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AMDL submits data to FDA for clearance to market its diagnostic test to monitor colorectal cancer patients

AMDL, Inc., developer and marketer of tests for the early detection of cancer and other serious diseases, announced today that it has filed with the U.S. Food & Drug Administration (FDA) for clearance to market its unique, proprietary DR-70 (FDP) ELISA tumor marker test for use as an aid in monitoring patients previously diagnosed with colorectal cancer. AMDL used the guidance provided at the meeting they had with the FDA on January 25, 2007.

15 Oct 2007

Biopharmaceutical infrastructure key to lower drug development costs

Improvements to the technology infrastructure for researching and developing new biopharmaceuticals would be expected to save the industry hundreds of millions of dollars annually, according to a new economic study sponsored by the National Institute of Standards and Technology (NIST).

12 Oct 2007

Generic Trileptal (oxcarbazepine) approved in U.S.

The U.S. Food and Drug Administration has approved the first generic versions of Trileptal (oxcarbazepine), an anticonvulsant drug.

10 Oct 2007

HIV drug designed for children wins FDA approval

A pill containing 3 anti-HIV drugs designed specifically for children has been given tentative approval by the United States Food and Drug Administration (FDA). Its use in Sub-Saharan Africa will benefit thousands of children living with HIV.

10 Oct 2007

Cautious optimism for new Alzheimer's medications

Alzheimer's disease takes a long time to develop, which suggests that it may be possible to design drugs that work early in the disease process, to delay the start of symptoms.

10 Oct 2007

$Accentia announces investigational new drug application for Revimmune for refractory MS$

Accentia announces investigational new drug application for Revimmune for refractory MS

Accentia Biopharmaceuticals has announced that it met with the Food and Drug Administration (FDA) on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting on Revimmune.

10 Oct 2007

Warnings about drugs used with ultrasounds

The Food and Drug Administration (FDA) is reportedly about to issue "blackbox" warnings for drugs used to enhance the images of ultrasound machines in the diagnosing of heart problems.

8 Oct 2007

Wyeth Pharmaceuticals to acquire Haptogen

Wyeth Pharmaceuticals, a division of Wyeth has announced the signing of a definitive agreement under which it has acquired Haptogen Ltd., a Scottish company based in Aberdeen that is focused on the discovery of biopharmaceutical therapies.

8 Oct 2007

Fraunhofer pharmaceutical agent speeds drug development

It takes a great deal of time and money to develop a new drug. At Biotechnica in Hanover from October 9 to 11, the Fraunhofer Life Sciences Alliance will demonstrate how a pharmaceutical agent can make its way more quickly from the research laboratory to the pharmacy.

8 Oct 2007

Bayer HealthCare clear to acquire Citracal calcium supplements in the United States

Bayer HealthCare (BHC) has announced that its Consumer Care Division has received regulatory approvals necessary to acquire the Citracal line of over-the-counter (OTC) calcium supplements in the United States.

8 Oct 2007

OxyContin drug company sued for millions

A private company in the United States is being sued by a number of counties in the state of Kentucky over the potent painkilling drug OxyContin.

7 Oct 2007

Genzyme receives Japanese marketing approval for Elaprase

Genzyme Corp. has announced that it has received approval to market Elaprase (idursulfase) in Japan for the treatment of Hunter syndrome.

4 Oct 2007

Osteoarthritis drug Prexige withdrawn from Canadian market

Health authorities in Canada have withdrawn the osteoarthritis drug Prexige from the market amid concerns the drug increases the risk for serious liver-related damage including hepatitis.

4 Oct 2007

New FDA program will fast forward generic drug approvals

The Food and Drug Administration (FDA) in the United States has a plan to fast forward it's approval process for generic drugs.

4 Oct 2007

FDA tightens potency specifications to ensure thyroid drugs last

The U.S. Food and Drug Administration is tightening the potency specifications for levothyroxine sodium, used to treat underactive thyroid glands and other thyroid conditions, to ensure the drug retains its potency over its entire shelf life.

4 Oct 2007

Behind-the-counter drugs could be on sale in U.S. pharmacies

The Food and Drug Administration (FDA) in the United states is considering creating a new category of drugs.

3 Oct 2007

Oseltamivir, the active substance in Tamiflu, unchanged through sewage treatment

Swedish researchers have discovered that oseltamivir (Tamiflu); an antiviral drug used to prevent and mitigate influenza infections is not removed or degraded during normal sewage treatment.

3 Oct 2007

Wal-Mart adds 11 generic drugs to discounted prescription drug program

Wal-Mart Stores on Thursday announced that it will begin selling eight additional generic drugs for $4 per 30-day prescription and several family-planning drugs for $9, USA Today reports (Appleby, USA Today, 9/28).

2 Oct 2007

Average premiums for stand-alone Medicare prescription drug plans will increase by 8.7%

Medicare beneficiaries have the ability to switch prescription drug plans, or enroll in the program for the first time, between Nov. 15 and Dec. 31 (Zhang, Wall Street Journal, 9/29). According to CMS spokesperson Tony Salters, about 10% to 15% of Medicare beneficiaries will switch prescription drug plans during the enrollment period (Moos, Dallas Morning News, 9/29).

2 Oct 2007

Early stage drug shows promise against cancer cells from young patients

A new drug has shown promising pre-clinical activity against cells from several types of children's cancers, scientists reveal at the National Cancer Research Institute Conference in Birmingham today (Tuesday).

2 Oct 2007