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FDA approves Perrigo's ANDA for OTC Miconazole Nitrate Vaginal Cream and Suppository

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter (OTC) Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat® -1 Combination Pack. Perrigo expects to begin shipping immediately.

4 Jun 2010

Antiviral drug oseltamivir appears safe and effective for infants hospitalized with influenza: Study

Given promptly, the antiviral drug oseltamivir (Tamiflu) appears safe and effective for infants hospitalized with influenza, reports a study in the June issue of The Pediatric Infectious Disease Journal. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

4 Jun 2010

Amorfix Life Sciences signs licensing agreement with PREVENT

Amorfix Life Sciences Ltd. and Pan-Provincial Vaccine Enterprise Inc. of Saskatoon, Saskatchewan, today announced that the two groups have entered into a licensing agreement granting PREVENT exclusive worldwide rights to Amorfix's lead amyotrophic lateral sclerosis vaccines.

3 Jun 2010

Taro's granisetron tablets receive FDA approval

Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Granisetron Hydrochloride Tablets USP, 1 mg (base) ("granisetron tablets").

3 Jun 2010

Local anesthetics may have potential therapeutic effects on IBD

Inflammatory bowel disease (IBD) is a disease of the gastrointestinal tract, mainly the intestines that may occur in the people who have genetic potential with a contribution of environmental factors.

3 Jun 2010

Bone-strengthening drug zoledronic acid can help fight breast cancer DTCs: Study

The bone-strengthening drug zoledronic acid (Zometa) can help fight metastatic breast cancer when given before surgery, suggests research at Washington University School of Medicine in St. Louis.

3 Jun 2010

Biovail: BLS, Kyowa Hakko Kirin sign license agreement

Biovail Corporation today announced that its subsidiary, Biovail Laboratories International SRL, has entered into a license agreement with Kyowa Hakko Kirin Co., Ltd. BLS has acquired the U.S. and Canadian rights to commercialize products containing istradefylline - a new chemical entity targeted for the treatment of Parkinson's disease.

3 Jun 2010

Medical marijuana hydroponics nutrients receive official US approval

In a landmark decision, Oregon regulators have given first-ever official US approval to a brand of medical marijuana hydroponics nutrients. Oregon and most other states have regulatory agencies that examine fertilizers and hydroponics plant supplements to determine the legitimacy, ingredients and effectiveness of plant growth products.

3 Jun 2010

FDA issues letter directing GSK to revise product labeling for Serevent and Advair

GlaxoSmithKline today announced that it has received a letter from the U.S. Food and Drug Administration directing revisions to product labeling for its respiratory products Serevent and Advair. The letter concludes discussions between GSK and the agency following FDA advisory committee meetings regarding the safety profile of long-acting beta2-agonists in the treatment of asthma, including salmeterol, the active ingredient in Serevent and one of the active ingredients in Advair.

3 Jun 2010

Motavizumab should not be licensed for marketing: FDA Antiviral Drugs Advisory Committee

MedImmune today announced that the U.S. Food and Drug Administration's Antiviral Drugs Advisory Committee has voted 14 to 3 to recommend that motavizumab should not be licensed for marketing regarding the prevention of serious respiratory syncytial virus disease in high-risk infants.

3 Jun 2010

ACT Biotech's Telatinib receives orphan drug designation from FDA for treatment of gastric cancer

ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, announced today that the company's highly selective oral kinase inhibitor, Telatinib, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of gastric cancer.

3 Jun 2010

Insulin pills to manage diabetes are finally moving ahead in clinical trials

After years of research and anticipation, insulin pills that could make it easier for millions of patients worldwide to manage diabetes are finally moving ahead in clinical trials and a step-closer to the medicine cabinet. That's among the topics highlighted in a two-part cover story on drug manufacturing in the current issue of Chemical & Engineering News, ACS' weekly newsmagazine.

3 Jun 2010

FDA accepts Eisai's NDA for rabeprazole sodium extended-release 50 mg

Eisai Inc. (Headquarters: Woodcliff Lake, NJ; Chairman and CEO: Hajime Shimizu), a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo; President and CEO: Haruo Naito) today announced that the U.S. Food and Drug Administration has accepted Eisai's New Drug Application for rabeprazole sodium extended-release 50 mg for the healing and maintenance of healing of erosive gastroesophageal reflux disease, and for the treatment of symptomatic GERD.

3 Jun 2010

Experts call on EU Parliament to ensure widespread benefits of nanomedicine

Experts from key EU projects united in Brussels at Nanomedicine in Europe today to deliver a strong message to the European Parliament that concerted and coordinated action is needed to ensure the widespread benefits offered by advances in nanomedicine are not squandered.

3 Jun 2010

New oral blood-thinning drugs may have dangerous interactions when taken with prescription drugs : Study

Three new oral blood-thinning drugs nearing approval by the Food and Drug Administration are more convenient than the standard drug Coumadin® because they do not require monthly visits to adjust doses.

2 Jun 2010

Competitive Technologies to raise over $5M to accelerate sales of Calmare Pain Therapy Treatment

Competitive Technologies, Inc. today announced that it has signed an agreement to raise over $5 million by selling 2 million shares of equity to Crisnic Fund, S.A. based on a 15% discount from the volume weighted average price on the date the SEC declares the registration effective, as detailed in the 8-K being filed today.

2 Jun 2010

Perrigo acquires rights to Novel Laboratories' pending ANDA for HalfLytely and Bisacodyl Tablets Bowel Prep Kit

Perrigo Company announced on May 26, 2010 that it had acquired rights to Novel Laboratories' pending ANDA for HalfLytely® and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets).

2 Jun 2010

Oculus launches Microcyn Negative-Pressure Wound Therapy Solution

Oculus Innovative Sciences, Inc., a commercial medical technology company that designs, produces and markets safe and effective tissue care products based upon the Microcyn® Technology platform, today introduced the Microcyn Negative-Pressure Wound Therapy Solution™ for the U.S. professional healthcare market. Within the pH ranges of 6-7.8 desired for optimum negative-pressure wound therapy, Microcyn is intended for the irrigation and management of wounds via these advanced systems.

2 Jun 2010

Barriers, misinformation still prevent many from seeking flu protection for their families: Canadian Flu Report

According to the Canadian Flu Report released today, 40 per cent of parents are now more interested in vaccinating themselves and their children against seasonal flu following last year's H1N1 outbreak. Yet, significant barriers and misinformation are still preventing many from actually seeking proper flu protection for their families.

2 Jun 2010

Aspirin may not be beneficial for young adults with diabetes

Experts are now recommending that low-dose aspirin therapy to prevent heart attacks be used somewhat more conservatively - that men younger than 50 and women younger than 60, who have diabetes but no other major risk factors, probably not use aspirin.

2 Jun 2010

Pharmaceutical News

FDA approves Perrigo's ANDA for OTC Miconazole Nitrate Vaginal Cream and Suppository

Antiviral drug oseltamivir appears safe and effective for infants hospitalized with influenza: Study

Amorfix Life Sciences signs licensing agreement with PREVENT

Taro's granisetron tablets receive FDA approval

Local anesthetics may have potential therapeutic effects on IBD

Bone-strengthening drug zoledronic acid can help fight breast cancer DTCs: Study

Biovail: BLS, Kyowa Hakko Kirin sign license agreement

Medical marijuana hydroponics nutrients receive official US approval

FDA issues letter directing GSK to revise product labeling for Serevent and Advair

Motavizumab should not be licensed for marketing: FDA Antiviral Drugs Advisory Committee

ACT Biotech's Telatinib receives orphan drug designation from FDA for treatment of gastric cancer

Insulin pills to manage diabetes are finally moving ahead in clinical trials

FDA accepts Eisai's NDA for rabeprazole sodium extended-release 50 mg

Experts call on EU Parliament to ensure widespread benefits of nanomedicine

New oral blood-thinning drugs may have dangerous interactions when taken with prescription drugs : Study

Competitive Technologies to raise over $5M to accelerate sales of Calmare Pain Therapy Treatment

Perrigo acquires rights to Novel Laboratories' pending ANDA for HalfLytely and Bisacodyl Tablets Bowel Prep Kit

Oculus launches Microcyn Negative-Pressure Wound Therapy Solution

Barriers, misinformation still prevent many from seeking flu protection for their families: Canadian Flu Report

Aspirin may not be beneficial for young adults with diabetes

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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