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European regulators begin rolling review of AZ’s COVID-19 vaccine

pharmaphorum

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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Federal Court refuses to issue injunction on infringed antibody formulation patent

Pharma in Brief

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. The Court found that this publication disclosed adalimumab and self-buffering protein formulations. A-203-22).

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Leading freeze-drying systems suppliers for the pharmaceutical industry

Pharmaceutical Technology

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity.

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Conversations from ESMO Targeted Anticancer Therapies Congress 2024 

Drug Discovery World

For example, progress made in developing gene mutant-specific inhibitors, antibody-drug conjugates (ADC), or cellular therapies. In addition to STC-15 and our METTL1, our pipeline contains a number of preclinical programs that are advancing rapidly for the treatment of viruses, neurodegeneration, cancer, and immuno-inflammatory conditions.

RNA 64
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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. The booster dose elicited a significantly higher neutralising antibody response against Omicron subvariants BA.4 Regulators are well-disposed to these boosters.

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Covid-19 vaccines targeting Omicron variants expected to be ready for this autumn

Pharmaceutical Technology

1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 In addition to providing protection against the Omicron BA.1 1 variant of concern. The prevalence of BA.2.12.1

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Sarepta’s Elevidys Reaches Finish Line as First Gene Therapy Approved for Duchenne Muscular Dystrophy

XTalks

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. Elevidys’ approval was based on data from a randomized trial that showed the therapy increased expression of the Elevidys micro-dystrophin protein, which was used as a surrogate endpoint, in DMD patients aged four to five years of age.