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FDA issues Complete Response Letter for CERTRIAD NDA

AstraZeneca and Abbott announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the New Drug Application (NDA) for CERTRIAD™ (rosuvastatin / fenofibric acid delayed release) Capsules.

31 Mar 2010

Access Pharmaceuticals, bioRASI sign collaborative agreement to develop Cobalamin oral insulin product

ACCESS PHARMACEUTICALS, INC. signed a collaborative development agreement with bioRASI, LLC, a full-service global CRO specializing in the accelerated development of novel therapeutics, to facilitate clinical development for its Cobalamin™-based oral insulin and other Cobalamin-based products.

31 Mar 2010

Ikaria Holdings acquires NDA and IND application for LUCASSIN drug

Ikaria Holdings, Inc. announced today that it has acquired the New Drug Application (NDA) and the Investigational New Drug (IND) application to LUCASSIN® (terlipressin for injection) from Orphan Therapeutics, assuming all future development and ownership of the drug in North America and Australia.

31 Mar 2010

Hospira acquires Orchid's injectables formulations business

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced it has completed the acquisition of the generic injectable pharmaceuticals business of Orchid Chemicals & Pharmaceuticals Ltd., a leading Indian pharmaceuticals company, for approximately $400 million.

31 Mar 2010

Savient Pharmaceuticals' resubmission of BLA for KRYSTEXXA accepted for FDA review

Savient Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has acknowledged receipt of and accepted for review the March 15, 2010 resubmission of the Biologics License Application for KRYSTEXXA™ (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy.

30 Mar 2010

Mood altering effects of Phenytoin

Phenytoin is a well known antiepileptic agent widely used throughout the world. Recent clinical studies in patients with bipolar disorder have suggested that, as for other anticonvulsant drugs commonly used in the treatment of bipolar patients including valproate and carbamazepine, phenytoin may have mood-stabilizing effects in addition to its well-known anticonvulsant properties.

30 Mar 2010

Wellness Formulations introduces Dermal Renu Sunshield

Wellness Formulations, LLC, a leader in anti-glycation research and product development, has launched Dermal Renu® Sunshield daily wear SPF 15 sunscreen. This mineral based sunscreen provides broad-spectrum protection from sun damage caused by UVA/UVB rays, while fighting the signs of aging through a unique combination of anti-glycation agents, antioxidants, moisturizing elements, peptides, and botanical extracts.

30 Mar 2010

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

30 Mar 2010

Britain popping “pills for every ill”, says research

A new study reports that Britons are turning to prescription drugs for every illness, minor or major. This recent paper titled “A Pill for Every Ill”, published in Social Science & Medicine journal says that while two decades earlier average number of prescriptions dispensed per person was only eight, it is more than 16 now.

30 Mar 2010

GSK re-submits sNDA for Avodart to FDA

GlaxoSmithKline announced today that it has re-submitted the supplemental New Drug Application for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease to the US Food and Drug Administration.

30 Mar 2010

NICE appraisal committee publishes preliminary recommendation of Multaq for AF

Sanofi-aventis announced today that the National Institute for Health and Clinical Excellence (NICE) in England and Wales, has just published a new appraisal consultation document for Multaq(R) (dronedarone) indicating its intention to recommend Multaq(R) use for the management of patients with atrial fibrillation.

30 Mar 2010

Decision Resources: Only 52.2% of first-line Alzheimer's disease patients prescribed AChEI

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that while approximately 70 percent of surveyed physicians' newly diagnosed patients have mild-to-moderate Alzheimer's disease, only 52.2 percent of first-line patients are prescribed an acetylcholinesterase inhibitor.

30 Mar 2010

Preclinical study of DAS181 for treatment and prevention of ILI published

NexBio, Inc. announced today the publication in the Journal of Infectious Diseases of a preclinical study suggesting that treatment with DAS181 (Fludase®) may reduce the risk of secondary bacterial pneumonia following influenza virus infection.

30 Mar 2010

Potential new target for treating HCV infection

A team of scientists including University of Utah researchers has discovered that binding of a potent inhibitor of the hepatitis C virus to the genetic material of the virus causes a major conformational change that may adversely affect the ability of the virus to replicate.

30 Mar 2010

Cangene extends botulism antitoxin contract with BARDA

Cangene Corporation today reports that it has signed a no-cost modification to extend its botulism antitoxin contract with the Biomedical Advanced Research and Development Authority ("BARDA"). BARDA is the department within the U.S. Department of Health and Human Services that manages the two biodefence-related, stockpiling contracts Cangene has with HHS.

30 Mar 2010

Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

Cephalon, Inc. today announced the company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL® (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

30 Mar 2010

Alcon acquires right to market DUREZOL ophthalmic corticosteroid in U.S.

Alcon, the world's leader in eye care, announced today that it received regulatory approval and finalized the acquisition of the rights in the United States for DUREZOL™ emulsion and the global rights, excluding Latin America, for ZYCLORIN™ from Sirion Therapeutics, Inc.

30 Mar 2010

GSK offers free vaccines for low income adults without insurance coverage

GlaxoSmithKline today announced the launch of the GSK Vaccines Access Program, which will provide the company's adult vaccines free of charge to eligible, low income individuals who do not have insurance coverage for vaccines. The program will cover the company's FDA-approved vaccines for Hepatitis A, Hepatitis B, tetanus, diphtheria, and pertussis for eligible persons ages 19 and older.

29 Mar 2010

Generex Biotechnology announces FDA Expanded Access Treatment IND Program for Generex Oral-lyn

Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has expanded its plans for its United States Food and Drug Administration (FDA) Expanded Access Treatment IND Program for its flagship product, Generex Oral-lyn™, to include licensed and qualified Nurse Practitioners in the United States.

29 Mar 2010

Oxygen Biotherapeutics commences distributing newly formulated Dermacyte Oxygen Concentrate

Oxygen Biotherapeutics, Inc. today announced that the company has begun distribution for its newly formulated Dermacyte™ Oxygen Concentrate for the beauty and skin care market. The over-the-counter product is a scientifically designed perfluorocarbon concentrate to enhance oxygen delivery to skin.

29 Mar 2010