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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 [email protected].

Vector. Modern backgrounds. Mind Map Team - Illustration
FDA
After FDA Cuts, Planning for Upcoming ODAC Meeting Has Been ‘Absolute Chaos’
As the FDA prepares for a busy Oncologic Drugs Advisory Committee next week, an agency insider told BioSpace that volunteers with little training are scrambling to secure the required expertise after workforce cuts decimated the adcomm planning office.
May 15, 2025
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4 min read
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Heather McKenzie
Podcast
Trump’s Drug Pricing Policy, Prasad’s CBER Nod, Bayer’s Layoffs and Galapagos’ Next Chapter
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
May 14, 2025
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2 min read
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Heather McKenzie
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Infectious disease
Biopharma Targets an HIV Cure as NIH Funding Cuts Threaten To Derail Progress
As the Trump administration slashes funding for HIV-related research and infrastructure, Gilead, Immunocore and more are targeting the next goalpost: a cure.
May 12, 2025
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7 min read
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Heather McKenzie
Pictured: Novavax/Getty Images, STR/NurPhoto
Earnings
Novavax Sales Jump 600% YoY as COVID-19 Vaccine Still in Limbo at FDA
After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its COVID-19 shot, CEO John Jacobs said on the company’s Q1 earnings call: “When we have it, we’ll have it. Until then, we don’t have it.”
May 8, 2025
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3 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
Is the New HHS Vaccine Requirement Anti-Vaccine Activism Disguised as Policy?
Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for vaccines and sought greater clarity: “I don’t know what they’re talking about.”
May 7, 2025
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6 min read
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Heather McKenzie
Podcast
Trump’s US Manufacturing Push, New Vaccine Policy, Novo’s Weight Loss Pill up for FDA Review
A new executive order aims to smooth the path for getting U.S. manufacturing facilities up and running; HHS says it will require placebo-controlled trials for all vaccine approvals; tariff threats hit BioNTech; Novo Nordisk’s FDA application for an oral version of Wegovy is accepted; and more.
May 7, 2025
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1 min read
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Heather McKenzie
FDA
Biotech Stocks Fall After FDA Names Vinay Prasad To Succeed Marks at CBER
The oncologist and former University of California, San Francisco, professor has long been critical of COVID-19 mandates and the accelerated approval of cancer drugs.
May 6, 2025
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3 min read
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Heather McKenzie
Cancel Culture concept or cultural cancellation and social media censorship as canceling or restricting opinions that are offensive or controversial to the public with 3D illustration elements.
Editorial
Biomedical Innovation in Jeopardy as Kennedy Distorts, Denies Scientific Truths
As the Trump administration—including HHS Secretary Robert F. Kennedy Jr.—plays fast and loose with scientific studies and facts, there may be a more sinister force at play: censorship.
May 2, 2025
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6 min read
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Heather McKenzie
Vaccine and syringe injection. Doctor hand with syringe. Vaccination of people for prevention, immunization and treatment from virus infection. Medicine, flu shot, test with needle. Vector
Policy
HHS To Require Placebo-Controlled Trials for All New Vaccines in ‘Radical Departure’ From Past
The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and less affordable,” according to vaccine expert Paul Offit. It could also further complicate the picture for companies like Novavax.
May 1, 2025
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3 min read
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Heather McKenzie
Podcast
Tariffs Continue to Dominate Q1 Earnings, AACR Excites Cancer Space, CEO Pay Gaps, More
As Q1 2025 earnings season continues, tariffs remain top of mind for pharma CEOs and investors. Meanwhile, the American Association for Cancer Research’s annual event kicks off this year’s oncology conference season. Plus, will the FDA become politicized under HHS Secretary RFK Jr.?
April 30, 2025
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1 min read
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Heather McKenzie
FDA
FDA Alumni, Experts Call on Makary To Stand Up Against Agency’s Politicization
In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment.
April 29, 2025
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6 min read
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Heather McKenzie
FDA
Cell and Gene Therapy Sector Enters ‘Critical’ Period After Marks’ FDA Exit
As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks’ legacy will carry on.
April 28, 2025
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7 min read
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Heather McKenzie
screenshot of Marty Makary speaking on the Megyn Kelly Show
FDA
Fact or Fiction? Unpacking FDA Commissioner Marty Makary’s First Interviews
As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
April 25, 2025
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7 min read
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Heather McKenzie
Podcast
Makary’s First Interview, US Manufacturing Push and Lilly vs. Novo in Obesity Pill Race
FDA Commissioner Marty Makary talks about his plans to revamp drug development and reduce ‘conflicts of interest’ between the agency and pharma industry; Roche and Regeneron jump on the U.S. manufacturing train as Trump’s tariffs loom; and Eli Lilly scores a big win for orforglipron while Novo Nordisk reveals it has applied for FDA approval of its oral semaglutide.
April 23, 2025
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1 min read
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Heather McKenzie
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FDA
Banning Industry From FDA Adcomms Won’t ‘Move the Needle Much’ in Makary, RFK’s Fight Against COIs
FDA Commissioner Marty Makary last week announced a directive that would limit industry participation in the agency’s advisory committees. But not only do company reps serve only as non-voting members, a 1997 law actually requires industry involvement.
April 21, 2025
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5 min read
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Heather McKenzie
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