BOSTON – In 2012, the last time the BIO International Convention was held in Boston, Jim Greenwood, president and CEO of BIO, noted in a statement that "the overarching sentiment shared by the majority of attendees is a positive outlook for the future of our industry." His view was spot on because in the intervening five years the industry has been on a tear, with the Nasdaq Biotechnology Index recording a 155 percent jump in value. Fundraising has also been off the charts and business development has continued at a frenetic pace. Read More
DUBLIN – The curious gap in understanding between the FDA and the EMA on which drugs work in Duchenne muscular dystrophy (DMD) and which drugs don't widened last week, as the EMA's Committee on Human Medicinal Products (CHMP) refused to recommend Exondys (eteplirsen) for approval in Europe while granting a label extension to Translarna (ataluren). Read More
Despite an initial complete response letter and a challenging bout with members of the Arthritis Advisory Committee and FDA reviewers, Eli Lilly and Co. and licensor Incyte Corp. have gained the agency's approval for a 2-mg dose of the once-daily oral JAK 1/2 inhibitor baricitinib, the lower of two doses the partners have sought to market. It's now approved to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors. Read More
CHICAGO – A call for trials more inclusive of racial and ethnic minorities opened the annual meeting of the American Society of Clinical Oncology (ASCO), as researchers unveiled the first prospective study of the hormonal therapy Zytiga (abiraterone) from Johnson & Johnson for advanced prostate cancer (PC) in black men vs. white men. Findings ratified what clinicians already had observed retrospectively: Black men respond better to the drug than white men. Read More
HONG KONG – South Korea is striving to be a global hub for biosimilars, as domestic biopharma firms such as Celltrion Inc., Samsung Bioepis Co. Ltd. and LG Chem Ltd. are all spearheading their biosimilars development. Read More
In the quest to bring chimeric antigen receptor (CAR) T cells to new groups of patients, a lot of work has been focused on engineering the CAR T cells themselves. Read More
After the approval by the FDA in February of Apadaz for short-term management of acute pain, eyes turned to Coralville, Iowa-based Kempharm Inc.'s partnering talks, which are expected to yield fruit by the year's end. (See BioWorld, Feb. 26, 2018.) Read More
Biostage Inc., of Holliston, Mass., said its securities purchase agreements have been fully funded and closed with 1 million shares sold at $3.60 each for total gross proceeds of $3.6 million. Read More
The Community Oncology Alliance (COA) filed a lawsuit in the U.S. District Court for the District of Columbia seeking an injunction to end the ongoing Medicare sequester for Part B drugs. Since 2013, a 2 percent sequester has been extended on Part B reimbursement and is currently set to continue through 2027. Read More
Tesaro Inc., of Waltham, Mass, said the U.K.'s National Institute for Health and Care Excellence (NICE) plans to make the PARP inhibitor Zejula (niraparib) available to women in England and Wales with recurrent platinum-sensitive ovarian cancer via the Cancer Drugs Fund (CDF). Read More
Early life complications (ELCs) can double the risk of developing schizophrenia, an effect that is greater than that of any common genetic variant. Researchers from the Lieber Institute for Brain Development have discovered that such ELCs affected gene expression in the placenta, and they did so in different ways in the placentas of male and female fetuses. Read More
