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The deal may offset billions of dollars in waning sales from Pfizer drugs slated to lose patent protection and provides Pfizer with a whole portfolio of biosimilar products.

Margaret Hamburg announced on Feb. 5, 2015 that she will step down as FDA Commissioner after serving in the position for almost six years.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

Under terms of the agreement, Zymeworks could earn up to $164 million per successful drug candidate.

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

A new study conducted by the National Institutes of Health found that a certain vector used in gene therapy (and its insertion site in the genome) may be associated with an increased risk of liver cancer.

Cosentyx (secukinumab) is the first IL-17A inhibitor for moderate-to-severe plaque psoriasis patients.

The move represents Hospira’s first biosimilar submission in the United States.

Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.

An FDA panel unanimously recommended the agency approve EP2006, Sandoz’s biosimilar for filgrastim.

Isis Pharmaceuticals announced that it entered into an agreement with Janssen Biotech to discover and develop antisense drugs for autoimmune disorders of the GI tract.

In 2014, FDA approved 41 new molecular entities, which is the highest number since 1996.

Roche’s LightMix Ebola test can give results in around three hours.

When used in combination with chlorambucil to treat chronic lymphocytic leukemia, Gazyva was found to be more effective than Rituxan.

Entrectinib has received FDA’s orphan drug and rare pediatric disease designations for the treatment of neuroblastoma.

Approval of anti-PD-1 antibody Opdivo represents a major milestone for patients who no longer respond to existing treatments for melanoma.

Pharmacy benefit manager Express Scripts offers Viekira Pak at a discount and excludes the drug’s higher-priced competitors from its formulary.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.

Xencor's technology focuses on the use of antibody and protein biotherapeutics to treat immune-related diseases.

The new bill calls for a data exclusivity period of 15 years for drugs that treat diseases with unmet medical need.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

Tufts research suggests costs to launch a new drug have doubled since 2003, but some question conclusions.

Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting

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

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

FDA opens public docket on proposed criteria for “first generic” ANDAs.