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Basaglar (insulin glargine injection) approved to improve glycemic control in diabetes patients

Basaglar (insulin glargine injection) approved to improve glycemic control in diabetes patients

The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. [More]
Bridion injection approved to reverse effects of neuromuscular blocking drugs used during certain types of surgery

Bridion injection approved to reverse effects of neuromuscular blocking drugs used during certain types of surgery

The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults. [More]
Lilly, Merck announce another immuno-oncology collaboration

Lilly, Merck announce another immuno-oncology collaboration

Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, today announced another immuno-oncology collaboration that will evaluate abemaciclib (LY2835219), Lilly's cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck's KEYTRUDA (pembrolizumab) in a Phase I study across multiple tumor types. [More]
Mylan releases Clozapine Orally Disintegrating Tablets in U.S.

Mylan releases Clozapine Orally Disintegrating Tablets in U.S.

Mylan N.V. today announced the U.S. launch of Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo. [More]
Lilly, Merck expand oncology clinical trial collaboration

Lilly, Merck expand oncology clinical trial collaboration

Eli Lilly and Company and Merck, known as MSD outside the United States and Canada, today announced the extension of an existing collaboration to evaluate the safety and efficacy of the combination of Lilly's ALIMTA (pemetrexed for injection) and Merck's KEYTRUDA (pembrolizumab) in a pivotal Phase III study in first-line nonsquamous non-small cell lung cancer (NSCLC). [More]
Lowering blood pressure below currently recommended targets reduces risk of stroke, heart attack

Lowering blood pressure below currently recommended targets reduces risk of stroke, heart attack

Using intensive treatment to lower blood pressure below currently recommended targets significantly reduces rates of major cardiovascular events like stroke and heart attack among a wide range of high-risk patients, according to a large meta-analysis involving almost 45000 individuals, published in The Lancet. [More]
Intensive management of high blood pressure reduces rates of cardiovascular disease, lowers risk of death

Intensive management of high blood pressure reduces rates of cardiovascular disease, lowers risk of death

Jackson T. Wright Jr., MD, PhD, and researchers from University Hospitals Case Medical Center presented new results from the Systolic Blood Pressure Intervention Trial (SPRINT) showing that in patients at high risk for cardiovascular events, targeting a systolic blood pressure of less than 120 mm Hg resulted in lower rates of fatal and non-fatal major events or death compared to targeting systolic blood pressure to the usually recommended target of less than 140 mm Hg. [More]
Early identification of physiological deterioration, appropriate care can improve outcomes in sepsis patients

Early identification of physiological deterioration, appropriate care can improve outcomes in sepsis patients

Researchers from Brooke Army Medical Center in San Antonio, Texas, evaluated the rapid response system (RRS) training program on call rates and code blue events and found significant improvements were made in staff awareness and patient outcomes. [More]
Sprout announces U.S. availability of Addyi for HSDD treatment in premenopausal women

Sprout announces U.S. availability of Addyi for HSDD treatment in premenopausal women

Sprout Pharmaceuticals, Inc., a division of Valeant Pharmaceuticals North America LLC, announced today that Addyi, a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, is now available in the United States through certified physicians and pharmacies. [More]
Boehringer Ingelheim announces FDA approval of Praxbind (idarucizumab)

Boehringer Ingelheim announces FDA approval of Praxbind (idarucizumab)

Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration granted approval of Praxbind (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. [More]
BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

BioDelivery Sciences International, Inc. announced that the U.S. Food and Drug Administration has approved the company's Supplemental New Drug Application (sNDA) for a manufacturing specification change for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII). [More]
Tresiba and Ryzodeg approved to improve blood sugar control in adults with diabetes mellitus

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

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. [More]
Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

Amgen gets positive CHMP opinions for Kyprolis (carfilzomib) and BLINCYTO (blinatumomab)

"We are pleased to receive positive CHMP opinions for Kyprolis and BLINCYTO as this is an important step in providing new treatment options for patients in Europe with rare forms of cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. [More]
Feeling dizzy after standing up may signal serious conditions, increased risk of death

Feeling dizzy after standing up may signal serious conditions, increased risk of death

People who get dizzy several minutes after standing up may be at risk of more serious conditions and even an increased risk of death, according to new research published in the September 23, 2015, online issue of Neurology, the medical journal of the American Academy of Neurology. [More]
Higher doses of hydrocortisone not linked to neurodevelopmental impairments in low birth weight infants

Higher doses of hydrocortisone not linked to neurodevelopmental impairments in low birth weight infants

Hydrocortisone is one of the 15 most frequently prescribed medications in extremely low birth weight (?1000 g) infants in the newborn intensive care unit (NICU). [More]
Amgen, Xencor partner to develop and commercialize new therapeutics for cancer immunotherapy, inflammation

Amgen, Xencor partner to develop and commercialize new therapeutics for cancer immunotherapy, inflammation

Amgen and Xencor, Inc. announced today that the two companies have entered into a research and license agreement to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation. [More]
Egalet announces launch of OXAYDO (oxycodone HCI, USP) Tablets and IMPACT-Rx initiative

Egalet announces launch of OXAYDO (oxycodone HCI, USP) Tablets and IMPACT-Rx initiative

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on discovering, developing and commercializing innovative pain treatments, today announced the launch of OXAYDO (oxycodone HCI, USP) tablets -CII in the United States. [More]
Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

Valeant Pharmaceuticals International, Inc. and Sprout Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which a wholly-owned subsidiary of Valeant will acquire Sprout, on a debt-free basis, for approximately $1 billion in cash, plus a share of future profits based upon the achievement of certain milestones. [More]
Hospira announces TGA approval of Inflectra (infliximab) for treatment of eight inflammatory conditions

Hospira announces TGA approval of Inflectra (infliximab) for treatment of eight inflammatory conditions

Hospira today announced that Inflectra (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia. This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS). [More]
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