Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
- Details
- Category: Novartis
Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira®*.
Novartis appoints Elizabeth Barrett as Oncology Head
- Details
- Category: Novartis
Novartis announced today that Elizabeth (Liz) Barrett, currently Global President Oncology at Pfizer, Inc., has been appointed CEO Novartis Oncology and a member of the Executive Committee of Novartis, effective February 1, 2018. She will be based in Basel. Mrs. Barrett succeeds Bruno Strigini who decided to retire from Novartis for personal reasons.
Sanofi and Regeneron to accelerate and expand investment for cemiplimab and dupilumab development programs
- Details
- Category: Sanofi
Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will accelerate and expand investment for the clinical development of the PD-1 (programmed cell death protein 1) antibody cemiplimab in oncology and dupilumab in Type 2 allergic diseases. Both of these breakthrough therapies have the potential to benefit a number of different patient populations and this strategic investment will enable the companies to evaluate cemiplimab and dupilumab in broad clinical development programs.
Novartis advances head-to-head superiority trials of Cosentyx® versus Humira®* and proposed biosimilar adalimumab**
- Details
- 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
- Details
- 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
- Details
- 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
- Details
- 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!
More Pharma News ...
- Roche and Ignyta reach definitive merger agreement
- US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer
- FDA approves new Pfizer biosimilar
- Novartis drug crizanlizumab shown to prolong time to patients' first sickle cell pain crisis in subgroup analysis of SUSTAIN study
- Boehringer Ingelheim marks great progress in immuno-oncology research partnerships in 2017
- Novartis tender offer for Advanced Accelerator Applications commences
- Sanofi explores combination treatments for multiple myeloma in new late-stage trials