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FDA approves GlaxoSmithKline’s Nucala to treat hypereosinophilic syndrome

The Pharma Data

This approval comes after GSK submitted results from its Phase 3 trial which enrolled 108 patients. Today’s approval gives these patients access to biologic treatment for the first time and demonstrates our commitment to maximising Nucala’s impact on eosinophil-driven diseases. “.

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U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine 52
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Oncorus Pivots to Scale Up Manufacturing with New GMP Facility

The Pharma Data

ONCR-177, its lead oncolytic herpes simplex virus (oHSV)-based immunotherapy, is in human trials as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) for a range of solid tumors. In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021.

Virus 52
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Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Pathologic Complete Response in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

The Pharma Data

Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Surgery was rarely canceled due to adverse events, only affecting two patients in each arm of the trial.

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The genetic modifier approach: identifying the right target for rare diseases

Drug Target Review

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Why Clinical Trials Stop: The Role of Genetics. Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. Are drug targets with genetic support twice as likely to be approved?

Disease 111
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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog: Biosimilars

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. That did not happen. Patent Nos.

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Harnessing the CD24/Siglec-10 pathway: immunotherapy innovation

Drug Target Review

This year we completed investigational new drug (IND) enabling studies of ONC-841, which is an antagonist of Siglec-10, and received US Food and Drug Administration (FDA) approval for first-in-human study (FIH) in patients with solid tumours. Biomarkers are the holy grail of clinical trials.