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CeloNova BioSciences submits a request for approval of its new Embozene Microsphere

CeloNova BioSciences today announced that the company is submitting to its European Notified Body a request for approval of its new, lime green, 2800 micron size Embozene(TM) Microsphere.

31 Oct 2009

Replenish+ delays the progression of AIDS in HIV-infected patients not receiving ART

Data presented today from a 310 patient, 52 week, double-blind, controlled clinical trial demonstrates that a micronutrient supplement, Replenish+™ delays the progression of AIDS in HIV-infected patients not receiving antiretroviral treatment (ART).

31 Oct 2009

Revised standards for four ingredients widely used in prescription and over-the-counter drugs announced

To further protect patients from adulterated medicines, the U.S. Pharmacopeial Convention (USP) today announced revised standards for four ingredients widely used in prescription and over-the-counter drugs.

31 Oct 2009

Procter & Gamble's Vicks products containing vitamin C being marketed unlawfully, FDA warns

The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.

31 Oct 2009

FDA approves Covidien's Abbreviated New Drug Application for CII

Covidien, a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

31 Oct 2009

Women may need smaller dose of H1N1 vaccine

THE emergence of the H1N1 swine flu has added urgency to what has become an annual ritual for millions of Americans: getting a flu shot. The good news is that scientists have developed a vaccine against the H1N1 virus. But it is taking much longer than expected to produce the hundreds of millions of doses the government had planned to distribute. And it is still too soon to know how effective the vaccine will be in preventing swine flu.

31 Oct 2009

FDA-approved drug PEG-ADA shows positive results in relieving major complication of priapism

Thousands of men are afflicted with an embarrassing and painful condition that triggers spontaneous, long-lasting erections. There are limited treatment options, but a solution could be on the way thanks to new research at The University of Texas Health Science Center at Houston.

31 Oct 2009

FDA approves an expanded indication for BYETTA injection

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes.

31 Oct 2009

Data from multiple clinical and preclinical studies evaluating Hematide announced

Affymax, Inc. and Takeda Pharmaceutical Global Research & Development Center, Inc., today announced data from multiple clinical and preclinical studies evaluating Hematide, including preliminary results of a Phase 2 trial which demonstrated that Hematide increased hemoglobin levels in a group of anemic hemodialysis (HD) patients.

31 Oct 2009

China Medicine announces acquisition of Guangzhou LifeTech Pharmaceuticals

China Medicine Corporation, a developer and leading distributor of prescription and over-the-counter pharmaceuticals, traditional Chinese medicines ("TCM"), nutritional and dietary supplements, and medical devices and medical formulations, today announced that through its wholly-owned subsidiary in China, Konzern Pharmaceuticals, it has signed an equity transfer agreement (the "Transfer Agreement") to acquire 100% of equity interests in Sinoform Limited.

30 Oct 2009

Impax Laboratories initiates patent challenge for TRICOR

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICOR® (fenofibrate) tablets, 48 mg and 145 mg.

30 Oct 2009

VIA Pharmaceuticals to discuss its cardio-metabolic product portfolio at the Target 2009 conference

VIA Pharmaceuticals, Inc., a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic diseases, today announced that Dr. Rebecca Taub, Senior Vice President Research & Development will present "Liver Directed Beta Agonist for Targeting Cardiometabolic Disease", and will discuss the Company's cardio-metabolic product portfolio, including VIA's inhibitor of 5 Lipoxygenase, its THR Beta Agonist, and its DGAT1 development programs, at the Cambridge Healthtech Institute Seventh International Discovery on Target 2009 program, on November 3, 2009 in Boston, MA.

30 Oct 2009

Health officials stress the need for continued prevention efforts in view of H1N1 vaccine delay

Responding to delays in the nationwide distribution H1N1 flu vaccine, Department of Health officials today urged Pennsylvanians to continue to take steps to prevent the spread of illness.

30 Oct 2009

Trusted Process thought leaders at INC Research named winners at the 2009 Clinical Research Excellence Awards

INC Research®, Inc., a therapeutically focused contract research organization (CRO) with a process for delivering reliable results, is pleased to announce that Trusted Process® thought leaders at INC Research were named winners at the 2009 Clinical Research Excellence Awards in London on October 20.

30 Oct 2009

Mollen Immunization Clinics sets US record for administering 14,000 vaccinations in a single event

With just 36 hours notice from the Maricopa County Department of Public Health, Mollen Immunization Clinics administered over 14,000 vaccinations to high-risk groups throughout the county, one of the nation's largest with a population of four million residents.

30 Oct 2009

Patients on immunosuppressant medication can receive H1N1 vaccine in the form of shots

The Centers for Disease Control and Prevention (CDC) have classified all children, 6-months to 24-years, one of the high risk groups for contracting the H1N1 (swine) flu, and recommend this population receive the H1N1 vaccine for immunity against the disease.

30 Oct 2009

36 individuals in Kentucky face federal prescription pill charges

The U.S. Attorney's Office announced today that 36 individuals face various federal prescription pill charges as part of the largest drug sweep operation in Kentucky's history.

30 Oct 2009

Mintel predicts increased sales of OTC drugs in upcoming months

Autumn has arrived in the northern hemisphere and with shades of yellow and orange comes a less-welcome visitor: cold and flu season. Made worse this year by the H1N1 (swine flu) pandemic, people around the world are flocking to drugstores and supermarkets to stock up on over-the-counter (OTC) medicine, says market research firm Mintel.

30 Oct 2009

Clinical data on the validation set 'Alzheimer patients versus healthy controls' for AclarusDx presented

ExonHit Therapeutics yesterday presented clinical data on the validation set “Alzheimer patients versus healthy controls” for AclarusDx™ (formerly EHT Dx21), its blood-based diagnostic test for the detection of Alzheimer’s disease (AD), at the 2nd Conference of Clinical Trials on Alzheimer’s Disease (CTAD) in Las Vegas, USA.

30 Oct 2009

ARYx Therapeutics to complete an out-licensing agreement for clinical development and commercialization of budiodarone

ARYx Therapeutics, Inc., a biopharmaceutical company, today announced that it has implemented a staffing plan to operate the company that anticipates licensing its lead development programs and resuming development of earlier stage product candidates.

30 Oct 2009

Pharmaceutical News

CeloNova BioSciences submits a request for approval of its new Embozene Microsphere

Replenish+ delays the progression of AIDS in HIV-infected patients not receiving ART

Revised standards for four ingredients widely used in prescription and over-the-counter drugs announced

Procter & Gamble's Vicks products containing vitamin C being marketed unlawfully, FDA warns

FDA approves Covidien's Abbreviated New Drug Application for CII

Women may need smaller dose of H1N1 vaccine

FDA-approved drug PEG-ADA shows positive results in relieving major complication of priapism

FDA approves an expanded indication for BYETTA injection

Data from multiple clinical and preclinical studies evaluating Hematide announced

China Medicine announces acquisition of Guangzhou LifeTech Pharmaceuticals

Impax Laboratories initiates patent challenge for TRICOR

VIA Pharmaceuticals to discuss its cardio-metabolic product portfolio at the Target 2009 conference

Health officials stress the need for continued prevention efforts in view of H1N1 vaccine delay

Trusted Process thought leaders at INC Research named winners at the 2009 Clinical Research Excellence Awards

Mollen Immunization Clinics sets US record for administering 14,000 vaccinations in a single event

Patients on immunosuppressant medication can receive H1N1 vaccine in the form of shots

36 individuals in Kentucky face federal prescription pill charges

Mintel predicts increased sales of OTC drugs in upcoming months

Clinical data on the validation set 'Alzheimer patients versus healthy controls' for AclarusDx presented

ARYx Therapeutics to complete an out-licensing agreement for clinical development and commercialization of budiodarone

Redefining control and consistency in anaerobic microbiome workflows

AI in Healthcare: How generative tools are transforming clinical practice

The future of automation: Machine learning–driven hepatocyte and organoid counting

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