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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 CDER director George Tidmarsh speaking in an FDA video
FDA
UPDATE: Tidmarsh Waffles on Resignation, Will Fight To Clear Name
Less than 24 hours after resigning his post as the FDA’s head drug regulator, George Tidmarsh is reportedly reconsidering his decision and vowing to fight for his name and credibility amid a probe into his “personal conduct” at the agency.
November 3, 2025
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3 min read
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Tristan Manalac
Pictured: uniQure headquarters in Amsterdam
Huntington’s disease
FDA Does ‘About-Face’ on UniQure’s Huntington’s Gene Therapy
A month after sparking optimism for patients with Huntington’s disease with highly positive data for AMT-130, uniQure revealed Monday that the FDA may be changing its tune on the evidence required for an approval application, a change of direction Stifel called “very challenging” for uniQure.
November 3, 2025
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3 min read
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Heather McKenzie
Pictured: BMS sign on a building in San Diego, California/iStock, JHVEPhoto
Earnings
BMS Battles ‘Deeply Ingrained’ Prescribing Habits in Schizophrenia as Cobenfy Misses Q3 Estimates
Bristol Myers Squibb beat analyst and consensus estimates for the third quarter with $12.2 billion in sales, but executives on the company’s investor call faced questions about a sluggish uptake for schizophrenia drug Cobenfy as well as a highly anticipated Alzheimer’s psychosis readout for the product.
October 30, 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.
Immunology and inflammation
Novartis Presents New Data From Potential First Targeted Sjögren’s Treatment
Late-breaking Phase III data show ianalumab, Novartis’ dual-targeted antibody, reduced disease activity and patient burden in Sjögren’s disease, the pharma reported at the American College of Rheumatology Convergence congress on Wednesday.
October 29, 2025
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3 min read
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Heather McKenzie
Podcast
Novartis’ Big Buy, Q3 Earnings, Regeneron’s Dropped Cell Therapy, More
As third-quarter earnings continue to roll out, Novartis makes headlines with the second biggest acquisition of the year; Novartis’ CEO also downplayed the impact of Big Pharma pricing deals with the Trump administration; Regeneron continued the trend of dropping cell therapy assets; BioSpace takes a look at how the FDA is functioning mid-shutdown.
October 29, 2025
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1 min read
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Heather McKenzie
Daniel and Kaori Barvin sharing their story of lay leadership at the Seattle Jewish Federation's Fall Fundraiser.
ALS
Coya Exec Daniel Barvin Is on a Mission To End Genetic ALS and FTD
The BioSpace 40 Under 40 winner opens up about his very personal career transformation from wealth management to biotech—and what it’s like to develop a drug for amyotrophic lateral sclerosis and frontotemporal dementia as a potential patient himself.
October 27, 2025
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5 min read
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Heather McKenzie
The journey forward, the successful forward progress and advancement of a business or profession, the achievement of success or the attainment of a goal, a group of businessmen running forward with arrows in their hands
Huntington’s disease
4 Huntington’s Therapies Chasing UniQure
Last month, “historic positive results” from uniQure’s gene therapy snapped the Huntington’s community out of years of failure. As the biotech prepares to submit for FDA approval, BioSpace looks at four more candidates on the near horizon.
October 27, 2025
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6 min read
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Heather McKenzie
Brain , concept idea art of thinking, surreal portrait painting, conceptual artwork, 3d illustration
Huntington’s disease
UniQure’s Huntington’s Breakthrough Brings Hope to Patients but Experts Urge Caution
Pivotal results from uniQure’s gene therapy for Huntington’s disease have brought new light to patients who have known only disappointment in recent years—but one expert worries that communication of the results is creating “false expectations.”
October 27, 2025
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6 min read
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Heather McKenzie
Marburg, Germany - July 6, 2013: Marburg Office of Swiss multinational company Novartis AG
M&A
Novartis To ‘Bolster’ Neuromuscular Pipeline With $12B Avidity Acquisition
The deal, announced early Sunday afternoon, will see Novartis gain access to Avidity’s neuroscience assets, while the San Diego biotech spins out a new company to shepherd its early-stage precision cardiology programs.
October 26, 2025
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2 min read
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Heather McKenzie
Pictured: Eli Lilly's headquarters in Indianapolis
Deals
Lilly Dives Deeper Into Gene Therapy With up to $262M Adverum Buy
The cornerstone of the deal is Ixo-vec, an intravitreal gene therapy currently in Phase III development for wet age-related macular degeneration. Eli Lilly made another foray into genetic medicine in June, picking up Verve Therapeutics for up to $1.3 billion.
October 24, 2025
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2 min read
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Heather McKenzie
Podcast
Novo Board Upended, ESMO Excitement, FDA Awards, Replimune’s U-Turn
Novo Nordisk’s leadership gets another shake-up as President Trump promises to significantly slash prices for its GLP-1 drugs; Summit/Akeso, Exelixis and more present new data at ESMO 2025; Replimune pops as FDA accepts resubmitted BLA; FDA names first winners of Commissioner’s National Priority Voucher program; and more.
October 22, 2025
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1 min read
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Heather McKenzie
The white plane flies against the blue sky, leaving a white trail. Vector illustration
FDA
Replimune Soars Upon FDA Resubmission for Advanced Melanoma Drug
Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.
October 20, 2025
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2 min read
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Heather McKenzie
business symbol for teamwork as abstract symbol
FDA
FDA’s Lost Leaders: Where Are They Now?
After a chaotic year that has seen the attrition of over half the FDA’s senior leadership, many of these individuals have landed new roles—at Eli Lilly, Pfizer, Iovance and more. The FDA’s loss, it seems, is largely the pharmaceutical industry’s gain.
October 20, 2025
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8 min read
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Heather McKenzie
Podcast
Q3 Earnings Are Here, Novo Ditches Cell Therapy but Buys Akero, Gov’t Shutdown Hits CDC
Johnson & Johnson has yet to make a drug pricing deal with Trump; Novo makes more moves under new CEO; more than 1,000 laid off from CDC, though many immediately hired back; the BIOSECURE Act is back and more.
October 15, 2025
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1 min read
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Heather McKenzie
Same goal. Two businesses on the growth graph. vector
FDA
Consistency in the Chaos: FDA Approvals Within Average Range as Q4 Kicks Off
Heading into the final quarter of a year that has seen dramatic upheaval at the FDA—from the exodus of numerous senior leaders to unclear policy changes and a safety saga that engulfed the gene therapy space—drug approvals appear roughly on par with recent years.
October 13, 2025
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4 min read
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Heather McKenzie
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