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FDA approves Opdivo to treat patients with advanced non-small cell lung cancer

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

11 Oct 2015

Research finding offers hope for more powerful aspirin-like drugs

Researchers have found that salicylic acid targets the activities of HMGB1, an inflammatory protein associated with a wide variety of diseases, offering hope that more powerful aspirin-like drugs may be developed.

11 Oct 2015

Lilly acquires worldwide rights to intranasal glucagon from Locemia

Eli Lilly and Company and Locemia Solutions today announced Lilly has acquired worldwide rights to Locemia's intranasal glucagon, a potential treatment for severe hypoglycemia in people with diabetes treated with insulin. Intranasal glucagon, which is currently in Phase III clinical trial testing, could be the first needle-free rescue treatment for severe hypoglycemia.

11 Oct 2015

FDA approves Lonsurf drug for patients with advanced form of colorectal cancer

The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.

9 Oct 2015

Hi-Tech Pharmaceuticals signs definitive agreement to acquire iForce

Hi-Tech Pharmaceuticals, a leading global provider of Sports Nutrition products, Contract Manufacturing, and iForce Nutrition ("iForce"), one of the fastest-growing Sports Nutrition companies in the United States, today announced that they have entered into a definitive agreement in which Hi-Tech has agreed to acquire iForce.

9 Oct 2015

IASLC commends pembrolizumab drug approval for cutting-edge lung cancer treatment

The International Association for the Study of Lung Cancer (IASLC) says the move by the U.S. Food and Drug Administration (FDA) to grant accelerated approval for a cutting-edge lung cancer treatment is a positive step forward that may help many patients improve their survival.

9 Oct 2015

Xuriden (uridine triacetate) now approved for patients with hereditary orotic aciduria

Today, the U.S. Food and Drug Administration approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disorder, which has been reported in approximately 20 patients worldwide.

9 Oct 2015

FDA approves Promacta to treat pediatric patients with chronic immune thrombocytopenic purpura

The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen.

9 Oct 2015

Aristada (aripiprazole lauroxil) extended release injection approved to treat adults with schizophrenia

On October 5, the U.S. Food and Drug Administration approved Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.

9 Oct 2015

Tresiba and Ryzodeg approved to improve blood sugar control in adults with diabetes mellitus

The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.

9 Oct 2015

Varubi (rolapitant) approved to prevent delayed phase chemotherapy-induced nausea and vomiting

The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

9 Oct 2015

Vraylar (cariprazine) capsules now approved by FDA to treat schizophrenia, bipolar disorder in adults

The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.

9 Oct 2015

Repatha (evolocumab) injection gets FDA approval for high cholesterol

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.

9 Oct 2015

Manchester researchers demonstrate safety, effectiveness of eltrombopag treatment in children with ITP

Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.

9 Oct 2015

Study: Women less likely than men to have good relief of chronic pain with long-term opioid use

Women, and especially younger women, are much less likely than men to have good relief of chronic, non-cancer pain with long-term opioid use, with only one in five women reporting low levels of pain and high levels of function with chronic opioid therapy in a new study published in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers.

9 Oct 2015

FDA grants accelerated approval for Keytruda to treat patients with advanced NSCLC

The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

9 Oct 2015

$Anti-osteoporotic therapy can decrease subsequent fracture risks by 40%: Study$

Anti-osteoporotic therapy can decrease subsequent fracture risks by 40%: Study

Osteoporosis, a disease of progressive bone loss, affects 70 percent of the U.S. population older than age 50: one in two women--and one in five men. These individuals are at risk for fragility fractures, a break that results from a fall, or occurs in the absence of obvious trauma, and most commonly seen in the wrist, the upper arm, the hip, and the spine.

9 Oct 2015

Research on investigational menopause drug wins first prize

Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women’s health products, today announced it received top honors for its research on investigational drug lasofoxifene at the 26th annual North American Menopause Society (NAMS) meeting in Las Vegas last week.

9 Oct 2015

FDA grants 12-year exclusivity to RUCONEST (C1 esterase inhibitor [recombinant])

Salix Pharmaceuticals and Pharming Group NV announced today that the U.S. Food and Drug Administration has granted 12 years of exclusivity to RUCONEST (C1 esterase inhibitor [recombinant]) 50 IU/kg.

8 Oct 2015

FDA grants Breakthrough Therapy Designation to Lilly's abemaciclib for treatment of metastatic breast cancer

Eli Lilly and Company today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.

8 Oct 2015

Pharmaceutical News

FDA approves Opdivo to treat patients with advanced non-small cell lung cancer

Research finding offers hope for more powerful aspirin-like drugs

Lilly acquires worldwide rights to intranasal glucagon from Locemia

FDA approves Lonsurf drug for patients with advanced form of colorectal cancer

Hi-Tech Pharmaceuticals signs definitive agreement to acquire iForce

IASLC commends pembrolizumab drug approval for cutting-edge lung cancer treatment

Xuriden (uridine triacetate) now approved for patients with hereditary orotic aciduria

FDA approves Promacta to treat pediatric patients with chronic immune thrombocytopenic purpura

Aristada (aripiprazole lauroxil) extended release injection approved to treat adults with schizophrenia

Tresiba and Ryzodeg approved to improve blood sugar control in adults with diabetes mellitus

Varubi (rolapitant) approved to prevent delayed phase chemotherapy-induced nausea and vomiting

Vraylar (cariprazine) capsules now approved by FDA to treat schizophrenia, bipolar disorder in adults

Repatha (evolocumab) injection gets FDA approval for high cholesterol

Manchester researchers demonstrate safety, effectiveness of eltrombopag treatment in children with ITP

Study: Women less likely than men to have good relief of chronic pain with long-term opioid use

FDA grants accelerated approval for Keytruda to treat patients with advanced NSCLC

Anti-osteoporotic therapy can decrease subsequent fracture risks by 40%: Study

Research on investigational menopause drug wins first prize

FDA grants 12-year exclusivity to RUCONEST (C1 esterase inhibitor [recombinant])

FDA grants Breakthrough Therapy Designation to Lilly's abemaciclib for treatment of metastatic breast cancer

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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