Biogen Idec Inc. is keeping its injectable bases covered in relapsing multiple sclerosis (RMS) with the approval Friday of Plegridy (peginterferon beta-1a), given by an auto-injector pen or prefilled syringe every two weeks, a significant half-life advantage over the firm's Avonex (interferon beta-1a) for RMS, given weekly. Read More
LONDON – With the number of biosimilars approved in Europe on the rise, the UK Bioindustry Association (BIA) and the Association of the British Pharmaceutical Industry (ABPI) have joined forces in a publicity campaign to ensure prescribers are aware that – unlike small-molecule generics – biosimilars are not straight swaps for the originator products. Read More
Nearly two years after the Buck Institute for Research on Aging partnered with British firm Biotica Technology Ltd. to explore diseases of aging through the creation of Delos Pharmaceuticals Inc., a similar deal is afoot in the area of autoimmune disorders. Read More
One of the biggest side effects of antibiotics may come not at the time of treatment, but years later. Scientists have shown that treatment with antibiotics early in life permanently altered the metabolism of mice, predisposing them to obesity. Read More
HONG KONG – A Chinese biopharma has received approval from South Korean regulators to conduct local clinical trials on its biosimilar drug. Genor Biopharma Co. Ltd., a subsidiary of Walvax Biotechnology Co. Ltd. since last October, received clinical trial approval from the Korean Ministry of Food and Drug Safety (MFDS) for GB232, a biosimilar version of Abbvie Inc.'s Humira. Read More
BOGOTA, Colombia – As the political and economic situation worsens in Venezuela, pharmaceutical and biotech companies in the Latin American country are among the most affected by a lack of access to foreign currency. Read More
Resverlogix Corp., of Calgary, Alberta, closed the previously disclosed amendments which provided for the loan granted to the company by Citibank N.A. to be increased by $30 million to $68.8 million. Read More
Expression Therapeutics LLC, of Tucker, Ga., entered a deal with biomedical contract research and manufacturing organization ABL Inc., which will perform cell line development studies to improve manufacturability and reduce the costs associated with large-scale production of recombinant factor VIII replacement therapy. Financial terms were not disclosed. Read More
Egalet Corp., of Wayne, Pa., said it completed an end-of-phase II meeting with the FDA regarding Egalet-002, an abuse-deterrent, extended-release, oral oxycodone product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. Read More
Pfizer Inc., of New York, completed the submission of a new drug application to the FDA for palbociclib, requesting approval of the compound in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive human epidermal growth factor receptor 2-negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. Read More
Pledpharma AB, of Stockholm, said the futility analysis in the study known as Pliant has been completed, and the data safety monitoring board found that the analysis turned up no negative impact on the anticancer effect of chemotherapy when the company's drug, Pledox (calmangafodipir), was used. Read More
