Fierce Biotech's Fierce 15 nominations are open
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Today's Rundown

Featured Story

Biohaven flunks first clinical test for rare disease drug post-Pfizer sell-off

Biohaven reported that troriluzole has failed a phase 3 trial in spinocerebellar ataxia, just weeks after CEO Vlad Coric, M.D., touted the company's future as a slimmed-down R&D engine after the migraine business was sold off to Pfizer for $11.6 billion.

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Sponsored: Agilex Biolabs Doubles in Size with Launch of New Large Molecule Facility as It Expands Its U.S. Presence

Bioanalytical Laboratory Offers Qualified U.S. Clients a 43.5% Cash Rebate for Conducting Studies in its Australia-based FDA-Inspected Labs

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Top Stories

Chasing Lilly and Pfizer, Concert's JAK inhibitor hits high notes in phase 3 alopecia trial

Concert Pharmaceuticals has hit the high notes in a phase 3 alopecia areata clinical trial, finding 41.5% of people had at least 80% scalp hair coverage after taking the high dose of its JAK inhibitor. The data put Concert in the wings as Eli Lilly and Pfizer prepare to take to the stage and compete for the market.

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Calling all Fierce 15 fans: Nominations for the 2022 Fierce Biotech Fierce 15 are now open

Fierce Biotech is once again seeking your nominations for the best, most exciting and innovative private biotechs.

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J&J's $230M blood pressure bet hits phase 3 endpoint, but questions linger about blockbuster potential

Johnson & Johnson’s $230 million blood pressure bet has hit the mark in phase 3. Idorsia-partnered aprocitentan significantly reduced blood pressure in patients with resistant hypertension, although the rate of fluid retention and initial lack of detail on efficacy leave scope to question whether it will live up to its blockbuster billing.

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Innoviva buys struggling antibiotic biotech Entasis, as the AstraZeneca spin out preps FDA filing

Holding company Innoviva is acquiring late-stage antibiotic biotech Entasis Therapeutics, a 2015 AstraZeneca spin-out that just posted phase 3 results worthy of an FDA filing last year.

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Unraveling how prostate tumors develop drug resistance to open up a window of opportunity for treatment

A Cleveland Clinic-led research team discovered how tumors evade prostate cancer therapy and identified a short timespan in which hard-to-treat tumors may respond to treatment, opening the door—or window—to potential new strategies.

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Most influential people in biopharma—the regulators and advocates

As the biopharma industry develops increasingly specialized treatments, regulators are being forced to adapt. And at the same time, the industry is making strides toward becoming more inclusive. These are the most influential regulators and advocates in biopharma.

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One year into Philips' ventilator foam recall, FDA tallies 124 deaths, 21,000 complaints

In the first year since Philips began taking precautions against a suspected safety issue with many of its ventilators and CPAP and BiPAP machines last April, the issue has sparked more than 21,000 complaints including reports of cancer, pneumonia, asthma, infection, headache, nodules, and chest pain as well as more than 120 deaths.

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Mayo Clinic posts $227M operating loss for Q1 as labor expenses shoot up

Mayo Clinic posted a $227 million net operating loss for the first quarter of 2022 as the system faced major headwinds from rising labor expenses to a volatile investment market.

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Monkeypox outbreak won't be the next global pandemic thanks to vaccines, drugs: analysts

An unusual wave of monkeypox cases in non-endemic regions has raised the possibility of another global health crisis. But two groups of biopharma experts argue monkeypox likely won’t escalate into another pandemic that humans struggle to contain.

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A vibrating pill for constipation heads to the FDA after completing phase 3 study

Vibrant Gastro is putting forward its novel approach as a completely drug-free alternative to treatments for infrequent or difficult bowel movements.

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Pfizer, BioNTech tout COVID booster data for young children and plan to finish FDA filing

A week after getting the FDA go-ahead for a booster in the 5 to 11 age group, Pfizer and BioNTech revealed positive data from a booster trial of their COVID vaccine in younger children. The companies plan to add the new data to their rolling emergency use authorization submission this week.

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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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