A day after resigning his seat in the U.S. House, former Rep. Chris Collins (R-N.Y.) pleaded guilty Tuesday to one count of conspiracy to commit securities fraud and one count of lying to the FBI when interviewed about insider trading involving Australian biotech Innate Immunotherapeutics Ltd. In 2017, Collins, who served on Innate's board and was one of the company's largest shareholders, tipped his son, Cameron Collins, with confidential information about negative clinical trial results for the Sydney-based company's multiple sclerosis drug, which was in phase IIb development. According to the SEC, the son then allegedly shared the news with Stephen Zarsky, his girlfriend's father. Before the market opened the next morning, Cameron Collins and Zarsky allegedly entered orders to sell their Innate shares. Over the next two trading days, Cameron Collins allegedly sold a total of nearly 1.4 million Innate shares. A few hours after the last of his sales, Innate publicly announced the trial results, triggering a stock price plummet of more than 92%. Because of their sales, Cameron Collins and Zarsky avoided losses of more than $700,000, the SEC said, adding that the two men contacted other friends and family members who also sold Innate shares in advance of the announcement. Chris Collins will be sentenced in January. He faces up to five years in prison on each count, according to the U.S. Department of Justice.

The NIH's National Institute of Allergy and Infectious Diseases is providing up to $51 million in first year funding for its new Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. The network of research centers will work together to develop universal influenza vaccines, which could provide longer-lasting protection than current vaccines and against a greater variety of viruses. In addition, the CIVICs network will explore ways to improve seasonal flu vaccines, including testing alternative vaccine platforms or incorporating new adjuvants.

Beginning this month, abbreviated new drug application (ANDA) applicants with secure email accounts will receive FDA action letters by secure electronic communication as the agency continues to move away from paper communications. To ensure timely receipt of letters from the Office of Generic Drugs, ANDA applicants should keep their FDA Form 356h updated with a current, monitored and secure email address. Applicants that don't have secure email will continue to receive paper copies of action letters, the FDA said.

The FDA slapped the Shanghai Institute of Pharmaceutical Industry with a warning letter after the firm wrote to the agency's China office refusing an announced preapproval inspection. The Chinese firm serves as a contract testing laboratory that provides active pharmaceutical ingredient characterization and identification testing to support several ANDAs, according to the letter.

No Comments