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PTC Therapeutics initiates reimbursed expanded access program for Translarna

PTC Therapeutics, Inc. today announced the initiation of a reimbursed expanded access program (EAP). PTC's EAP program is intended to make Translarna (ataluren) available to patients before commercial availability in certain countries.

9 Jul 2014

Astellas seeks isavuconazole approval from FDA for treatment of life-threatening fungal infections

Astellas today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients.

9 Jul 2014

Telemedicine could improve quality of life of patients with chronic liver diseases

Although telemedicine could improve the quality of life of patients with chronic liver diseases, viable home care systems are still lacking. Scientists working on the EU-project "d-LIVER" mean to remedy this situation. Initial results have now been released.

9 Jul 2014

Independent testing organization confirms VSL#3 formulation as probiotic product

Probiotics have gained in popularity in recent years and consumers now have many to choose from. However, only 14 of 19 successfully tested through Consumer Lab's quality certification program probiotics.

9 Jul 2014

FDA approves Protein Sciences' strain change amendment for Flublok influenza vaccine

Protein Sciences Corporation announced today that the FDA has approved the Company's strain change amendment for its seasonal influenza vaccine, Flublok.

9 Jul 2014

Perrigo receives final approval from FDA for congestion relief tablets

Perrigo Company today announced that it was the first to receive final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for ibuprofen and phenylephrine hydrochloride tablets, 200 mg/10 mg (over-the-counter), the store brand equivalent to Advil Congestion Relief Tablets, 200 mg/10 mg.

8 Jul 2014

Use of performance enhancing drugs unmonitored in young elite athletes

The use of performance enhancing drugs is prevalent and unmonitored in junior elite athletes as young as 12, according to research by Griffith University and the University of Canberra that will be presented tomorrow.

8 Jul 2014

KoACT supplement optimal for bone strength, flexibility in post-menopausal women

Data presented at April's Experimental Biology 2014 Annual Scientific Meeting shows that KoACT, a dietary supplement that combines a proprietary formulation of calcium and collagen is optimal for bone strength and flexibility in post-menopausal women.

8 Jul 2014

Reaction Biology awarded Phase I SBIR grant to create epigenetic database

Reaction Biology Corporation announced today that it has been awarded a Phase I SBIR grant from the National Center for Advancing Translational Sciences to create a database of epigenetic drug interactions.

8 Jul 2014

Survey shows biggest barrier to receiving Human Papillomavirus vaccine

A survey of first-year Grand Valley State University students showed the biggest barrier to receiving a Human Papillomavirus (HPV) vaccine was moral or religious beliefs, or a perceived promotion of sexual behavior, according to graduate physician assistant researchers.

8 Jul 2014

CASI's ENMD-2076 gets FDA Orphan Drug designation for HCC treatment

CASI Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and other diseases, announced today that its orally-active, Aurora A/angiogenic kinase inhibitor, ENMD-2076, has received Orphan Drug designation from the U.S. Food and Drug Administration for the treatment of hepatocellular carcinoma (HCC).

7 Jul 2014

$FDA grants Breakthrough Therapy status to Novartis' CTL019 for treatment of relapsed/refractory ALL$

FDA grants Breakthrough Therapy status to Novartis' CTL019 for treatment of relapsed/refractory ALL

Novartis announced today that the United States Food and Drug Administration has granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor (CAR) therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL).

7 Jul 2014

Bayer announces Health Canada approval of Nexavar for differentiated thyroid cancer treatment

Bayer Inc. is pleased to announce the Health Canada approval of Nexavar for the treatment of patients with locally advanced or metastatic, progressive, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).

7 Jul 2014

Grunenthal Group submits Marketing Authorization Application to EMA for ZALVISO

AcelRx Pharmaceuticals, Inc. and Grunenthal Group announced today that Grunenthal has submitted a Marketing Authorization Application (MAA) to the European Medicines Authority for ZALVISO for the management of moderate to severe acute pain in adult patients in a medically supervised environment.

7 Jul 2014

Metal-free chemical reaction for anti-HIV, anti-cancer and anti-bacterial drugs

A team of researchers from KU Leuven, in Belgium, has developed an economical, reliable and heavy metal-free chemical reaction that yields fully functional 1,2,3-triazoles. Triazoles are chemical compounds that can be used as building blocks for more complex chemical compounds, including pharmaceutical drugs.

4 Jul 2014

TxCell announces launch of POSITIVE project to automate manufacturing process for Ovasave

TxCell SA, a biotech developing innovative, personalized cell-based immunotherapies using antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases, announces today the launch of, and funding awarded to, the POSITIVE project in collaboration with the Gene and Cell therapy Unit (UTCG) developing new antiviral cell-based immunotherapies and Biosafe, a Swiss private company, a developer of innovative solutions for cell processing.

4 Jul 2014

Pneumonia patients treated with azithromycin face lower risk of death, slightly increased risk of heart attack

In a study that included nearly 65,000 older patients hospitalized with pneumonia, treatment that included azithromycin compared with other antibiotics was associated with a significantly lower risk of death and a slightly increased risk of heart attack, according to a study in the June 4 issue of JAMA.

4 Jul 2014

Promising new drug for metabolic syndrome

University of Utah researchers have discovered that an enzyme involved in intracellular signaling plays a crucial role in developing metabolic syndrome, a finding that has a U of U spinoff company developing a drug to potentially treat the condition.

4 Jul 2014

Scientists produce drug compound with potential to block HIV transmission in women

Scientists at the University of Nebraska-Lincoln College of Engineering's Biological Process Development Facility have successfully produced a drug compound with potential to block HIV transmission in women.

4 Jul 2014

Beleodaq gets FDA approval for treatment of patients with peripheral T-cell lymphoma

The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency's accelerated approval program.

3 Jul 2014

Pharmaceutical News

PTC Therapeutics initiates reimbursed expanded access program for Translarna

Astellas seeks isavuconazole approval from FDA for treatment of life-threatening fungal infections

Telemedicine could improve quality of life of patients with chronic liver diseases

Independent testing organization confirms VSL#3 formulation as probiotic product

FDA approves Protein Sciences' strain change amendment for Flublok influenza vaccine

Perrigo receives final approval from FDA for congestion relief tablets

Use of performance enhancing drugs unmonitored in young elite athletes

KoACT supplement optimal for bone strength, flexibility in post-menopausal women

Reaction Biology awarded Phase I SBIR grant to create epigenetic database

Survey shows biggest barrier to receiving Human Papillomavirus vaccine

CASI's ENMD-2076 gets FDA Orphan Drug designation for HCC treatment

FDA grants Breakthrough Therapy status to Novartis' CTL019 for treatment of relapsed/refractory ALL

Bayer announces Health Canada approval of Nexavar for differentiated thyroid cancer treatment

Grunenthal Group submits Marketing Authorization Application to EMA for ZALVISO

Metal-free chemical reaction for anti-HIV, anti-cancer and anti-bacterial drugs

TxCell announces launch of POSITIVE project to automate manufacturing process for Ovasave

Pneumonia patients treated with azithromycin face lower risk of death, slightly increased risk of heart attack

Promising new drug for metabolic syndrome

Scientists produce drug compound with potential to block HIV transmission in women

Beleodaq gets FDA approval for treatment of patients with peripheral T-cell lymphoma

How GLP‑1 Agonists Are Shaping the Future of Obesity Treatment With Dr Bryony Henderson

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

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