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Heather McKenzie

Heather McKenzie

Senior Editor

Heather McKenzie is an award-winning journalist specializing in the biopharma industry. With nearly a decade of experience in the sector, she possesses deep expertise in drug development and regulatory affairs, with a particular focus on neuroscience, rare disease and the FDA. She joined BioSpace in 2020 and has managed the ClinicaSpace newsletter since its inception. Her recent coverage was recognized when BioSpace was named winner of a prestigious Jesse H. Neal Award for the Best Government, Legislative and Regulatory Coverage, and National and Regional Golds for Industry News Coverage in the 2026 Azbee Awards of Excellence.

Heather has traveled internationally to cover global biotech hubs, including Israel. In previous roles, she covered current affairs, sports, education and politics. She also spent eight years as a senior content producer for executive-level business conferences in the pharma/biotech, legal, energy and business strategy sectors.

Heather lives outside London, Ontario. In her free time, she enjoys creative writing, watching baseball—especially the Toronto Blue Jays —and spending time with family, friends and her energetic Russian Blue cat Roofus. You can reach her at heather.mckenzie@biospace.com.

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Regulatory
FDA opens Operation TrialBlazer for applications, hoping to reshore early trials
The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new drug review process and expedite the path to first-in-human development in the U.S. The initial application period will close on Oct. 30.
September 15, 2026
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1 min read
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Heather McKenzie
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Regulatory
Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting
The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.
September 15, 2026
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6 min read
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Heather McKenzie
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Psychedelics
Definium moves toward FDA submission for LSD drug in anxiety after ‘another clear win’
Positive topline results from a second straight study in generalized anxiety disorder shift the narrative for Definium Therapeutics’ DT120 to commercialization, Jefferies analysts said Monday, while Stifel wrote that the asset is moving towards an FDA submission.
September 14, 2026
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3 min read
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Heather McKenzie
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mRNA
After a brief storm of political headwinds, mRNA is back with strong momentum
A year to the day after the Trump administration slashed $500 million in funding from mRNA-based programs, the FDA approved Moderna’s flu vaccine based on the technology. Weeks later, Moderna and Merck revealed positive Phase 3 results for their personalized mRNA-based cancer vaccine. In the words of one mRNA specialist, “science won.”
September 14, 2026
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6 min read
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Heather McKenzie
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FDA
Biohaven takes another hit as FDA pauses enrollment in pivotal trials for embattled epilepsy drug
The enrollment pause comes after BHV-7000 failed to show efficacy in a midstage depression trial late last year. The news is another regulatory hit for Biohaven after the FDA declined to approve its spinocerebellar ataxia treatment in November 2025.
September 10, 2026
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3 min read
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Heather McKenzie
FDA
Novo’s canned heart disease trials, Novartis’ clinical fails, first approval for Alexander disease
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.
September 9, 2026
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1 min read
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Jef Akst
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Obesity
Structure’s obesity portfolio impresses on GLP-1 and amylin fronts in dual data drop
Structure Therapeutics’ oral GLP-1 candidate aleniglipron showed 72-week efficacy “in line” with Novo Nordisk’s oral Wegovy, BMO Capital Markets wrote in a note to investors. Meanwhile, Structure’s amylin and calcitonin receptor agonist ACCG-2671 showed “impressive” target engagement in a Phase 1 trial of healthy volunteers, according to Leerink Partners.
September 8, 2026
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2 min read
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Heather McKenzie
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Approvals
FDA approves Ionis’ antisense drug as first targeted therapy for Alexander disease
Zanvastro, an antisense oligonucleotide therapy, represents the first independent neurology launch for Ionis Pharmaceuticals, which intends to leverage the foothold for more approvals in rare neurodegenerative diseases, including Angelman syndrome.
September 3, 2026
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5 min read
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Heather McKenzie
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Lung cancer
RevMed’s newly approved Rasonque could ‘hold up’ in non-small cell lung cancer
The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.
September 3, 2026
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2 min read
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Heather McKenzie
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China
FDA raises bar for foreign site inspections as China trials surge
Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites.
September 2, 2026
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4 min read
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Heather McKenzie
Huntington’s disease
UniQure files for FDA, UK approval of first gene therapy for Huntington’s disease
The biologics license application follows months of public speculation—and regulatory reversals—for uniQure’s AMT-130. If accepted by the FDA for priority review, approval could come in the second quarter of 2027.
September 2, 2026
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3 min read
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Heather McKenzie
FDA
Novartis’ and BMS’ paused CAR T trials, RevMed’s pancreatic cancer approval, more MFN deals
Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in President Donald Trump’s Most Favored Nation drug pricing scheme.
September 2, 2026
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2 min read
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Jef Akst
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Vaccines
GSK to launch Phase 3 trial for mRNA-based flu vaccine amid resurgence for the modality
GSK’s vaccine—which targets two primary flu antigens—elicited higher immune responses in both younger and older adults in a mid-stage study. The Phase 3 launch, planned for September, follows the FDA’s recent approval for Moderna’s mRNA flu vaccine.
September 1, 2026
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1 min read
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Heather McKenzie
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Neurodegenerative disease
BMS’ neuro renaissance was built on back of Celgene mega-merger
Well-known for its oncology efforts and making recent headlines for a rumored mega merger with AstraZeneca, Bristol Myers Squibb is also dedicating considerable resources to neurological and psychiatric diseases, with a “continuum of care” mindset.
August 31, 2026
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7 min read
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Heather McKenzie
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Cancer
BioNTech halts mid-stage trial of personalized mRNA vaccine in colorectal cancer
Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma.
August 28, 2026
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2 min read
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Heather McKenzie