Annalee Armstrong headshot

Annalee Armstrong

Senior Editor

Annalee Armstrong is an award-winning biopharma journalist covering the business of drug development. She has been a journalist for more than 18 years, covering the pharmaceutical and biotech industry for the last eight.

Annalee began her career at small newspapers across Western Canada. During the assignment of a lifetime, the Yukon Quest Sled Dog Race, she met her husband in Alaska and eventually moved to the U.S. Since then, Annalee has covered energy, environmental regulations, healthcare and biopharma. Prior to BioSpace, Annalee was senior editor for Fierce Biotech, where she received several awards for her writing and editing. She lives in Ottawa, Ontario, with her husband, two wild boys, an anxious Rhodesian Ridgeback and an indifferent tabby cat.

She is senior editor at BioSpace and curates the Biopharm Executive newsletter every Wednesday. You can reach her at  annalee.armstrong@biospace.com. Follow her on LinkedIn.

FDA
Citing the urgent unmet need for patients with advanced biliary tract cancer, Compass Therapeutics will continue to seek an approval path for its drug after the FDA recommended the biotech conduct a new clinical study.
While Vertex is laser-focused on an upcoming FDA decision for povetacicept in immunoglobulin A nephropathy, the APOL1 inhibitor inaxaplin has demonstrated potential “best-in-class” data in a different kidney disease.
Novo CEO Maziar Mike Doustdar disclosed an additional 4,000 staff departures, which a spokesperson told BioSpace are linked to attrition and other measures.
The mid-stage readout is one link in a chain of catalysts that analysts were watching for this year from Roche’s metabolic pipeline, which features assets from the $2.7 billion acquisition of Carmot Therapeutics as well as partner Zealand Pharma.
As Big Pharma adds AI technology to bolster drug development, a cadre of new, upstart biotechs are pushing drug discovery to new heights.
Novo has “gone shopping” to fill pipeline gaps, with a focus on obesity and diabetes, plus an expansion in blood and endocrine disorders, liver diseases and cardiovascular conditions.
A new five-year biotech plan has been released by the Chinese government, revealing ambitious goals such as achieving five blockbuster medicines on the global markets in that time.
As Xenon Pharmaceuticals announced that azetukalner has reached the FDA for focal seizures, the company also disclosed the emergence of psychosis adverse events in psychiatric trials of the drug, triggering a temporary pause.
While increases in the interest rate from the Federal Reserve are usually bad for biotech, the sector at this moment is poised to withstand the blow, according to analysts, though earlier stage companies may be left in the lurch.
Big Pharma needs more—not fewer—bold bets on rare and difficult diseases after Novartis’ efforts to invest in muscular dystrophy and ALS hit major roadblocks this month.
FDA
The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.
Analysts tentatively welcomed Novo’s new corporate rebrand—so long as it comes with a larger change to the company’s overall business strategy.
Novartis’ shares fell 13% this week after the report of three separate late-stage asset setbacks. The impact went beyond the Swiss drugmaker, dragging peers down across the market.
With multiple drug pricing initiatives like Most Favored Nation now in force, drugmakers have to reinvent their commercial strategies to stay ahead of the fast-moving policy environment, according to a new report from Numerof & Associates.
FDA
September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way.