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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
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
Concept business people work with modern laptop. Double exposure. Meeting room in office building background
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
Two arrow signs representing the new way and old way approach to business
Editorial
Here Today, Gone Tomorrow: Trump’s Policies Give Biopharma Whiplash
Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.
April 18, 2025
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4 min read
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Jef Akst
Diverse cultures, international communication concept. Human silhouette with speech bubbles.
Regulatory
Former FDA Officials Sound Alarm: Visible Changes May Be ‘Tip of the Iceberg’
In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER director spoke to analysts about potential implications for drug review timelines and agency morale.
April 16, 2025
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3 min read
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Heather McKenzie
Podcast
Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed
Donald Trump takes biopharma on a tariff-themed rollercoaster ride; J&J kicks off the Q1 earnings season; experts express concern about the FDA’s future; Pfizer’s obesity setback could be Viking’s gain; and BioSpace reveals the highest paid pharma CEOs.
April 16, 2025
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1 min read
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Heather McKenzie
American Flag Umbrella Standing Out in the Rain Among Dark Umbrellas
FDA
FDA After the Storm: Drug Review Delays and Increased Executive Oversight Expected
After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees.
April 14, 2025
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6 min read
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Heather McKenzie
Blindness and crisis, blindfolded businessman walks to the cliff
FDA
Threat to FDA User Fees Program Could Set US Back 35 Years
Experts express concern that last week’s unprecedented FDA layoffs will trigger a little-known mechanism that could result in a “disaster” the Trump administration doesn’t see coming.
April 10, 2025
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5 min read
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Heather McKenzie
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