SUBSCRIBE
SUBSCRIBE
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.

Person buried in paperwork hand raised collage art. Man drown in work concept. Overwork illustration for news banner, web articles, and posters
FDA
FDA Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli Lilly’s Alzheimer’s antibody Kisunla, Sarepta’s DMD gene therapy Vyondys 53 and Gilead’s HIV drug Sunlenca.
July 11, 2025
 · 
5 min read
 · 
Annalee Armstrong
Podcast
Second Half Milestones, KalVista’s Surprise Approval, Another RFK Jr. Lawsuit, More
H2 2025 catalysts to watch, biopharma implications of President Trump’s tax law, KalVista’s new hereditary angioedema drug that Marty Makary reportedly tried to reject, another lawsuit aimed at Health Secretary Robert F. Kennedy Jr. and a plea from patients with ALS for access to BrainStorm’s NurOwn.
July 9, 2025
 · 
1 min read
 · 
Heather McKenzie
FDA signage at its headquarters in Maryland
ALS
ALS Community Petitions FDA To Reconsider BrainStorm’s NurOwn, Pointing to Recent Survival Data
BrainStorm Cell Therapeutics issued a statement Tuesday supporting a Citizens’ Petition submitted to the FDA requesting the approval of its cell therapy NurOwn, whose BLA was withdrawn in 2023. A Phase IIIb trial was scheduled to begin last month.
July 8, 2025
 · 
3 min read
 · 
Heather McKenzie
Podcast
CAR T Expands, M&A Ticks Up, Two Psychedelics Read Out, and the Supreme Court Rules on PrEP
The high court sides with HHS on HIV PrEP drugs; Health Secretary RFK Jr.’s newly appointed CDC vaccine advisors discuss thimerosal in flu vaccines, skip vote on Moderna’s mRNA-based RSV vaccine; FDA removes CAR T guardrails; AbbVie snaps up Capstan for $1.2B to end first half; and psychedelics take off again with data from Compass and Beckley.
July 2, 2025
 · 
1 min read
 · 
Heather McKenzie
Modern halftone collage. Concept of starting a new business, opening ceremony, launching a new product. Halftone hand cutting red ribbon with scissors symbolizing opening or starting a new. Modern business collage for design. Vector illustration
Cell therapy
CAR T Guardrail Removal Earns FDA Favor with CGT Community
Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been attached to approved CAR T cancer therapies reflects “thoughtful consideration of real-world evidence” and “regulatory trust.”
July 1, 2025
 · 
6 min read
 · 
Heather McKenzie
Medical characters fighting the epidemic flat vector concept operation hand drawn illustration
Obesity
Analysts Home In on Safety as Novo, Lilly, Amgen Highlight Weight Loss Data at ADA
In the race to make the most tolerable obesity drug, there seems to be no clear winner—at least not according to analysts parsing the data presented at the American Diabetes Association annual meeting this week.
June 27, 2025
 · 
5 min read
 · 
Heather McKenzie
Podcast
FDA Churn Continues, RFK Faces Congress, Obesity Insights at ADA, BIO2025 Recap
Robert F. Kennedy Jr. testified in front of largely combative congresspeople on vaccine policy, his MAHA report and more; the mass leadership exodus at the FDA continues as CDER and CBER shed key staff; Kennedy’s revamped CDC vaccine advisors convene for their first meeting; Novo and Lilly present new data at the American Diabetes Association’s annual meeting; and BioSpace recaps BIO2025.
June 25, 2025
 · 
2 min read
 · 
Heather McKenzie
Pictured: (From L) Joe Ross, Camille Bedrosian, Emil Kakkis and Heather McKenzie
Rare diseases
FDA Conditional Pathway Not Necessary, Rare Disease Experts Say, While Applauding Intent
Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway proposed by FDA Commissioner Marty Makary. They acknowledged, however, that creative thinking is required to enable more treatments for patients with ultrarare diseases.
June 24, 2025
 · 
3 min read
 · 
Heather McKenzie
Rare diseases
IRA Leaves Orphan Drugs Stranded Even as Regulators Promise Progress
The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from sufficient to maintain momentum in the rare disease space.
June 23, 2025
 · 
7 min read
 · 
Heather McKenzie
Vaccines
Quick on Its Feet: Novavax Adapts to Continued Regulatory Uncertainty
After the delayed approval of its next-generation COVID-19 vaccine, Novavax now awaits the first meeting of the recently overhauled CDC vaccine advisory committee next week. Throughout a tumultuous season, the Maryland-based company is relying on agility and a diverse pipeline to stay ahead of rapidly changing regulations.
June 20, 2025
 · 
3 min read
 · 
Heather McKenzie
Pictured: Eli Lilly Campus in San Diego
Business
More Than a One Trick Pony, Lilly Feeds Success Back Into Biotech
On the sidelines of BIO2025, Julie Gilmore, head of Lilly Gateway Labs, shares her thoughts on the $1.3 billion Verve Therapeutics buy, where Lilly’s therapeutic puck is potentially going and how the company is leveraging its unprecedented success in obesity to support young biotechs.
June 18, 2025
 · 
3 min read
 · 
Heather McKenzie
Podcast
Another Gene Therapy Death; Biopharma M&A Picks Up; a Vaccine Board of Vaccine Skeptics
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines.
June 18, 2025
 · 
1 min read
 · 
Heather McKenzie
Medical 2D illustration
Vaccines
As New CDC Vaccine Advisors Gear Up for First Meeting, Experts Ask, ‘Where’s Cassidy?’
Scientists and analysts express concern that the newly appointed ACIP members—which include known anti-vaxxers—could relitigate recommendations that have already been made. Many are imploring Sen. Bill Cassidy to step up.
June 12, 2025
 · 
4 min read
 · 
Heather McKenzie
Policy
Makary, Prasad Lay Out Mission for FDA in Journal Kennedy Called ‘Corrupt’
FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s priorities, including accelerating cures and the rapid deployment of artificial intelligence.
June 11, 2025
 · 
3 min read
 · 
Heather McKenzie
Podcast
RFK Axes CDC Vaccine Advisors; Metsera’s Weight Loss Win; FDA Supports CGT
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
June 11, 2025
 · 
1 min read
 · 
Heather McKenzie
Load More