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Researchers observe worrisome increase in anaphylaxis rate

Researchers observe worrisome increase in anaphylaxis rate

Anaphylaxis, known to be a sudden and potentially life-threatening allergic reaction, seems to be increasing among children, according to a new study led by a team at the Research Institute of the McGill University Health Centre. [More]
Pediatric researchers develop minimally invasive techniques to treat plastic bronchitis

Pediatric researchers develop minimally invasive techniques to treat plastic bronchitis

Pediatric researchers have devised an innovative, safe and minimally invasive procedure that helps relieve rare but potentially life-threatening airway blockages occurring in children who had surgery for congenital heart defects. [More]
Entresto drug shows added benefit in symptomatic chronic heart failure

Entresto drug shows added benefit in symptomatic chronic heart failure

The fixed-dose combination of sacubitril and valsartan (trade name: Entresto) has been approved since November 2015 for adults with symptomatic chronic heart failure with reduced pump function (ejection fraction). The German Institute for Quality and Efficiency in Health Care (IQWiG) now examined in an early benefit assessment whether this drug combination offers an added benefit for patients in comparison with the appropriate comparator therapy. [More]
FDA approves Defitelio to treat hepatic veno-occlusive disease in adults, children

FDA approves Defitelio to treat hepatic veno-occlusive disease in adults, children

The U.S. Food and Drug Administration today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT). [More]
Romosozumab for postmenopausal women with osteoporosis meets co-primary endpoints in Phase 3 study

Romosozumab for postmenopausal women with osteoporosis meets co-primary endpoints in Phase 3 study

Amgen and UCB today announced top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME). [More]
Promising phase II results for ozanimod in MS

Promising phase II results for ozanimod in MS

The selective sphingosine 1-phosphate receptor inhibitor ozanimod significantly reduces lesion activity in patients with relapsing-remitting multiple sclerosis, shows a phase II study published in The Lancet Neurology. [More]
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]
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