Roche’s balovaptan has picked up a Breakthrough Therapy Designation in the US for its potential as a treatment for people with autism spectrum disorder (ASD), potentially placing the drug on a faster path to market.
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.
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 ...
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.
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.
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.
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