Top News

EU and US Pledge to Recognize Each Other’s GMP Inspections

March 02, 2017

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

PhRMA Urges USTR to Ramp Up Patent Enforcement Activities Overseas

February 16, 2017

PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.

The Broad Institute Triumphs in CRISPR Patent Battle

February 16, 2017

The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the institution to keep patents for its CRISPR-Cas9 gene-editing technology.

Biotech Executives Express Concern Over Immigration Order

February 10, 2017

A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.

FTC: Shire ViroPharma Filed Bogus Petitions to Delay C. Diff Generic

February 07, 2017

Aggressive petitioning by ViroPharma kept a generic equivalent to Vancocin off the market for more than two years.

Pfizer Reacts to Trump’s Comments and Discusses Pipeline in Its Q4 Earnings Call

February 01, 2017

A change in the tax code could help the company create more jobs in the United States, while fewer FDA regulations could help reduce drug prices, according to Pfizer CEO Ian Read.

President Trump Meets with Pharma Manufacturers

January 31, 2017

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.

J&J to Acquire Actelion for $30 billion

January 26, 2017

The companies will split Actellion’s drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.

Cellectis Describes Novel CAR-T Design in New Paper

January 25, 2017

Researchers from Cellectis investigate how external signals in the tumor microenvironment could control the cell-surface expression and specificity of engineered CARs.

Merck Settles Litigation with Bristol-Myers Squibb on Use of Antibody Targeting PD-1

January 24, 2017

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.