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.

Approvals

Eli Lilly’s Oral Obesity Pill Approved, Kicking Off Renewed Novo Rivalry

The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.

April 1, 2026

3 min read

Heather McKenzie

Podcast

Biopharma M&A Heats Up, Rare Diseases Win Three Approvals, Wave Crashes

Biogen, Eli Lilly, Merck and Novartis spent more than $20 billion to absorb biotechs with promising or approved drugs; the rare disease space notched approvals for therapies from Denali Therapeutics, Rocket Pharmaceuticals and Biogen; and Wave’s stock lost half its value after its RNA-based obesity candidate failed to impress investors.

April 1, 2026

1 min read

Heather McKenzie

Illustration showing a downward graph trend

Rare diseases

PepGen Loses Half of Share Price on Mixed Data in Rare Muscle-Wasting Disease

PepGen’s lead candidate for myotonic dystrophy type 1 barely beat the placebo in a Phase 2 trial in terms of fixing incorrect gene splicing, but the biotech attributed the poor result to an outlier.

March 31, 2026

2 min read

Heather McKenzie

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Immunology and Inflammation

Biogen’s Lupus Drug Reduces Disease Activity, Further Deresking I&I Pipeline

William Blair hailed a positive readout in cutaneous lupus erythematosus as a turning point for Biogen, while RBC Capital analysts called the results “another derisking step” for the company’s immunology and inflammation pipeline.

March 30, 2026

4 min read

Heather McKenzie

FDA

Webinar: Aligning With the FDA on a Regulatory Pathway To Avoid Decision Day Surprises

Watch this critical discussion on how regulators and biotech companies can bridge the expectation gap during the regulatory review process to ensure novel therapies reach patients in a timely manner—because patients don’t have time to wait.

March 27, 2026

1 min read

Heather McKenzie

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Obesity

Wave Stock Cut in Half on Underwhelming Higher Dose Obesity Data

While participants on a lower dose of Wave Life Sciences’ RNA therapy lost 5.3% total fat at the six-month mark, those receiving the higher dose saw a less than 1% drop at three months.

March 26, 2026

2 min read

Tristan Manalac

Drug Development

Maze Loses Nearly a Third of Market Cap on Mixed Midstage Kidney Drug Data

Besting Vertex Pharmaceuticals’ kidney disease asset wasn’t enough to impress Wall Street, which appears to be “getting hung up” with the broad population data in Maze Therapeutics’ trial, according to Mizuho.

March 25, 2026

2 min read

Heather McKenzie

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Weight Loss

Despite Novo’s Robust Oral Wegovy Launch, Access Remains a Challenge for Obesity Drugs

This year’s catalysts in the space include a near-term FDA decision on Eli Lilly’s oral challenger to the new Wegovy pill. Looking further ahead, Novo Nordisk is expecting more clinical data for next-gen weight loss asset CagriSema, which recently lost a head-to-head battle with Lilly’s Zepbound.

March 25, 2026

3 min read

Heather McKenzie

Podcast

Gilead’s Ouro Buy, J&J/Protagonist’s Approval, Aurinia’s Revamp, ACIP Confusion, More

Gilead continues its dealmaking spree in the sizzling hot space of I&I as Johnson & Johnson, along with partner Protagonist, notched an FDA approval for a new psoriasis drug. Plus, Aurinia Pharmaceuticals gets a new C-suite, FDA releases draft guidance on non-animal models and the CDC’s vaccine advisory committee is not being disbanded after all.

March 25, 2026

1 min read

Heather McKenzie

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FDA

Rezolute Lauds ‘Unusual’ FDA Feedback Supportive of Path Forward for Hypoglycemia Drug

While ersodetug missed the Phase 3 primary endpoint of a reduction in hypoglycemia events, Rezolute argued that this goal was confounded in part by behavioral factors. The FDA acknowledged the validity of this argument.

March 24, 2026

3 min read

Heather McKenzie

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Vaccines

Pfizer ‘Confident’ in Valneva-Partnered Lyme Vaccine Despite Missed Primary Endpoint

The multivalent candidate, being developed by Pfizer and French partner Valneva under a 2020 pact, generated higher than 73% efficacy against the tick-borne disease in a Phase 3 trial—but failed to hit a predetermined confidence interval.

March 23, 2026

2 min read

Heather McKenzie

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FDA

9 Months In, FDA’s New Priority Voucher Program Still Clouded With Uncertainty

The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.

March 23, 2026

7 min read

Heather McKenzie

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Approvals

Novo’s High Dose Wegovy Scores FDA Priority Voucher Program’s 4th Nod

With the approval of Wegovy HD, Novo Nordisk joins Johnson & Johnson, Boehringer Ingelheim and USAntibiotics as beneficiaries of the FDA’s Commissioner’s National Priority Voucher program, which aims to review products that align with certain national priorities in less than two months.

March 19, 2026

2 min read

Heather McKenzie

Podcast

Kennedy’s Vaccine Agenda Stalled, Structure’s ‘Competitive’ Obesity Pill, Novo’s Warning Letter

Heath Secretary Robert F. Kennedy Jr.’s efforts to overhaul vaccine policy are likely illegal, a Massachusetts District Court Judge ruled; Structure’s GLP-1 weight loss pill succeeds in Phase 2 while Rhythm’s Phase 3 basket trial fails to find the beat; Eli Lilly warns of potential safety risks of taking compounded tirzepatide, and Novo Nordisk is hit with an FDA warning letter regarding adverse events potentially linked to Ozempic.

March 18, 2026

1 min read

Heather McKenzie

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FDA

Third FDA Rejection for Aldeyra’s Dry Eye Disease Drug Sends Shares Plummeting

In its complete response letter, the FDA said Aldeyra had failed to demonstrate reproxalap’s efficacy in adequate and well-controlled studies. The FDA previously turned the candidate away in November 2023 and April 2025.

March 17, 2026

2 min read

Heather McKenzie