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Heather McKenzie

Heather McKenzie

Senior Editor

Heather McKenzie is a professional journalist with more than 8 years’ experience in the biopharmaceutical industry. Since joining BioSpace, she has written more than 300 features and breaking news articles, including multiple award-winning stories. Her particular focuses are neuroscience, rare disease and regulatory science. She has also traveled internationally to cover global biotech hubs, including 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, watching her American League champion Toronto Blue Jays, 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.

External view of the U.S. Capitol building
Government
US Government Shuts Down, FDA Closed for New Applications
Due to policies regarding industry user fees, the FDA will not be able to accept any new drug applications for the duration of the government shutdown, according to Leerink Partners.
October 1, 2025
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4 min read
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Annalee Armstrong
Podcast
M&A Picks Up, Walmsley Moves On, Pfizer’s MFN Deal and Hope for Huntington’s
M&A headlined for a second straight week as Genmab acquired Merus for $8 billion; Pfizer strikes most-favored-nation deal with White House; CDER Director George Tidmarsh caused a stir with a now-deleted LinkedIn post; GSK CEO Emma Walmsley will step down from her role; and uniQure’s gene therapy offers new hope for patients with Huntington’s disease.
October 1, 2025
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2 min read
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Heather McKenzie
Pictured: uniQure headquarters in Amsterdam
Huntington’s disease
UniQure ‘Exceeds Expectations’ in Much-Anticipated 3-Year Huntington’s Readout
If approved, uniQure’s gene therapy AMT-130—which slowed disease progression by 75%—would be the first genetic treatment for Huntington’s disease. A BLA submission is planned for the first quarter of 2026.
September 24, 2025
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2 min read
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Heather McKenzie
Podcast
FDA’s Autism Endeavor, Pfizer’s Obesity Comeback Bid, Psychedelics Revival, ACIP Confusion, More
The FDA is hoping to repurpose GSK’s Wellcovorin for cerebral folate deficiency; Pfizer acquired fast-moving weight-loss startup Metsera for nearly $5 billion after suffering a hat trick of R&D failures; psychedelics are primed for M&A action and Eli Lilly may be next in line; RFK Jr.’s revamped CDC advisory committee met last week with confounding results; and Stealth secured its Barth approval.
September 24, 2025
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2 min read
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Heather McKenzie
An umbrella protects the human brain from negative influences. Art collage.
Psychedelics
Psychedelics Space Enters New Era as AbbVie Dives In
With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval.
September 22, 2025
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6 min read
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Heather McKenzie
Business vision and opportunity and determination. Businessman standing on cliff edge looking ahead. vector
Rare diseases
Stealth Wins Expedited FDA Nod for First-Ever Barth Syndrome Treatment
A decade-long journey has come to an end for Stealth BioTherapeutics and the Barth syndrome community with the first-ever treatment for this uncommon mitochondrial disease. CEO Reenie McCarthy called it a “pivotal victory” that “offers hope for expedited regulatory attention to other ultra-rare diseases.”
September 21, 2025
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7 min read
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Heather McKenzie
Cardiovascular disease
Deep Dive: Oral Obesity Drugs on the Cusp
In this deep dive, BioSpace explores the next big thing in obesity.
September 18, 2025
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3 min read
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Heather McKenzie
CDC
Republicans Ratchet Up Pressure as Monarez Levels Damning Allegations Against Kennedy
During a hearing in front of the Senate’s HELP committee, Susan Monarez addressed her controversial firing and recalled a conversation where Health Secretary Robert F. Kennedy Jr. allegedly said that “CDC employees were killing children and they don’t care.”
September 17, 2025
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4 min read
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Heather McKenzie
Podcast
China Crackdown, UK Exit, Novo Layoffs, Adcomm Flip Flop, More
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms.
September 17, 2025
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2 min read
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Heather McKenzie
Podcast
Unpacking the Latest MAHA Report, RFK’s Senate Appearance, FDA’s CRL Drop and More
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
September 10, 2025
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1 min read
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Jef Akst
Health and Human Services Secretary Robert F. Kennedy Jr. makes remarks at an event announcing the MAHA (Make America Healthy Again) Commission, Thursday, May 22, 2025, in the East Room of the White House. (Official White House Photo by Joyce N. Boghosian)
Government
Second MAHA Report Emphasizes Chronic Disease, Tilts at Vaccine Reform
In a livestreamed meeting Tuesday afternoon, Health Secretary Robert F. Kennedy Jr. drew a dark portrait of the state of America’s health while addressing the MAHA Commission’s most recent report, which includes plans to research potential links between vaccines and rising rates of chronic disease.
September 9, 2025
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3 min read
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Heather McKenzie
Biogen’s headquarters in Massachusetts
Immunology and inflammation
Lupus Reveal Gives Investors a Peek at Biogen’s ‘Underappreciated’ Pipeline
With two late-stage programs set to read out in the next 48 months, Biogen is translating its wealth of experience in multiple sclerosis to lupus—developing a pipeline BMO Capital Markets analysts called “thoughtful.”
September 9, 2025
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4 min read
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Heather McKenzie
Blue growth graph business chart data diagram on success financial presentation background with abstract up arrow bar symbol or finance marketing price statistic and economy market profit investment.
Neuroscience
Rapport Jumps 180% on ‘Best Case’ Mid-Stage Data for Epilepsy Pill
Shares of Rapport Therapeutics popped Monday morning after Phase IIa data for RAP-219 exceeded analyst and Wall Street expectations, reducing seizures by almost 78% in patients with drug-resistant focal onset seizures.
September 8, 2025
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2 min read
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Heather McKenzie
Bright streaks of light of a spinning carousel in motion, capturing the energy and excitement of a night at the fairground
FDA
5 Companies Caught on a Carousel of FDA Confusion
Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.
September 8, 2025
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8 min read
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Heather McKenzie
Robert F Kennedy Jr speaking in front of the Senate finance committee
Government
Senate Hearing Devolves Into Theater as Kennedy Accused of Breaking Vaccine Promises
Robert F. Kennedy Jr. repeated a series of anti-vaccine talking points during his appearance in front of the Senate finance committee on Thursday, as Democratic and Republican senators alike hammered the Health Secretary on recent COVID-19 vaccine restrictions and his views on Operation Warp Speed.
September 5, 2025
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4 min read
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Dan Samorodnitsky
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