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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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Psychedelics
HHS pumps up to $25M into ibogaine, other psychotropic drugs on Veteran’s Day
Ibogaine, which operates via a “matrix pharmacology,” has long been a focus of Health Secretary Robert F. Kennedy Jr. and the Trump administration.
November 13, 2026
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3 min read
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Heather McKenzie
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Psychedelics
Deep dive: Cardiovascular calamities and catalysts
BioSpace reviews upcoming cardiovascular milestones after a summer of missed targets.
November 12, 2026
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3 min read
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Heather McKenzie
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FDA
FDA’s commissioner voucher program reportedly shuttered ahead of Senate vote on Overton
In advance of a Senate vote on Heidi Overton as the next FDA commissioner, the agency has shelved the Commissioner’s National Priority Voucher program introduced by former leader Marty Makary, Reuters reported Thursday.
November 12, 2026
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3 min read
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Heather McKenzie
Company downsizing, staff reduction and layoffs. Employee dismissal, firing and unemployment. Business concept.
Layoffs
Capricor parts ways with 10% of staff as FDA decision on DMD cell therapy nears
Awaiting a decision on Nov. 22 for its embattled Duchenne muscular dystrophy cell therapy deramiocel, Capricor has reduced its workforce by 10% and slowed programs not directly related to deramiocel, the biotech revealed in its third quarter earnings report.
November 11, 2026
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3 min read
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Heather McKenzie
Podcast
Novartis’ Zolgensma woes, BIO’s China plan, GLP-1s’ new safety warning, FDA’s stacked November
Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about the risk of a rare eye condition that can lead to vision loss; and the agency is set to decide on no fewer than 11 therapies this month, including closely watched applications from Summit Therapeutics, Vertex and Capricor Therapeutics.
November 11, 2026
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2 min read
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Jef Akst
Inspiration Business Opportunity. Businessman looks at stairs in the door arrow pointing up
Sickle cell disease
Beam preps FDA run for industry-first base-edited therapy after pivotal sickle cell success
Beam Therapeutics’ risto-cel provided at least 12 consecutive months of freedom from severe pain crises for patients with sickle cell disease in a mid-stage trial, setting the stage for an FDA application as early as this year.
November 10, 2026
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3 min read
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Heather McKenzie
Close up shot of the dart arrow hit on bulleyes of dartboard to represent that the business reached the target with dark tone picture style. Target and goal as concept.
GLP-1
Lilly to seek second sleep apnea approval after Foundayo reduces disease severity in Phase 3
If approved, the oral GLP-1 would be Eli Lilly’s second marketed drug for obstructive sleep apnea after the GIP/GLP-1 injectable Zepbound secured the first approval in the space in December 2024.
November 9, 2026
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2 min read
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Heather McKenzie
Zigzag upward arrow chart, financial progress, market growth,
Psychedelics
Update: Compass submits psilocybin depression drug for approval after stock wobbles
Compass Pathways has completed an FDA filing for COMP360, with an expected launch in the first half of next year. The update follows a reported regulatory submission for Usona Institute’s own psilocybin candidate for depression last Monday.
November 9, 2026
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3 min read
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Heather McKenzie
Missed Target
Cardiovascular disease
Details from Novartis’ failed cardiovascular trial offer ‘little silver lining’ for rivals
Full data from the Phase 3 HORIZON trial of Novartis’ pelacarsen failed to show any apparent benefit, leading analysts to further reduce the odds of success for Lp(a)-lowering competitors such as Amgen’s olpasiran.
November 9, 2026
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4 min read
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Heather McKenzie
Blue Magnifying Glass Focusing Sunlight on Blue Background
Drug Development
Update: FDA investigates Novartis’ Zolgensma following 9 cases of tumors in treated patients
After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgensma or for the pharma’s similar product Itvisma.
November 9, 2026
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4 min read
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Heather McKenzie
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FDA
FDA’s new rare disease framework aims to leverage patient voices for better innovation
Inclusion of the patient perspective is currently an “optional” part of the rare disease drug development process, CBER Director Karim Mikhail told BioSpace. Mikhail, along with his CDER counterpart Michael Davis and other agency rare disease leaders, is trying to change that.
November 9, 2026
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7 min read
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Heather McKenzie
Drug Development
Sanofi’s axing of Nurix STAT6 program ‘not a target-related issue’
Sanofi has discontinued an early-stage STAT6 degrader program licensed from Nurix Therapeutics, a decision analysts say is related to the asset itself or Sanofi’s strategic reprioritization rather than the drug class more broadly.
November 4, 2026
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3 min read
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Heather McKenzie
Podcast
Q3 earnings roll on, FDA pushes rare disease, uniQure’s Huntington’s therapy reaches review
The majority of the large pharmas have now reported third quarter earnings—spoiler alert: Eli Lilly made more money than anyone expected. Plus, the FDA dropped another initiative aimed at accelerating rare disease treatments; HHS greenlights the compounding of six unapproved peptides; and uniQure’s embattled gene therapy for Huntington’s disease has finally been accepted for review.
November 4, 2026
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1 min read
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Jef Akst
Light at the end of railroad tunnel. Natural lighting.
FDA
UniQure snags May Day decision date for Huntington’s gene therapy after arduous year
After a year of controversial regulatory reversals, the FDA has accepted uniQure’s application for ifezuntirgene inilparvovec for priority review, with a May 1 action date. If approved, the therapy—also called AMT-130—would be the first disease-modifying treatment for Huntington’s disease.
November 2, 2026
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2 min read
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Heather McKenzie
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FDA
Plug-and-play gene therapy: FDA executes on vision that’s been in the works for years
Former biologics boss Peter Marks had a vision. With the FDA’s latest draft guidance, it’s coming to fruition. Speaking with BioSpace, current CBER leader Karim Mikhail said the “adapted pathway” is designed to develop personalized gene therapies more quickly.
November 2, 2026
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6 min read
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Heather McKenzie