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Your Daily Pharma Scoop: Puma Progresses, Kala In Phase 3, Teva Fails


  • Puma’s NDS is under review.
  • Kala commences Phase 3 trial.
  • Teva fails to reach Phase 2 endpoint.
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Stocks in the News: PBYI, KALA

Puma Bio's Nerlynx marketing application in Canada under review

Puma Biotechnology's (NASDAQ:PBYI) New Drug Submission (‘NDS) for NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer is accepted for review by Health Canada. The current adjuvant therapy follows the earlier adjuvant trastuzumab-based therapy regime. As mandated by Health Canada, the candidate has now completed its mandatory validation period before moving to the review period.

The company claims that their therapy will be able to reduce the recurrence of the disease in patients with early stage HER2-positive breast cancer, following trastuzumab therapy. Last year in July FDA approved Neratinib and it is marketed as NERLYNX®. The drug is an oral irreversible pan-HER kinase inhibitor, was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.

While the company waits the successful transition from positive CHMP June 2018 recommendation to marketing authorization from the European Commission, this approval comes as boost for the company. Three drug candidates — PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357 — are in-licensed by the Puma for the global development and commercialization rights.

Over-expression of the HER2 protein occurs in ~20%-25% of breast cancer tumors. Further, this particular cancer sub-type is often more aggressive than other types of breast cancer. It is estimated that ~12.4% of American women will develop invasive breast cancer over the course of their lifetime. It is further estimated that in spite of decreasing rates there is apprehension of 40,920 women dying of breast cancer in the U.S. alone. The aggressiveness of the HER2 sub-type increases the risk of disease progression and may even lead to death. Trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery. But

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