Novartis advances head-to-head superiority trials of Cosentyx® versus Humira®* and proposed biosimilar adalimumab**
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- Category: Novartis
Novartis announced today the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab** in ankylosing spondylitis (AS). SURPASS is the first head-to-head clinical trial in AS investigating superiority of Cosentyx in slowing spinal bone damage versus proposed biosimilar adalimumab**. SURPASS is currently recruiting patients, with the 'first patient first visit' already achieved in November 2017.
Novo Nordisk has proposed to acquire Ablynx for upto €30.50 per share in cash, consisting of €28.00 upfront and €2.50 in Contingent Value Rights
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- Category: Novo Nordisk
Novo Nordisk today confirms that it made a proposal on 22 December 2017 to acquire Ablynx for €28.00 per share in cash and one CVR with total potential cash payments over time of up to €2.50 per share. This proposal implies a total equity valuation of approximately €2.6 billion(1) for Ablynx and represents a premium of up to 60% over Ablynx's share price as of 6 December 2017 of €19.12, which was the day prior to our first proposal, and up to 66% over Ablynx's 3 month VWAP of €18.39 as of 5 January 2018.
Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer
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- Category: Novartis
Novartis today announced Kisqali® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.
Top 20 breaking World Pharma News of 2017
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- Category: Business
We are proud to announce the top 20 most popular breaking World Pharma News from 2017. Have a wonderful 2018 new(s) year filled with health, happiness, and spectacular success!
Roche and Ignyta reach definitive merger agreement
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ignyta, Inc. (NASDAQ: RXDX) today announced they have entered into a definitive merger agreement for Roche to fully acquire Ignyta at a price of US$ 27.00 per share in an all-cash transaction. This corresponds to a total transaction value of US$ 1.7 billion on a fully diluted basis.
US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer
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- Category: AstraZeneca
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).
FDA approves new Pfizer biosimilar
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) announced that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab) for all eligible indications of the reference product.
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