Pharmaceutical News

RSS

Star Scientific seeks FDA approval of Stonewall-BDL as "modified risk tobacco product"

Star Scientific, Inc. announced that on Friday, June 18 the company filed an application with the Food & Drug Administration for approval to market Stonewall-BDL™ as a "modified risk tobacco product" under the Family Smoking Prevention and Tobacco Control Act of 2009. This is Star's second such application to the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

22 Jun 2010

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product's safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

22 Jun 2010

WHO issues comprehensive recommendations on children's medicines

The WHO on Friday issued "its first-ever guidance on how to use more than 240 essential medicines for children under 13," the Associated Press reports. "The data provide information on use, dosage and side effects of medicines as well as warnings about which children should not take them" and possible complications from interactions from drugs taken together, according to the WHO, the news service reports (6/19).

22 Jun 2010

Walgreens will stay in Caremark's prescription network

Los Angeles Times: Walgreens and Caremark announced Friday "they had settled a dispute that threatened to prevent thousands of people from filling their prescriptions at Walgreens stores." Caremark runs CVS stores and pharmacies. "At issue: the way Caremark, one of the nation's biggest prescription-plan operators, prices discounts for prescriptions filled at Walgreens pharmacies, which often compete fiercely with nearby CVS stores nationwide.

22 Jun 2010

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Forest Laboratories, Inc. and Merz Pharmaceuticals GmbH announced today that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA.

22 Jun 2010

Martek extends sole-source supply agreement with Mead Johnson for DHA and ARA for infant formula products

Martek Biosciences Corporation announced today that it has extended its sole-source supply agreement with Mead Johnson & Company, LLC, for DHA (docosahexaenoic acid) and ARA (arachidonic acid) for infant formula products. Under the terms of the amendment, Martek will remain Mead Johnson's global sole-source supplier of DHA and ARA for all of its infant formula products through December 31, 2015, an extension of four years beyond the earliest possible termination date of the current agreement.

21 Jun 2010

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB). In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.

21 Jun 2010

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

ViroPharma is increasing its Cinryze manufacturing capacity through two concurrent efforts. The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE.

21 Jun 2010

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

Dyax Corp. and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA, announced today a strategic partnership to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema and other therapeutic indications throughout Europe, North Africa, Middle East and Russia.

21 Jun 2010

Researchers develop new drugs that relieve cancer pain without side effects

Researchers at the University of Leicester and the University of Ferrara in Italy have collaborated to develop new drugs which have the potential to relieve cancer pain without causing many of the side effects of current pain-treatments like morphine.

21 Jun 2010

Study shows effective and efficient methods for producing recombinant proteins

A shift in the life science market has begun to steer cell culture scientists to re-evaluate their use of native transferrin and iron chelators to pursue recombinant alternatives. Transferrin regulates the uptake, transport and utilization of iron for cellular function, increasing cell growth and productivity. Native transferrin found in bovine or human serum has been widely used in cell culture for these added benefits. However, regulatory issues continue to arise with the use of native transferrin due to blood-borne pathogens.

21 Jun 2010

APP Pharmaceuticals receives FDA approval to market Aztreonam for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Aztreonam for Injection, USP in two dosage strengths. Aztreonam is therapeutically equivalent to the reference-listed drug Azactam, which is marketed by Bristol-Myers Squibb.

21 Jun 2010

Early-life exposure to PCBs diminishes immune response to diphtheria and tetanus vaccinations: Study

Children exposed to polychlorinated biphenyls early in life later had a diminished immune response to diphtheria and tetanus vaccinations, according to a study published online June 20 ahead of print in the peer-reviewed journal Environmental Health Perspectives. This result suggests that PCB exposure during the first years of life, a critical period in immune system development, could undermine the effectiveness of childhood vaccinations and possibly impair immune system responses to infection.

21 Jun 2010

Exelixis announces regaining of rights to develop and commercialize XL184

Exelixis, Inc. today announced that it has regained full rights to develop and commercialize XL184. Exelixis and Bristol-Myers Squibb Company entered into a global development collaboration for XL184, the clinically most advanced MET inhibitor, in December 2008. Under the agreement, BMS and Exelixis had originally agreed to certain clinical development plans, and Exelixis maintained key rights regarding timing and funding of current and future clinical trials.

21 Jun 2010

Magic Power Coffee can dangerously lower blood pressure, warns FDA

The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.

21 Jun 2010

European drug companies' lead in making medicines available to developing countries shrinking: Report

European pharmaceutical companies outcompete their U.S. counterparts in making medicines available to people in developing countries, but their lead is shrinking, according to the second Access to Medicine Index, released today.

21 Jun 2010

Pfizer Canada announces temporary suspension of Lipitor Continuity Card Program

The Regie d'Assurance Maladie du Quebec (RAMQ) recently advised Pfizer that they are examining all pharmaceutical card programs in Quebec. In light of this they have sent us a formal request dated June 16, 2010 to temporarily suspend the Lipitor Continuity Card Program. As part of our ongoing collaboration with the RAMQ, we have made the decision to temporarily suspend the distribution of the Lipitor Continuity Card in Quebec while they complete their analysis.

19 Jun 2010

Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

The Reproductive Health Drugs Advisory Committee met today to discuss the new drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. The advisory committee was convened by and makes recommendations to the U.S. Food and Drug Administration (FDA). The FDA will consider the committee's advice as part of its final assessment of the NDA.

19 Jun 2010

DEA, Harvard Drug Group announce agreement to modify suspension

Today, the Drug Enforcement Administration and U.S. Attorney's Office, and Harvard Drug Group announced their agreement to immediately modify the suspension, upon certain conditions, of Harvard's registration to distribute schedule III through V controlled substances out of its Livonia Distribution Center, and a mutual commitment to commence discussions, towards resolution of the issues raised in the DEA's suspension order. The suspension remains as to schedule II controlled substances.

19 Jun 2010

Pharmaceutical News

Star Scientific seeks FDA approval of Stonewall-BDL as "modified risk tobacco product"

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

WHO issues comprehensive recommendations on children's medicines

Walgreens will stay in Caremark's prescription network

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Martek extends sole-source supply agreement with Mead Johnson for DHA and ARA for infant formula products

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

Dyax signs partnership agreement with Sigma-Tau to develop and commercialize subcutaneous DX-88

Researchers develop new drugs that relieve cancer pain without side effects

Study shows effective and efficient methods for producing recombinant proteins

APP Pharmaceuticals receives FDA approval to market Aztreonam for Injection, USP

Early-life exposure to PCBs diminishes immune response to diphtheria and tetanus vaccinations: Study

Exelixis announces regaining of rights to develop and commercialize XL184

Magic Power Coffee can dangerously lower blood pressure, warns FDA

European drug companies' lead in making medicines available to developing countries shrinking: Report

Pfizer Canada announces temporary suspension of Lipitor Continuity Card Program

Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

DEA, Harvard Drug Group announce agreement to modify suspension

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

Latest News