FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 8-5 to recommend approval of Natpara from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) to treat hypoparathyroidism. The PDUFA date is October 24.more >>
Affimed Therapeutics B.V. (NASDAQ:AFMD) was down $1.30 to $5.70 on its first day of trading Friday after raising $56 million through the sale of 8 million shares at $7 in an IPO. The IPO price values the company at $167.9 million. Earlier this month, the company said it planned to sell 6.3 million shares at $11-$13. A midpoint sale of those shares would have raised $75.6 million. Jefferies; Leerink Partners; BMO Capital Markets Corp.; and Trout Capital are underwriters.more >>
Polar Capital is fundraising for an open-ended global biotech fund focused on large cap companies. The Polar Capital Healthcare Blue Chip Fund will be managed by Gareth Powell and Daniel Mahony, who have both been with Polar since 2007.more >>
Kolltan Pharmaceuticals Inc. (New Haven, Conn.) filed to raise up to $86.3 million in an IPO on NASDAQ underwritten by Leerink Partners; Stifel; Guggenheim Securities; and Janney Montgomery Scott.more >>
Eli Lilly and Co. (NYSE:LLY) said ramucirumab plus chemotherapy increased overall survival, the primary endpoint, in a Phase III trial as second-line therapy for metastatic colorectal cancer (mCRC). The company declined to provide specific data until it presents them at an unspecified scientific meeting in 2015.more >>
Oncothyreon Inc. (NASDAQ:ONTY) said in an SEC filing that partner Merck KGaA (Xetra:MRK) will stop development of tecemotide (L-BLP25) as a monotherapy for non-small cell lung cancer (NSCLC). The compound was in Phase III testing.more >>
Delenex Therapeutics AG (Zurich, Switzerland) said DLX105 led to no significant clinical improvements in a Phase II trial in mild to moderate plaque psoriasis. The co-primary efficacy endpoints were local Psoriasis Area Severity Index (PASI) score per plaque vs. baseline and placebo.more >>
The House Energy and Commerce Committee's Subcommittee on Health will hold a hearing Sept. 19 to discuss ways to combat antibiotic resistance and foster new drug development. The event is part of the committee's 21st Century Cures initiative.more >>
In a Phase III dry eye trial, MIM-D3 from Mimetogen Pharmaceuticals Inc. (Montreal, Quebec) significantly improved total corneal fluorescein staining vs. placebo (p=0.05). The Sept. 10 BioCentury Extra misstated the result.more >>
Researchers in France have shown that the eIF4F complex is a hub in which resistance pathways for BRAF and MEK converge and suggest that combining eIF4F inhibitors with marketed melanoma drugs could circumvent resistance.
An NYU School of Medicine-GSK collaboration has shown that an inhibitor of the chromatin regulator JMJD3 could help treat T cell acute lymphoblastic leukemia and might avoid the safety pitfalls of other notch 1-targeted therapies.
A few years ago, many companies threw in the towel on neurological diseases because poor understanding of their biology made R&D too risky. The field is finally receiving increased private and public funding, but some not-for-profit organizations contend the renewed interest still does not meet the diseases' societal burden.