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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.

Podcast
CDC Faces Critical Meetings Amid COVID Vaccine Uncertainty, Plus Deals, FDA Approvals, More
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
September 3, 2025
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1 min read
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Jef Akst
FDA
Offit Out at FDA Vaccine Advisory Committee After HHS Rebuff
Paul Offit, longtime member of the FDA’s vaccine advisory committee and an outspoken critic of Health Secretary Robert F. Kennedy Jr., was recently informed by the Department of Health and Human Services that his services are no longer required.
September 2, 2025
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3 min read
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Heather McKenzie
Building a rocket. Halftone hands assemble a rocket shaped puzzle. Concept of a startup, new business. Hasty rocket launch. Innovation, teamwork, development of ideas and technologies
Deals
Vertex, Enlaza Declare War on Autoimmune Disease in Potential $2B+ Pact
Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy.
September 2, 2025
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2 min read
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Heather McKenzie
Hand holding a puzzle piece shaped like a brain, sunlight shining through in a forest setting.
ALS
New Wave of ALS Therapies Signals Renaissance After Incremental Regression
After a demoralizing period punctuated by the withdrawal of one of the few marketed therapies for ALS, investment in new biotechs, state-backed collaborative initiatives and buzz at BIO2025 suggest a new day in drug development for one of medicine’s most intractable diseases.
September 2, 2025
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6 min read
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Heather McKenzie
Policy
Kennedy Promised Medical Freedom. New COVID-19 Vaccine Restrictions Provide the Opposite
During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
August 29, 2025
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5 min read
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Heather McKenzie
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
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