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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.

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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Pharmaceutical Technology

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. It can suppress Th2 immune responses by binding to IL-17RB on Type 2 innate lymphoid cells (ILC2s).

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How did pharma develop a vaccine so quickly?

World of DTC Marketing

First, a novel approach was used that didn’t require traditional vaccine production in cell cultures or eggs. Once introduced into the human body, the protein-making machinery uses this genetic material in our cells to churn out the coronavirus “spike protein,” triggering an immune response. Then there are the finances.

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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. 1) versus the 50µg mRNA-1273 booster dose. 1 variant as well as the original 2020 strain.”.

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HDT Bio receives Emergency Use Approval for Covid-19 vaccine in India

Pharmaceutical Technology

At present, the vaccine is being analysed in clinical trials in the US, Brazil and South Korea. This technology can stimulate an immune response with a dose up to 20 times lower than current vaccines, which enhances safety, lowers costs, and increases production speed. .

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Influenza vaccine 2 by Shanghai Institute of Biological Products for Pandemic Influenza: Likelihood of Approval

Pharmaceutical Technology

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company is headquartered in Shanghai, China.

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Influenza vaccine 2 by Shanghai Institute of Biological Products for Pandemic Influenza: Likelihood of Approval

Pharmaceutical Technology

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company is headquartered in Shanghai, China.