Editas' cell therapy nabs orphan drug tag
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Today's Rundown

Catalent Trending Topic: Cell & Gene Therapy
Read on to understand how the industry is addressing gene therapy and cell therapy research and development.

Featured Story

Roche's TIGIT flop prompts GSK, iTeos to reevaluate next steps for rival drug

That was fast. Just 39 hours after the bombshell failure of Roche’s TIGIT trial, iTeos Therapeutics revealed it and GlaxoSmithKline are assessing “how best to proceed with additional clinical development” of their rival asset in light of the phase 3 flop.

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Top Stories

BridgeBio adds another $110M to coffers with voucher sale a day after mega BMS deal

A day after getting a nice fat—and sorely needed—paycheck from Bristol Myers, BridgeBio has sold off a priority review voucher, adding $110 million to its coffers.

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FDA tags Editas' thalassemia cell therapy an orphan drug as it rounds final bend in race to clinic

Editas Medicine has picked up more regulatory privileges for its ex vivo gene-edited medicine, securing FDA orphan-drug designation in beta thalassemia ahead of the start of a clinical trial in the indication.

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Checkmate details bleak future if $250M Regeneron merger does not close

Checkmate Pharmaceuticals has detailed a difficult future in a regulatory filing if the $250 million merger with Regeneron does not close.

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Adagio still hopes to build omicron offense for lead COVID-19 therapy

Hoping to still make the case for an FDA authorization for its COVID-19 antibody, Adagio Therapeutics is making modifications and exploring higher doses in search of an omicron offense.

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'The Top Line' podcast: Big Pharma's M&A lull, the shake-up in top 10 highest paid R&D execs, plus this week's headlines

This week on "The Top Line," we talk about why Big Pharma is resisting the temptation to go on a biotech M&A spree. We also discuss the 10 biggest earners among R&D chiefs and the drastic changes from last year's list, plus the week's biggest headlines.

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Human Cell Atlas initiative makes strides as scientists piece together 'Google Map' of human cells

The Human Cell Atlas consortium has added important pieces to the creation of the full map of human cells, offering new insights into gene activity in specific cell types and how immune cells behave in various human tissues and organs.

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As Siemens AG leaves Russia over Ukraine war, Siemens Healthineers will stay

Siemens AG’s decision to exit Russia does not include Siemens Healthineers, according to the company, which previously said it would continue to support healthcare providers and patients in the country.

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GSK's ViiV, Horizon and Pfizer earn top scores from U.S. patient groups: survey

When it comes to sizing up pharma’s corporate reputation, U.S. patient groups put GlaxoSmithKline’s ViiV Healthcare, Horizon Therapeutics and Pfizer on top.

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Healing the heart: Moderna cofounder, researchers near ‘Holy Grail’ for heart regeneration

Healing a broken heart has taken on new meaning—researchers led by Moderna's cofounder have a new approach that may repair heart function after damage, closing in on the long-awaited “Holy Grail” for patients awaiting heart transplant.

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Chutes & Ladders—Moderna CFO Gomez departs after just one day following unearthed investigation

Gomez steps down as Moderna CFO after just one day following an unearthed investigation at his former employer. Seagen puts Siegall on leave after domestic violence arrest. Inovio taps new leader following "particularly challenging period" and persistent COVID vax failures.

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Fierce Pharma Asia—Takeda's patent cliff and rare disease setback; FDA's censure of Sun, Aurobindo

Takeda is preparing for the patent loss of its third-largest product and called it quits on a rare disease therapy. Sun Pharma and Aurobindo Pharma received new Form 483s from the FDA. Eisai has completed the rolling submission of its second Alzheimer's disease candidate. And more.

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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.

Research: Healthcare Has No Borders: The Role of Rescue Sites in Times of Global Calamity

More than 570 clinical trials in Ukraine have been disrupted. Unanticipated disruptions to medical testing and clinical trials impede progress toward new breakthroughs and new therapies that millions of patients around the world hang their hope on. What role do rescue sites play?

Infographic: 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.

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