Roche – Page 2 – media

Seven medicines leap closer to EU approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has put forward seven new medicines for approval in the region, including new treatment options for haemophilia A, diabetes, and a very rare genetic disorder.
- Source: pharmatimes
- 994
- January 30, 2018
CHMP diabetes EMA haemophilia A Hemlibra polices Roche
Biosimilar Avastin wins EU approval

European regulators have issued a green light for Amgen and Allergan’s Mvasi, marking the first biosimilar of Roche’s Avastin to be approved in the region. The drug has been cleared to treat a range of indications spanning carcinoma of the colon or rectum, breast cancer; nonsquamous non-small cell lung cancer, renal cell cancer; platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer. The companies noted that the approval came after trial data showed a high degree of similarity between Mvasi (biosimilar bevacizumab) and its reference drug, “with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products”. Mvasi is the first product borne out of an alliance between Amgen and Allergan to bag marketing authorisation from the European Commission, “highlighting the success of our joint commitment to developing cancer biosimilars,” noted David Nicholson, chief research and development officer at ...
- Source: Pharmatimes
- 565
- January 23, 2018
Avastin Mvasi New Approvals Roche
GE Healthcare and Roche join forces to create clinical decision support tools

GE Healthcare and Roche have launched a partnership to assist clinicians in making better choices and help patients get individualized care.
- Source: MedCityNews
- 575
- January 12, 2018
Clinical Company Insight Roche
Roche introduces new sample collection device for HIV plasma viral load testing

The new card solution helps to simplify blood collection and sample transportation through providing a small amount of a patient’s blood from a fingertip.
- Source: MDBR
- 505
- January 9, 2018
Company Insight HIV Roche
Roche and Ignyta Reach Definitive Merger Agreement

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. This price represents a premium of 74% to Ignyta’s closing price on 21 December 2017 and a premium of 71% and 89% to Ignyta’s 30-day and 90-day volume weighted average share price on 21 December 2017, respectively. The merger agreement has been unanimously approved by the boards of Ignyta and Roche.
- Source: Roche
- 527
- December 25, 2017
Ignyta Market Views Roche
FDA Grants Genentech’s Avastin Full Approval for Most Aggressive Form of Brain Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA's accelerated approval program.
- Source: Gene
- 558
- December 8, 2017
FDA Genentech New Approvals Roche
Roche’s Erivedge no longer funded by the NHS

Roche’s Erivedge will indeed no longer be funded on the National Health Service(NHS) as a treatment for skin cancer after cost regulators issued final guidance ruling that it is not cost effective.
- Source: news.open-medical
- 547
- November 27, 2017
BCC Company Insight Erivedge NHS Roche skin 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
- 642
- November 24, 2017
biosimilar Company Insight FDA Genentech herceptin Pfizer Roche
US FDA grants Breakthrough Therapy Designation for Roche’s Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC

The latest BTD was granted for the treatment of adult patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.
- Source: Roche
- 558
- November 23, 2017
anaplastic lymphoma kinase Company Insight FDA non-small cell lung cancer Roche

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.