Vertex wants to be biggest in Boston
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Today's Rundown

Oracle

Trending Topic: Decentralized Trials
Explore the latest news and insight on decentralized clinical trials, and FDA oversight of studies that leverage telemedicine and local healthcare providers.

Featured Story

AstraZeneca bags pan-variant COVID-19 antibodies from stealthy biotech in $157M deal

AstraZeneca is keeping its foot on the gas on COVID-19 R&D, striking a deal to license RQ Biotechnology’s early-stage monoclonal antibodies against SARS-CoV-2 in a deal worth up to $157 million plus royalties.

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Sponsored: Q&A: Steve Thompson on Compliant, Hands-Free Validation

AR-driven hands-free validation isn’t just a futuristic concept. It’s available now, and it has the power to transform the life sciences. Read more.

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Sponsored: mRNA Unlocked: How Technology Convergence Is Driving the Next Wave

The Life Sciences companies at Danaher are setting the template for end-to-end creation of new mRNA medicines, with innovations in plasmid DNA, RNA oligonucleotides, lipid nanoparticles and more.

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Top Stories

Scholar Rock in a hard place as biotech lays off 25% of staff, narrows pipeline and loses CMO

Scholar Rock is the latest biotech to scale back its ambitions in the face of a tough funding climate, laying off a quarter of its staff as well as trimming its pipeline and waving goodbye to its CMO.

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After 14 years, Agios is looking for a partner to tango with, but tough changes lie ahead

After going it alone for the past 14 years, Agios is ready to find a dance partner to help move its pipeline forward. But as part of the hunt for a company or companies that may nod back to Agios’ cabeceo, some tough choices lay ahead.

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Aiming to be biggest biotech in Boston, Vertex plots 500-person cell, gene therapy R&D center

Vertex is doubling down on cell and genetic therapy R&D. Having recently opened a 400-person center in Boston, the biotech has set out plans for a 344,000-square-foot facility just around the corner.

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FDA has change of heart, plans to convene advisory meeting for Cytokinetics' cardiac med

The FDA will convene an advisory committee to discuss Cytokinetics inconsistent heart failure med after all, more than three months after the agency first indicated it would not.

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Ampio's years of troubles come to a head with internal investigation, trio of COVID trial failures

An osteoarthritis trial ravaged by COVID, an FDA rejection, three failed clinical trials in COVID and now this: Ampio’s board is conducting an internal investigation.

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Remix closes $70M funding with pipeline 'really humming,' but to what tune?

Remix Therapeutics has closed a $70 million series B, bringing the total amount raised to more than $150 million since December 2020. But the company has yet to disclose specific details about its pipeline beyond potential therapeutic areas.

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Gilead HIV prospect escapes FDA hold after glass compatibility glitch triggered regulatory setbacks

Gilead Sciences received the all-clear to pick up studies of its investigational HIV med lenacapavir. Still, the long-acting injectable has yet to fully recover from the sting of its recent glass compatibility snafu.

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New antiviral class offers hope of halting rampage of treatment-resistant viruses and beyond

The current crop of herpesvirus drugs are designed to poison the machinery that viruses use to multiply inside an infected cell. Enter feedback disruptors—a class of therapy being developed by San Francisco’s Gladstone Institutes that have the potential to get around a virus’s mutation defense.

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ObvioHealth's new AI-based tools aim to take subjectivity out of pediatric trials

Subjectivity is a stumbling block in pediatric drug research, according to ObvioHealth, which has developed tools to make studies involving kids more objective.

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24 states support federal government in 340B drugmaker lawsuit

A collection of 24 states announced support for the federal government who are in several lawsuits with drugmakers over 340B restrictions.

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FDA smiles on 2nd cavity-spotting AI in a month with clearance for Overjet's tech

Not content to simply grin and bear it as another dental artificial intelligence developer, VideaHealth, snagged FDA clearance for cavity-spotting AI just a few weeks ago, Overjet has quickly followed suit.

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Pfizer, Merck and AstraZeneca led Big Pharma's growth in Q1 but they couldn't match mRNA hotshots

Big Pharma posted major growth in the first quarter of 2022, providing more evidence of the industry’s rebound from the pandemic. Most of the growth leaders sell COVID-19 products. A quarter-over-quarter comparison however told a different tale as seasonal effects prevented most companies from exceeding their fourth-quarter revenues.

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Resources

Executive Summary: PBPK Modelling for Optimizing Controlled Release Dosage Form Development

In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes.

Whitepaper: Gain Operational Speed and Velocity by Sharing Quality Incident Data

Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders.

Whitepaper: Medical Affairs Metamorphosis: Trends Driving Change & What They Mean

Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve.

eBook: Streamline HCP interactions management

Don’t miss these critical considerations when evaluating your HCP interactions management program.

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