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Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the
Company has received a complete response letter from the U.S. Food and
Drug Administration (FDA) for its New Drug Application (NDA) for
balsalazide tablet studied as a treatment of mild-to-moderate active
ulcerative colitis in patients 18 years and older. Based on its review,
the FDA has determined that the application cannot be approved in its
present form and that clinical data from Read the rest of this entry »
Eurand N.V.
PHILADELPHIA, Dec. 26, 2008 (GLOBE NEWSWIRE) — Eurand N.V. (Nasdaq:EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, today announced that it has been advised by GlaxoSmithKline (NYSE:GSK) that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter for the New Drug Application (NDA) for EUR-1048. Read the rest of this entry »
Since announcing our intention not to renew the lease for Community Hospital of Los Gatos, we have diligently worked with the hospital owner, HCP, as it sought a new facility operator. Once informed that HCP had selected El Camino Hospital to fill this role, we engaged in negotiations with the hope of transitioning a fully functional and operating hospital to ECH.
Unfortunately, we were unable to reach an agreement with ECH. After being informed Read the rest of this entry »
Contract manufacturer PrimaPharm was cited by the FDA for GMP violations related to its sterile drug products.
The company did not establish and follow written procedures to prevent microbiological contamination of sterile drugs, according to the FDA’s Oct. 31
, posted recently to its website.
Media fills used to validate unidentified processes were deficient, and the environmental monitoring program did not include sampling of critical Read the rest of this entry »
Michelle Jehenson (“Residents should help Cole with medical bills,” letters, Sept. 30) asks if we as a community can come together to help Sara Cole with her medical bills. Does Ms. Jehenson not understand that this is precisely what the lawsuit filed against the town accomplishes?
I was honored to meet and greet Sara Cole at the Los Gatos Little League opening ceremonies last fall. I was grateful for her remarkable recovery, and my heart went out Read the rest of this entry »
The application, filed by Scolr on August 5, 2008, seeks approval to market a 120mg 12 hour pseudoephedrine tablet based on its patented Controlled Delivery Technology (CDT) platform.
The complete response letter requests additional information, all of which was identified by the FDA as ‘minor’. The company said that it believes it can provide the information to the FDA expeditiously. None of the issues cited by the FDA involve the safety or efficacy Read the rest of this entry »
COPENHAGEN, Dec 11 (Reuters) – Danish drugmaker Novo Nordisk
(NOVOb.CO:
,
,
,
) said on Thursday it had received a letter from U.S.
regulators regarding its once-weekly version of liraglutide,
setting out future requirements for extra cardiovascular
studies.
The letter from the Food and Drug Administration relates to
Novo’s experimental product NN9535, which is currently in Phase
II clinical trials, and contains general requirements, a
spokesman Read the rest of this entry »
WASHINGTON – As Barack Obama prepares to spend billions on health information technology as part of his plan to revive the US economy, some specialists are warning against investing too heavily in existing electronic recordkeeping systems.
In a recent open letter to the president-elect, a top technology adviser to the American Academy of Family Physicians said that current systems are expensive, cumbersome to use, and cannot easily exchange information Read the rest of this entry »
” (Personal Health, Jan. 27): I remember my last serving of dirt. I sneaked a sample from my mother’s potted rubber plant and realized the delicious taste was not worth the effort of sorting out the sandy grit with my teeth and tongue. It doesn’t embarrass me to think I used to eat dirt, however; I’ve always felt a bit guilty that the whole family had to be treated for intestinal worms after worms were discovered in my diapers. Read the rest of this entry »
” (Personal Health, Jan. 27): I remember my last serving of dirt. I sneaked a sample from my mother’s potted rubber plant and realized the delicious taste was not worth the effort of sorting out the sandy grit with my teeth and tongue. It doesn’t embarrass me to think I used to eat dirt, however; I’ve always felt a bit guilty that the whole family had to be treated for intestinal worms after worms were discovered in my diapers. Read the rest of this entry »