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FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The submission of the NDA was based on the findings of the CAPItello-291 Phase III trial.

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Targeted breast cancer drug extends lives of patients in Phase III trial

Drug Discovery World

A new type of targeted medicine has shown ‘remarkable’ benefits for patients with advanced breast cancer in a major Phase III clinical trial. . The drug capivasertib combined with hormone therapy doubled the time it took for cancer to progress in people with advanced forms of the most common type of breast cancer. .

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Lumos Pharma’s Patient-Centric Strategy for Rare Disease Drug Development

XTalks

Among these, rare pediatric diseases present unique challenges and opportunities for rare disease drug development. Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development. This venture also led me to identify a gap in the market for contract manufacturing of recombinant proteins.

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Pfizer puts up $1bn to buy into Arvinas breast cancer programme

pharmaphorum

Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. billion in backloaded milestone payments.

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Amvuttra RNAi Therapeutic Wins FDA Approval for Rare Genetic Protein Disorder

XTalks

Alnylam Pharmaceuticals, a leading RNA interference (RNAi) therapeutics biopharmaceutical company, announced it received approval from the US Food and Drug Administration (FDA) for its RNAi therapeutic Amvuttra (vutrisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis in adults.

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Sym-021 by Les Laboratoires Servier for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Sym-021’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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Scientists create compound that can block cancer metastasis

Drug Discovery World

Scientists from the Chemistry and Biochemistry Departments at the University of Liverpool and Nanjing Medical School in China have discovered a possible way to block proteins that cause metastasis. The post Scientists create compound that can block cancer metastasis appeared first on Drug Discovery World (DDW).