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Heather McKenzie

Heather McKenzie

Senior Editor

Heather McKenzie is a professional journalist with more than five years experience in the biopharmaceutical industry. Since joining BioSpace, she has written more than 200 features and breaking news articles with a particular focus in neuroscience and gene therapy. She has also traveled internationally to cover global biotech hubs such as 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, 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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FDA
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for confirmatory trials for therapies seeking the shortened path to market.
January 7, 2025
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3 min read
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Heather McKenzie
NextGen
BioSpace’s NextGen Class of 2025 Leans Into Biopharma’s Hottest Trends
From ADCs and radiopharmaceuticals to cell and gene therapies, eager young startups are betting on advances in biopharma’s most competitive therapeutic spaces—and attracting dollars from Big Pharma.
January 7, 2025
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5 min read
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Heather McKenzie
Right and left sides of the brain/iStock, Warrenra
Depression
Neumora’s Novel Depression Drug Strikes Out in First Pivotal Trial
In a highly anticipated readout for the kappa opioid receptor class in major depressive disorder, Neumora’s navacaprant failed to meet the primary and key secondary endpoint in the first of three identical Phase III studies.
January 2, 2025
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2 min read
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Heather McKenzie
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Regulatory
5 Companies That Celebrated First Approvals in 2024
Madrigal Pharmaceuticals, X4 Pharmaceuticals and Day One Biopharmaceuticals secured their maiden approvals this year in metabolic dysfunction-associated steatohepatitis, WHIM syndrome and pediatric low-grade glioma. Geron Corporation and ImmunityBio also notched wins.
December 23, 2024
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6 min read
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Heather McKenzie
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Neuroscience
2024 Highlights the Rollercoaster That Is Neuro
This year saw lofty highs and devastating lows for neuroscience drug developers like Bristol Myers Squibb, Eli Lilly and AbbVie, following the predictable pattern of successes and failures that characterizes this space.
December 23, 2024
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6 min read
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Heather McKenzie
3d illustration showing amyloid plaques in Alzheimer's disease
Alzheimer’s disease
Amyloid Hypothesis in Doubt as Newly Approved Drugs Hit Hurdles
Even as Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla slowly roll out onto the market, experts question the efficacy of these anti-amyloid antibodies and the amyloid hypothesis overall.
December 16, 2024
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6 min read
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Heather McKenzie
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Neuroscience
5 Clinical Assets That Flopped in 2024
Some 90% of investigational drugs fail—and success rates are even more dire in the neuro space. Here, BioSpace looks at five clinical trial flops that stole headlines over the past 12 months.
December 16, 2024
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6 min read
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Heather McKenzie
Podcast
Highlights From ASH, Lilly and Novo’s Manufacturing Boon, Momentum in Neuro, More
GSK, Gilead and Arcellx, Vertex and more present new data at the American Society of Hematology annual meeting just as sickle cell therapies Casgevy and Lyfgenia have a new outcomes-based payment model; Eli Lilly and Novo Nordisk pump new funds into manufacturing; and AbbVie makes a Cerevel comeback while uniQure clears a path toward accelerated approval in Huntington’s disease.
December 11, 2024
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1 min read
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Heather McKenzie
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Depression
Relmada Considering ‘Strategic Alternatives’ After Failure of Depression Asset
Relmada Therapeutics will halt two Phase III trials of a major depressive disorder drug after a futility assessment and explore strategic alternatives including a potential sale to maximize shareholder value.
December 9, 2024
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1 min read
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Heather McKenzie
GLP-1
Evidence Mounts for Potential of GLP-1s in Alzheimer’s Disease
The darlings of the weight loss and diabetes spaces, GLP-1 receptor agonists have shown promise against Alzheimer’s in recent studies—with Phase III results expected next year from Novo Nordisk.
December 9, 2024
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6 min read
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Heather McKenzie
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Series A
Obesity-Focused Antag Debuts With $84M and Backing From Novo Holdings
The Danish startup, whose lead candidate has parallels to Amgen’s MariTide, launches on the heels of Amgen’s Phase II data release for the drug last week.
December 4, 2024
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2 min read
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Heather McKenzie
Podcast
Biopharma’s Shopping Spree, Applied Crashes on Rejection, Skysona’s Safety Concerns, More
Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona.
December 4, 2024
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1 min read
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Heather McKenzie
Roche's signage at its office in France
Immunology & inflammation
Roche Partners With COUR in Autoimmune Deal Potentially Worth More Than $900M
The collaboration will see COUR and Roche’s Genentech leverage the biotech’s antigen-specific immune tolerance platform to develop and commercialize therapies for an undisclosed autoimmune disease.
December 3, 2024
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1 min read
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Heather McKenzie
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Editorial
FDA’s Accelerated Approval Pathway Drives Momentum for Intractable, Fatal Diseases
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track record of propelling R&D for some of medicine’s most challenging illnesses.
December 2, 2024
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6 min read
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Heather McKenzie
Podcast
BridgeBio’s ATTR-CM Approval, Cassava’s Alzheimer’s Failure, Trump’s Cabinet Picks, More
BridgeBio’s Attruby wins approval for transthyretin amyloid cardiomyopathy while the FDA accepts Alnylam’s application for Amvuttra in the indication; Cassava’s controversial Alzheimer’s drug flunks Phase III; Amgen’s MariTide fails to impress investors, Donald Trump’s controversial nominations continue.
November 27, 2024
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1 min read
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Heather McKenzie
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