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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

Lack of patient understanding of the true cost of medication non-adherence

A new report released today, Friday 16th October, by Omnicell, throws the spotlight on the ‘missing millions’ in the NHS and the staggering cost to the nation of medication non-adherence.

16 Oct 2015

New manganese-based catalyst may accelerate drug discovery, development

Chemists have long believed that inserting nitrogen -- a beneficial ingredient for making many pharmaceuticals and other biologically active molecules -- into a carbon-hydrogen bond requires a trade-off between catalyst reactivity and selectivity.

15 Oct 2015

Omeros launches OMIDRIAssure program to provide expanded patient access to Omidria

Omeros Corporation today announced that it has launched OMIDRIAssure, a comprehensive reimbursement services program to provide expanded access to Omidria® (phenylephrine and ketorolac injection) 1% / 0.3% for cataract surgery patients and reimbursement assistance for physicians and facilities.

15 Oct 2015

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

BioDelivery Sciences International, Inc. announced that the U.S. Food and Drug Administration has approved the company's Supplemental New Drug Application (sNDA) for a manufacturing specification change for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII).

15 Oct 2015

BREVENA Laboratories receives National Eczema Association's Seal of Acceptance award for Restorative Skin Balm

BREVENA Laboratories, LLC, a luxury skincare cosmetics company that combines beauty and advanced medical technology, announces that the National Eczema Association has awarded the Seal of Acceptance to the brand's Restorative Skin Balm.

15 Oct 2015

Merck unveils new global brand as a science and technology company

Merck, a leading science and technology company, today announced the relaunch of its brand identity. The fundamental revision of the visual appearance as well as the introduction of a new logo reflect the transformation into a global science and technology company. At the same time, the brand architecture at business level has been simplified. Outside the United States and Canada, the company will operate uniformly as Merck.

15 Oct 2015

Pharmaceutical News

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

Lack of patient understanding of the true cost of medication non-adherence

New manganese-based catalyst may accelerate drug discovery, development

Omeros launches OMIDRIAssure program to provide expanded patient access to Omidria

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

BREVENA Laboratories receives National Eczema Association's Seal of Acceptance award for Restorative Skin Balm

Merck unveils new global brand as a science and technology company

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