Search Results for “biosimilar ” – Page 6 – media

Novartis advances head-to-head superiority trials of Cosentyx® versus Humira®* and proposed biosimilar adalimumab**

Novartis announced 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.
- Source: drugdu
- 724
- January 11, 2018
adalimumab** Company Insight Cosentyx® Novartis Researches
FDA approves first biosimilar for the treatment of certain breast and stomach cancers

The US Food and Drug Administration (FDA) today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the US for the treatment of cancer.
- Source: mdlinx
- 628
- December 5, 2017
breast cancer FDA herceptin New Approvals Ogivri stomach cancer
Pfizer and Genentech Duke it Out in Court Over Herceptin Biosimilar Patents

On Friday, November 17, Genentech, a Roche company, sued Pfizer in a federal court in Wilmington, Delaware, over Pfizer’s biosimilar for Genentech’s Herceptin. Genentech is claiming that Pfizer’s proposed biosimilar infringes 40 of its patents. Genentech also is demanding compensation for lost sales if Pfizer launches its copycat version before the Herceptin patents expire.
- Source: Biospace
- 644
- November 24, 2017
biosimilar Company Insight FDA Genentech herceptin Pfizer Roche
Boehringer bags first biosimilar approval in the EU

Boehringer Ingelheim has won its first biosimilar approval in Europe with authorisation of Cyltezo for a range of chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
- Source: Pharmatimes
- 594
- November 16, 2017
arthritis biosimilar chronic Cyltezo New Approvals
Amgen And Simcere Announce Strategic Collaboration To Co-Develop And Commercialize Biosimilars In China

Amgen and Simcere Pharmaceutical Group today announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.
- Source: Amgen
- 642
- September 28, 2017
biosimilar inflammation Market Views oncology
FDA approves first cancer biosimilar

The US Food and Drug Administration(FDA) has approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Roche/Genentech’s Avastin (bevacizumab) for the treatment of multiple types of cancer, making it the first biosimilar approved in the country for the treatment of cancer.
- Source: Pharmatimes
- 685
- September 18, 2017
biosimilar cancer FDA New Approvals
Celltrion expands European market, acquires iQone Healthcare for 30 billion

On Friday, South Korean biosimilar giant Celltrion said it had completed the acquisition of iQone Healthcare Switzerland for approximately 30 billion won (about 155 million yuan) as part of its European expansion strategy. After the acquisition, iQone Healthcare Switzerland will become a wholly-owned subsidiary of Celltrion Healthcare Hungary Kft. The transaction will also provide Celltrion with the opportunity to obtain authorizations, further enhancing its pipeline of innovative therapies. In 2022, iQone’s annual revenue was 18.9 billion won (about 18.9 million US dollars), and sales increased by 57% to 29.6 billion won in 2023. Celltrion said the acquisition will further accelerate the expansion of its prescription drug business in Switzerland. According to IQVIA data, sales performance in the country remains strong, with the Ramsima series (IV and SC) accounting for 61% of the market share in the second quarter of this year. The company noted that its follow-up products are expected ...
- Source: drugdu
- 33
- November 20, 2024
Pharma’s capital operation era

On October 31, CSPC Pharmaceutical Group issued a third-quarter profit warning announcement. It is expected that the company’s net profit in the first three quarters of this year will decrease by about 16% year-on-year from 4.495 billion yuan in the same period last year. In total, CSPC Pharmaceutical Group’s net profit in the first three quarters of this year is about 3.776 billion yuan. According to the interim report, CSPC Pharmaceutical Group’s revenue in the first half of the year was 16.284 billion yuan, a year-on-year increase of 1.27%, and its net profit was 3.02 billion, a year-on-year increase of 1.8%. According to this calculation, the net profit in the third quarter was only 760 million yuan, while the same period last year, this figure was 1.528 billion yuan. In other words, the net profit in the third quarter of this year was halved, a year-on-year decrease of 50%. As ...
- Source: drugdu
- 44
- November 11, 2024
Gan & Lee aims at the hypoglycemic drug market

Collective procurement ‘big winner’ In 1995, Gan Zhongru, who had worked as a postdoctoral fellow and senior biochemist at Merck&Co. in the United States, returned to China to start a business. Three years later, the team formed by Gan Zhongru developed China’s first genetically recombinant human insulin, becoming the third company after Eli Lilly and Novo Nordisk to produce and sell recombinant human insulin. Subsequently, under the leadership of Gan Zhongru and his R&D team, Gan Li Pharmaceutical continued to develop the first long-acting insulin analog, the first fast acting insulin analog, the first pre mixed insulin analog, and the first winter insulin in China. The products covered three insulin functional segments: long-acting, fast acting, and medium acting, becoming the “king of insulin” in China. With the acceleration of domestic insulin substitution in recent years, Ganli Pharmaceutical’s operating revenue has increased from 1.771 billion yuan in 2016 to 3.612 billion ...
- Source: drugdu
- 72
- November 8, 2024
Another GLP-1 drug king, is it on the way?

Recently, the Q3 financial reports of MNCs have been released one after another, and some are happy and some are sad. When a number of MNCs began to lower their full-year EPS, Amgen’s Q3 financial report earnings gave a high score answer sheet. Among them, Amgen’s total revenue in the third quarter increased by 23%, and its GAAP net earnings per share (EPS) increased by 62% year-on-year, from US$3.22 to US$5.22. What is more imaginative is that with the data catalysis of the new macromolecular weight loss drug AMG133, this macromolecular antibody that goes against the grain and antagonizes GIPR may become Amgen’s next gold mine. According to Amgen’s Q3 2024 financial report, the most significant year-on-year growth is LUMAKRAS (AMG510) – a targeted drug for KRASG12C mutation-positive lung cancer. The sales ceiling of this gene mutation in European and American countries will be much higher than that in Asian ...
- Source: drugdu
- 60
- November 6, 2024

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