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Pfizer’s Prevenar 13 gets US approval for adults

Health authorities of United States have approved the expansion of Pfizer Inc's Prevnar vaccine for use in adults 50 and older to fight pneumonia, meningitis and other diseases cause by pneumococcus bacteria. The vaccine, which had been approved for children in the United States, is already one of Pfizer's biggest brands and an expanded population of adults could generate more than $1.5 billion in annual sales.

2 Jan 2012

FDA notes shortage of ADHD medicines

According to the U.S. Food and Drug Administration (FDA) drugs to treat attention deficit hyperactivity disorder (ADHD) are in such short supply that hundreds of patients complain daily to the agency that they are unable to find a pharmacy with enough pills to fill their prescriptions.

2 Jan 2012

Similar sounding drug names should come with warnings

There have been mix ups and medication errors with similar sounding names of drugs - eye drops called Durezol and salicylic acid-containing wart remedy Duresal for example.

1 Jan 2012

FDA approves Prevnar 13 pneumococcal conjugate vaccine for adults 50 and older

Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

31 Dec 2011

HimalayaUSA recalls two batches of Organique by Himalaya Nourishing Night Cream

HimalayaUSA announced today it is conducting a voluntary recall of Organique by Himalaya Nourishing Night Cream with batch #S691001 and batch #S691002 effective immediately.

31 Dec 2011

ProStrakan announces FDA approval for Transmucosal Immediate Release Fentanyl REMS Access program

ProStrakan, Inc., a subsidiary of Kyowa Hakko Kirin Co. Ltd., and an international specialty pharmaceutical company, today announces that the U.S. Food and Drug Administration has approved the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access program.

31 Dec 2011

ARCA biopharma extends pharmacogenetic intellectual property protection around bucindolol

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Patent and Trademark Office has issued a patent on methods for treating patients with bucindolol based on genetic targeting and focused on a specific genotype - homozygous wildtype for Deletion 322-325 in the alpha-2C adrenergic receptor.

31 Dec 2011

FDA approves Pfizer's Prevnar 13 pneumococcal conjugate vaccine as a single dose for adults

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the Company's pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults.

31 Dec 2011

Patented ribose for food, beverage and supplement applications

Since 2008, the sales of ribose as an energy supplement increased by over 85%. This in conjunction with $9 billion sales of functional energy drinks in 2011 suggests that demand has never been higher for ingredients with a wide array of applications in functional food and beverage industries. Enter Bioenergy Ribose – the Superior Energy Ingredient.

31 Dec 2011

No Cronobacter detected in Mead Johnson products

Mead Johnson Nutrition was notified today by the United States Food & Drug Administration and the Centers for Disease Control that health inspectors have completed their testing on all formula samples collected from the company. These tests confirmed that the Mead Johnson products were safe, and no presence of Cronobacter was detected.

31 Dec 2011

Single shared REMS for TIRF products receives FDA approval

The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system.

30 Dec 2011

Avastin fails to live up to expectations for extending survival in ovarian cancer

Cancer drug Avastin has been found to add about four months to the time it takes for the cancer to worsen for women with advanced cases of ovarian cancer says a new report. However it may not extend survival significantly.

29 Dec 2011

Bevacizumab delays disease progression in ovarian cancer

Treating ovarian cancer with the drug bevacizumab ("Avastin") delays the disease and may also improve survival, show the results of an international clinical trial co-led by Drs. Amit Oza of the Princess Margaret Cancer Program, University Health Network and Timothy Perren, St James's Institute of Oncology, Leeds, UK.

29 Dec 2011

Powerful painkiller on its way to the market: Experts worry about addiction woes

Drug makers are on their way to a pure, more powerful version of the nation’s second most-abused medicine, which has addiction experts worried that it could spur a new wave of abuse. The new pills contain the highly addictive painkiller hydrocodone, packing up to 10 times the amount of the drug as existing medications such as Vicodin.

28 Dec 2011

Mylan receives final FDA approval for Levetiracetam ER Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Extended-release (ER) Tablets, 500 mg and 750 mg.

28 Dec 2011

Mylan receives final FDA approval for Eprosartan Mesylate ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base).

28 Dec 2011

Perrigo receives final approval from FDA for Desloratadine ANDA

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Desloratadine tablets.

27 Dec 2011

Eisai resubmits NDA for perampanel to treat epilepsy-associated seizures

Eisai Inc. announced today that it resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the U.S. Food and Drug Administration (FDA) on December 22, 2011.

26 Dec 2011

Synthetic drugs treat Crohn's disease in mice

A team of Weizmann Institute scientists has turned the tables on an autoimmune disease. In such diseases, including Crohn's and rheumatoid arthritis, the immune system mistakenly attacks the body's tissues. But the scientists managed to trick the immune systems of mice into targeting one of the body's players in autoimmune processes, an enzyme known as MMP9.

26 Dec 2011

AJHP examines pharmacists' prescribing medications in current issue

Pharmacists' prescribing medications is a topic often discussed when health policy experts explore how to improve patient safety, medication-use outcomes, and access to medical services.

26 Dec 2011