Pharmaceutical News

RSS

Sedative-hypnotic drugs to get stronger warning labels

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks.

14 Mar 2007

Tykerb (lapatinib) - new anti-cancer treatment approved

The Food and Drug Administration (FDA) has approved Tykerb (lapatinib), a new targeted anti-cancer treatment, to be used in combination with capectabine (Xeloda), another cancer drug, for patients with advanced, metastatic breast cancer that is HER2 positive (tumors that exhibit HER2 protein).

14 Mar 2007

Technologies to improve prevention, tracking and detection of counterfeit medicines

More than twenty technology companies are responding to a call to support the fight against counterfeit medicines spearheaded by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) set up by the World Health Organization (WHO) and partners.

13 Mar 2007

Roche files NDA for pediatric Tamiflu capsules

Roche has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) to market Tamiflu (oseltamivir phosphate) capsules in pediatric doses of 30 mg and 45 mg.

12 Mar 2007

Survey says some children's medicines contain a "cocktail of additives"

Researchers in Britain are warning that most medicines for babies and young children contain additives which are often banned from foods and drinks aimed at under-threes.

12 Mar 2007

FDA strengthens safety information for Erythropoiesis-Stimulating Agents (ESAs)

The U.S. Food and Drug Administration (FDA) has issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia.

11 Mar 2007

CMS investigates allegations that Humana encouraged its highest-cost beneficiaries to join competing Medicare prescription drug plan

CMS officials are investigating whether Humana inappropriately advised the highest-cost beneficiaries in its Medicare prescription drug benefit plans to switch to plans provided by Sierra Health Services, The Hill reports.

11 Mar 2007

Advocates call on Kroger Pharmacies to make emergency contraceptive Plan B available

Advocates are calling on Cincinnati-based Kroger stores to make the emergency contraceptive Plan B available to women at its pharmacies after a Georgia woman said a store did not sell her the drug, the AP/Akron Beacon Journal reports.

11 Mar 2007

FDA needs authority to approve generic biologics

AARP called on Congress today to give the Food and Drug Administration (FDA) the authority to approve safe, cost-effective generic versions of often expensive biologic drug therapies.

8 Mar 2007

Lipitor given the green light for more heart risk patients

The Food and Drug Administration (FDA) in the U.S. has given approval for the best seller drug Lipitor to be used in five new categories.

8 Mar 2007

Allowing greater access to drug safety data would enable researchers to better evaluate risks

For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products.

8 Mar 2007

House panel requests marketing documents from pharmaceutical companies regarding off-label drug promotion

The House Committee on Oversight and Government Reform has asked two stent manufacturers and three drug manufacturers to provide documents regarding the marketing of their products as part of the committee's investigation into the off-label use of drug-coated stents and prescription drugs, the Wall Street Journal reports.

8 Mar 2007

Prescription drug prices for U.S. residents ages 50 and older increased at about twice inflation rate

Manufacturers' prices for the 193 prescription drugs most commonly used by U.S. residents ages 50 and older increased at about twice the rate of inflation in 2006, according to an annual report released on Tuesday by AARP, Cox/Atlanta Journal-Constitution reports.

8 Mar 2007

Tekturna new hypertension drug - first in a decade

The Food and Drug Administration (FDA) in the United States has given it's approval for the use of a new drug to treat hypertension.

7 Mar 2007

FDA approves Tekturna for the treatment of high blood pressure

The U.S. Food and Drug Administration (FDA) today announced the approval of Tekturna (aliskiren) tablets for the treatment of high blood pressure, or hypertension, which affects an estimated 25 percent of Americans and causes increased risk of stroke, heart attack, kidney failure, heart failure and death.

6 Mar 2007

FDA accepts two Roche diagnostics HPV tests for review

Roche has announced today that the United States (U.S.) Food & Drug Administration has accepted for review its applications for two human papillomavirus (HPV) tests.

From Roche Sequencing and Life Science 6 Mar 2007

Safety of Merck's HPV vaccine Gardasil 'lost' in debate

The effectiveness and safety of Merck's human papillomavirus vaccine Gardasil has "been lost" because of Merck's lobbying campaign for mandating vaccination for school attendance, and the "real losers" might be "girls and women who need access" to the vaccine, Boston Globe columnist Ellen Goodman writes in an opinion piece .

5 Mar 2007

CMS Administrator Norwalk says releasing data on Medicare prescription drug benefit discounts would undermine negotiations

CMS Administrator Leslie Norwalk in a letter to lawmakers on Thursday said that the agency will not disclose information on discounts obtained by pharmacy benefit managers for Medicare prescription drug plans, CQ HealthBeat reports.

5 Mar 2007

FDA is using a "dysfunctional" computer system to track the safety of prescription drugs

...and efforts to establish a new system to track adverse drug events have been delayed by at least four years, according to a November 2006 report commissioned by the agency, the Wall Street Journal reports.

5 Mar 2007

Lilly to acquire neuroscience drug discovery co. Hypnion

Eli Lilly and Company and Hypnion, Inc. today announced that they have signed a definitive merger agreement whereby Lilly will acquire Hypnion, a privately held neuroscience drug discovery company focused on sleep disorders.

5 Mar 2007

Pharmaceutical News

Sedative-hypnotic drugs to get stronger warning labels

Tykerb (lapatinib) - new anti-cancer treatment approved

Technologies to improve prevention, tracking and detection of counterfeit medicines

Roche files NDA for pediatric Tamiflu capsules

Survey says some children's medicines contain a "cocktail of additives"

FDA strengthens safety information for Erythropoiesis-Stimulating Agents (ESAs)

CMS investigates allegations that Humana encouraged its highest-cost beneficiaries to join competing Medicare prescription drug plan

Advocates call on Kroger Pharmacies to make emergency contraceptive Plan B available

FDA needs authority to approve generic biologics

Lipitor given the green light for more heart risk patients

Allowing greater access to drug safety data would enable researchers to better evaluate risks

House panel requests marketing documents from pharmaceutical companies regarding off-label drug promotion

Prescription drug prices for U.S. residents ages 50 and older increased at about twice inflation rate

Tekturna new hypertension drug - first in a decade

FDA approves Tekturna for the treatment of high blood pressure

FDA accepts two Roche diagnostics HPV tests for review

Safety of Merck's HPV vaccine Gardasil 'lost' in debate

CMS Administrator Norwalk says releasing data on Medicare prescription drug benefit discounts would undermine negotiations

FDA is using a "dysfunctional" computer system to track the safety of prescription drugs

Lilly to acquire neuroscience drug discovery co. Hypnion

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

Latest News