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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.

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
Podcast
Tariff-Triggered Recession Fears, Fallout From HHS Cuts, Knockoff GLP-1s and More
A consumer-driven weight loss market could put pharma at greater risk if a recession hits; the continued turmoil at FDA and other HHS agencies magnifies the uncertainty facing the industry; Lilly files a lawsuit against a med spa selling its drugs; and more.
April 9, 2025
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1 min read
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Heather McKenzie
Huge leg kick throw upset businessman out of office. Giant foot fire dismiss unhappy man employee of work. Job dismissal concept. Flat vector illustration, cartoon character.
Editorial
FDA Gutted Under Trump, RFK Jr., With More Than Half of Senior Leadership Now Gone
While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.
April 4, 2025
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7 min read
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Jef Akst
Outline of two people moving through revolving doorway
FDA
FDA Job Cuts, Key Departures Bring ‘Revolving Door’ Debate Front and Center
With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary? It depends on who you ask.
April 2, 2025
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6 min read
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Heather McKenzie
Podcast
FDA on Fire, Novo’s Mixed Bag of Semaglutide Cardio Data, Kisunla’s EU Miss, More
Biopharma leaders react to the forced resignation of CBER Head Peter Marks as RFK Jr.’s promised job cuts begin at the FDA; Novo Nordisk presents mixed results from oral semaglutide in cardiovascular disease; the EU’s Committee for Medicinal Products for Human Use declines to recommend Eli Lilly’s Alzheimer’s drug; and pharma R&D returns grew in 2024.
April 2, 2025
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1 min read
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Heather McKenzie
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
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