Federal Judge Rules Clinical Trial Sponsors Must Publish a Decade's Worth of Missing Data

                                                                                          Issue # 3142 | February 26th, 2020      








News Alert


Federal Judge Rules Clinical Trial Sponsors Must Publish a Decade's Worth of Missing Data

For years, government research agencies have misinterpreted a law that requires them to collect and post clinical trial data, a federal judge ruled this week, leaving behind a 10-year gap in data that now must be made publicly available. Now, potentially hundreds of universities, drug companies, and medical device manufacturers are on the hook to release previously unpublished data. The ruling affects trials conducted for as-yet-unapproved drugs and devices in that 10-year stretch, according to a lawyer for the plaintiffs - meaning hundreds or even upwards of 1,000 noncompliant trials would be forced to post data. The ruling puts sponsors of clinical trials during that span out of compliance if they have not posted results. Learn More


Genentech Signs Early Discovery Collaboration Agreement with Bicycle

Bicycle Therapeutics has entered into a strategic collaboration agreement with Genentech. Under the terms of the agreement, Genentech and Bicycle will collaborate on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Bicycle will be responsible for discovery research and early pre-clinical development up to candidate selection, and Genentech will be responsible for further development and commercialization upon the selection of candidates.to discover, develop and commercialize novel immuno-oncology therapies. For its part, Bicycle will receive a $30 million upfront payment with commercial-based milestone payments worth up to $1.7 billion. Learn More


Promising Novartis Drug Beovu Subject of Warning About Worrying Side Effects

This week the American Society of Retina Specialists issued a note to eye doctors warning about worrying side effects seen with Novartis' new macular degeneration treatment, Beovu. A drug which has been targeting the market share of Regenerons' Eylea. According to the warning, there have been several cases of a dangerous form of eye inflammation called vasculitis; although this was seen in Beovu's clinical program, these occurrences appear to confirm that this is a real issue for the product. Retinal vasculitis can lead to blindness and although only 14 cases were reported to the ASRS, 11 were classified as occlusive retinal vasculitis. Learn More

Quote Alert

On this Day Alert

1929  Grand Teton National Park is Established

On this day in 1929, after more than a decade of political maneuvering, Grand Teton National Park was created. As a concession to the ranchers and tourist operators in the area, the park only encompassed the mountains and a narrow strip at their base. Jackson Hole itself was excluded from the park and designated merely as a scenic preserve. Learn More

TED Alert

Creative Ways to Get Kids to Thrive in School

To get young kids to thrive in school, we need to do more than teach them how to read and write -- we need to teach them how to manage their emotions, says educator Olympia Della Flora. In this practical talk, she shares creative tactics she used to help struggling, sometimes disruptive students -- things like stopping for brain breaks, singing songs and even doing yoga poses -- all with her existing budget and resources. "Small changes make huge differences, and it's possible to start right now ... You simply need smarter ways to think about using what you have, where you have it," she says. Learn More

Poll Alert

Do you prefer your peanut butter creamy or crunchy?


Bioprocess Alert

Case Study: Rubius Therapeutics

This video, produced by G-Con, tells the story of how prefabricated PODs were delivered in 8 months to Rubius Therapeutics' cGMP facility in Smithfield, Rhode Island. Meeting their aggressive timeline and providing speed to market for clinical manufacturing.

Market Alert

Event Alert


Microbial Engineering II

April 19th - 24th, 2020 

Albufeira, Portugal

The first ECI Conference on Microbial Engineering in March 2018 in Santa Fe, New Mexico brought together leaders in Synthetic Biology, Metabolic Engineering and Fermentation Technology both from industry and the academic community. Examples of applications included natural products, therapeutic proteins, vaccines and biosynthesis of a great variety of organic chemicals.

Resource Alert

Assessment of Recombinant Protein Production in E. Coli with Time-Gated Surface Enhanced Raman Spectroscopy (TG-SERS)

Time-Gated Surface-Enhanced Raman spectroscopy (TG-SERS) was utilized to assess recombinant protein production in Escherichia coli. TG-SERS suppressed the fluorescence signal from the biomolecules in the bacteria and the culture media. Characteristic protein signatures at different time points of the cell cultivation were observed and compared to conventional continuous wave (CW)-Raman with SERS. TG-SERS can distinguish discrete features of proteins such as the secondary structures and is therefore indicative of folding or unfolding of the protein. A novel method utilizing nanofibrillar cellulose as a stabilizing agent for nanoparticles and bacterial cells was used for the first time... Learn More

Regulatory Alert

FDA Warns Chinese Crude Heparin Manufacturer, 2 Drugmakers in India

The US FDA this week released three warning letters sent earlier this month. One to Yibin Lihao noted that the company told FDA inspectors that they had not produced crude heparin "for months," but inspectors found "two batches of crude heparin manufactured just a few days before the FDA inspection." The FDA's warning letter to India's JHS Svendgaard Hygiene Products notes how the firm lacked adequate testing for incoming API and thus relied on its suppliers' certificates of analyses (COA). While for India CMO Essnd, the FDA said the firm released drug product without adequate testing, including identity and strength testing of the active ingredient. Learn More

Discovery Alert


CRISPR Gene Cuts May Offer New Way to Chart Human Genome

In search of new ways to sequence human genomes and read critical alterations in DNA, researchers at Johns Hopkins Medicine say they have successfully used the gene cutting tool CRISPR to make cuts in DNA around lengthy tumor genes, which can be used to collect sequence information. The researchers say that pairing CRISPR with tools that sequence the DNA components of human cancer tissue is a technique that could, one day, enable fast, relatively cheap sequencing of patients' tumors, streamlining the selection and use of treatments that target highly specific and personal genetic alterations.

Project Alert

WuXi Vaccines to Build Additional Biologics Manufacturing Facility