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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.

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
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
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2 min read
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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
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7 min read
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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
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2 min read
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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
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1 min read
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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
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9 min read
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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
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2 min read
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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
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1 min read
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Heather McKenzie
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