Pfizer invests half billion dollars to advance state-of-the-art gene therapy facility in Sanford, North Carolina
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- Category: Pfizer
Pfizer announced an additional half billion dollar investment for the construction of its state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina. This facility is anticipated to support Pfizer's continuing investment in gene therapy research and development, similar to Pfizer's Chapel Hill and Kit Creek, North Carolina research and development sites.
FDA grants Fast Track designation for Farxiga in chronic kidney disease
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- Category: AstraZeneca
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD).
Amgen to acquire Otezla® for $13.4 billion in cash
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- Category: Amgen
Amgen (NASDAQ: AMGN) announced today that it has entered into an agreement with Celgene Corporation (NASDAQ: CELG) in connection with its previously announced merger with Bristol-Myers Squibb Company (NYSE: BMY) to acquire worldwide rights to Otezla® (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, and certain related assets and liabilities, for $13.4 billion in cash, or approximately $11.2 billion, net of the present value of $2.2 billion in anticipated future cash tax benefits.
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.
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