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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.

Businessman walks on the street and sees a question mark.
Huntington’s disease
UniQure crashes as Huntington’s gene therapy shows less slowing of disease at 4 years
The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2 study of AMT-130 underestimates disease progression.
September 29, 2026
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4 min read
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Heather McKenzie
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Rare diseases
Milestone Sanfilippo nod helps Ultragenyx regroup after tough Angelman defeat
The recent FDA approval of Fayuvi for a rare, childhood neurodegenerative disease was “particularly special” for Ultragenyx CEO Emil Kakkis. It could also, along with an August nod for another gene therapy, help offset recent challenges brought on by two asset failures.
September 28, 2026
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5 min read
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Heather McKenzie
The United States Capitol Building against a clearing blue sky viewed from the east front of the U.S. Capitol building in Washington, DC.
Government
US senators grill FDA nominee Overton on ability to ‘stand up’ to Trump
In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as about her views on vaccines and abortion drugs.
September 24, 2026
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4 min read
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Heather McKenzie
New Opportunity, Businessman Walks Up Stairs Finds Exit Big Door
Drug Development
Kyverna steps closer to FDA-first CAR T for an autoimmune condition with durability data
Kyverna Therapeutics’ miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year.
September 24, 2026
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3 min read
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Heather McKenzie
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ALS
Ionis-Otsuka offer ‘groundbreaking’ improvement in function and survival for genetic type of ALS
Ulefnersen, an RNA-targeted therapy being developed by Ionis Pharmaceuticals and Otsuka Pharmaceutical, improved measurements of functional impairment and survival in patients with a rare, genetic ALS subtype in a Phase 3 trial. The partners plan to approach the FDA with the results to determine potential pathways for approval.
September 23, 2026
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4 min read
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Heather McKenzie
FDA
Novo’s turnaround plan, weight loss wins, Ultragenyx’s Sanfilippo approval, IPO blitz
Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming.
September 23, 2026
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2 min read
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Jef Akst
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Obesity
Viking achieves ‘maintenance trifecta’ as GLP-1/GIP dual agonist exceeds expectations
Viking Therapeutics’ VK2735 met Truist’s “best-case scenario,” with robust weight loss that was largely maintained when patients transitioned to less frequent dosing. Viking’s stock popped more than 30% on Tuesday.
September 22, 2026
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3 min read
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Heather McKenzie
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GLP-1
Lilly presents early data supporting GLP-1/GIP candidate’s potential in depression, alcohol use disorder
With a trillion-dollar market cap and a wildly successful GLP-1 portfolio, Eli Lilly isn’t resting on its laurels. At the Psych Congress 2026, the company presented early-stage data that could support the potential of its next-gen GLP-1 and GIP receptor agonist to treat diseases far beyond obesity.
September 22, 2026
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5 min read
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Heather McKenzie
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Rare diseases
Mikhail, Davis on board with regulatory framework tailored to rare disease therapies
Newly permanent CBER and CDER directors Karim Mikhail and Michael Davis are widely expected to continue the FDA’s efforts toward an adaptive framework for rare disease therapies. If approved by the Senate, will commissioner nominee Heidi Overton stay the course?
September 21, 2026
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6 min read
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Heather McKenzie
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Psychedelics
Deep dive: Psychedelics back on FDA’s doorstep
BioSpace takes stock of the psychedelic therapeutics space, which is once again on the cusp of its first FDA approval.
September 16, 2026
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3 min read
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Heather McKenzie
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ALS
Novartis halts TREM2 targeting ALS program in 4th trial stumble in a month
The TREM2 stabilizer failed to show efficacy in a Phase 2 trial of patients with early-stage ALS. This development follows two late-stage trial failures reported by Novartis last week, plus the news that the pharma has paused multiple CAR T cell trials following patient deaths.
September 16, 2026
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2 min read
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Heather McKenzie
FDA
FDA hears input on psychedelics, PDUFA, lung cancer’s next-gen therapies boost survival
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.
September 16, 2026
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1 min read
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Jef Akst
Creative concept of leadership and innovation with a glowing blue light bulb leading paper planes. Symbol of advanced technology, AI-driven strategy, and visionary direction in a digital future.
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