Industry News

The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.

As FDA advisory committees meet on two potential PCSK9 inhibitors, Prime Therapeutics analyzes the impact that this class of drugs may have on overall drug spending.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

CPhI Pharma Insights’ Turkey Market Report reveals, the growth and strategic plans for the future of the pharmaceutical industry in Turkey.

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

BIO announces that for the second year in a row, it will feature the Innovation Zone at its 2015 conference in Philadelphia, PA.

Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.

Will biosimilars share a compendial identity like generic drugs do?

The IPEC-Americas Foundation is accepting applications for graduate student, research, and industry research achievement awards.

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

New guidance complements ICH guidelines on impurities.

MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.

EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.

The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.

CVS Health signed a definitive agreement to acquire Omnicare for $12.7 billion to expand its reach to assisted living and long-term care facilities.

The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.

The Critical Path Institute launched a consortium to help develop therapies for newborns.

CPhI Worldwide announces the 2015 Expert Panel, including 2014 panel veterans and three new members.

Supply chain consortium establishes a working group to address quality problems in India.

CPhI Istanbul to feature materials, manufacturing, packaging and contract services solutions.

Turkey continues to dominate the MENA pharma region as regional manufactures expand at double-digit pace with the arrival of international players.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

A range of packages is available for industry partners to implement charity giving.

CPhI Russia opens in Moscow as the government seeks to boost domestic manufacturing production.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.