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Drug labels sometimes lack key safety warnings: Consumer Reports Health

It's comparable to driving a car without a seatbelt—a new investigation from Consumer Reports Health finds that drug labels sometimes lack key safety warnings and some pharmacies fail to include the medication guides required by the federal government.

28 Jun 2011

NUROMOL non-prescription painkiller now available in pharmacies across the UK

A new non-prescription painkiller is now available in pharmacies across the UK, heralding the first UK painkiller combination of ibuprofen and paracetamol in 'over-the-counter' pain relief.

28 Jun 2011

DSM introduces Kremer Method for rapid, cost effective production of biopharmaceuticals

Royal DSM, the global Life Sciences and Materials Sciences company, today announced the introduction of the Kremer Method, an innovative proprietary technology developed by DSM scientists which improves downstream processing of monoclonal antibodies (mAbs) for faster and more cost effective production of biopharmaceuticals

28 Jun 2011

Drug shortages have tripled during the last six years

The drugs are among hundreds that have been in short supply at the nation's hospitals, and more recently, community pharmacies.

28 Jun 2011

FDA hearing on breast cancer drug set for this week

Genentech, the maker of Avastin, will appeal to the Food and Drug Administration to make its drug available as a treatment for breast cancer — asking for one more chance to prove its efficacy.

28 Jun 2011

Amgen files sBLA for XGEVA with FDA to treat castrate-resistant prostate cancer

Amgen today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

28 Jun 2011

Accelerated hepatitis B vaccination schedule effective for high-risk pregnant women

UT Southwestern Medical Center maternal-fetal specialists have confirmed a potential new protocol to protect pregnant women who are at risk for hepatitis B, a health problem that affects 2 billion people worldwide.

28 Jun 2011

Australian Nobel Prize winner closer to delivering vaccines in food after positive first study in humans

The Australian scientist who won a Nobel Prize for identifying a cancer-causing stomach bacterium, today said a clinical trial had shown that some strains of the bacteria (Helicobacter pylori or H. pylori) were safe and well tolerated in humans.

27 Jun 2011

New and effective diabetes drug seeking approval

A new drug for diabetes from Bristol-Myers Squibb Co. and AstraZeneca PLC was effective in lowering blood sugar. The pharmaceutical drug makers are looking for approval for the drug, dapagliflozin, as the first in new class of pills designed to lower blood sugar by increasing the amount of glucose excreted in the urine.

27 Jun 2011

FDA directive on anemia drug in kidney disease patients

The U.S. Food and Drug Administration (FDA) has issued new warnings for anemia drugs for patients with kidney disease after studies suggested such drugs could increase stroke risks. The new warnings are the latest to hit the widely used medications since 2007, when the FDA first said they could cause fatal side effects.

27 Jun 2011

EMA acceptance of brentuximab vedotin MAA triggers $5M milestone payment to Seattle Genetics

Seattle Genetics, Inc., today announced that it will receive a $5 million milestone payment under its brentuximab vedotin (ADCETRIS) collaboration with Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

27 Jun 2011

Endo recalls two lots of Endocet Tablets

Endo Pharmaceuticals today issued a voluntary nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV.

27 Jun 2011

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

Over a decade ago, Canadian patients diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec (imatinib mesylate) was approved in Canada.

27 Jun 2011

FDA accepts for filing Columbia's PROCHIEVE progesterone gel NDA

Columbia Laboratories, Inc. and Watson Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Columbia's New Drug Application (NDA) for PROCHIEVE (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy.

27 Jun 2011

FDA issues Complete Response Letter for Pfizer's REMOXY NDA

DURECT Corporation today reported that Pfizer Inc. has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY, a controlled-release form of oxycodone designed to discourage common methods of tampering.

27 Jun 2011

Anticholinergic medications linked to risk of cognitive impairment, death in older population

A large, long-term study confirms that medications with anticholinergic activity, which include many drugs frequently taken by older adults, cause cognitive impairment. The research is also the first to identify a possible link between these drugs - which include over-the-counter and prescription sleep aids and incontinence treatments - and risk of death.

27 Jun 2011

Study finds no adverse effects of vitamin D supplements in pregnant women, newborns

Use of vitamin D supplements during pregnancy has long been a matter of concern but now researchers writing in the Journal of Bone and Mineral Research report that even a high supplementation amount in healthy pregnant women was safe and effective in raising circulating vitamin D to a level thought by some to be optimal.

27 Jun 2011

EMA accepts Millennium's MAA for ADCETRIS to treat lymphoma

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for ADCETRIS for the treatment of relapsed or refractory Hodgkin lymphoma (HL) and relapsed or refractory systemic anaplastic large cell lymphoma.

27 Jun 2011

FDA recommends conservative dosing guidelines for ESAs to treat anemia in patients with CKD

The U.S. Food and Drug Administration today recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.

27 Jun 2011

New anti-inflammatory drug improves kidney function in patients with type 2 diabetes

A new anti-inflammatory drug used by patients with type 2 diabetes improved their kidney function during a year-long study involving researchers from UT Southwestern Medical Center.

27 Jun 2011

Pharmaceutical News

Drug labels sometimes lack key safety warnings: Consumer Reports Health

NUROMOL non-prescription painkiller now available in pharmacies across the UK

DSM introduces Kremer Method for rapid, cost effective production of biopharmaceuticals

Drug shortages have tripled during the last six years

FDA hearing on breast cancer drug set for this week

Amgen files sBLA for XGEVA with FDA to treat castrate-resistant prostate cancer

Accelerated hepatitis B vaccination schedule effective for high-risk pregnant women

Australian Nobel Prize winner closer to delivering vaccines in food after positive first study in humans

New and effective diabetes drug seeking approval

FDA directive on anemia drug in kidney disease patients

EMA acceptance of brentuximab vedotin MAA triggers $5M milestone payment to Seattle Genetics

Endo recalls two lots of Endocet Tablets

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

FDA accepts for filing Columbia's PROCHIEVE progesterone gel NDA

FDA issues Complete Response Letter for Pfizer's REMOXY NDA

Anticholinergic medications linked to risk of cognitive impairment, death in older population

Study finds no adverse effects of vitamin D supplements in pregnant women, newborns

EMA accepts Millennium's MAA for ADCETRIS to treat lymphoma

FDA recommends conservative dosing guidelines for ESAs to treat anemia in patients with CKD

New anti-inflammatory drug improves kidney function in patients with type 2 diabetes

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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