Wednesday 29-07-2020 Post #18 FarmaKology
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Issue #51 Issue #52
News
Novartis receives Piqray? approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation
Novartis today announced the European Commission has approved Piqray? (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy. Piqray is the first and only treatment specifically approved for people with advanced breast cancer whose tumours harbour a PIK3CA mutation, which stimulates tumour growth and is associated with poor response to therapy13.
European Commission secures EU access to Remdesivir for treatment of COVID-19
The European Commission has signed a contract with the pharmaceutical company Gilead to secure treatment doses of Veklury, the brand name for Remdesivir. Veklury was the first medicine authorised at EU level for treatment of COVID-19. As from early August onwards, and in order to meet immediate needs, batches of Veklury will be made available to the Member States and the UK, with the coordination and support of the Commission.
Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine
Sanofi and GSK have reached an agreement, subject to final contract, with the UK government for the supply of up to 60 million doses of a COVID-19 vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.“With our partner GSK, we are pleased to cooperate with the UK government as well as several other countries and global organizations as part of our ongoing efforts to develop a safe and effective vaccine and make it available as quickly as possible. We greatly appreciate the UK government’s support of this shared vision,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi.
Samus Therapeutics Presents Phase 1 PU-AD Study Results at AAIC 2020 Advancing the Company's Platform for Treating Neurodegenerative Diseases
Samus Therapeutics, a privately held, a biopharmaceutical company developing small molecule epichaperome inhibitors, today announced the presentation of safety and pharmacokinetic data from the Company's recently completed PU-AD healthy volunteer Phase 1 study at the Alzheimer's Association International Conference. PU-AD is Samus' orally bioavailable, small molecule epichaperome inhibitor designed to cause degradation of aberrant proteins associated with the progression of Alzheimer's disease, amyotrophic lateral sclerosis, and other major neurodegenerative diseases. The Phase 1 study results presented today support Samus' advancement of PU-AD into its now initiated Phase 2a study in AD, and its upcoming Phase 2a study in ALS expected to initiate later this year.