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Phase III clinical trial results of XIAFLEX published in a journal

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products today announced results of the pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of Dupuytren's disease, was published in today's edition of the New England Journal of Medicine.

4 Sep 2009

FDA review on postmarketing studies for approved drugs and biologics

Makers of approved drugs and biologics generally are meeting their regulatory obligations and complete their postmarketing studies in a timely manner, according to a study released today by the U.S. Food and Drug Administration.

4 Sep 2009

FDA approves new xTAG Cystic Fibrosis 39 Kit v2 from Luminex

Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new cystic fibrosis (CF) test: the xTAG® Cystic Fibrosis 39 Kit v2.

From Thermo Fisher Scientific Inc. 4 Sep 2009

Department of Health's guidance on swine flu vaccination leaves local health chiefs confused

Thousands of frontline health workers in England are trapped in a postcode lottery after Department of Health (DH) guidance on swine flu vaccination has left local health chiefs confused over who is eligible for the jab.

4 Sep 2009

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV- (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

4 Sep 2009

Giant Eagle offers generic prescription antibiotics for free at its in-store pharmacies

At a time when many families affected by a difficult economy are struggling with the costs of prescription medications, supermarket retailer Giant Eagle, Inc. is making ten broadly used generic prescription antibiotics in 46 common dosages available for free every day at all of its 210 in-store pharmacies.

4 Sep 2009

Lawsuits filed against Johnson & Johnson, Ortho-McNeil Pharmaceutical and Walgreen

St. Louis-based law firm Carey & Danis LLC announces the filing of four civil lawsuits on behalf of twenty plaintiffs against Johnson & Johnson (NYSE: JNJ) and Ortho-McNeil Pharmaceutical Inc., the makers of the powerful antibiotic Levaquin, as well as the Walgreen Co. (NYSE:WAG), which sells the drug.

4 Sep 2009

Sodium chloride for treating head lice

At just 31 years of age, and with a first grader in tow, single mom Wendy Langley set out to take on the giants in the head lice industry. The reason? She couldn't, as she says, stand putting a popular but potentially toxic head lice treatment that "smelled like bug spray" on her kid's head to kill lice. Plus, she was constantly terrified the runny liquid would seep into her daughter's eyes.

4 Sep 2009

Acticoat Flex dressings with NUCRYST's SILCRYST nanocrystalline silver coatings launched in Europe

NUCRYST Pharmaceuticals, a developer and manufacturer of medical products that fight infection and the Advanced Wound Management division of Smith Nephew plc announced today the European launch of Acticoat(TM) Flex3 and Acticoat(TM) Flex7. The Flex range is the newest addition to the Acticoat(TM) portfolio of dressings with NUCRYST's proprietary SILCRYST(TM) nanocrystalline silver coatings.

4 Sep 2009

SFDA approves production license for Sinovac's H1N1 vaccine

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the State Food and Drug Administration (SFDA) has approved the registration application for PANFLU.1, Sinovac's H1N1 vaccine, and has issued Sinovac a production license for this vaccine.

4 Sep 2009

ERT celebrates a significant milestone: Completes 150Th QT clinical Trial

ERT (Nasdaq: ERES) has celebrated a significant milestone by completing its 150th thorough QT clinical Trial (TET). ERT provides full TET support to the biopharmaceutical industry, including consultation, study design, and provision of ECG equipment to ECG analysis, data processing, management, reconciliation, reporting, quality control and regulatory support.

4 Sep 2009

Acurox's New Drug Application discussed with the FDA

Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. announced today that they met with the U.S. Food and Drug Administration ("FDA") on September 2, 2009 to discuss the FDA’s June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox (oxycodone HCl and niacin) Tablets CII (NDA).

4 Sep 2009

IND for Cytopia's CYT387 clears the FDA review

Cytopia Limited's Investigational New Drug Application (IND) for CYT387 has passed US Food and Drug Administration (FDA) review. CYT387 is a small-molecule oral JAK1/JAK2 kinase inhibitor designed to treat various haematological disorders.

4 Sep 2009

Two new antibodies for targeting HIV virus discovered

Researchers at and associated with the International AIDS Vaccine Initiative (IAVI), at The Scripps Research Institute, and at the biotechnology companies Theraclone Sciences and Monogram Biosciences have discovered two powerful new antibodies to HIV that reveal what may be an Achilles heel on the virus. They published their work in Science this week.

3 Sep 2009

H1N1 vaccine to cost countries $2.50 - $20 per dose

The H1N1 (swine) flu vaccine will cost countries between $2.50 and $20 per dose, based on their ability to pay, according to the director of the Initiative for Vaccine Research at the WHO, Marie-Paule Kieny, Agence France-Presse/Khaleej Times reports. During an interview published in the September issue of the WHO Bulletin, Kieny "also warned that there would not be enough vaccines for the world's population and that people should not rely entirely on the vaccine," the news service writes (9/2).

3 Sep 2009

Updated Blue Spoon Consulting briefing note available for web download

Blue Spoon Consulting Group, LLC, today updated its briefing note examining the degrading trends in pharmaceutical marketing, and what can be done about it. Available for download through the Blue Spoon Consulting website (www.bluespoonconsulting.com), ‘Pharmaceutical Promotion At Its Productivity Frontier’ is currently the only piece of strategic writing that looks at a total context of change shaping how pharmaceutical companies market and measure performance.

3 Sep 2009

Endo Pharmaceuticals launches VALSTAR for treating recurrent carcinoma in situ bladder tumors

Endo Pharmaceuticals (Nasdaq: ENDP) today announced the availability of VALSTAR(TM) (valrubicin) for the treatment of a distinct form of bladder cancer. VALSTAR is the only FDA-approved intravesical therapy for patients with Bacille Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder for whom immediate removal of the bladder would be associated with unacceptable medical risks.

3 Sep 2009

China Aoxing submits an NDA to the China SFDA for its Codeine Phosphate

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a pharmaceutical company specializing in research, development, manufacturing and marketing of narcotic and pain-management products, today announced that it has submitted a new drug application (NDA) to the China State Food and Drug Administration (SFDA) for its Codeine Phosphate, a compound oral solution for the treatment of acute moderate to severe cough.

3 Sep 2009

China Sky One Medical submits application to perform clinical trials for two new generic drugs

China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that the Company has finished the required research for two new generic drugs for eye treatment and submitted application to the State Food and Drug Administration (SFDA) in China to perform clinical trials.

3 Sep 2009

Criminal pricing of Merck’s HIV/AIDS drug Isentress challenged by the AIDS Healthcare Foundation

As part of its ongoing campaign to lower drug prices and increase access, AIDS Healthcare Foundation (AHF) today unveiled its latest advocacy campaign challenging Merck and Co. Pharmaceuticals over the steep price of its key HIV/AIDS drug, Isentress (raltegravir). The first phase of the public awareness campaign includes a postcard mailer, scheduled to arrive this week in the mailboxes of residents of Whitehouse Station, New Jersey, where Merck is headquartered.

3 Sep 2009

Pharmaceutical News

Phase III clinical trial results of XIAFLEX published in a journal

FDA review on postmarketing studies for approved drugs and biologics

FDA approves new xTAG Cystic Fibrosis 39 Kit v2 from Luminex

Department of Health's guidance on swine flu vaccination leaves local health chiefs confused

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

Giant Eagle offers generic prescription antibiotics for free at its in-store pharmacies

Lawsuits filed against Johnson & Johnson, Ortho-McNeil Pharmaceutical and Walgreen

Sodium chloride for treating head lice

Acticoat Flex dressings with NUCRYST's SILCRYST nanocrystalline silver coatings launched in Europe

SFDA approves production license for Sinovac's H1N1 vaccine

ERT celebrates a significant milestone: Completes 150Th QT clinical Trial

Acurox's New Drug Application discussed with the FDA

IND for Cytopia's CYT387 clears the FDA review

Two new antibodies for targeting HIV virus discovered

H1N1 vaccine to cost countries $2.50 - $20 per dose

Updated Blue Spoon Consulting briefing note available for web download

Endo Pharmaceuticals launches VALSTAR for treating recurrent carcinoma in situ bladder tumors

China Aoxing submits an NDA to the China SFDA for its Codeine Phosphate

China Sky One Medical submits application to perform clinical trials for two new generic drugs

Criminal pricing of Merck’s HIV/AIDS drug Isentress challenged by the AIDS Healthcare Foundation

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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