Ethics/Regulatory

EMA launches PRIME for unmet medical need medicines

Monday, March 7, 2016

The EMA has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).

[Read More]

WIRB-Copernicus develops ethics tool kit for clinical research protocols

Wednesday, March 2, 2016

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services and software to support clinical research, has announced the publication of an innovative Ethics Tool Kit in the Journal of Medical Ethics. Developed by the Multi-Regional Clinical Trials (MRCT) Center of Harvard and Brigham and Women’s Hospital working group, the toolkit was co-written by 20 experts in clinical research, including WCG Chief Medical Officer and President of Consulting Services Lindsay McNair, M.D., MPH, MSB, and WCG Chief Compliance Officer David Forster, JD, MA, CIP.

[Read More]

PhRMA sues to block Ohio drug pricing initiative from Nov. 2016 ballot

Tuesday, March 1, 2016

Backers of an Ohio ballot initiative addressing inflated drug prices have criticized the Pharmaceutical Researchers and Manufacturers of America (PhRMA), a drug industry trade group, for filing a lawsuit to block the ballot initiative from even appearing on the November 2016 ballot. The lawsuit was filed in the Supreme Court of Ohio (Case # 2016-313) challenging The Ohio Drug Price Relief Act, a citizen-driven ballot initiative that will revise Ohio law to require state programs pay no more than the U.S. Department of Veterans Affairs for prescription medications. V.A. pricing is generally believed to be 20% to 24% lower than for almost any other government program.

[Read More]

Recipharm pours €40M into serialization

Tuesday, February 16, 2016

Recipharm, a contract development and manufacturing organization (CDMO), has taken the decision to lead the market in coding and serialization to actively help pharmaceutical companies prepare for the implementation of new regulations. 

[Read More]

FDA seeks $5.1B for FY 2017

Wednesday, February 10, 2016

The FDA is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget—an 8% increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative being led by the vice president.

[Read More]

Bipartisan legislation introduced to combat Zika virus

Friday, February 5, 2016

U.S. Representatives G. K. Butterfield (NC-01) and Susan Brooks (IN-05) have introduced H.R. 4400, a bipartisan bill that seeks to add the Zika virus to the list of diseases included in the Tropical Disease Priority Review Voucher Program at the FDA. The Zika virus, which is transmitted to humans by mosquitoes, can infect pregnant women and result in birth defects, including microcephaly and neurological disorders in newborns. The virus also causes skin rashes, conjunctivitis, muscle and joint pain, and headaches in adults. The World Health Organization has labeled Zika a global public health emergency.

[Read More]