Big Pharma "Fountain Of Youth" Drug, FDA Approvals, And Other Pharma News
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
In the news recently, we may be closer to slowing aging with a new “Fountain of Youth” drug; two phase 3 clinical trials have reported developments in schizophrenia and female sexual disorder; and the FDA’s 2014 drug approval record has turned some heads.
A new anti-aging drug is in the works in the Novartis labs, Design & Trend reports. Its effects so far have been promising, leading the company to describe the drug as the “Fountain of Youth.” The drug, known as Rapamycin (an mTOR inhibitor), was tested in 200 people aged 65 and up. Patients who received the drug were also given a flu shot, which resulted in the production of 20 percent more antibodies. Previously, the drug was tested in mice and other animals and was found to slow aging and the development of age-related diseases.
The FDA approved 44 new drugs in 2014—the highest number of drugs it has approved since 1996 when it gave the nod to 53 drugs, says Forbes. Companies seeing the most approvals in 2014 include AstraZeneca, AbbVie, and Eli Lilly. The approved drugs covered 10 therapeutic areas, with the most popular disease targets being infectious diseases, cancer, and rare diseases.
FDA advisers have officially backed Novartis’ biosimilar, arguing that it is “highly similar” to Amgen’s reference drug Neupogen, Bloomberg reports. The FDA will take into account the panel’s decision when it announces it final decision to approve or deny the biosimilar in March. Earlier this week prior to the panel’s favorable opinion, FDA staff supported the drug to treat all 5 of the conditions for which Neupogen is prescribed.
RTT News says OncoGenex Pharma and Teva have ended their partnership over the experimental cancer drug custirsen. Following the dissolution of the partnership, OncoGenex will regain the rights to the prostate and lung cancer compound that is currently in Phase 3 clinical development.
Biopharm Palatin Technologies has announced the launch of the Phase 3 reconnect study of bremelanotide for female sexual dysfunction. Bremelanotide, a subcutaneous melanocortin agonist, will be investigated in the trial enrolling 550 women with hypoactive sexual desire disorder in North America.
Sumitomo Dainippon announced results from its Phase 3 lurasidone clinical trial for patients with schizophrenia. The PASTEL study, which enrolled 457 patients, found that patients taking 40 mg/day attained a statistically significant improvement in change from baseline of the Positive and Negative Syndrome Scale (PANSS)*1 total score compared to placebo. The company is working to put together an application for production and marketing approval in Japan in the future.
A new collaboration is in the works between AstraZeneca and GSK, reports Biospace. As the industry continues to embrace open innovation, AstraZeneca, GSK, and five other companies have put their failed compounds together into a shared “virtual” library in the hopes that the partners may be able to find alternative uses for them. Other partners in this arrangement include Janssen, Eli Lilly, Takeda, Pfizer, and UCB.
According to Time, new research from Johns Hopkins recently published in the journal Science has found that “bad luck” is a major cause of cancer, rather than genetics or life style choices. Researchers examined 31 different types of cancer and determined that 22 (or two-thirds) of these cancers (including ovarian, brain, bone, testicular, pancreatic cancers and leukemia) resulted from unpreventable and random mutations in stem cells.