Caroline Hroncich

The dispute over who has the rights to key CRISPR-Cas9 patents continues. On April 12, 2017 the University of California, Berkeley, in conjunction with the University of Vienna and Emmanuelle Charpentier, filed an appeal to overturn an earlier decision by the United States Patent Trial and Appeal Board (PTAB).

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

Pharmaceutical Technology spoke with Ben Locwin and Tom Fox ahead of their CPhI North America presentation to discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.

A new study in NEJM compares the regulatory review processes of FDA and EMA.

The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.

The company received priority review for its investigational CAR-T therapy to treat leukemia.

Tony Pidgeon, process technology director at Patheon discusses challenges associated with and recent innovations in the fill/finish process for biopharmaceuticals.

FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.

The company said it plans to expand diabetes manufacturing facilities in the United States.

Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.