Bio/Pharma News

Generic Versions of Crestor Hit US Market Post Court Decision

July 21, 2016

Generic versions of AstraZeneca’s blockbuster Crestor will hit the US market after a federal judge refused to issue a restraining order blocking the approval of rosuvastatin ANDAs.

FDA Votes in Favor of Brodalumab, But Cautions of Risks

July 20, 2016

The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.

Celgene Partners with Jounce Therapeutics for Immunotherapy Development

July 19, 2016

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.

Ionis Pharmaceuticals Licenses Oral RNA-based Therapeutic to Janssen

July 19, 2016

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

Sandoz's Biosimilar to Enbrel Gets FDA Support Ahead of Panel

July 11, 2016

FDA reviewers have found that Sandoz's GP2015, a biosimilar version of Amgen's Enbrel, is highly similar to the original product in terms of purity, safety, and potency.

Sanofi Collaborates with US Government on Zika Vaccine R&D

July 08, 2016

The company will collaborate with the Walter Reed Army Institute of Research to co-develop a Zika vaccine candidate.

Federal Court Weighs in on Biosimilar Patent Dance

July 08, 2016

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

Novo Nordisk Expands Insulin Manufacturing Facility in Denmark

July 06, 2016

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

Teligent Breaks Ground on Manufacturing and R&D Expansion

July 06, 2016

Teligent is expanding its manufacturing and R&D complex in New Jersey.

Bristol-Myers Squibb Acquires Cormorant Pharmaceuticals

July 05, 2016

The acquisition will give Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program.