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Coagadex now approved by FDA for patients with hereditary Factor X deficiency

The U.S. Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today's orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency.

21 Oct 2015

Dietary calcium better than supplemental calcium in reducing kidney stone formation

Calcium supplements may increase the risk of kidney stone recurrence, according to a study that will be presented at ASN Kidney Week 2015 November 3¬-8 at the San Diego Convention Center in San Diego, CA.

20 Oct 2015

Biosimilars offer access to both established and new treatment options for inflammatory diseases

Drugs produced using biotechnology are among the most expensive medicines available. Biosimilars that offer a real alternative are becoming increasingly available on the market.

20 Oct 2015

Leading obesity groups stress need to regulate weight-loss dietary supplements

On the heels of a new study tying dietary supplements to more than 23,000 emergency room visits each year, four leading obesity research, treatment and prevention groups issue a joint scientific statement recommending dietary supplements for weight loss claiming curative or medicinal qualities be subject to review and approval by the United States Food and Drug Administration (FDA).

20 Oct 2015

LEO Pharma's Enstilar gets FDA approval for topical treatment of plaque psoriasis

LEO Pharma Inc., a wholly owned U.S. subsidiary of LEO Pharma A/S, announced today that Enstilar has been approved by the U.S. Food and Drug Administration for the topical treatment of plaque psoriasis in adults 18 years of age and older.

19 Oct 2015

Sprout announces U.S. availability of Addyi for HSDD treatment in premenopausal women

Sprout Pharmaceuticals, Inc., a division of Valeant Pharmaceuticals North America LLC, announced today that Addyi, a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, is now available in the United States through certified physicians and pharmacies.

19 Oct 2015

TARSA Therapeutics' TBRIA NDA accepted by FDA for review

TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM (calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015, has been accepted for review, with a PDUFA date of May 30, 2016.

19 Oct 2015

Outreach program increases completion of HPV vaccination series by teens in safety-net settings

A joint study by UT Southwestern Medical Center and Parkland Health & Hospital System investigators found that a multicomponent outreach program increased completion of the three-dose human papillomavirus (HPV) vaccination series that reduces the risk of cervical cancer caused by the virus.

19 Oct 2015

UAMS researchers report positive results from treating Metastatic Merkel-cell carcinoma with idelalisib drug

Identifying a patient's genetic mutation led University of Arkansas for Medical Sciences (UAMS) physician-researcher Ling Gao, M.D., Ph.D., to an existing drug that eliminated the patient's stage IV Merkel-cell carcinoma. Gao's findings, made in collaboration with two other UAMS researchers, were published today in The New England Journal of Medicine.

19 Oct 2015

FDA grants accelerated approval to Praxbind (idarucizumab)

The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa's blood-thinning effects.

19 Oct 2015

Misuse of prescription drugs common among U.S. college students

Seven out of 10 college students say it is somewhat or very easy to obtain controlled stimulants without a prescription, according to a new survey conducted on eight U.S. campuses.

19 Oct 2015

Boehringer Ingelheim announces FDA approval of Praxbind (idarucizumab)

Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration granted approval of Praxbind (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

16 Oct 2015

Study shows vitamin D, calcium supplements fail to protect against colorectal cancer

A large, randomized study at 11 U.S. hospitals including Dartmouth-Hitchcock Medical Center found that vitamin D and calcium supplements fail to protect against developing colorectal cancer.

16 Oct 2015

Safe, effective douche-based rectal microbicide can prevent HIV in gay men

Enemas are commonly used by men who have sex with men (MSM) and transwomen (TW) before sexual intercourse. But these groups are vulnerable to HIV and a host of other sexually transmitted infections because enemas -- even those that use tap water -- can seriously damage the thin tissue lining the rectum, allowing for easier transmission of harmful viruses and bacteria.

16 Oct 2015

Study suggests combination of MMF and CNIs can protect against rare lymphoma

A study led by Johns Hopkins researchers has linked the immunosuppressive drug mycophenolate mofetil (MMF) to an increased risk of central nervous system (CNS) lymphoma in solid organ transplant patients.

16 Oct 2015

Study shows why cancer anemia therapy stimulates tumor growth

Scientists have shown why a drug widely used to treat chemotherapy-induced anemia in ovarian and breast cancer patients also may shorten survival times in some patients by inadvertently stimulating tumor growth.

16 Oct 2015

Rutgers-led research consortium receives NIH grant to support continuous manufacturing systems for pharmaceuticals

The U.S. Food and Drug Administration (FDA) has awarded $4.9 million in grant funding to institutions in a research consortium based at the Rutgers University School of Engineering to support the introduction of continuous manufacturing techniques for pharmaceuticals.

16 Oct 2015

Sanofi Pasteur, IDRI establish Global Health Vaccine Center of Innovation

In an effort to accelerate timelines and decrease development costs of life-saving vaccines, the Infectious Disease Research Institute (IDRI) and Sanofi Pasteur today announce the establishment of the Global Health Vaccine Center of Innovation (GHVCI), to be headquartered at IDRI in Seattle.

16 Oct 2015

WHO officials hope to eradicate polio by 2024

Shortly after the successful global Smallpox Eradication Programme (SEP) in the 80's, world leaders and public health officials announced a plan to eradicate poliomyelitis (polio) off the face of the Earth; the Pan American Health Organization and the World Health Organization (WHO) together championed the cause.

16 Oct 2015

Medical experts launch crowd funding project to investigate effect of malaria drug on colorectal cancer

Medical experts investigating whether a common malaria drug could have a significant impact on colorectal cancer have launched a crowd funding project to fund their work.

16 Oct 2015

Pharmaceutical News

Coagadex now approved by FDA for patients with hereditary Factor X deficiency

Dietary calcium better than supplemental calcium in reducing kidney stone formation

Biosimilars offer access to both established and new treatment options for inflammatory diseases

Leading obesity groups stress need to regulate weight-loss dietary supplements

LEO Pharma's Enstilar gets FDA approval for topical treatment of plaque psoriasis

Sprout announces U.S. availability of Addyi for HSDD treatment in premenopausal women

TARSA Therapeutics' TBRIA NDA accepted by FDA for review

Outreach program increases completion of HPV vaccination series by teens in safety-net settings

UAMS researchers report positive results from treating Metastatic Merkel-cell carcinoma with idelalisib drug

FDA grants accelerated approval to Praxbind (idarucizumab)

Misuse of prescription drugs common among U.S. college students

Boehringer Ingelheim announces FDA approval of Praxbind (idarucizumab)

Study shows vitamin D, calcium supplements fail to protect against colorectal cancer

Safe, effective douche-based rectal microbicide can prevent HIV in gay men

Study suggests combination of MMF and CNIs can protect against rare lymphoma

Study shows why cancer anemia therapy stimulates tumor growth

Rutgers-led research consortium receives NIH grant to support continuous manufacturing systems for pharmaceuticals

Sanofi Pasteur, IDRI establish Global Health Vaccine Center of Innovation

WHO officials hope to eradicate polio by 2024

Medical experts launch crowd funding project to investigate effect of malaria drug on colorectal cancer

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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