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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.

FDA signage at its headquarters in Maryland
FDA
FDA Layoffs Continue as Former Commissioner Robert Califf Speaks Out
The latest cuts, which are part of a larger reduction of 10,000 at the Department of Health and Human Services, were reportedly underway Tuesday, with CDER Office of New Drugs Director Peter Stein added to the list of casualties.
April 1, 2025
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2 min read
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Heather McKenzie
FDA
Marks’ Sudden Departure From FDA Magnifies Uncertainty, Sends Biopharma Shares Down
The stock market—and biotech insiders—reacted negatively to the allegedly forced resignation of CBER Director Peter Marks, who said RFK Jr. does not seek “truth and transparency” but rather “subservient confirmation of his misinformation and lies.”
March 31, 2025
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3 min read
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Heather McKenzie
Heart rate cardiogram, heart rate indicators, EKG monitoring, electrocardiogram. The illustration is in red colors and the background is dark red with a grid.
Complete response letters
Milestone Stock Crashes After Surprise Tachycardia Drug Rejection
Milestone Pharmaceuticals hit another bump in the road in its quest to get Cardamyst approved for paroxysmal supraventricular tachycardia when the FDA issued a Complete Response Letter on Friday.
March 28, 2025
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2 min read
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Heather McKenzie
Histology microscope image of motor unit synapse of muscle fibers (100x)
Duchenne muscular dystrophy
Safety Questions Loom in Duchenne as Dyne, Wave and Others Plan FDA Filings
Several companies will head to the FDA seeking approval of new Duchenne muscular dystrophy treatments next year but the death of a patient taking Sarepta’s Elevidys raises important safety questions.
March 27, 2025
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8 min read
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Heather McKenzie
Abstract oriental Japanese art vector background in red color, traditional style design, wavy shapes and mountains terrain landscape, runny like sea lines.
Duchenne muscular dystrophy
Wave’s Duchenne Exon-Skipper Reverses Muscle Damage in Mid-Stage Trial
WVE-N531, an oligonucleotide, elicited significant functional benefit and reversal of muscle damage in the Phase II FORWARD-53 trial. Wave plans to file for accelerated approval of the candidate in 2026.
March 26, 2025
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3 min read
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Heather McKenzie
Podcasts
Trump’s Pharma Tariffs, Monarez for CDC, Novo’s New Obesity Play, More
President Donald Trump continues to warn of tariffs on the pharmaceutical industry; Susan Monarez replaces Dave Weldon as CDC director nominee; Novo Nordisk joins the triple-G race; Alnylam wins approval for Amvuttra in ATTR-CM; and Cassava Sciences ends development of simufilam in Alzheimer’s.
March 26, 2025
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1 min read
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Heather McKenzie
3D Illustration of Human Heart Anatomy
Cardiovascular disease
Alnylam’s Amvuttra Approved as First RNAi Silencer for Rare Type of Cardiomyopathy
The FDA approval of Alnylam’s Amvuttra sets up a three-way race with Pfizer and BridgeBio, which both market transthyretin stabilizers for transthyretin amyloid cardiomyopathy.
March 20, 2025
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8 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.
Spinal muscular atrophy
Novartis’ Intrathecal Zolgensma Effective in Older Children
After bringing Zolgensma to market in 2019 as the first gene therapy for spinal muscular atrophy, Novartis is back with an intrathecal formulation intended for older patients.
March 19, 2025
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6 min read
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Heather McKenzie
Podcasts
Sarepta’s Elevidys Death, FDA’s Vaccine Move, Weldon Whiplash, PDUFAs in Cardio
Sarepta will update Elevidys’ label after a patient died following treatment; the FDA issues flu vaccine recommendations without advisor input; Trump CDC nominee Dave Weldon pulled at last minute; and FDA decisions expected for Alnylam’s Amvuttra in ATTR-CM and Milestone’s etripamil in tachycardia.
March 19, 2025
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2 min read
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Heather McKenzie
Podcasts
COVID Reflections, Novo’s Next-Gen Weight Loss Struggles, Another Depression Miss, More
BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.
March 12, 2025
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1 min read
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Heather McKenzie
Man with medical or hygienic mask standing over dead covid 19 or Corona virus raised their hand to win the Covic-19 or Coronavirus, At last mankind will win and survive over the virus concept
Editorial
The Shape of a Pandemic: Boom, Bust and Recover
As we reflect on five years of COVID-19, it’s clear that the impacts are still unfolding. The life sciences—and we as individuals—will never be the same again.
March 11, 2025
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6 min read
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Jef Akst
Modern collage with human heart and hands stock illustration
Cardiovascular disease
Deep Dive: Cardiovascular Disease Back in the Spotlight
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
March 10, 2025
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2 min read
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Heather McKenzie
Pictured: Novavax/Getty Images, STR/NurPhoto
COVID-19
Novavax Applies Lessons Learned From Turbulent COVID-19 Experience
As sales of its COVID vaccine plummet, Novavax is looking ahead toward other novel vaccines, brought to market with the help of the company’s pharma partners—something it opted not to do as the pandemic swept the globe in 2020.
March 10, 2025
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6 min read
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Heather McKenzie
Editorial
FDA Weathers Bait-and-Switch Storm as Staff and Sites Come and Go
Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
March 7, 2025
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3 min read
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Jef Akst
Podcasts
Tariff Threat Continues, More Meetings Cancelled, AbbVie Makes Obesity Play, More
Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie and Eli Lilly strike mid-sized deals in obesity and molecular glues, priority review vouchers set to take a hit and immuno-oncology matures.
March 5, 2025
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1 min read
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Heather McKenzie
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