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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.

Podcast
Weight Loss Waves, Pazdur’s Exit and FDA Instability, New Neuro Breakthroughs
Pfizer deals again in obesity space as Wave and Structure drop splashy weight loss results; what CDER Director Richard Pazdur’s sudden retirement means for biopharma; neuro diseases take center stage at CTAD; and more.
December 10, 2025
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1 min read
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Heather McKenzie
Two businessmen negotiating with big speech bubbles
Rare diseases
Saol To Pitch Ultrarare Disease Drug as “Poster Child” for RDEP Program
Saol Therapeutics received a complete response letter for its pyruvate dehydrogenase complex deficiency treatment a week after the FDA unveiled its Rare Disease Evidence Principles program. On Dec. 18, in a Type A meeting, the biotech will attempt to convince the agency that its drug fits perfectly into the framework.
December 9, 2025
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2 min read
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Heather McKenzie
Balance, equilibrium and stability in a risky environment concepts. Spheres balancing on a seesaw. Abstract 3D render.
FDA
Rare Disease Leaders Call for Regulatory Consistency After Chaotic Year
As the FDA unveils a parade of initiatives aimed at accelerating drug development for rare diseases, experts appeal for a consistent approval process that will support and further catalyze momentum.
December 8, 2025
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8 min read
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Heather McKenzie
Sagittal brain showing cortical thinning and ventricular enlargement associated with Alzheimer disease, displayed on a blue background for anatomical clarity.
Alzheimer’s disease
Eisai Still Confident in Anti-Tau Asset as J&J Becomes Latest Victim in Spiraling Space
Days after Johnson & Johnson’s posdinemab failed to slow clinical decline in patients with Alzheimer’s disease, Eisai Chief Clinical Officer Lynn Kramer expressed unwavering conviction in his company’s own anti-tau asset, while others suggest the Alzheimer’s field is heading in a completely different direction.
December 5, 2025
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4 min read
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Heather McKenzie
Courtesy of uniQure
Huntington’s disease
FDA Minutes Confirm Challenging Path Ahead for UniQure’s Huntington’s Gene Therapy
Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s Phase I/II studies of AMT-130 are “unlikely” to provide the primary evidence to support a biologics license application.
December 4, 2025
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2 min read
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Heather McKenzie
Burning bird phoenix digital painting.
Duchenne muscular dystrophy
Capricor Heads Back to FDA With Pivotal Results for DMD Cardiomyopathy Therapy
Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” Capricor’s cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial.
December 3, 2025
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3 min read
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Heather McKenzie
Podcast
Prasad’s Leaked FDA Memo, Alzheimer’s Ups and Downs, Next-Gen Obesity Drugs
Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results.
December 3, 2025
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1 min read
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Heather McKenzie
Richard Pazdur
FDA
Pazdur To Retire Weeks After Taking On Coveted FDA Role
Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.
December 2, 2025
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3 min read
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Heather McKenzie
Dorval, Quebec, Canada - September 3, 2021: Novartis Pharmaceuticals Canada Inc. head office building in Dorval, Quebec, Canada. Novartis is a global healthcare company based in Switzerland.
Approvals
Novartis Expands Spinal Muscular Atrophy Gene Therapy Market With FDA’s Itvisma Greenlight
The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access to patients two years and older in what one Stanford Medicine professor called a “game changing advance” for the field.
November 25, 2025
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3 min read
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Heather McKenzie
Brain shaped maze. Concept image of study and brain behavior.
Alzheimer’s disease
J&J’s Anti-Tau Bet Falls Flat in Mid-Stage Alzheimer’s Trial
Johnson & Johnson will discontinue the Phase II Auτonomy study of posdinemab after a scheduled review found the anti-tau antibody failed to slow clinical decline in patients with early Alzheimer’s disease.
November 24, 2025
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1 min read
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Heather McKenzie
Yellow paper plane coming out from the advancing white paper planes. Change and different way concept.
Alzheimer’s disease
Biogen’s Leqembi Rises After Novo GLP-1 Fails in Alzheimer’s
Analysts agree that the failure of Novo Nordisk’s semaglutide to reduce Alzheimer’s disease progression removes a “modest” or “perceived” overhang on Biogen and the anti-amyloid antibody class in general, clearing the way for increased uptake of Leqembi and Eli Lilly’s Kisunla.
November 24, 2025
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3 min read
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Heather McKenzie
Symbolic image: Sign 180 degree turn
FDA
FDA Reversals Send UniQure, Biohaven, Capricor, More Into a ‘Tailspin’
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
November 24, 2025
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7 min read
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Heather McKenzie
Podcast
Billions More in M&A, Another Bidding War and More FDA Drama
Merck has made a $9.2 billion play for Cidara, and there’s another bidding war afoot, this one for sleep biotech Avadel. Meanwhile, Rick Pazdur has taken the helm at CDER while tensions run high between FDA Commissioner Marty Makary and Health Secretary RFK Jr.
November 19, 2025
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1 min read
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Heather McKenzie
White plane in blue sky flies above clouds towards hot sun. Vector background
Approvals
Arrowhead Secures Maiden Approval, First FDA Nod for Rare Genetic Metabolic Disorder
The FDA approval of the siRNA drug Redemplo caps off a tumultuous 12 months for Arrowhead, whose partnership with Sarepta caused its own stock to drop during the gene therapy maker’s safety troubles this summer.
November 18, 2025
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2 min read
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Heather McKenzie
Richard Pazdur
FDA
Makary Got His Man in Pazdur—But Can He Last as CDER Director?
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
November 18, 2025
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6 min read
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Heather McKenzie
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