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Biocon receives regulatory approval for biosimilar product, trastuzumab

Mylan Inc. today announced that its partner Biocon has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India. This is the first regulatory approval for a Mylan-Biocon developed biosimilar product.

26 Nov 2013

Researchers analyze effects of MXE drug usage

Researchers from Sweden have attempted to create an understanding to the subjective effects from use of Methoxetamine (MXE), a drug belonging to a class known as "legal highs" or "research chemicals," and available for purchase on the Internet.

26 Nov 2013

FDA grants priority review status to Avedro's riboflavin ophthalmic solution/KXL system

Avedro Inc, a Boston-based ophthalmic medical device and pharmaceutical company announces that it received notification from the U.S. Food and Drug Administration stating that their NDA for riboflavin ophthalmic solution/KXL system has been filed, and has been granted priority review status. The priority review status places the application action date at March 15th, 2014.

25 Nov 2013

CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's: Committee for Medicinal Products for Human Use has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.

25 Nov 2013

Antidepressants in pregnancy do not cause autism, study finds

New research cannot establish a close connection between the use of antidepressant medication - the so-called SSRIs - during the course of pregnancy and the risk of having a child with autism.

25 Nov 2013

Researchers discover how type 2 diabetes drug metformin actually works

Researchers from St. Vincent's Institute of Medical Research in Melbourne, Australia, in collaboration with researchers at McMaster University in Canada, are reportedly the first to discover how the type 2 diabetes drug metformin actually works, providing a molecular understanding that could lead to the development of more effective therapies. Mass spectrometry technologies from AB SCIEX, a global leader in analytical technologies, played a critical role in the analysis that led to this breakthrough finding.

25 Nov 2013

CHMP recommends approval of Otsuka's Deltyba for pulmonary multidrug-resistant tuberculosis

Otsuka Pharmaceutical Co., Ltd. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Deltyba (delamanid) in combination with a WHO recommended optimized background regimen for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB). The CHMP opinion will help form the basis for a European Commission decision expected early next year.

25 Nov 2013

Diabetes patients who receive medications by mail are less likely to visit emergency room

Patients with diabetes who received prescribed heart medications by mail were less likely to visit the emergency room than those patients who picked up prescriptions in person, according to a new Kaiser Permanente study published in the American Journal of Managed Care.

25 Nov 2013

Steroid injections given before premature birth may increase child's mental health risks

Steroid injections given to pregnant women before premature birth may increase the child's risk of later behavioural and emotional difficulties, a study has found.

23 Nov 2013

EC approves INVOKANA (canagliflozin) medication for adults with type 2 diabetes mellitus

Janssen-Cilag International NV announced today that the European Commission has approved INVOKANA (canagliflozin) in the European Union for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control[1]. Canagliflozin is an oral, once-daily medication, which belongs to a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors.

23 Nov 2013

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

23 Nov 2013

NEXAVAR tablets receive FDA approval for treatment of patients with thyroid cancer

Bayer HealthCare and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, today announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for the oral multi-kinase inhibitor NEXAVAR (sorafenib) tablets for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

23 Nov 2013

New NPS Direct article reveals that vaccinations fight against antibiotic resistance

During Antibiotic Awareness Week (18-24 November) NPS MedicineWise is urging health professionals to use vaccinations as one important way to limit Australia’s use of antibiotics.

22 Nov 2013

New NPS Direct article reveals that vaccinations fight against antibiotic resistance

During Antibiotic Awareness Week (18-24 November) NPS MedicineWise is urging health professionals to use vaccinations as one important way to limit Australia’s use of antibiotics.

22 Nov 2013

Teenage cannabis use increases in developing countries

It's common to associate cannabis use with affluent youth in wealthy societies. But the relationship between societal and family affluence and cannabis use appears to be changing.

22 Nov 2013

EYLEA Injection gets approval in Japan for treatment of macular edema following CRVO

Regeneron Pharmaceuticals, Inc. today announced that EYLEA (aflibercept) Injection has received approval for the treatment of Macular Edema Following Central Retinal Vein Occlusion from the Japanese Ministry of Health, Labour and Welfare.

22 Nov 2013

Research: New drugs show ability to rapidly shrink melanoma tumors

Melanoma is the deadliest form of skin cancer, killing more than 8,000 in the U.S. each year. Approximately 40 percent of advanced melanoma tumors are driven to grow by the presence of mutations in a gene known as the BRAF gene.

21 Nov 2013

Pharmaceutical powder characterisation and inhaler testing workshop to include expert presentations

A new workshop organised by Monash University will include invited presentations from Copley Scientific, the world’s leading provider of inhaler testing equipment, Freeman Technology, global leaders in the field of powder characterisation, and ATA Scientific, distributors of Malvern Panalytical materials characterisation systems.

From Malvern Panalytical 21 Nov 2013

Probe to measure immune function could lead to determine nanoparticle-based drugs for cancer patients

The development of a probe to measure the body's immune function could lead to more accurate, individualized doses for cancer patients prescribed nanoparticle-based drugs, according to research conducted at the University of North Carolina.

21 Nov 2013

Vaccinating kids against rotavirus may also reduce risk of seizures

A new study suggests an additional-and somewhat surprising-potential benefit of vaccinating children against rotavirus, a common cause of diarrhea and vomiting. Besides protecting kids from intestinal illness caused by rotavirus, immunization may also reduce the risk of related seizures, according to findings published in Clinical Infectious Diseases and available online.

21 Nov 2013

Pharmaceutical News

Biocon receives regulatory approval for biosimilar product, trastuzumab

Researchers analyze effects of MXE drug usage

FDA grants priority review status to Avedro's riboflavin ophthalmic solution/KXL system

CHMP adopts positive opinion for ABRAXANE with gemcitabine for treatment of metastatic pancreas

Antidepressants in pregnancy do not cause autism, study finds

Researchers discover how type 2 diabetes drug metformin actually works

CHMP recommends approval of Otsuka's Deltyba for pulmonary multidrug-resistant tuberculosis

Diabetes patients who receive medications by mail are less likely to visit emergency room

Steroid injections given before premature birth may increase child's mental health risks

EC approves INVOKANA (canagliflozin) medication for adults with type 2 diabetes mellitus

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

NEXAVAR tablets receive FDA approval for treatment of patients with thyroid cancer

New NPS Direct article reveals that vaccinations fight against antibiotic resistance

New NPS Direct article reveals that vaccinations fight against antibiotic resistance

Teenage cannabis use increases in developing countries

EYLEA Injection gets approval in Japan for treatment of macular edema following CRVO

Research: New drugs show ability to rapidly shrink melanoma tumors

Pharmaceutical powder characterisation and inhaler testing workshop to include expert presentations

Probe to measure immune function could lead to determine nanoparticle-based drugs for cancer patients

Vaccinating kids against rotavirus may also reduce risk of seizures

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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