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Meningitis vaccine comes to the forefront with impressive study results

Pharmaceutical Technology

A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. for serogroup W to 20.5

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).

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Accelerated development for Covid-19 monoclonal antibody

Drug Discovery World

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . The commencement of the trial triggers a $5 million milestone payment to RQ Bio and will enable the company to execute its four scientific programmes focused on viral diseases. .

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CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III

XTalks

The study compared the immune responses evoked by Moderna’s mRNA vaccine to those generated by a previous vaccine candidate, namely, the MF59-adjuvanted glycoprotein B (gB) proten subunit vaccine (gB/MF59) developed by Sanofi. Paduano Professor in Pediatrics at Weill Cornell Medicine, in a news release.

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AbbVie preps filings for lymphoma bispecific licensed from Genmab

pharmaphorum

The drugmaker has reported top-line results from the phase 1/2 EPCORE trial of epcoritamab as a third-line therapy for relapsed/refractory LBCL, revealing an overall response rate of 63% and a median duration of response of 12 months. Two years after signing a $3.9 billion product at peak.

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Calidi Biotherapeutics gets FDA go-ahead for US trial  

Drug Discovery World

Biotechnology company Calidi Biotherapeutics has announced that a Phase I US clinical trial will use the company’s licensed oncolytic virotherapy platform NeuroNova to deliver an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma. . less than one year. Camaisa. .

Trials 52
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Revolo Biotherapeutics’ Unique Approach to Developing Treatments for Autoimmune and Allergic Diseases

XTalks

The company is developing unique therapeutic assets with strategic visions. With headquarters in Gaithersburg, MD, US and London, UK, Revolo Biotherapeutics is focused on developing therapies that reset the immune system to achieve superior efficacy and long-term disease remission without compromising the immune system.