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.

Facade of Novo Nordisk's office in Fremont, California
C-suite
Novo Nordisk Names New Leader, Cuts 2025 Sales Guidance By 5%
In a surprise double announcement Tuesday, Novo reduced sales guidance by 5%—attributing the change to slowed growth of its semaglutide franchise in the U.S.—and named current international operations head Maziar Mike Doustdar as its new president and CEO.
July 29, 2025
 · 
2 min read
 · 
Heather McKenzie
Art and Paintings around and inside human's brain profile - Collage
Alzheimer’s disease
As Alzheimer’s Space Heats Up, Biopharma Leans In to Holistic Treatment
Acknowledging the limits of disease-modifying drugs like Leqembi and Kisunla, companies like Bristol Myers Squibb, Acadia, Otsuka and Lundbeck are renewing a decades-old search for symptomatic treatments, including in high-profile drugs like Cobenfy.
July 28, 2025
 · 
7 min read
 · 
Heather McKenzie
A silhouetted roller coaster, taken on high speed black and white film for dramatic effect.
Duchenne muscular dystrophy
Sarepta Craters as FDA Considers Requesting Halt to Elevidys Shipments
The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a stop to all shipments of the Duchenne muscular dystrophy therapy Elevidys following a third patient death linked to the underlying platform.
July 18, 2025
 · 
2 min read
 · 
Heather McKenzie
Courtesy of Sarepta Therapeutics
Layoffs
Sarepta Up 18% After Business Overhaul as Analysts Cautiously Optimistic
Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant pipeline shift and adding a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys.
July 17, 2025
 · 
1 min read
 · 
Heather McKenzie
L-R: Deb Bellina, Mitze Klingenberg, Nicole Cimbura, Lorri Cavalierre, Kandy Simons, Rebecca Andrews
ALS
Patients Fight for Access to BrainStorm’s ALS Drug After Expanded Access Data ‘Defy Logic’
Participants in trials of BrainStorm Cell Therapeutics’ NurOwn filed a Citizens’ Petition with the FDA earlier this month seeking a new review of the stem cell therapy that was rejected in 2022 based on real-world data and 90% survival in an expanded access program.
July 17, 2025
 · 
9 min read
 · 
Heather McKenzie
Layoffs
Sarepta Tags DMD Gene Therapy Elevidys With Black Box Warning, Axes 500 Staff
Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.
July 16, 2025
 · 
2 min read
 · 
Heather McKenzie
Podcast
FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
July 16, 2025
 · 
1 min read
 · 
Heather McKenzie
Acadia CEO Catherine Owen Adams,
Rare diseases
Acadia Debuts New Team, Pipeline With ‘Biotech Powerhouse’ Ambitions
More than thirty years since its 1993 founding, Catherine Owen Adams and Elizabeth Thompson—the R&D combo that has led Acadia since last year—are managing two products on the market and a pipeline estimated to be worth an additional $12 billion in sales.
July 15, 2025
 · 
5 min read
 · 
Heather McKenzie
Psychedelics
Can Psychedelics Break Through in Depression? Recent Readouts Leave Investors Wanting More
Market reaction to recent readouts from Compass Pathways and Beckley Psytech/atai in treatment-resistant depression speaks to the hurdles psychedelic therapies must clear to quell concerns about commercial viability.
July 14, 2025
 · 
8 min read
 · 
Heather McKenzie
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
Load More