AstraZeneca agrees to buy US FDA Priority Review Voucher from Sobi
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- Category: AstraZeneca
AstraZeneca announced that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of $95m from a subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi). A PRV entitles the holder to FDA priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and may potentially lead to an expedited approval.
Amgen and Allergan announce positive top-line results from comparative clinical study of ABP 798, biosimilar candidate to Rituxan® (rituximab)
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- Category: Amgen
Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan® (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin's lymphoma.
The Pfizer Foundation invests in 20 organizations tackling infectious diseases and antimicrobial resistance
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- Category: Pfizer
The Pfizer Foundation announced 20 grants* to help non-governmental organizations (NGOs), non-profits and social enterprises address critical health challenges related to infectious diseases, including the increasing threat of antimicrobial resistance (AMR), in some of the world's most vulnerable communities.
Farxiga met primary endpoint in landmark Phase III DAPA-HF trial for the treatment of patients with heart failure
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- Category: AstraZeneca
AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent heart failure visit), compared to placebo.
Roche's first FDA-approved tumour-agnostic medicine
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients 12 years of age and
Lynparza Phase III PAOLA-1 trial met primary endpoint as 1st-line maintenance treatment with bevacizumab for advanced ovarian cancer
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- Category: AstraZeneca
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced positive results from the Phase III PAOLA-1 trial in women with advanced ovarian cancer. The trial, in the 1st-line maintenance setting, compared Lynparza (olaparib) added to standard-of-care (SoC) bevacizumab vs. bevacizumab alone in women with or without BRCA gene mutations.
Boehringer Ingelheim and MD Anderson form unique Virtual Research and Development Center to rapidly advance new cancer therapies
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- Category: Boehringer Ingelheim
Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center announced a new multi-year partnership to conduct collaborative research to rapidly advance therapies for various types of cancers, including gastrointestinal and lung cancers. The establishment of a joint Virtual Research and Development Center will enable effective data sharing and analysis between the organizations.
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