WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Two former Genentech employees have pleaded guilty to using the company’s trade secrets to accelerate R&D at the biotech they co-founded, JHL Biotech, as it chased biosimilars for blockbuster cancer drugs such as Avastin and Herceptin. The charges also cover fraud related to a $101 million Rituxan biosimilar deal that JHL signed with Sanofi in late 2016. Meanwhile, the fraud trial for Theranos’ Elizabeth Holmes is just getting underway, with the first round of jury selection. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Angus Liu After two former staffers at Roche’s Genentech pleaded guilty to stealing biologics trade secrets from the company, their co-conspirators didn’t put up much of a fight before admitting to their roles in the scheme. read more |
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| | Webinar: Removing Antibody Drug Discovery's DNA Bottleneck Tuesday, September 14 | 2pm ET / 11am PT GPCRs have proven to be one of the most challenging targets for antibody drug development. In this webinar, we describe the use of next-generation DNA synthesis tools to overcome the DNA bottleneck in antibody-based GPCR drug discovery. Learn More. |
Top Stories Of The Week By Annalee Armstrong COVID-19 wasn’t even in the picture when mRNA was developed, but with the regulatory runway cleared, biotechs that have been working on the tech for years are ready for liftoff. Yes, Moderna and BioNTech are the rock stars in the business—launched to household name status with the COVID-19 vaccines at the end of 2020. But there's more to the pipeline than just these headliners. read more By Angus Liu The safety problem for Pfizer’s arthritis drug Xeljanz has caused collateral damage across its drug class. The FDA is now requiring new heart safety and cancer warnings for Xeljanz, AbbVie’s Rinvoq and Eli Lilly’s Olumiant and is pushing back their use behind TNF blockers. read more By Andrea Park Holmes faces nine counts of wire fraud and two counts of conspiracy to commit wire fraud. The charges carry a maximum sentence of 20 years in prison and fines of $250,000 plus restitution for each of the 11 counts. read more By Kevin Dunleavy Amid the discovery of foreign material in another vial of Moderna’s COVID-19 vaccine in Japan, the company said it has identified the source of contamination found last week. Stainless steel is the material and it was produced from friction between two pieces of metal on a Rovi manufacturing line. read more By Annalee Armstrong Cassava Sciences’ battle over the science backing up an Alzheimer’s disease treatment took another turn Friday, as one of the companies involved in laboratory work for the therapy denied involvement in preparing some of the data in question. Shares of Cassava crashed once again, opening down more than 20% to $54 as the markets opened Friday. This compares to a prior close of $80. read more By Beth Snyder Bulik The FDA gets more than a fair share of jabs on social media, but lately its Twitter account has been showing its own spunk. It's a purposeful decision to get people's attention and combat viral misinformation, the agency says. read more By Nick Paul Taylor Rivals are closing in on Sanofi and Regeneron’s Dupixent. With AbbVie’s Rinvoq having already bested Dupixent in atopic dermatitis, Pfizer has now chalked up its own efficacy win over the blockbuster incumbent without sharing key details of safety data that could shape the category. read more By Arlene Weintraub Cancer cells adapt to a harsh, acidic environment by spewing enzymes that neutralize the acid. Canadian researchers discovered that inhibiting one of those enzymes, Carbonic Anhydrase IX (CAIX), while simultaneously promoting a form of cancer-cell death, slows tumor growth. read more By Eric Sagonowsky Catalent has kept busy during the pandemic by helping vaccine heavyweights scale up their supply chains. In an expansion bid beyond its ongoing pandemic work, the company is buying a leading producer of gummies in the nutritional supplements field. read more Resources Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: XIFIN inc. Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives. Sponsored by: EVERSANA Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how. Sponsored by: Thermo Fisher Scientific Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications. Sponsored by: Blue Matter This white paper provides a concise overview of the trends currently shaping the market access environment in Europe, as well as the implications for biopharma companies. Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. | 