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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.

Susan Monarez speaking to a senator at her confirmation hearing as CDC director
Policy
Monarez Fired From Top CDC Spot Following Friction Over New COVID-19 Vaccine Policy
The CDC director—the first to be confirmed by the Senate under new legislation—has been ousted after less than a month following internal unrest regarding new, more restrictive approvals for updated COVID-19 vaccines, according to multiple sources.
August 28, 2025
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3 min read
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Heather McKenzie
Podcast
Lilly’s Obesity Pill Heads to the FDA, AbbVie Bets on Psychedelics, HHS Unveils More Change
Eli Lilly drops a second Phase III readout for orforglipron; AbbVie committed to the psychedelic therapeutics space with the $1.2 billion acquisition of Gilgamesh’s depression asset; the CDC taps vaccine skeptic Retsef Levi to lead its COVID-19 immunization working group; and the FDA prioritizes overall survival in cancer drug development.
August 27, 2025
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1 min read
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Jef Akst
Podcast
Oral Weight-Loss Race Heats Up as New Data From Lilly, Viking Reset Expectations
Closely watched data from Eli Lilly and Viking Therapeutics this month have reignited the discussion around oral weight-loss drugs—and their ultimate place within the anti-obesity medication market.
August 26, 2025
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1 min read
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Jef Akst
Colorful, cartoon capsules on a race track
Weight Loss
Oral Obesity Candidates Disappoint With Novo Emerging as Leader of the Pack
With results from highly anticipated trials of Eli Lilly’s orforglipron and Viking Therapeutics’ VK2735 “underwhelming” investors, William Blair’s Andy Hsieh predicts weight loss pills will play a bigger role in low- and middle-income countries than in the U.S.
August 22, 2025
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5 min read
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Heather McKenzie
Podcast
MAHA Report Emphasizes Vaccines, Safety Vexes Viking’s Obesity Win, Novo Gains Momentum
A draft copy of an upcoming MAHA report reveals a strategy in lockstep with recent HHS actions such as reviving the Task Force on Safer Childhood Vaccines; Viking Therapeutics reports robust efficacy from mid-stage oral obesity candidate but is tripped up by tolerability concerns; Novo Nordisk wins approval for Wegovy in MASH; and Lilly takes a pricing stand.
August 20, 2025
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2 min read
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Heather McKenzie
Glowing red neon heartbeat pulse rate line. Health and Medical concept. EKG Pulse Wave, cardiogram and rhythm
Duchenne muscular dystrophy
With Prasad Back at FDA, Capricor To Fight DMD Cardiomyopathy Rejection
Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.
August 20, 2025
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7 min read
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Heather McKenzie
FDA
Leaked MAHA Strategy Emphasizes Vaccine Overhaul, Streamlined Access to Novel Therapies
A draft copy of the Make America Healthy Again Commission’s latest report, obtained by Politico, focuses on vaccine-related injuries and expediting access to investigational medicines for children—even though the FDA has recently rejected several of them.
August 18, 2025
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3 min read
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Heather McKenzie
Podcast
Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout Continues
CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out after reportedly sparring with other agency officials over communications strategy; Eli Lilly’s first Phase III readout for oral obesity drug orforglipron missed analyst expectations; and Arrowhead Pharmaceuticals addresses the recent woes of its of partner Sarepta.
August 13, 2025
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2 min read
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Heather McKenzie
FDA
Prasad Back at CBER After 10-Day California ‘Vacation’
After exiting the FDA less than two weeks ago for unclear reasons, Vinay Prasad is once again director of the Center for Biologics Evaluation and Research, HHS confirmed to several outlets Saturday.
August 9, 2025
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2 min read
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Heather McKenzie
Podcast
FDA In Flux, Pfizer Talks to Trump on MFN, Merck Cuts 6K Jobs, More
George Tidmarsh takes over temporarily at CBER following Vinay Prasad’s abrupt departure; Replimmune trial leaders protest rejection reportedly driven by FDA’s top cancer regulator Richard Pazdur; Merck’s $3 billion savings push claims 6,000 jobs; and Pfizer CEO Albert Bourla addresses President Donald Trump’s new threats around Most Favored Nation drug pricing.
August 6, 2025
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2 min read
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Heather McKenzie
Venture capital
Building Pharma’s Farm System: Eli Lilly, Boehringer Ingelheim, More Invest in the Future
While a substantial portion of pipeline assets are externally sourced, many Big Pharmas are tapping into incubators and venture funds to uncover cutting-edge scientific trends, determine their future focus points and even carve out a niche in an emerging geographical hotspot.
August 6, 2025
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5 min read
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Heather McKenzie
businesspeople talking through messy chaos, tangled phone line make other confused miscommunicate unclear message and informationBad communication concept vector
FDA
‘Unprecedented’ FDA Leaks Sow Confusion For Patients, Sarepta and Capricor
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public.
August 4, 2025
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7 min read
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Heather McKenzie
Pictured: Eli Lilly's headquarters in Indianapolis
Diabetes
Lilly’s Mounjaro ‘Good Enough’ in Cardio Trial, Will Seek Expanded Approval
While Eli Lilly’s diabetes blockbuster was non-inferior to its older incretin therapy Trulicity in a highly anticipated Phase III cardiovascular outcomes trial, analysts had hoped for statistical significance in reducing major events such as cardiovascular death, heart attack and stroke.
July 31, 2025
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2 min read
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Heather McKenzie
Podcast
Sarepta Gets Reprieve, RFK Jr.’s New Changes, Roche’s Alzheimer’s Comeback and Q2 Earnings
Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task Force and “fix” the vaccine injury compensation program, Merck, AstraZeneca and more report Q2 earnings, Novo names a new leader and Roche’s trontinemab impresses at AAIC25.
July 30, 2025
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2 min read
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Heather McKenzie
FDA
Prasad Out at CBER Following Sarepta Rollercoaster and Conservative Criticism
The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, where he had been the head of the Center for Biologics Evaluation and Research for less than three months.
July 29, 2025
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1 min read
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Heather McKenzie
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