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ThromboGenics resubmits ocriplasmin BLA with FDA to treat symptomatic VMA

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announced that it has resubmitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ocriplasmin intravitreal injection, 2.5 mg/mL, for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole.

17 Apr 2012

Inspiration submits IB1001 BLA with FDA for treatment of hemophilia B

Ipsen today announced that its partner, Inspiration Biopharmaceuticals, Inc., has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of IB1001, an intravenous recombinant factor IX (rFIX) for the treatment and prevention of bleeding in individuals with hemophilia B.

17 Apr 2012

Bruker launches novel AVANCE III HD NMR spectrometer

At the Experimental Nuclear Magnetic Resonance Conference (ENC) 2012, Bruker introduces the novel AVANCE III HD NMR spectrometer.

17 Apr 2012

Australian nutrition researcher to receive Alexander Leaf Distinguished Scientist Award

After decades of research, scientists continue to uncover the health benefits of omega-3 fatty acids - and there are many more discoveries yet to come, according to a nutrition researcher being honored for his lifetime of achievement in this field.

17 Apr 2012

High-fibre diet protects women from cardiovascular disease

Foods high in fibre provide good protection against cardiovascular disease, and the effect is particularly marked in women. This is shown in a new study from Lund University in Sweden.

17 Apr 2012

Novasep’s outstanding results in scale-up and biomanufacturing of Apo-A1 acknowledged by Cerenis at BioProcess International Conference

Novasep, a provider of purification-based manufacturing solutions for lifescience molecules, has announced that Cerenis Therapeutics has been invited by BioProcess International to present its major project CER – 001 ApoA1 - HDL mimetic drug candidate, and describe how Novasep played a critical role in the project by successfully achieving the transfer and scale up of Apo-A1 production.

16 Apr 2012

Synthon receives tentative approval for tadalafil tablets

Synthon has announced that its subsidiary Synthon Pharmaceuticals, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for tadalafil tablets, 20 mg on April 13, 2012. Synthon's product is a generic and bioequivalent version of Eli Lilly & Co and United Therapeutics’ Adcirca® tablets, which are indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.

16 Apr 2012

Gestational diabetes on the rise

Although the disease usually goes away after delivery, it can have permanent consequences. Not only can the mother be prone to develop diabetes later in life, but their babies are also at greater risk for chronic health problems.

16 Apr 2012

British doctors tackle the obesity epidemic

According to the Academy of Medical Royal Colleges the approach of using voluntary agreements with industry is “failing to have a significant impact” on obesity. Obesity, says the organization is a “huge crisis waiting to happen”.

16 Apr 2012

Salmonella link with yellowfin tuna: mass recall follows

A yellowfin tuna product used to make dishes like sushi, ceviche and sashimi sold at restaurants and grocery stores has been connected with with an outbreak of salmonella that has sickened more than 100 people in 20 states and the District of Columbia, federal health authorities announced last Friday.

16 Apr 2012

Fluidigm begins direct service to customers in China

Fluidigm Corporation has begun direct service to customers in China. Through the establishment of a wholly-owned Fluidigm subsidiary in China in late January 2012, officially known as Fluidigm (Shanghai) Instrument Technology Co., Ltd..

16 Apr 2012

American Red Cross in operation across the Midwest tornado affected region

The American Red Cross is responding across the Midwest where dozens of tornadoes ripped through communities overnight, destroying buildings and downing power lines. Red Cross workers are already operating shelters and providing meals, and more help is on the way.

16 Apr 2012

House GOP dusts off old budget ideas to replace some automatic cuts

When they return to Capitol Hill next week, Republicans on key House committees are expected to take up earlier proposals as they look for ways to replace some of the automatic budget cuts scheduled to take effect in January. Members of the House Judiciary Committee will make another go at revamping medical liability laws.

16 Apr 2012

UM hosts symposium on next generation characterization tools for therapeutic proteins

In a concerted effort to boost regional collaboration on developing new protein drug and diagnostics, the University of Maryland (UM) School of Pharmacy has hosted the first Interdisciplinary Symposium on Next Generation Characterization Tools for Therapeutic Proteins.

16 Apr 2012

Congressional leaders' budget dispute is a preview to fall elections

Democrats and Republicans in Congress can't agree on a budget, but there's no disagreement about using (Rep. Paul) Ryan's to highlight an election-year divide. ... The debate underscores the broader dispute between the two parties about the role and size of government. From town halls to job fairs to meet-and-greets with voters during Congress' two-week recess, Democrats and Republicans focused on the budget in a preview of the seven-month campaign to November.

16 Apr 2012

U.S. halts North Korean food aid after country launches long-range missile

"The U.S. will halt planned shipments of thousands of tons in food aid to North Korea after the reclusive Asian nation's launch of a long-range rocket, two Obama administration officials said," Bloomberg News reports.

16 Apr 2012

Disruption of key cellular functions produces physiologic and behavioral responses

Two Massachusetts General Hospital (MGH)-based research teams, along with a group from the University of California at San Diego, have discovered that animals have a previously unknown system for detecting and responding to pathogens and toxins. In three papers published in the journals Cell and Cell Host & Microbe, the investigators describe finding evidence that disruptions to the core functions of animal cells trigger immune and detoxification responses, along with behavioral changes.

16 Apr 2012

Biologists decipher novel functions of metal-binding molecule nicotianamine

In order to survive, plants should take up neither too many nor too few minerals from the soil. New insights into how they operate this critical balance have now been published by biologists at the Ruhr-Universit-t in a series of three papers in the journal The Plant Cell. The researchers discovered novel functions of the metal-binding molecule nicotianamine.

16 Apr 2012

First study to show genetic adaptation of human fat metabolism

About 300 000 years ago humans adapted genetically to be able to produce larger amounts of Omega-3 and Omega-6 fatty acids. This adaptation may have been crucial to the development of the unique brain capacity in modern humans. In today's life situation, this genetic adaptation contributes instead to a higher risk of developing disorders like cardiovascular disease.

16 Apr 2012

Mylan receives final FDA approval for generic Lescol Capsules ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol Capsules.

16 Apr 2012