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FDA issues Complete Response Letter to QRxPharma regarding Moxduo NDA

QRxPharma Limited announced today the United States Food and Drug Administration has issued a Complete Response Letter regarding the Moxduo New Drug Application for the treatment of moderate to severe acute pain.

27 May 2014

EMA recommends marketing authorisation for Octapharma’s human cell line recombinant human FVIII, Nuwiq

Octapharma confirmed today the European Medicines Agency (EMA) has adopted a positive opinion towards human cell line recombinant human FVIII, Nuwiq®, recommending the granting of a marketing authorisation for the medicinal product for treatment and prophylaxis of bleeding (also during and after surgery) in paediatric and adult patients with haemophilia A (congenital FVIII deficiency).

27 May 2014

Alligator Bioscience acquires rights to drug development candidate ADC-1013

BioInvent International AB (publ) (OMXS:BINV) today announced that the company has sold back all its rights to drug development candidate ADC-1013 to former partner Alligator Bioscience for an undisclosed sum.

27 May 2014

Abiogen Pharma, Lee's Pharma sign deal to market Neridronic Acid

Abiogen Pharma S.p.A. of Pisa Italy and Lee's Pharm jointly announced the agreement for License, Distribution and Supply for marketing of Attila® (Neridronic Acid) throughout China, Hong Kong, Macau and Taiwan.

27 May 2014

Estrogen therapy and venlafaxine treatment effective for hot flashes, night sweats

A new research study from Brigham and Women's Hospital (BWH) that compares low-dose oral estrogen and low-dose non-hormonal venlafaxine hydrochloride extended release (XR) to placebo were both found effective in reducing the number of hot flashes and night sweats reported by menopausal women.

27 May 2014

Employers to implement mandatory influenza vaccination policies for health care workers

Employers planning to implement mandatory influenza vaccination policies for health care workers need to understand the implications, according to an analysis published in CMAJ (Canadian Medical Association Journal).

27 May 2014

McGill researchers show melatonin supplements may make bones stronger in old rats

McGill researchers have shown that melatonin supplements may make bones stronger in old rats. This suggests a possible avenue for the prevention of osteoporosis.

27 May 2014

Researchers discover novel enzyme that promotes insulin secretion in type 2 diabetes animal model

A signal that promotes insulin secretion and reduces hyperglycemia in a type 2 diabetes animal model is enhanced by the inhibition of a novel enzyme discovered by CHUM Research Centre (CRCHUM) and University of Montreal researchers.

26 May 2014

Analytik announces UK and Ireland release of the SciAps Inspector 500 SWIR Raman for the pharmaceutical industry

Analytik, leading suppliers of innovative analytical instrumentation, announce the SciAps Inspector 500 SWIR Raman system for the pharmaceutical industry.

23 May 2014

EMA's CHMP gives positive opinion for PTC Therapeutics' Translarna

PTC Therapeutics, Inc. today announced that following its request for re-examination, the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion regarding the company's application for a conditional marketing authorization of Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients aged five years and older.

23 May 2014

Analysis of key cellular protein demonstrates the effectiveness of Taxol anti-cancer drug

A pathway to the design of even more effective versions of the powerful anti-cancer drug Taxol has been opened with the most detailed look ever at the assembly and disassembly of microtubules, tiny fibers of tubulin protein that form the cytoskeletons of living cells and play a crucial role in mitosis.

23 May 2014

Presentation at NMS 2014 highlights growing dangers of non-steroidal anti-inflammatory drugs

A presentation at this week’s National Medicines Symposium in Brisbane has highlighted the dangers of people taking common medicines such as non-steroidal anti-inflammatories (NSAIDs) without thinking about the potential risks or harms.

23 May 2014

European Commission grants Marketing Authorization for empagliflozin for treatment of type 2 diabetes

The European Commission has granted Marketing Authorisation for empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor from Boehringer Ingelheim and Eli Lilly and Company.

23 May 2014

Growing resistance to antibiotics demands a coordinated global response, say experts

Growing resistance to antibiotics and other drugs demands a coordinated global response on the same scale as efforts to address climate change, experts say.

23 May 2014

Study: Children born with HIV more likely to develop resistance to antiretroviral drugs than adults

Children born with HIV are far more likely to develop resistance to antiretroviral drugs than adults, according to a new Tulane University School of Medicine study.

23 May 2014

New database allows researchers to match old drugs for new diseases

There are thousands of drugs that silence many thousands of cancer-causing genetic abnormalities. Some of these drugs are in use now, but many of these drugs are sitting on shelves or could be used beyond the disease for which they were originally approved.

23 May 2014

Pain receptors may hold key to treating obesity, diabetes and improving metabolic health

Blocking a pain receptor in mice not only extends their lifespan, it also gives them a more youthful metabolism, including an improved insulin response that allows them to deal better with high blood sugar.

23 May 2014

EMA grants Advanced Therapy Medicinal Product classification for TxCell's Col-Treg

TxCell SA, a biotechnology company developing innovative, personalized cell-based immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that Col-Treg, its second therapeutic candidate from its ASTrIA platform, has been granted Advanced Therapy Medicinal Product (ATMP) classification by the Committee for Advanced Therapies (CAT) of the European Medicines Agency.

22 May 2014

IBM collaborates with Zambian Ministry of Health to provide life saving drugs to citizens

IBM today announced a collaboration with the Zambian Ministry of Health to provide citizens with improved access to 200 life saving drugs.

22 May 2014

Eisai launches new class of epilepsy treatment Fycompa in France

Fycompa (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), has today received reimbursement approval from the Comité Economique des Produits de Santé.

22 May 2014

Pharmaceutical News

FDA issues Complete Response Letter to QRxPharma regarding Moxduo NDA

EMA recommends marketing authorisation for Octapharma’s human cell line recombinant human FVIII, Nuwiq

Alligator Bioscience acquires rights to drug development candidate ADC-1013

Abiogen Pharma, Lee's Pharma sign deal to market Neridronic Acid

Estrogen therapy and venlafaxine treatment effective for hot flashes, night sweats

Employers to implement mandatory influenza vaccination policies for health care workers

McGill researchers show melatonin supplements may make bones stronger in old rats

Researchers discover novel enzyme that promotes insulin secretion in type 2 diabetes animal model

Analytik announces UK and Ireland release of the SciAps Inspector 500 SWIR Raman for the pharmaceutical industry

EMA's CHMP gives positive opinion for PTC Therapeutics' Translarna

Analysis of key cellular protein demonstrates the effectiveness of Taxol anti-cancer drug

Presentation at NMS 2014 highlights growing dangers of non-steroidal anti-inflammatory drugs

European Commission grants Marketing Authorization for empagliflozin for treatment of type 2 diabetes

Growing resistance to antibiotics demands a coordinated global response, say experts

Study: Children born with HIV more likely to develop resistance to antiretroviral drugs than adults

New database allows researchers to match old drugs for new diseases

Pain receptors may hold key to treating obesity, diabetes and improving metabolic health

EMA grants Advanced Therapy Medicinal Product classification for TxCell's Col-Treg

IBM collaborates with Zambian Ministry of Health to provide life saving drugs to citizens

Eisai launches new class of epilepsy treatment Fycompa in France

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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