Construction of major radioligand therapy manufacturing site begins
The new site will be Europe's first industrial-scale pharmaceutical facility dedicated to the production of lead-212 based radioligand therapies.
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The new site will be Europe's first industrial-scale pharmaceutical facility dedicated to the production of lead-212 based radioligand therapies.
Part of Biogen’s prioritisation of its portfolio includes focusing on the advancement of its leading anti-amyloid beta Alzheimer’s treatment, LEQEMBI® (lecanemab-irmb).
The bacterial detection method is robust and highly sensitive over a wide concentration range and does not require DNA amplification, research suggests.
First use of a BCMA CAR T-cell therapy for immune-mediated necrotising myopathy (IMNM), enabled sustained depletion of autoantibodies beyond 18 months, a study shows.
Recommendation of AbbVie’s bispecific antibody for NHS use is based on a Phase I/II trial, which observed a 62 percent overall response rate in diffuse large B-cell lymphoma (DLBCL) patients.
The environmentally-sustainable inaugural manufacturing run at WuXi Biologics’ GMP-certified facility in Ireland combined four 4,000-litre single-use bioreactors.
Major findings from a Phase III trial show that using immunotherapy drug pembrolizumab post-surgery extended survival and delayed disease recurrence in kidney cancer.
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
To ensure timely market entry of generics and biosimilars in the EU, the Supplementary Protection Certificate (SPC) Manufacturing Waiver must be clearer, asserts Medicines for Europe.
Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo.
UK scientists have unlocked the potential of bioengineering vaccine adjuvants, based on a study of the molecule QS-21.
Following her leading contribution in key manufacturing and quality projects in Ireland and the US, Eli Lilly and Company’s Executive Vice President (EVP) of Global Quality is set to retire after nearly 35 years of service.
In draft guidance on quality considerations for topical ophthalmic drug products, the US Food and Drug Administration (FDA) provided recommendations for E&L testing.
Phase III data for Janssen’s innovative IL-23 inhibitor has revealed that the biologic is effective for adults with moderate to severe plaque psoriasis (PsO) across all skin tones.