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Heather McKenzie

Heather McKenzie

Senior Editor

Heather McKenzie is a professional journalist with more than 8 years’ experience in the biopharmaceutical industry. Since joining BioSpace, she has written more than 300 features and breaking news articles, including multiple award-winning stories. Her particular focuses are neuroscience, rare disease and regulatory science. She has also traveled internationally to cover global biotech hubs, including Israel. In previous roles, she has covered current affairs, sports, education and politics. She previously spent eight years as a senior content producer for executive-level business conferences in the pharma/biotech, legal, energy and business strategy sectors. In her free time, Heather enjoys creative writing, watching her American League champion Toronto Blue Jays, spending time with family and playing with her energetic Russian Blue cat Roofus. She hails from Toronto and has also lived in Chicago and Chesapeake, Virginia. You can reach her at heather.mckenzie@biospace.com.

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Approvals
Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists and a 10-3 advisory committee vote in its favor.
August 6, 2026
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3 min read
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Heather McKenzie
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Layoffs
Bespoke gene-editing outfit abandons lead program, cuts ‘several’ employees
Seven months after launching with $16 million in seed financing, Jennifer Doudna’s Aurora Therapeutics is pivoting away from its lead indication, phenylketonuria, owing to growing competition in the field.
August 5, 2026
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2 min read
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Heather McKenzie
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Editorial
Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad
The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings last week for Replimune and Capricor Therapeutics only created more confusion and frustration.
August 5, 2026
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6 min read
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Heather McKenzie
FDA
Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcomms
The industry has been abuzz since the weekend when talks of a potential mega-merger between Bristol Myers Squibb and AstraZeneca were reported. Meanwhile, Pfizer, Merck and others release second quarter earnings, with some disclosing pipeline discontinuations and cost-cutting measures. Finally, all eyes turn to the FDA in the wake of heated advisory committee meetings for Capricor Therapeutics and Replimune.
August 5, 2026
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1 min read
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Jef Akst
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FDA
Biotech leaders call for streamlining of INDs as FDA’s Trialblazer rolls out
The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.
August 3, 2026
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9 min read
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Jef Akst
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Regulatory
Capricor CEO won’t rule out legal action against FDA after negative adcomm
After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior motive” and “biased intentions.”
July 31, 2026
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6 min read
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Heather McKenzie
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FDA
FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
During a perplexing advisory committee meeting in which FDA reviewers focused largely on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, experts pointed to “very fragile” data. The committee voted 9-3 against approval of deramiocel.
July 29, 2026
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8 min read
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Heather McKenzie
FDA
Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
The FDA published briefing documents ahead of advisory committee meetings for therapies from Capricor Therapeutics and Replimune indicate an uphill battle for the biotechs; GSK and AstraZeneca outline ambitious plans in second quarter presentations; Sarepta taps Michael Severino as its new CEO; and Amgen launches its official defense of Tavneos.
July 29, 2026
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1 min read
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Heather McKenzie
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FDA
UPDATE: FDA disputes Capricor’s claims of Phase 3 success for DMD cell therapy
In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor’s assertion that a Phase 3 trial met its primary outcome measures.
July 27, 2026
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3 min read
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Heather McKenzie
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China
Summit, Merck must navigate new regulatory terrain in China-first cancer landscape
Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be required for Summit and China-based partner Akeso—and other transnational tandems—to secure FDA approval?
July 27, 2026
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10 min read
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Heather McKenzie
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Rare diseases
Arrowhead puts pressure on Ionis with positive data for triglyceride lowering drug
With Phase 3 data showing what analysts called a “potentially best-in-class profile,” Arrowhead Pharmaceuticals plans to submit for FDA approval of plozasiran by the end of the year—hoping to follow to market Ionis Pharmaceuticals’ Tryngolza, which got the regulator’s nod in severe hypertriglyceridemia last month.
July 22, 2026
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2 min read
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Heather McKenzie
Podcast
Q2 earnings underway, FDA’s CRL kerfuffle, IPOs full speed ahead in H2
Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics space; more drama unfolds at FDA as the agency goes back and forth on its policy of publishing complete response letters in real-time; and IPO fever continues.
July 22, 2026
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1 min read
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Jef Akst
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Psychedelics
Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst cautioned, however, that the transaction should not be seen as “supporting a uniform re-rating of every psychedelic developer.”
July 20, 2026
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3 min read
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Heather McKenzie
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Alzheimer’s disease
AAIC 2026: Anti-tau space begins to clarify as Biogen presents detailed data on antisense drug
New mid-stage data from Biogen’s Ionis-partnered therapy diranersen served to both validate the tau hypothesis in Alzheimer’s disease and raise questions that could soon be elucidated by anti-tau candidates from Denali Therapeutics, Eisai and Eli Lilly.
July 15, 2026
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6 min read
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Heather McKenzie
Podcast
Biogen validates anti-tau approach at AAIC, psychedelics full speed ahead, ATTR-CM shakeup
Biogen’s new data, presented at the Alzheimer’s Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.
July 15, 2026
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1 min read
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Jef Akst