manufacturing. Vaccizone has developed and patented a

Peer-reviewed research published this week showed the novel vaccine – developed at Caltech and The University of Oxford – provided broad protection in pre-clinical trials. The funding will support its development through Phase 1 trials, with the aim to establish first-in-human clinical proof of concept for the vaccine. CEPI (The Coalition for Epidemic Preparedness Innovations)

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.  The company’s announced this week that the drug’s Biologics License Application (BLA) has been accepted under the FDA’s

The agreement will involve a shared clinical development phase as well as allowing IBMP exclusive rights for the commercialization of the vaccine candidates in Brazil. In addition, clinical stage manufacturing of the vaccines will be conducted by Emergex; with a transition to commercial scale manufacturing being conducted in the region by IBMP. Dengue is a

TeneoTwo is developing an experimental therapy, TNB-486, part of a class of therapeutic antibodies known as T-cell engagers, which are emerging as a promising therapeutic approach in hematologic malignancies and solid tumors, said the Anglo-Swedish pharma giant. By binding to both CD19, an antigen expressed on B-cells, and to the CD3 receptor on T-cells, TNB-486

They will undertake work on in vivo​ regenerative medicine approaches in this respect. Utilizing Mogrify’s cellular reprogramming platform, the partners want to identify the transcription factors involved in cell differentiation to generate new cochlear hair cells, the sensory cells of the auditory system.  Astellas Gene Therapies, a division of Astellas, is covering the research cost of

CureVac – whose own first-generation mRNA COVID-19 vaccine was withdrawn from regulatory review last year in favor of developing a second-generation candidate – believes its tech played a fundamental part in fellow German mRNA specialist BioNTech’s creation of a vaccine against the virus.     “The CureVac intellectual property portfolio protects multiple inventions that are considered

Researchers have been isolating NK cells from cord blood for CAR-NK therapies as well as using it for induced pluripotent stem cell (iPSC) generation, said Donna Regan, director of customer-ready products for the National Marrow Donor Program/Be The Match, including Be The Match Biotherapies (BTMB). Cord blood has been used as a cell source for

Last Wednesday, the European Commission (EC), in its response​​ to a call from the EU Ombudsman, said that a search undertaken by the EC president’s cabinet for relevant text messages corresponding to a request for access to documents has “not yielded any results”.​ The EU watchdog said a full analysis of the EC response would be

According to reports​, the latter company looks set to make another move, with talks on-going between Merck and Seagen, a biotech focused on antibody drug conjugate (ADC) development, around a potential buyout. Should the deal happen, it is likely to be a huge figure involved – with Seagen having a market cap of approximately $30bn

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The investment will be used to establish a new lipid facility as part of a new multi-purpose cGMP site in Lamar, Pennsylvania. The developer will also invest up to US$58m in the project. Construction on the Lamar site is expected to start later this year. This will be Croda’s third manufacturing facility for lipid systems,