UPDATE 1-US panel says Optimer’s antibiotic effective
Optimer Pharmaceuticals Inc’s (OPTR.O) experimental antibiotic is safe and effective in treating a bacterial infection that causes diarrhea, a U.S. advisory panel said on Tuesday. The advisory panel of...
View ArticleSoy food safe for breast cancer
A new study has revealed that soy food consumption does not increase the risk of cancer recurrence or death among survivors of breast cancer. Researchers investigated the association between soy food...
View ArticleHazardous and untested flame retardants pervasive in baby products
A study of products designed for babies and toddlers – including car seats, nursing pillows, changing pads, bassinet mattresses and other items made with polyurethane foam – found that 80% of products...
View ArticleFDA Okays New HIV Drug
WASHINGTON — The FDA has approved rilpivirine (Edurant) for the treatment of HIV patients who have not yet begun therapy. The drug, a non-nucleoside reverse transcriptase inhibitor, is intended to be...
View ArticleWHO Says Cell Phones May Cause Cancer
A work group of the World Health Organization has declared the radiofrequency electromagnetic fields emitted by cell phones to be “possibly carcinogenic to humans.” The declaration was made after a...
View ArticleBlood pressure drugs not linked to cancer risk, says FDA
A type of blood pressure-lowering medication known as angiotensin receptor blockers won’t increase a patient’s risk for cancer, the Food and Drug Administration said this week. So those taking the...
View ArticleUPDATE 1-Pfizer stop-smoking pill raises heart risk-FDA
WASHINGTON, June 16 (Reuters) – Pfizer Inc’s (PFE.N) stop-smoking drug Chantix can lead to a small increase in cardiovascular problems such as heart attacks for patients who already have cardiovascular...
View ArticlePfizer, Acura Say FDA Clears Painkiller Oxecta
Pfizer Inc. and Acura Pharmaceuticals Inc. said Monday the Food and Drug Administration approved a powerful painkiller that is designed to be harder to abuse. The FDA cleared marketing of Oxecta as an...
View ArticleNew Drug Effectively Treats Hepatitis C
WEDNESDAY, June 22 (HealthDay News) — The recently approved drug Incivek, combined with two standard drugs, is highly effective at treating hepatitis C, a notoriously difficult-to-manage liver disease,...
View ArticlePfizer’s Remoxy Fails to Win FDA Approval
WASHINGTON — The latest attempt at an abuse-resistant formulation of oxycodone (Remoxy) failed to win approval from the FDA, according to a statement from Pfizer. Late Thursday, the company said it had...
View ArticleGenentech to Appeal to F.D.A. for Breast Cancer Drug
Genentech this week will step up its efforts to keep the drug Avastin available as a treatment for breast cancer, urging the Food and Drug Administration to give it one more chance to prove the...
View ArticleFDA Clears Abbott’s Confirmatory Chagas Disease Assay
FDA approved Abbott’s in vitro enzyme strip assay for Chagas disease. The Abbott ESA Chagastest detects antibodies to the causative pathogen Trypanosoma cruzi in serum or plasma samples. It is...
View ArticleFDA says new cholesterol drugs may not need outcome studies
Members of an experimental class of cholesterol-lowering drugs could get U.S. regulatory approval based on their ability to lower “bad” cholesterol, and may not need to show that they reduce the risk...
View ArticleEarly FDA approval for Portola
South San Francisco-based Portola Pharmaceuticals ($PTLA) has nabbed boasting rights to the FDA’s new breakthrough drug designation for andexanet alfa (PRT4445), its Factor Xa inhibitor antidote...
View ArticleNew drug approvals plunge in 2013
The wave of new drug approvals that had been building at the FDA has broken. According to the official tally of new drug and biologics approvals at the agency, the biopharma industry registered only 27...
View ArticleFDA Grants Breakthrough Status to Gene Therapy for First Time
Celladon became the first company to receive breakthrough status for a gene therapy treatment in development. The treatment, MYDICAR, is intended to reduce the risk of heart failure in patients with a...
View ArticleCubist’s superbug drug clears FDA panel
Cubist’s latest antibiotic won praise from a panel of FDA advisers, setting the stage for a likely approval and head-to-head competition with Pfizer’s blockbuster Zyvox. The FDA’s Anti-Infective Drugs...
View ArticleUCSF, Stanford and Johns Hopkins join FDA partnership to speed drug development
At a time when Big Pharma is increasingly tapping academic institutions for expertise in informatics and data-driven computer models for drug discovery, the FDA has selected Johns Hopkins University,...
View ArticleAnalyzing the Winners and Losers in the Growth of Non-oral Patient...
Success of Delivery Device Developers in Solving Formulation Limitations a Key Factor according to Greystone Research Associates (Amherst, NH) – As patients live longer and the prevalence and incidence...
View ArticleSeegene Receives FDA Clearance for its Herpes Simplex Virus Molecular Test
Gaithersburg, Maryland and SEOUL, Korea, February 17, 2015 - Seegene Inc. (096530.KQ), a leading developer of multiplex PCR technologies, today announced that the U.S. Food and Drug Administration...
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