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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.

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FDA
Replimune cries foul on regulatory flexibility. But many Americans want a stricter FDA
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
April 17, 2026
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5 min read
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Heather McKenzie
Pictured: CDC signage at its headquarters in Georg
CDC
Trump nominates new CDC director, appoints various leaders to embattled agency
Erica Schwartz, a former deputy surgeon general and member of the U.S. military, will take over from what has amounted to a rapid succession of CDC leaders over the past year.
April 16, 2026
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2 min read
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Heather McKenzie
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FDA
Drug pricing watchdog calls for increased transparency into FDA’s accelerated approval decisions
Greater transparency in FDA decision-making was possibly the most common theme for stakeholders interviewed by the Institute for Clinical and Economic Review in a new report focused on strengthening the agency’s accelerated approval program.
April 16, 2026
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4 min read
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Heather McKenzie
Podcast
J&J targets $100B revenue, Replimune rebuffed again and a “Revolution” in pancreatic cancer
Johnson and Johnson kicked off first-quarter earnings season with a “modest” beat and an ambitious goal; Replimune failed again to gain approval for its advanced melanoma therapy, as analysts tout increased accountability brought by the FDA’s new policy of publicizing complete response letters; and Revolution Medicines’ pancreatic cancer candidate doubled survival in one of cancer’s most intractable foes.
April 15, 2026
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1 min read
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Heather McKenzie
FDA
Deep dive: Checking in with the FDA
BioSpace looks back at 2025 and where the FDA is going in 2026.
April 15, 2026
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2 min read
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Heather McKenzie
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Earnings
With nearly a quarter billion in Q1, J&J targets $100B revenue in 2026
With robust sales performance from oncology darling Darzalex and immunology superstar Tremfya, Johnson & Johnson is “off to a fast start in 2026,” CEO Joaquin Duato told investors on Tuesday.
April 14, 2026
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3 min read
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Heather McKenzie
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Cancer
IDEAYA and Servier’s eye cancer drug heads to FDA after delivering ‘best in class’ efficacy
Darovasertib, in combination with crizotinib, more than doubled progression-free survival in a registrational trial, leading Truist analysts to declare a “best-in-class efficacy profile” for the PKC inhibitor.
April 13, 2026
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2 min read
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Heather McKenzie
Success transformation and Transform to succeed or improving concept and leadership in business through innovation and evolution with paper origami changed for the better.
Regulatory
FDA flexibility isn’t absent but evolving regulations come with growing pains
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
April 13, 2026
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5 min read
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Heather McKenzie
A person and a group of people are separated by a yellow line. Establishing contact. Distrust. Quarantine. Distance with strangers. Barrier to understanding, difficult integration. Rejection, refusal.
Complete response letters
Replimune’s advanced melanoma drug rebuffed by FDA for second time
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
April 10, 2026
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2 min read
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Heather McKenzie
Podcast
Lilly’s Foundayo Nod Launches New Battle With Novo, M&A Mania Continues, Tariffs Hit Pharma
The approval of Eli Lilly’s oral obesity drug officially ignites an intense competition with Novo Nordisk’s oral Wegovy; Gilead Sciences and Neurocrine Biosciences keep the M&A train chugging; Trump hits pharma with his long promised tariffs, and the FDA proposes many changes with 2027 budget.
April 8, 2026
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1 min read
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Heather McKenzie
businesswoman drawing big fish on the wall
Mergers & acquisitions
Gilead Swallows Another Partner, Paying up to $5B for ADC Specialist Tubulis
The acquisition of Tubulis GmbH—Gilead Sciences’ latest of the year after buying Arcellx and Ouro Medicines—brings into the fold a novel ovarian cancer candidate that has demonstrated promising mid-stage data.
April 7, 2026
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2 min read
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Heather McKenzie
Doubtful person, hands on hips, choosing the way as multiple arrows on the road showing a mess of different directions. Choosing the correct pathway, difficult decision concept, confusion symbol.
FDA
FDA Reversals in Rare Disease Space Highlight Confusion Around External Controls
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent. One former regulator says the situation is more nuanced.
April 6, 2026
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6 min read
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Heather McKenzie
Control, Fluctuation, Uncertainty, Businessman balancing with an umbrella
Rare diseases
Rare Disease Leaders Call for Regulatory Clarity as FDA Balances Urgency With Rigor
With CBER director Vinay Prasad set to depart the agency at the end of the month, a coalition of patient groups and biotech executives penned a letter imploring the Trump administration to “restore regulatory clarity” for rare disease therapies. Experts on a BioSpace panel last week also acknowledged the challenges faced by a more stringent FDA.
April 2, 2026
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6 min read
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Heather McKenzie
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
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3 min read
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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
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1 min read
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Heather McKenzie
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