AskBio touts early gene therapy data
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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

To TIGIT or not to TIGIT? Roche's latest trial flop casts shadow on Big Pharma's $6B bet

Once hailed as the future of immuno-oncology, it looks like TIGITs could now be in trouble. Roche admitted last week to a second phase 3 trial failure for tiragolumab, which was unable to demonstrate the progression-free survival achieved by Tecentriq alone in patients with non-small cell lung cancer.

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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

From Redditors to creditors: Orphazyme's wild ride ends with $13M sale to satisfy bankruptcy court

Orphazyme’s vertiginous decline is over. Having briefly commanded a market cap of $2.7 billion in June 2021, the Danish meme stock is now selling substantially all of its assets and business activities to KemPharm for $12.8 million in cash.

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AskBio and you shall receive as the Bayer-backed gene therapy maker touts early phase 1 data

AskBio's gene therapy to treat congestive heart failure is showing promise in initial data from an open-label phase 1 trial. Among three patients, there were no safety concerns through one year of treatment, and all three showed clinical improvement.

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AbbVie coughs up nearly $50M for Cugene's autoimmune med in a bid to shore up life post-Humira

AbbVie is spending nearly $50 million in upfront cash to have first dibs at Cugene's autoimmune med nearing a phase 1b study. The drug is a concerted effort by AbbVie to plan for life after Humira's patent expiration.

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Kriya cashes in $270M series C to further finance all-in-one gene therapy biz

Kriya Therapeutics has reeled in a whopping $270 million from its series C round, surpassing the $180 million raised in total over the last two years and solidifying ample financing to build out its all-in-one gene therapy business. 

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Shionogi splashes $100M on F2G's rare fungal disease drug to unlock new class of medicine

Shionogi is betting $100 million upfront on a new class of antifungal medicine, teaming up with F2G to land the Asian and European rights to a late-phase drug candidate that could help immunocompromised patients failed by existing therapies.

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VC firm Sofinnova banks $1B from Apollo to invest in early-stage biotech solutions

Biotechs may be seeing their valuations plummet, but Apollo Global Management still wants in. The asset manager has committed up to 1 billion euros ($1.04 billion) in capital commitments to Sofinnova Partners, one of Europe’s largest early-stage healthcare venture capital funds, to expand its presence in the sector.

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AstraZeneca puts further $75M up for grabs in expanded Proteros cancer drug deal

AstraZeneca is extending its oncology partnership with Proteros biostructures, adding a new drug discovery program and boosting the potential biobucks payout for the German life sciences company by $75 million.

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Most influential people in biopharma—the entrepreneurs

The leaders in this week's Most Influential People in Biopharma category have led companies of all types in this industry⁠—and they're still building today. While they may have scientific and medical expertise, the Fierce team felt their contributions to the business aspects of biopharma made them worth featuring this week.

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Medtronic makes FTC-mandated sale to close Intersect ENT deal and scores FDA nod to boot

It may have taken an order from the FTC to get there, and Medtronic may be getting less bang for its buck than initially expected, but the medtech giant’s acquisition of Intersect ENT is finally complete.

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Otsuka drops beleaguered Akebia after FDA snub. Will AstraZeneca follow suit with FibroGen?

Akebia Therapeutics is slipping into even more trouble after the FDA's surprise rejection of its oral anemia drug vadadustat. After a round of layoffs, the beleaguered biotech has found its partner Otsuka and the Nasdaq stock exchange rubbing salt in its wounds.

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RaDonda Vaught sentenced to 3 years probation for fatal medication error

The lenient sentence was applauded by healthcare workers observing outside of the courthouse as well as professional organizations, which warned that "criminalization of medical errors will not preserve safe patient care environments."

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Seagen CEO Siegall resigns after domestic abuse arrest

Less than a month after he was arrested and charged with domestic abuse, Seagen CEO and co-founder Clay Siegall, M.D., has resigned from the Seattle-area biotech that he helped build into one of the most successful in the world.

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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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