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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

Vanda acquires license from Lilly to develop and commercialize NK-1R antagonist

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, announced today that it has acquired an exclusive world-wide license from Eli Lilly and Company (Lilly) to develop and commercialize a small molecule neurokinin 1 receptor (NK-1R) antagonist for all human indications.

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

Study pinpoints compounds that repress cancer gene’s activity

A research team pursuing one of the most commonly altered genes in cancer has laid a critical foundation for understanding this gene that could point the way toward developing drugs against it. A recent study of cancer genetics pointed to the gene MCL1, which encodes a protein that helps keep cells alive

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

Merck, Endocyte enter vintafolide development and commercialization agreement

Merck, known as MSD outside the United States and Canada, and Endocyte Inc., today announced that they have entered into an agreement to develop and commercialize Endocyte's novel investigational therapeutic candidate vintafolide (EC145).

16 Apr 2012

NTD experts push forward on plan to eradicate yaws

Yaws, a skin and bone disease caused by a treponematoses bacterium that can cause long-term deformities, "has recently been put on WHO's list of 17 so-called neglected tropical diseases (NTDs)" and, along with Guinea worm, is "slated for eradication," the Lancet reports.

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

As world's first polio vaccine turns 57, scientists working to develop better alternatives

In this post in the Bill & Melinda Gates Foundation's "Impatient Optimists" blog, Pulitzer Prize-winning author David Oshinsky examines the development of the world's first polio vaccine, noting that the vaccine, developed by Jonas Salk of the University of Pittsburgh, turned 57 on Thursday.

16 Apr 2012

Study identifies potential biomarkers associated with chemo resistant breast cancers

Biomarkers which could help to predict resistance to chemotherapy in breast cancer patients have been identified by researchers from the University of Hull, UK.

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

Indomethacin given after digestive diagnostic procedure may prevent pancreatitis: Study

There is a high risk of pancreatitis after a diagnostic procedure - ERCP (endoscopic retrograde cholangiopancreatography). ERCP is a procedure that is commonly utilized to treat or diagnose problems of the bile and pancreatic ducts. During an ERCP procedure, a lighted scope is inserted through the mouth while X-ray pictures are taken to check the tubes that drain the liver, pancreas and gallbladder.

15 Apr 2012

Impax initiates challenge of patents related to generic Gralise

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Gralise (gabapentin tablets, 300 mg and 600 mg).

12 Apr 2012

C3BS' new production facilities in Mont-Saint-Guibert granted GMP Certification

The Belgian biotechnology company Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases, today announces that it has been granted Good Manufacturing Practice (GMP) Certification for its new production facilities in Mont-Saint-Guibert.

12 Apr 2012

Johnson & Johnson fined $1.2B for hiding anti-psychotic drug dangers, deceptive marketing

An Arkansas judge fined the drug maker and a subsidiary for misleading doctors and the public on the risks involved with taking an anti-psychotic drug, Risperdal, and for marketing the drug for an off-label use to the state's Medicaid system.

12 Apr 2012

Consumption of long-chain omega-3 PUFAs lowers risk of colorectal polyps in women

New research finds that omega-3 polyunsaturated fatty acids (PUFAs) found in seafood (long-chain omega-3s) may reduce the risk of precancerous colorectal polyps in women, enhance the muscular benefits of strength training in older women and improve eye health after corneal surgery.

12 Apr 2012

Discontinuing antibiotic used to prevent opportunistic infections among HIV patients could increase risk of malaria, diarrhea

"Abruptly discontinuing co-trimoxazole -- an antibiotic used to prevent opportunistic infections in HIV-positive people -- can lead to a higher incidence of malaria and diarrhea compared with patients who keep on taking the drug," according to a study conducted by the CDC in eastern Uganda and published by the Oxford Journal of Clinical Infectious Diseases in March, PlusNews reports.

12 Apr 2012

AstraZeneca introduces DUTOPROL for hypertension

AstraZeneca today announced the availability of DUTOPROL (metoprolol succinate extended release/hydrochlorothiazide) Tablets, the first and only once-daily antihypertensive agent that contains the active ingredient of TOPROL-XL (metoprolol succinate) plus a low-dose diuretic that provides proven blood pressure lowering at 24 hours.

12 Apr 2012

PPIs improve sleep and daytime quality of life for sufferers of GERD

The use of proton pump inhibitors improves the sleep and daytime quality of life for sufferers of gastroesophageal reflux disease, according to a systematic literature review in the April 2012 issue of Otolaryngology-Head and Neck Surgery.

12 Apr 2012

Pharmaceutical News

Inspiration submits IB1001 BLA with FDA for treatment of hemophilia B

Vanda acquires license from Lilly to develop and commercialize NK-1R antagonist

Australian nutrition researcher to receive Alexander Leaf Distinguished Scientist Award

Study pinpoints compounds that repress cancer gene’s activity

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

Synthon receives tentative approval for tadalafil tablets

Merck, Endocyte enter vintafolide development and commercialization agreement

NTD experts push forward on plan to eradicate yaws

UM hosts symposium on next generation characterization tools for therapeutic proteins

As world's first polio vaccine turns 57, scientists working to develop better alternatives

Study identifies potential biomarkers associated with chemo resistant breast cancers

Mylan receives final FDA approval for generic Lescol Capsules ANDA

Indomethacin given after digestive diagnostic procedure may prevent pancreatitis: Study

Impax initiates challenge of patents related to generic Gralise

C3BS' new production facilities in Mont-Saint-Guibert granted GMP Certification

Johnson & Johnson fined $1.2B for hiding anti-psychotic drug dangers, deceptive marketing

Consumption of long-chain omega-3 PUFAs lowers risk of colorectal polyps in women

Discontinuing antibiotic used to prevent opportunistic infections among HIV patients could increase risk of malaria, diarrhea

AstraZeneca introduces DUTOPROL for hypertension

PPIs improve sleep and daytime quality of life for sufferers of GERD

Exploring the nanoscale: How AFM is transforming cosmetic science

Innovating Texture and Culture in Plant-Based Foods

Advancing brain microphysiological systems (bMPS)

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