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 ...
Tweeting to the top, GlaxoSmithKline and Pfizer tied for the No. 1 spot in the inaugural ranking of global pharma influencers by Owen Health. The U.K.-based healthcare marketing agency evaluated 22 pharma companies on authority, reach, activity, engagement and influence to rate the most and least adept when it comes to Twitter.
Pandion Therapeutics, Inc., a biotechnology company developing bispecific antibody therapeutics to achieve localized immunomodulation, today announced the completion of a $58 million Series A financing. This funding will be used to advance its initial drug programs for autoimmune and inflammatory diseases toward the clinic, as well as to continue building the company’s technology platform and pipeline. Polaris Partners, the founding investor that provided the initial seed funding, co-led the Series A financing along with Versant Ventures and Roche Venture Fund. SR One and BioInnovation Capital also participated in the round.
After expanding its partnership with Syndax $SNDX earlier this week on their lead drug, Genentech has beefed up their pipeline of PD-L1 combos with a fresh pact with Stanford spinout Forty Seven.
It's not just specialty drugmakers raising prices in recent days. Big Pharma has pushed through a spate of increases, and while all of them are sub-10%—the cap some companies have adopted—some of them will cost payers and consumers plenty.
New drug approvals all but screeched to a halt in 2016, with a measly 22 new OKs after a pair of bountiful years. But the FDA wasted no time in 2017, signing off on 12 drugs in the first quarter alone—besting its record for the same period of any year in recent history.
A new paper-based sensor patch developed by researchers at Binghamton University, State University of New York could allow diabetics to effectively measure glucose levels during exercise.
Ionis Pharmaceuticals, Inc. (IONS) announced today that Roche has exercised its option to license IONIS-HTTRx following the completion of a Phase 1/2a randomized, placebo-controlled, dose escalation study of IONIS-HTTRx in people with Huntington's disease (HD). Roche will now be responsible for all development and commercial activities. IONIS-HTTRx is the first therapy in clinical development designed to target the underlying cause of HD by reducing the production of the toxic mutant huntingtin protein (mHTT). In conjunction with the decision to license IONIS-HTTRx, Ionis earned a $45 million license fee from Roche.
A DNA double helix is seen in an undated artist's illustration released by the National Human Genome Research Institute to Reuters on May 15, 2012. REUTERS/National Human Genome Research Institute/Handout.
The overall market value of in vitro diagnostics (IVD) stands at $52 billion this year, and is projected to grow at a compound annual growth rate (CAGR) of 4.2% to $69 billion in 2024. According to GlobalData, a leading data and analytics company.
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