TherapeuticsMD bags FDA approval for hormone therapy
The FDA has nodded hormone therapy of TherapeuticsMD for hot flashes that are associated with menopause. Bijuva is an oral treatment that contains molecularly identical (bio-identical) versions of the hormones estradiol and progesterone for menopausal women with a uterus experiencing moderate-to-severe vasomotor symptoms. It was approved with a warning written on it for cardiovascular disorders, probable dementia as well as breast and endometrial cancer. The drug will be made available next year.
Pfizer and Novartis collaborate to aim NASH
Pfizer declared plans to challenge the untreated fatty liver disease with Novartis. A build-up of excess fat in the liver is the characterization of NASH that induces chronic inflammation and eventually leads to scarring, which lead to cirrhosis, liver failure, cancer and death. The disease is associated with obesity and diabetes that will obscure hepatitis C as the leading reason for liver transplants by 2020. It is difficult to diagnose in the early stages, because of which estimating its prevalence is hard, however, studies indicate that it afflicts up to 12% of the adult population in developed countries. There are no approved drugs for the disease yet.
The cholesterol drug of Esperion passes the last safety impediment
Esperion, American- based pharmaceutical company, is all set to make the last step in marketing application at the FDA. However, the recent batch of positive safety and efficacy data will not banish the questions on its sales strategy. The drug arm had a moderate drop in LDL of 18% with a 19% cut in high-sensitivity C-reactive protein. In Esperion studies, the therapy fits precisely between the generics that rule the market and the PCSK9s that have had difficulty finding traction, spurring some deep discounting that could spell trouble for Esperion.
Roche extends its PhIII program for Eylea rival as long-acting data back its blockbuster contender faricimab
The Genentech of Roche has secured success to challenge Regeneron and the Big Pharma contender, Novartis. The Researchers told that their bispecific Ang-2/VEGF drug faricimab came up with an improved profile over the player, Lucentis as a long-acting drug for wet AMD. And they scored on long-acting 16-week data, while Regeneron and Novartis have been duking it out over the 12-week niche. Eylea has been the leader of this market, giving Regeneron the profitable franchise market it needs to establish the company’s pipeline and new product offerings. Novartis has been making a mark with brolucizumab (RTH258).