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.

FDA

FDA’s Prasad To Depart FDA Following Tumultuous Term as CBER Chief

Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle feathers in biopharma after presiding over the rejection of several rare disease therapies.

March 6, 2026

3 min read

Heather McKenzie

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Cardiovascular disease

Alnylam Unites With Tenaya in Potential $1B+ Pact To Find New Genetic Heart Disease Targets

The alliance, which pairs Tenaya’s modality agnostic target identification and validation capabilities with Alnylam’s deep experience in RNA interference therapeutics, comes during a period of resurgence for the cardiovascular space.

March 5, 2026

2 min read

Heather McKenzie

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Huntington’s disease

UniQure’s Path for Huntington’s Gene Therapy Clouded by Ethical Questions as Potential Phase 3 Looms

While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be considered for approval, experts believe there is an alternate path forward for the therapy, perhaps even based on precedent from the recent drama surrounding Moderna’s mRNA flu vaccine.

March 5, 2026

7 min read

Heather McKenzie

Podcast

UniQure’s Delay, REGENXBIO’s Rejection Explained, Sarepta’s Ingram Steps Down, More

UniQure and REGENXBIO are both dealing with FDA setbacks for their respective gene therapies, as regulatory experts question the FDA’s decision-making processes; CBER director Vinay Prasad is under probe for allegedly fostering a toxic workplace; Sarepta CEO Doug Ingram is stepping down after several years of tumult at the top of the muscular dystrophy–focused company; and Eli Lilly again tops Novo Nordisk in a weight loss trial.

March 4, 2026

1 min read

Heather McKenzie

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FDA

FDA’s Circle of Trust Is Shrinking, Making Many Decisions Feel Like ‘Fiat’

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications. This type of “fiat” decision-making, as multiple regulatory experts have called it, is also bleeding into the agency’s policymaking.

March 3, 2026

4 min read

Heather McKenzie

Man walking on a long wavy path with flag at the end, persistence, determination and ultimate business success - 3D Render

Rare disease

UniQure Eyes Phase 3 for Huntington’s Gene Therapy Despite Makary’s Apparent Criticism

Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with CNBC, the agency confirmed to the biotech that a sham surgery–controlled study is needed before submitting the gene therapy for approval.

March 2, 2026

3 min read

Heather McKenzie

The fight over the Affordable Care Act and the repeal and replace of Obamacare concept.In American politics US parties are represented by either the democrat donkey or republican elephant

Rare diseases

Rare Disease Groups Lobby for Regulatory Expediency as Makary Defends ‘Rigorous’ Approach

This week’s Capitol Hill meetings come on the heels of rejections of ultra-rare disease drugs developed by Biohaven and Saol Therapeutics. Physicians and patient groups implored the FDA to expedite these treatments.

February 27, 2026

6 min read

Heather McKenzie

Two men walking on separate winding paths that merge into a single large upward arrow representing business partnership and shared goals, 3d render

FDA

FDA’s One Trial Policy Not a Revolution but a Potentially Risky Evolution

Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.

February 26, 2026

7 min read

Heather McKenzie

Podcast

Lilly Bests Novo Again, Rare Disease Week Goes Regulatory, More CDC Leadership Upheaval

Eli Lilly notches another win over Novo Nordisk, as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Disease Week, providing draft guidance on its new plausible mechanism pathway, while a bipartisan senate hearing on Thursday will focus on the authorization process for rare conditions; Another leadership change shakes up CDC; and Gilead acquires CAR T partner Arcellx for nearly $8 billion.

February 25, 2026

2 min read

Heather McKenzie

Glowing Dollar sign in light bulb - 3D Rendering

Rare diseases

Cashing In on ‘Creative Fundamentals’ To Fund Rare Disease R&D

Rare disease drug developers struggle to survive in a biopharma investment market that prioritizes large patient populations. Initiatives like the Orphan Therapeutics Accelerator are attempting to solve what CEO Craig Martin says is not a science problem, but a math problem.

February 25, 2026

7 min read

Heather McKenzie

Drug pricing

Novo Slashes GLP-1 Prices Again, Touts New Weight Loss Data on Heels of Lilly Loss

Following Monday’s clinical defeat by Eli Lilly, Novo Nordisk cut the 2027 list prices for its three GLP-1 medicines by as much as 50%, while boasting Phase 2 data for its invesigational triple-G agonist.

February 24, 2026

3 min read

Jef Akst

Person isolating in solitude separated behind a wall concept for being different, shyness, self isolation or individuality

Sickle cell disease

Sickle Cell Gene Therapies Casgevy and Lyfgenia Still Lacking Traction 2 Years In

The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.

February 23, 2026

6 min read

Heather McKenzie

FDA

Makary, Prasad Under Fire as FDA Turmoil Reaches President Trump

Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.

February 20, 2026

7 min read

Heather McKenzie

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).

FDA

FDA Reverses Course on Moderna’s mRNA Flu Shot Application, Promising August Decision

The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.

February 18, 2026

3 min read

Heather McKenzie

Podcast

Modernagate Fallout, Disc’s Rejection, Compass’ Psilocybin Data, CDC’s Lost Leaders

The FDA outright refuses to review Moderna’s mRNA-based flu vaccine as CBER director Vinay Prasad’s conduct is scrutinized; Disc Medicine receives an unexpected rejection, which Prasad may also have had a hand in; Compass Pathways posts new late-stage data on its psilocybin-based depression drug; CDC is once again leaderless.

February 18, 2026

1 min read

Heather McKenzie