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FDA advisory committee to dscuss PMA for Genzyme's Synvisc-One

Genzyme Corporation has announced that its Premarket Approval (PMA) application supplement for Synvisc-One (hylan G-F 20) will be discussed this Tuesday, December 9th, at a public meeting of the FDA's Orthopaedic and Rehabilitation Devices Advisory Committee in Gaithersburg, Maryland.

8 Dec 2008

FDA advisory committee recommends approval for Bausch & Lomb's besifloxacin ophthalmic suspension

The U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee today voted unanimously to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis.

8 Dec 2008

Azur Pharma to acquire U.S. rights to Elestrin

Azur Pharma Limited has announced that it has entered into a definitive agreement with BioSante Pharmaceuticals, Inc to acquire U.S. rights to Elestrin.

8 Dec 2008

Anti-seizure drug Epilim shows promise for Alzheimer's

A drug commonly used to treat epilepsy could help clear the plaques in the brain associated with Alzheimer's disease, according to researchers at the University of Leeds. The plaques are known to lead to the progressive death of nerve cells in the brain linked to many forms of dementia.

8 Dec 2008

Good advice to cut prescription drug costs

Just like saving money on groceries or finding the best deal on gas, smart consumers can cut their prescription drug costs with just a little bit of work, say pharmacists at the University of North Carolina at Chapel Hill.

3 Dec 2008

NicOx signs agreement with DSM for the commercial manufacture of naproxcinod drug substance

NicOx S.A. has announced it has signed an agreement with DSM for the commercial manufacture and supply of naproxcinod drug substance (or API, active pharmaceutical ingredient).

3 Dec 2008

Mylan settles with Novartis on Femara

Mylan Inc. has announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis' Femara.

3 Dec 2008

Patient safety compromised with faster drug approvals

With new drugs being reviewed by regulatory agencies and then released onto the market faster than ever before, patients' safety is being compromised, warns a study published on bmj.com.

3 Dec 2008

Generics as good as brand-name drugs when treating heart diseases

Contrary to the perception of some patients and physicians, there is no evidence that brand-name drugs are clinically superior to their generic counterparts, according to an article in the December 3 issue of JAMA, which examined studies comparing the effectiveness of generic vs. brand-name drugs for treating cardiovascular diseases.

3 Dec 2008

Antineoplaston treatment for gliomas granted orphan drug designation by FDA

The Burzynski Research Institute, Inc. (BRI) has announced that its antineoplaston A10 and antineoplaston AS2-1 therapy (ANP) has been granted orphan drug designation by the U.S. Food and Drug Administration ("FDA") for the treatment of gliomas. It is estimated that in 2008 more than 21,000 men and women in the U.S. will be diagnosed with this type of cancer, with prevalence estimated at approximately 84,000 cases.

2 Dec 2008

WHO says governments must do more to improve access to essential medicines

An alarming lack of availability of essential medicines in the public sector drives patients to pay higher prices in the private sector or go without, according to a WHO study reported in the online edition of The Lancet. The results confirm that governments must do more to improve access to essential medicines as part of their efforts to make national health systems more efficient and equitable.

2 Dec 2008

Warning of serious side-effects of quit-smoking drug Champix

Australian doctors have been warned about the the quit-smoking drug Champix, according to the Therapeutic Goods Administration (TGA) care must be taken when prescribing Champix (varenicline), because of possible serious side-effects.

2 Dec 2008

ViroPharma Inc. submits sBLA for Cinryze to treat acute attacks of hereditary angioedema

ViroPharma Inc. has announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Cinryze C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema (HAE).

1 Dec 2008

New cream for vaginal dryness approved

Barr Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Synthetic Conjugated Estrogens-A (SCE-A) 0.625 mg/g Vaginal Cream.

1 Dec 2008

FDA accepts Zevalin supplemental biologics license application

Cell Therapeutics, Inc. (CTI) has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review, and has granted priority review status for, the supplemental Biologics License Application (sBLA) for use of Zevalin ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need.

1 Dec 2008

Anadys Pharmaceuticals receives fast track for ANA598 treatment of chronic hepatitis C virus

Anadys Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to ANA598 for the treatment of chronic hepatitis C virus (HCV) infection. ANA598 is Anadys' investigational hepatitis C non-nucleoside polymerase inhibitor.

1 Dec 2008

Eli Lilly withdraws application for additional U.S. indication for Cymbalta for chronic pain

Eli Lilly and Company has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta (duloxetine HCl) for the management of chronic pain.

30 Nov 2008

Watson Pharmaceuticals receives FDA approval for generic Wellbutrin XL

Watson Pharmaceuticals, Inc. has announced that its subsidiary, Watson Laboratories, Inc., has received final approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength.

26 Nov 2008

Sun Pharma acquires Chattem Chemicals, Inc

Sun Pharmaceutical Industries Ltd. has announced that its fully owned US subsidiary, Sun Pharmaceutical Industries, Inc., has acquired 100% ownership of Chattem Chemicals, Inc. (Chattem) from Elcat, Inc,.

26 Nov 2008

Generic drug competition benefits Ontarians

Following yesterday's release of the Competition Bureau's report, "Benefiting from Generic Drug Competition in Canada: The Way Forward," the Ontario Pharmacists' Association (OPA) is emphasizing that competition in the generic drugs industry is already benefiting Ontarians through accessible, high quality, cost-effective professional pharmacy care.

26 Nov 2008