Shire's marketing application for SHP555, or prucalopride, being developed as a once-daily treatment for adult patients with chronic idiopathic constipation, has been accepted by the FDA for review. The agency has set the PDUFA date of Dec. 21.

Bioventus has launched Durolane as a treatment for patients with knee osteoarthritis-associated pain who did not respond adequately to conservative nonpharmacological therapy or simple analgesics.

A preclinical study to assess the efficacy of a combo regimen of Gilead Sciences' GS-9620 and PGT121 showed potential in eliminating simian-human immunodeficiency virus in non-human primates taking suppressive antiretroviral therapy, according to data presented at the Conference on Retroviruses and Opportunistic Infection. The testing was conducted on 44 SHIV-infected rhesus monkeys after being treated with ART for 96 weeks who received varying doses of either PCT121, GS-9620, a placebo or the combination treatment.

Preliminary data from Onconova Therapeutics' early-stage trial to assess the efficacy of its lead candidate rigosertib combined with Celgene's Vidaza, or azacitidine, in patients with myelodysplastic syndromes indicated a 76% overall response rate, with results also showing a 62% response rate in patients who had hypomethylating agent failure, while HMA-naive patients registered an 85% response rate. The data was presented by Onconova at a special conference of the American Association for Cancer Research in Atlanta, Ga.

Celgene signed a four-year partnership with Vividion Therapeutics to discover and develop small molecules against undisclosed targets for oncology, inflammation and neurodegenerative diseases. Under the terms of the deal, Vividion will get a $101 million upfront payment and lead the discovery while Celgene will have the option to license program rights upon acceptance of an investigative new drug application.

Takeda is going to build a new facility in Dublin to manufacture a novel stem cell therapy. The plant is expected to be completed in 2021.

Learn more about key policy issues affecting biotechnology in Washington, D.C., and state capitals around the country. With the unpredictability of the federal level coupled with the increasingly hostile state legislatures, it is vital that the biotechnology industry amplify its voice on the federal, state and local levels. Become an advocate for biotechnology by joining BIO Action today. Now, more than ever, we need your voice! Text BIO to 52886 or visit BIO's website.

UK Prime Minister Theresa May said the country would be willing to pay for membership in the European Medicines Agency and other regulatory agencies post-Brexit, but EU leaders were skeptical that her "cherry picking" demands were likely to be met.

A Dutch early-stage clinical trial of a biosimilar referencing Genentech’s Pulmozyme, or dornase alfa, for cystic fibrosis will begin this month, according to maker JHL Biotech.

Centro de Tecnologia Canavieira's biotech sugarcane that is resistant to cane borers has been planted in an initial area of 400 hectares, in cooperation with about 100 Brazilian sugar mills.

President Donald Trump has shown his support for renewable fuels during a meeting about the Renewable Fuel Standard. "The President understood that RIN prices go down with continued growth of biofuel volumes. Then, it was made abundantly clear by all parties in the room that none of them have an issue with biodiesel's role in the RFS," said Randy Howard, Renewable Energy Group president and CEO.

BIO Business Solutions®, BIO's cost-savings program, has a partnership with Airgas, an Air Liquide company, to offer preferred pricing on a broad range of industrial, specialty and medical gases. The program also provides 10-25% preferred discounts on equipment and supplies. Learn more.