Tag:

Amoxicillin

Latest Headlines

Latest Headlines

Top 20 generic molecules worldwide

The big news in generic drugs in the last couple of years has been all of the marquee brands that are getting their tails kicked by generic competition. The best example is the loss of the patent on...

MiddleBrook shares soar on FDA's strep therapy OK

Investors cheered the news of the FDA's approval of MiddleBrook Pharma's once-daily, 775 milligram Moxatag Tablets for strep throat by tripling the value of its shares. Its stock soared $2.30 to

ALSO NOTED: Elan, Biogen submit Tysabri for Crohn's; Affymax prices IPO;and much more...

> Shares of Elan and Biogen Idec were on the rise this morning after the two developers announced that they had submitted Tysabri as a therapy for Crohn's disease. Report > Affymax priced its IPO of 3.7 million shares at $25 a share. Release > Advancis Pharmaceutical …

SPOTLIGHT: FDA says Advancis ready to file

Advancis Pharmaceutical announced that the FDA had informed the drug developer that it had enough data to submit an application for marketing approval of the strep throat therapy Amoxicillin Pulsys. Advancis says it will file for approval in December or January. Report

Advancis' new antibiotic formulation hits endpoints

A year after undergoing a painful restructuring, Advancis Pharmaceutical announced that its once-daily formulation of the antibiotic amoxicillin--its lead product--met its primary endpoints in a Phase III trial. The news led to a sharp jump in the company's stock price, which was pummeled a year ago after executives announced that its trial on the new formulation had failed to achieve its endpoints. After laying off half of its staff, Advancis went back to the drawing board and mounted a …

ALSO NOTED: Safeguard acquires Acsis for $26M; Biogen issues 'Dear Doctor' letter; and much more...

> Safeguard Scientifics announced yesterday that it will acquire Acsis for about $26 million in cash. Article > Biogen Idec has issued a "Dear Doctor" letter warning physicians not to prescribe Amevive to HIV patients. Amevive is for the treatment of plaque psoriasis. Report > …

ALSO NOTED: Par drops Advancis partnership; Diovan gets new indication; Pozen makes case for MT-100; and much more...

> Par Pharmaceutical has pulled out of its development partnership with Advancis, saving itself a scheduled $4.75 million payment. The news follows Advancis' announcement that it would slash its staff following the failure of Amoxicillin PULSYS in Phase III trials. Story > The FDA has approved a new indication for Novartis' bestselling Diovan, adding its use to improve survival after a heart attack. …

Advancis cutting workforce by one-third

Advancis Pharmaceutical is on a cost-cutting spree that involves cutting its workforce by one-third and eliminating all nonessential temporary workers. A total of 33 jobs will be cut, including six corporate officer jobs. The company hopes to reduce annual spending by $4.1 million. The changes come on the heels of failures in a second final-stage trial of the company's lead product, a once-a-day amoxicillin formulation.- read this story from the Baltimore Business Journal for more

Advancis looks to cut costs following trial failure

Days after its lead product failed a second Phase III trial, the CEO of Advancis told analysts that he was looking at cutting costs, including possible layoffs. Advancis had been developing a new form of the antibiotic amoxicillin, but it has now failed pivotal trials for adults and children. The biotech has about $40 million in cash on hand.- read this report from Washington Business Journal for more

Advancis drug fails again

Advancis Pharmaceutical said that its lead product, a once-a-day version of the widely used antibiotic amoxicillin, has failed testing for a second time. In its study of its drug in children with strep throat, it was only 65.3 percent successful, far less than the 85 percent needed to qualify as a primary treatment. Standard penicillin worked better. Advancis has about $40 million in cash and could afford more testing, but company executives said they will have to take a critical look at …