Drug developers typically turn to investors to finance clinical work on drug candidates. Chelsea Therapeutics (NASDAQ:CHTP) executives and directors are slashing their own paychecks to help pay for that work themselves. Corporate officers and directors for Chelsea have volunteered to take a 25 percent cut in compensation until the Charlotte, North Carolina company gets phase […]
Chelsea Therapeutics‘ (NASDAQ:CHTP) rheumatoid arthritis treatment failed in phase 2 clinical trials and leaves the beleaguered drug developer to focus its remaining resources on an orphan drug candidate that has already fallen short of regulatory approval. The experimental rheumatoid arthritis drug CH-4051 demonstrated some effect on patients, but did not prove better than existing rheumatoid […]
Chelsea Therapeutics (NASDAQ:CHTP), regrouping from orphan drug Northera’s failure to secure regulatory approval, now plans to resubmit a new drug application in early 2013 with data from a modified phase 3 study. The Charlotte, North Carolina drug developer announced the plans following its meeting with the U.S. Food and Drug Administration to discuss the complete […]
Life science current events this week include: a narrower target for Chelsea's Northera hypotension drug, Covidian collaboration with Maya Medical, Colbert's take on Accretive scandal, Lilly Ventures-led pharmaceutical startup
Chelsea Therapeutics (NASDAQ:CHTP) won’t meet with regulators until later this month to discuss its orphan drug Northera but the company is already staking out scenarios of a more limited approval for the drug. If results of an ongoing phase 3 study don’t support the durability of Northera’s effect over time, the company said in its […]
Chelsea Therapeutics‘s (NASDAQ:CHTP) drug candidate Northera failed in its bid to secure U.S. Food and Drug Administration approval. But a door to approval remains cracked open for the company. The FDA’s complete response letter asks for more data on the durability of Northera over a two- to three-month period. Chelsea said it plans to use […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Northera, the Chelsea Therapeutics (NASDAQ:CHTP) compound developed to treat dizziness and fainting in Parkinson’s disease patients, could get word from regulators today on marketing approval. The Prescription Drug User Fee Act (PDUFA) action date was set when the U.S. Food and Drug Administration granted priority review for the compound. Northera passed a hurdle last month […]
Updated 7:29 p.m. Northera, the Chelsea Therapeutics (NASDAQ:CHTP) drug developed to treat dizziness and fainting experienced by Parkinson’s disease patients, has the nod for approval from an advisory committee to the U.S. Food and Drug Administration. The 7-4 vote with one abstention and one “non-vote” from the independent panel does not bind the FDA to […]
Chelsea Therapeutics (NASDAQ:CHTP) CEO Simon Pedder’s recent defense of drug candidate Northera omitted a key detail: The U.S. Food and Drug Administration reviewer for Northera recommended the agency not approve the drug. Release of that finding as well as the reviewer’s safety and clinical trial concerns now cast questions on a compound that was on […]
Chelsea Therapeutics (NASDAQ:CHTP) won’t meet with a U.S. Food and Drug Administration advisory committee to discuss drug candidate Northera for another 10 days, but CEO Simon Pedder used a biosciences conference today to preemptively defend the drug amid emerging agency concerns about Chelsea’s trials. Pedder, speaking at the BIO CEO and Investor Conference in New […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Drug developer Chelsea Therapeutics (NASDAQ:CHTP) is expanding its financial cushion to the tune of $100 million in advance of a regulatory decision on what could be the company’s first approved drug. A recently filed shelf registration shows the company laying groundwork to raise the money if needed. Pharmaceutical companies often make shelf filings to give […]
The stock offering that Chelsea Therapeutics (NASDAQ:CHTP) expected to bring in $19.2 million in fresh capital has raised even more money with the sale of additional shares. Chelsea net $22.1 million that the company will devote to commercializing a Parkinson’s disease treatment and developing additional products from its drug pipeline. Including the over allotment, Chelsea […]
Chelsea Therapeutics (NASDAQ:CHTP) has priced its stock offering and aims to raise $19.2 million to launch its first product and fund continued development of its drug pipeline. Charlotte, North Carolina-based Chelsea is offering 4.3 million shares of common stock for $4.75 per share. Chelsea’s shares are currently trading at around $5 per share. The stock […]
Chelsea Therapeutics (NASDAQ:CHTP) is preparing for the launch of its first product — a drug for Parkinson’s disease patients — and the company plans to arm itself with nearly $20 million to do it. Chelsea aims to raise up to $19.7 million through a stock offering of more than 65 million shares, according to an […]
One year after Shire (NASDAQ:SHPGY) pulled its drug for low blood pressure, ProAmatine, from the market after reaching an impasse with the U.S. Food and Drug Administration, it has agreed to do the additional clinical tests the regulator wanted. The agreement was made with the Center for Drug Evaluation and Research, a division of the […]
