CMHP recommends against serelaxin for heart failure use

The Committee for Medicinal Products for Human Use (CMHP) has advised the European Medicines Agency (EMA) not to approve the drug for the treatment of heart failure. This rejection comes several days after a similar rejection by the FDA.

By Nicole Gray • May 27, 2014

AstraZeneca rethinks its drug R&D process

The cost of drug development is much higher than often cited, which means that research and development failure is even more costly. What factors influence success, and how are companies, like AstraZeneca attempting to improve research and development productivity?

By Nicole Gray • May 27, 2014

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Inhibikase receives orphan drug designation for PML treatment

Imatanib is used to treat various cancers, and has been tested extensively by Inhibikase Therapeutics for the treatment of PML, a potentially fatal side effect associated with immunomodulatory therapy for patients with autoimmune diseases. It represents the only treament option for PML and has been granted orphan drug designation by FDA. 

By Nicole Gray • May 23, 2014

Growing fear of MERS virus increases urgency of researchers

MERS has killed 181 people worldwide, but its appearance in the U.S. this month surprised authorities. Researchers at NovaVax are using a new method to develop vaccines, which could decrease the decade-long timeline and $1 billion cost associated with vaccine development.

By Nicole Gray • May 22, 2014

FDA grants orphan drug status to AbbVie's Humira

AbbVie's Humira has been granted orphan drug status for the treatment of uveitis. It is currently a $2.6 billion drug used to treat various inflammatory conditions.

By Nicole Gray • May 21, 2014

Bristol-Myers Squibb gains 'breakthough therapy' designation for cancer drug

The pharmaceutical company gains the designation from the FDA for an oncology product being developed for the treatment of multiple myeloma.

By Nicole Gray • May 21, 2014

FDA: Fluzone not linked with febrile seizures

After a CDC warning that Fluzone may be linked to the increase in febrile seizures during the winter of 2010-11, researchers looked at epidemiologic data. Their analysis confirmed no significant association.

By Nicole Gray • May 16, 2014

Cetirix Orthopaedics obtains new financing, patents

Ceterix Orthopaedics, which makes surgical equipment for arthroscopic procedures, received two new patents and a new round of financing. 

By Nicole Gray • May 16, 2014