WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Moderna added two more vaccine programs to its roster, including one targeting all four endemic viruses behind the common cold. The other will offer a single combo shot for SARS-CoV-2, the flu and respiratory syncytial virus—while the company’s current COVID shot heads to the FDA for its second booster dose nod. Meanwhile, shortly after two recalls in Canada for two of its blood pressure drugs, Pfizer is pulling three of its meds off U.S. shelves after finding cancer-causing impurities. And #FierceMadness continues: Go vote for your favorite drug names in the round of 16. | |
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Featured Story By Annalee Armstrong Moderna is adding two more vaccine programs to its roster: a combination respiratory candidate and a shot targeting all four endemic human coronaviruses that cause the common cold. read more |
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Top Stories Of The Week By Kevin Dunleavy Pfizer has recalled six lots of its blood pressure drug Accuretic along with five lots of two of its generic hypertension treatments because of cancer-causing agents. The recalls come three weeks after Pfizer went through two rounds of recalls in Canada for two of its blood pressure medicines. read more By Max Bayer Two years since its inception, Volastra Therapeutics is partnering with Bristol Myers Squibb for up to three oncology targets focused on chromosomal instability, a deal that could exceed $1.1 billion should the assets hit milestones. read more By Kevin Dunleavy Moderna has asked the FDA to authorize a second booster dose of its COVID-19 vaccine for all adults. The move comes on the heels of a similar request from Pfizer and BioNTech for authorization of a second booster shot of their vaccine for people 65 and older. read more By Andrea Park,Conor Hale The medtech industry’s impressive venture funding activity was an anomaly in 2020, when most other sectors were floundering to stay afloat during the COVID-19 pandemic. A year later, as businesses around the globe returned to (somewhat) normal operations and overall VC activity hiked back up, medtech continued to ride that wave, coasting to its highest-ever annual funding total by the end of 2021. read more By Ben Adams It’s March, so it’s time for some #FierceMadness. We’re looking for the best of the best in drug names—and this round we saw wins for Bristol Myers, BioMarin, Gilead, Eli Lilly and more, as AstraZeneca and Takeda drugs dropped out. Now it's time to get voting for your Elite 8. read more By Nick Paul Taylor Can a 0% response rate represent success in an oncology clinical trial? Investors said yes on Wednesday, sending shares in 4D pharma up 30% after enough patients in its Keytruda combination trial had stable disease for the study to hit its primary endpoint. read more By Eric Sagonowsky Pfizer has already reeled in tens of billions of dollars in sales for its COVID-19 shot Comirnaty. Now, one of the company's partners says rival companies are eyeing "hundreds of millions, if not billions, of dollars in unjustified royalties" through a potential patent lawsuit. read more By Andrea Park Years after the NIH's All of Us project kicked off, researchers can begin reaping the fruits of that work, as the program this week unveiled a database comprising about 10% of its ultimate goal. read more By Natalie Missakian AstraZeneca and Allergan are among five pharma companies in hot water with the UK's Prescription Medicines Code of Practice Authority for marketing activities that ran afoul of industry standards. read more By Angus Liu A team of scientists in Spain has discovered a promising approach to increasing immunotherapy's effectiveness in triple-negative breast cancer by targeting cancer stem cells. The researchers created a mRNA therapy prototype based on the findings and showed promising results in mice. read more By Joseph Keenan Takeda’s long slog to manufacture and relaunch its hypoparathyroidism drug Natpara got a lot tougher after the pharma giant announced it received a new complete response letter from the FDA. read more Resources Sponsored by: H1 Read why many MSLs are still challenged in developing integrated strategies to increase the volume of meaningful engagements. Download this industry report to find out what the top challenges are and suggestion strategies to solve them. Download now. Sponsored by: Medidata, a Dassault Systèmes company The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates. Sponsored by: Thermo Fisher Scientific Learn how to navigate the top manufacturing challenges and achieve a seamless transition from discovery to clinical manufacturing across the CAR T-cell therapy workflow. Sponsored by: Oracle Health Sciences Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research. Sponsored by: Oracle Health Sciences How to overcome top challenges faced in decentralized trials. Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Drug Development Boot Camp® HYBRID and VIRTUAL in real time November 16-17, 2022 Fierce Promotional Review Committee Compliance and Best Practices Summit April 12-14, 2022 | New Brunswick, NJ Fierce Medical Affairs Strategic Summit (MASS) East April 12-14, 2022 | New Brunswick, NJ Accelerating Immuno-Oncology and Oncology Drug Development Using Humanized Mice Thursday, April 21, 2022 | 12pm ET / 9am PT Fierce Trial Master File Summit May 2-4, 2022 | New Orleans, LA & Streaming Live Fierce Leaders in Life Sciences Forum May 24, 2022 | Free Virtual Event Fierce Health Tech Forum May 25, 2022 | Free Virtual Event Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Free Virtual Event Fierce Pharma PR & Communications Summit July 19-20, 2022 | Jersey City, NJ Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 2022 | San Diego, CA Medical Affairs Strategic Summit (MASS West) September 2022 | San Diego, CA Fierce Health Payer Summit October 12, 2022 | Free Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Drug Development Boot Camp® HYBRID/VIRTUAL November 16-17, 2022 Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce New Product Planning Summit November 30 - December 1, 2022 | Boston, MA Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual |