Alkermes plc is working to resolve the complete response letter (CRL) sent by the FDA regarding ALKS-3831, the company’s oral therapy for schizophrenia and bipolar I disorder in adults. Regulators reviewed manufacturing records and said the Dublin-based firm needs to supply documents related to making the tablet’s coating at the Wilmington, Ohio, facility. No clinical or non-clinical concerns were raised, the Dublin-based firm noted. Shares (NASDAQ:ALKS) were unfazed, trading midday at $17.96, up 12 cents.

Brainstorm's Nurown falls short in phase III ALS trial

Shares of Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) fell 67% by midday on news that its autologous cell therapy candidate, Nurown, missed the primary efficacy endpoint of a phase III amyotrophic lateral sclerosis (ALS) study. While treatment responses in the trial's Nurown arm aligned with investigator expectations, response in the placebo arm exceeded expectations, the company said. CEO Chaim Lebovits said an FDA review of the data is next, "to see if there is a path forward to support approval."

Peptidream launches joint venture to find COVID-19 cure

HONG KONG – Peptidream Inc. has partnered with four other Japanese companies to research and develop peptide therapeutics capable of neutralizing the SARS-CoV-2 virus as well as potential future coronavirus outbreaks. Peptiaid Inc., the joint venture established with Fujitsu Ltd., Mizuho Financial Group Inc. subsidiary Mizuho Capital Co. Ltd., Takenaka Corp. and Kishida Chemical Co. Ltd., will have capital totaling ¥599 million (US$5.73 million) by Dec. 31, with Peptidream and Fujitsu each owning a 25% stake. Mizuho Capital will own 24.9%, Takenaka will hold 16.7% and Kishida 8.3%, according to the Dec. 31 projection.

Test rapidly diagnoses any known pathogen from any available body fluid

Researchers at the University of California at San Francisco have developed a method to diagnose any known pathogen from any body fluid within a day – or, depending on the sequencing method, within a few hours. For an unknown pathogen, the method spits out its nearest known relative. The team published results demonstrating the method’s ability to identify Bacteria and fungi in the Nov. 9, 2020, online issue of Nature Medicine. But senior author Charles Chiu, who is a professor of laboratory medicine at UCSF and director of the UCSF-Abbott Viral Diagnostics and Discovery Center, said that he and his colleagues are working on applying the same method to both DNA and RNA viruses, with promising preliminary results. “Strictly speaking, it is a research advance,” Chiu told BioWorld. “But we deliberately developed this test… to be compatible with clinical workflow.”

Industry commits to improving diversity in clinical trials

Just days after the FDA finalized its guidance on enhancing diversity in clinical trials, the Pharmaceutical Research and Manufacturers of America (PhRMA) released the first-ever industrywide principles on trial diversity. The principles, which are to take effect in April, focus on four main areas: “building trust and acknowledging the historic mistrust of clinical trials within Black and Brown communities, reducing barriers to clinical trial access, using real-world data to enhance information on diverse populations beyond product approval, and enhancing information about diversity and inclusion in clinical trial participation.”

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