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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
Novo Launches Oral Obesity Pill, Lilly Targets Lofty Revenue, FDA and M&A in Focus
Novo Nordisk follows Christmas oral Wegovy approval with quick launch; Eli Lilly is headed for $94.3 billion in annual revenue by 2027, analysts predict; nine more pharmas strike Most Favored Nation deals but half remain unsigned; experts call for stability and rare disease action at FDA, and all eyes are on M&A ahead of the J.P. Morgan Healthcare conference next week.
January 7, 2026
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2 min read
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Heather McKenzie
Neuroscience
Deep Dive: Huntington’s at a Crossroads
Recent breakthroughs and three decades of progress in treating Huntington’s disease
January 6, 2026
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2 min read
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Heather McKenzie
A handshake of businessmen. Modern design with a positive context. Concept of help, support, and agreement between businessmen. Modern art collage, trendy magazine style.
Obesity
Lilly Doubles Down With Nimbus, Paying $55M for Preclinical Obesity Drug
Eli Lilly kicked off a pivotal 2026 campaign with a multi-year collaboration with current partner Nimbus Therapeutics worth a potential $1.3 billion for a preclinical obesity therapeutic. The deal follows a 2022 partnership struck by the companies to target the AMPK protein in cardiometabolic diseases.
January 6, 2026
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2 min read
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Heather McKenzie
Business concept, disagreement, dispute, collapse. The gap between two people. Obstacle to the merger.
FDA
FDA Went Against Adcomm Votes More, Held Fewer Meetings in 2025
In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer meetings than usual and agreed with its advisors only 57% of the time, Jefferies reported.
January 6, 2026
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3 min read
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Heather McKenzie
Digital overload and its impact on the human brain, showcasing fragmented thoughts, information overload. Abstract design art collage. Social media digital addiction, mental health, stress, anxiety
Business
BioSpace Editors’ Top 5 Biggest News Stories of the Year
Pfizer and Metsera, Sarepta and uniQure made the list with dramatic tales. The other two spots went to the regulatory challenges facing biopharma under the new administration, especially in the vaccines sector.
December 22, 2025
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10 min read
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Annalee Armstrong
Digital compass. Business strategic explorer, Vision crisis, Mission path, Agency creative, Digital strategy, Market decision, Achievement strategy, Financial stock, Company vision concepts
FDA
FDA Policy Tracker: 2025 Was a Year of Change
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
December 22, 2025
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13 min read
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Heather McKenzie
Podcast
Lilly’s Triple Triumph, Prasad’s COVID Error, J&J’s Surprise Voucher, M&A Targets
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy.
December 17, 2025
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2 min read
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Heather McKenzie
Unvaccinated And vaccinated people as anti-vaxxer or individuals that oppose taking the vaccine with 3D illustration elements.
Vaccines
Makary Denies FDA Plans To Levy Black Box Warning on COVID-19 Vaccines
Speaking on Bloomberg TV on Monday, FDA Commissioner Marty Makary contradicted recent reporting that suggested the agency was planning to add a black box label—its most serious warning—to COVID-19 vaccines.
December 16, 2025
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3 min read
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Heather McKenzie
Targeting cancer as oncology drugs and oncologist symbol for preventing malignant tumor growth disease as a symbol for pharmaceutical science and immunology or fighting human cancers.
Cancer
Immunome Heads to the FDA With Desmoid Tumor Drug After Phase III Sweep
Varegacestat, a gamma secretase inhibitor, significantly improved progression-free survival while also meeting all key secondary endpoints in the pivotal RINGSIDE trial. Immunome is planning an FDA application for the second quarter of 2026.
December 15, 2025
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2 min read
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Heather McKenzie
RED pawn beating competition. 3D illustration. economic status and social achievement.3D rendering on black background.
Regulatory
FDA’s ‘Conundrum’: What To Do With Approved Drugs That Fail Pivotal or Confirmatory Trials
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
December 15, 2025
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7 min read
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Heather McKenzie
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
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