Just like you never want to hear a doctor say “oops” in the operating room, you never want to see a going-concern statement
in a financial report about a company you own. Accountants throw these in when they’ve been over the books, talked to customers,
and checked the horoscopes and have concluded there is “substantial doubt” about a company’s ability to remain in business.
In short, don’t blame the accountants Read the rest of this entry »

Eurand N.V. (NASDAQ: EURX), a specialty
pharmaceutical company that develops enhanced pharmaceutical and
biopharmaceutical products based on its proprietary drug formulation
technologies, is pleased to announce that the U.S. Food and Drug
Administration (FDA) has acknowledged the Company’s response to the June
2008 approvable letter for EUR-1008 (ZENTASE®) as a complete response. The
FDA has assigned an action date under the Prescription Drug User Read the rest of this entry »

(Recasts; adds details, background, share movement)
Nov 7 (Reuters) – Discovery Laboratories Inc (DSCO.O:
,
,
,
) said
the U.S. Food and Drug Administration accepted for review its
complete response for Surfaxin, its experimental lung drug for
infants, and has set April 17, 2009 as a target action date to
complete the review of the drug.
The FDA has designated the complete response as a Class 2
resubmission. The company had expected a Read the rest of this entry »

(Recasts; adds details, stock movement)
Nov 20 (Reuters) – Vanda Pharmaceuticals Inc (VNDA.O:
,
,
,
) said
U.S. health regulators accepted the complete response for its
experimental schizophrenia drug, iloperidone, sending its
shares up 40 percent in pre-market trade.
The company, which received a not-approvable letter for the
drug from the U.S. Food and Drug Administration in July, said
the FDA has set May 6 as a new target action date Read the rest of this entry »

Dyax Corp. (NASDAQ: DYAX) announced today that the U.S. Food and Drug
Administration (FDA) has accepted for filing the Company’s Biologics
License Application (BLA) for DX-88 (ecallantide) for the treatment of
acute attacks of hereditary angioedema (HAE) and has designated the
application for Priority Review. Based on this designation, the FDA
Prescription Drug User Fee Act (PDUFA) target action date is March 23,
2009, or six months from the BLA Read the rest of this entry »

Marmora and Lake – Mike Sniderhan and Eric Brick have, for many years, worked to better the access to health care for residents of the Central Hastings area. Both men were active on the Central Hastings Sustainable Communities Association (CHSCA) and more recently, the Central Hastings Family Health Team (CHFHT) that followed in June, 2007. Now the two have decided to retire from the board, and on Dec. 9, they were honoured by their fellow Read the rest of this entry »