Randi Hernandez

CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Bio/pharma employees say they are more secure in their jobs, but may seek better opportunities with other employers.

Opdivo and investigational agent FPA008 will be tested in combination for their efficacy in boosting antitumor immune response.

Approximately 40% of total global growth will come from specialty medications, according to a new report from the IMS Institute for Healthcare Informatics.

A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.

Pfizer will pay $850 million upfront and as much as $2 billion later in a deal to jointly develop one of Merck?s cancer drugs.

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

The transaction provides Allergan stockholders with immediate value and enhanced commercial opportunities, according to a company statement.

After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.

ANSM wants company data on the benefits and risks of using Avastin over Lucentis in the treatment of wet age-related macular degeneration.

The deal between the two companies will strengthen Perrigo's presence in Europe.

M&A transactions accounted for nearly $15 billion more this year than for the same period a year ago.

Amgen is suing Sandoz over Sandoz's biosimilar application for filgrastim.

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

The board of directors at Sanofi unanimously agree to remove Sanofi's CEO.

New research will focus on a superfamily of protein receptors linked to various diseases.

The Yale School of Medicine and Gilead will continue their research on cancer targets for a minimum of three additional years.

The divestment will create the number two player in the global influenza vaccine industry.

Shire announces it will expand its orphan drug portfolio and is ready for future M&A discussions.

A customer complaint prompts the recall of a lot of anticoagulants from a plant in Puerto Rico.

The renovation to Roche's historic office building in Basel, Switzerland will feature sustainable workplaces and a state-of-the-art research center.

Personalized immunotherapy treatments help 90% of acute lymphoblastic leukemia patients achieve remission in a new study.

Pfizer's addition of a new vaccine suite and multiproduct bioprocess suite to its Ireland facility win the company the title of 2014 Facility of the Year.

Iclusig?s original indication will remain unchanged after a thorough examination of its safety information by EMA.

A change in the supply chain for three important Genentech cancer medications elicits a strong reaction from one of the nation?s largest operators of hospitals.

Almac expands its blister-packaging suite to meet the needs of two Japanese clients.

New rules from the Treasury Department regarding inversion affect merger activity in the pharmaceutical sector.

Impurities, particulates, and a lack of communication are among Hospira's recent violations described in a warning letter from FDA.

Delivery of large protein biopharmaceuticals may now be administered orally with the help of microneedles, according to researchers at MIT.