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DNA vaccines may offer hope in multiple sclerosis

Authors from the VA North Texas Health Care System Neurology Section and the Department of Neurology at the University of Texas Southwestern Medical Center at Dallas have highlighted the potential benefits for DNA-based vaccine administration in patients with multiple sclerosis (MS).

24 Apr 2008

Tredaptive and Janumet recommended for approval in European Union

Food and Drug Administration (FDA) is currently reviewing the combination of extended release (ER) niacin and laropiprant under the trademark Cordaptive (ER niacin/laropiprant). The CHMP recommendation does not apply to regulatory decisions by the FDA and no inferences should be made about pending FDA regulatory actions based on the recommendation of the CHMP.

24 Apr 2008

FDA approves Relistor for opioid-induced constipation - helps reduce effects of drugs like morphine on bowel function

The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

24 Apr 2008

Former Bristol-Myers Squibb exec indicted for lying about Plavix blood-thinning drug

The Department of Justice announced today that the former senior vice president of Bristol-Myers Squibb Company (BMS), Andrew Bodnar, was indicted for his role in lying to the federal government about a patent deal involving the popular blood-thinning drug, Plavix, used by heart attack, stroke and other patients.

23 Apr 2008

Medicare prescription drug benefit improved access to medications for most seniors, but sickest seniors continued skipping pills because of cost issues, study finds

The percentage of seniors who said they skipped taking medications because of costs declined after the Medicare prescription drug benefit took effect in January 2006, but the sickest beneficiaries still skip prescriptions because they cannot afford to pay for them, according to a study published Wednesday in the Journal of the American Medical Association, Reuters reports.

23 Apr 2008

NACDS seeks passage of E-prescribing bill to finance Medicaid reimbursement rule change

National Association of Chain Drug Stores CEO Steven Anderson on Tuesday in a letter asked lawmakers to pass a bill (HR 4296) that would require physicians who participate in Medicare to adopt e-prescribing by 2011 to finance legislation (S 1951, HR 3700) that would revise a new rule related to Medicaid reimbursements to pharmacies, CongressDaily reports (Edney, CongressDaily, 4/23).

23 Apr 2008

FDA cannot properly inspect foreign companies that manufacture medications, medication ingredients, report finds

FDA does not have adequate resources to inspect foreign companies that manufacture medications or medication ingredients, and current funding levels for the agency will not address the issue, according to a Government Accountability Office report presented on Tuesday at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee, the Newark Star-Ledger reports.

23 Apr 2008

Biopharmaceutical spin-out company Domainex, secures funding

Headquartered in London, Domainex is a contract research company specialising in the provision of structural biology and chemistry services to major pharmaceutical and biotechnology firms. The Company is also developing a pipeline of pre-clinical drugs and targets.

From Domainex 23 Apr 2008

MacroChem acquires Virium Pharmaceuticals

MacroChem Corporation announced today that on April 18, 2008 it acquired Virium Pharmaceuticals Inc., a non-public, development stage company developing and commercializing novel therapeutics, with a portfolio of clinical stage product candidates focused in oncology, including its next generation nucleoside analogue licensed from the Southern Research Institute.

23 Apr 2008

Sickest patients still struggle under new Medicare Part D benefit

A recent study finds that the advantages of the new Medicare Part D drug benefit-a program that for the first time offers Medicare recipients prescription drug coverage-are mixed.

22 Apr 2008

Still lack of knowledge regarding Medicare's Part D prescription drug program

There still appears to be some lack of knowledge regarding Medicare's Part D prescription drug program, although there is evidence that cost-related medication nonadherence may have improved overall, according to two studies in the April 23/30 issue of JAMA, the Journal of the American Medical Association.

22 Apr 2008

GlaxoSmithKline to acquire Sirtris Pharmaceuticals

GlaxoSmithKline and Sirtris Pharmaceuticals Incorporated announced today that they have entered into a definitive agreement pursuant to which GlaxoSmithKline will acquire Sirtris Pharmaceuticals for approximately USD720 million (or approx. GBP362 million) through a cash tender offer of USD22.50 (or approx. GBP11.33) per share.

22 Apr 2008

Taro Pharmaceutical receives final FDA approval for Cetirizine Hydrochloride oral solution

Taro Pharmaceutical Industries Ltd. reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride oral solution, 1 mg / 1 mL ("Cetirizine Oral Solution").

22 Apr 2008

FDA approves Cimzia as treatment for Crohn's disease

A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide.

22 Apr 2008

Lorus initiates development program exploring novel route of administration for LOR-2040

Lorus Therapeutics Inc. today announced the start of a development program aimed at expanding the therapeutic application of its lead clinical-stage drug LOR-2040 for the treatment of superficial bladder cancer.

22 Apr 2008

U.S. and China at loggerheads over contaminated Heparin

Health officials in the U.S. appear to be at loggerheads with Chinese officials over the contamination of the blood-thinning drug Heparin.

22 Apr 2008

New York Times examines opposition to proposed off-label promotion guidelines amid allegations of ghostwriting

The New York Times on Saturday examined how a recent report indicating that Merck used "ghostwriters" to produce medical journal articles in support of the COX-2 inhibitor Vioxx "has galvanized opponents to a federal proposal that would relax some restrictions on drug promotion" in the U.S.

21 Apr 2008

New York Times examines increasing prices of specialty drugs distributed exclusively by pharmacy benefit managers

The New York Times on Saturday examined how pharmacy benefit managers in recent years "have built lucrative side businesses ... acting as exclusive or semi-exclusive distributors of expensive specialty drugs."

21 Apr 2008

BioAlliance Pharma announces preliminary results from U.S. phase III trial for Loramyc

BioAlliance Pharma SA today announced the preliminary positive results for its US pivotal Phase III clinical trial with Loramyc (miconazole Lauriad), Mucoadhesive Buccal Tablets (MBT) developed for the treatment of OroPharyngeal Candidiasis in immunocompromised population. This trial was conducted to support an NDA filing to market the product in the US.

21 Apr 2008

Orphan Europe files NDA with FDA for Carbaglu (carglumic acid)

Recordati announced the submission to the U.S. FDA by Orphan Europe (a Recordati group company) of an Original New Drug Application (NDA) for Carbaglu (carglumic acid).

21 Apr 2008

Pharmaceutical News

DNA vaccines may offer hope in multiple sclerosis

Tredaptive and Janumet recommended for approval in European Union

FDA approves Relistor for opioid-induced constipation - helps reduce effects of drugs like morphine on bowel function

Former Bristol-Myers Squibb exec indicted for lying about Plavix blood-thinning drug

Medicare prescription drug benefit improved access to medications for most seniors, but sickest seniors continued skipping pills because of cost issues, study finds

NACDS seeks passage of E-prescribing bill to finance Medicaid reimbursement rule change

FDA cannot properly inspect foreign companies that manufacture medications, medication ingredients, report finds

Biopharmaceutical spin-out company Domainex, secures funding

MacroChem acquires Virium Pharmaceuticals

Sickest patients still struggle under new Medicare Part D benefit

Still lack of knowledge regarding Medicare's Part D prescription drug program

GlaxoSmithKline to acquire Sirtris Pharmaceuticals

Taro Pharmaceutical receives final FDA approval for Cetirizine Hydrochloride oral solution

FDA approves Cimzia as treatment for Crohn's disease

Lorus initiates development program exploring novel route of administration for LOR-2040

U.S. and China at loggerheads over contaminated Heparin

New York Times examines opposition to proposed off-label promotion guidelines amid allegations of ghostwriting

New York Times examines increasing prices of specialty drugs distributed exclusively by pharmacy benefit managers

BioAlliance Pharma announces preliminary results from U.S. phase III trial for Loramyc

Orphan Europe files NDA with FDA for Carbaglu (carglumic acid)

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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