List of projects implemented with European funds
Located in the heart of Europe & EU
Our headquarters is based in central Poland, 1.5 hours’ drive from the Warsaw airport. As one would anticipate from an EU based CDMO, we guarantee the highest levels of production and analytics standards for your business. Additionally, our “can-do” approach to our clients’ needs offers solutions to unforeseen challenges which we overcome as a team.
Read what’s happening at Mabion and in the world of biologics.
Marty Henehan will strengthen Mabion’s sales operations as Vice President of Business Development for North America
20 February 2024 experienced executive Marty Henehan has taken up the position of Vice President of Business Development for North America at Mabion S.A.
Effectiveness of 2023-24 season COVID vaccines: First estimates are in
First studies estimating the effectiveness of updated COVID-19 vaccines have been published. Effectiveness against hospitalization was calculated at 70.7%-76.1% and against symptomatic SARS-CoV-2 infection at 54%.
Monoclonal antibody targeting CD3 receptor preserves insulin secretion in early type 1 diabetes
Teplizumab, an anti-CD3 monoclonal antibody, was found to preserve the function of pancreatic β cells in newly diagnosed type 1 diabetes mellitus. Earlier, the drug has received FDA approval in the prevention of type 1 diabetes in high-risk individuals.
EMA and FDA investigating cancer signal for CAR-T therapies
EMA and FDA have started a safety review of CAR-T therapies following the notification of 23 cases of T-cell malignancies. The investigation involves all registered CAR-T products, which are used for treating relapsed and treatment-resistant hematologic malignancies.
Antisense therapy fails to delay the progression of Huntignton’s disease
A trial of investigational antisense therapy for Huntington’s disease, tominersen, has been halted early for lack of efficacy and possibly harm with more frequent dosing. However, the quest for effective therapy of Huntington’s disease is still ongoing and the developer of tominersen decided to continue research, this time enrolling younger patients with early disease.
Bispecific antibodies: success story continues
A great number of clinical studies confirmed high efficacy and safety of bispecific antibodies in the treatment of various cancers. Breaking results from another three, evaluating amivantamab, blinatumomab and tarlatamab, continue their success story.
Moderna succeeds in the pivotal trial of RSV vaccine
An mRNA-based vaccine against respiratory syncytial virus (RSV) succeeded in a Phase III trial conducted in elderly subjects. Vaccine efficacy was 83.7% against RSV-related lower respiratory tract disease with at least two symptoms. It is hoped that the use of RSV vaccines along with influenza and COVID-19 immunization campaigns will further mitigate the morbidity and mortality of elderly people during the winter seasons.
A new affordable HPV vaccine will help fight cervical cancer
Novel HPV vaccine manufactured by Serum Institute of India (Cervavac®) elicits comparable immune responses and is as safe as the original HPV vaccine. Availability of a cheaper version of HPV vaccine can foster the global efforts to reduce the incidence of cervical cancer.
Researchers infect human volunteers with Zika virus in a quest for effective vaccine
Zika virus infection in pregnancy has been associated with microcephaly in newborns. In a pioneering experiment, female volunteers were challenged with live Zika virus and monitored for viral shedding, symptoms and immune responses. Researchers hope that human challenge experiments will speed up the development of novel vaccines and antiviral medications.
The power of antibody-drug conjugates revealed in recent cancer trials
A new treatment combination containing antibody-drug conjugate called enfortumab vedotin, doubled the survival of patients with metastatic bladder cancer compared with the standard chemotherapy.
A case to remove redundant trials of biosimilars reaches FDA
The calls to reduce the scope of clinical trials of biosimilars are slowly reaching regulatory agencies. The FDA has just announced a new initiative to make trials more effective and useful, which, among others, will discuss the usefulness of confirmatory clinical studies of biosimilars.
Remote FDA inspections: new guidance released
The FDA has recently published a new draft guidance describing the remote oversight tools used for pre-approval evaluation of manufacturing facilities. The published regulations are expected to reduce the time to approval and facilitate the availability of innovative, generic and biosimilar drugs. The introduced oversight tools will also help agency to stay operational during the […]
Popular obesity drug cuts the risk of heart attacks and strokes
Semaglutide (Ozempic) has been found to reduce the risk of cardiovascular events in obese people.
FDA approves first ustekinumab biosimilar
FDA approves first ustekinumab biosimilar Ustekinumab (Stelara®), a blockbuster monoclonal antibody originally developed by Janssen Pharmaceuticals, has just got a biosimilar counterpart. The new biosimilar, Wezlana®, manufactured by Amgen, received FDA approval in all indications of the originator, which include plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The FDA also granted it an […]
Another win for antibody-drug conjugates in breast cancer
Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2 antigen, was reported to increase survival in HR-positive, EGFR2-negative breast cancer.
Updated Novavax’s COVID vaccine effectively neutralizes…
Novavax’s vaccine for 2023-24 season induced neutralizing responses against newly emerging subvariants EG.5.1 and XBB.1.16.6. in in vivo models.