Plus medtech’s top 10 money raisers of 2021
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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.

 

Featured Story

Moderna trains its mRNA tech on the common cold and a triple whammy against 3 respiratory diseases

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.

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Top Stories Of The Week

Pfizer pulls blood pressure medicines in US over cancer-causing impurities

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.

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Bristol Myers lands $1.1B biobucks oncology pact with Volastra, a biotech with phones 'ringing off the hook'

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.

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After Pfizer's pitch for 2nd round of COVID boosters, Moderna files a more ambitious FDA submission

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.

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Medtech's top 10 money raisers of 2021

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.

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#FierceMadness: BMS' Zeposia, Gilead's Trodelvy and Lilly's Retevmo advance to Sweet 16 as Horizon's Tepezza wins big

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.

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Despite 0% response rate, 4D hits primary endpoint in Keytruda combo trial, sending stock skyward

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.

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As rivals eye 'unjustified royalties,' Pfizer partner sues to defend COVID-19 shot Comirnaty

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.

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NIH's All of Us project opens floodgates, releasing first 100K sequenced genomes to researchers

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.

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UK watchdog slaps AZ, Allergan, GSK, Sanofi and Britannia for marketing breaches

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.

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An mRNA therapy improves breast cancer response to immunotherapy in mice

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.

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Takeda's Natpara relaunch bid falls flat as manufacturing concerns drag on

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.

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Resources

Industry Report: The Top Four Barriers to Successful KOL Engagement

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.

eBook: Leveraging Clinical Data for Study Success

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.

Whitepaper: Autologous CAR T-Cell Manufacturing: Semiautomatic, Closed, Modular Workflow

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.

eBook: EMEA Regulatory Roadblocks around Decentralized Trials

Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research.

Whitepaper: Top 5 Challenges Of Decentralized Clinical Trials And How To Overcome Them

How to overcome top challenges faced in decentralized trials.

Paid Marketplace: United Cargo: Providing comprehensive solutions for the most critical shipments

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.

Case Study: Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Whitepaper: Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?

Webinar: The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Whitepaper: Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

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