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Heather McKenzie

Heather McKenzie

Senior Editor

Heather McKenzie is a professional journalist with more than 8 years’ experience in the biopharmaceutical industry. Since joining BioSpace, she has written more than 300 features and breaking news articles, including multiple award-winning stories. Her particular focuses are neuroscience, rare disease and regulatory science. She has also traveled internationally to cover global biotech hubs, including 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, watching her American League champion Toronto Blue Jays, 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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Alzheimer’s disease
AAIC 2026: Anti-tau space begins to clarify as Biogen presents detailed data on antisense drug
New mid-stage data from Biogen’s Ionis-partnered therapy diranersen served to both validate the tau hypothesis in Alzheimer’s disease and raise questions that could soon be elucidated by anti-tau candidates from Denali Therapeutics, Eisai and Eli Lilly.
July 15, 2026
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6 min read
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Heather McKenzie
Podcast
Biogen validates anti-tau approach at AAIC, psychedelics full speed ahead, ATTR-CM shakeup
Biogen’s new data, presented at the Alzheimer’s Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.
July 15, 2026
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1 min read
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Jef Akst
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Alzheimer’s disease
AAIC 2026: Biogen delivers hope, validation with anti-tau Alzheimer’s win
Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
July 14, 2026
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5 min read
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Heather McKenzie
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Huntington’s disease
Exit of Roche’s embattled Huntington’s drug ‘tightens’ case for Wave’s more selective ASO
The failure of Roche’s Ionis-partnered tominersen in Huntington’s disease may indicate that Wave Life Sciences’ allele-specific antisense oligonucleotide candidate WVE-003 is on the right track, according to analysts at Rodman & Renshaw.
July 13, 2026
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4 min read
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Heather McKenzie
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FDA
Cancer, rare disease dominate FDA approvals in H1 2026 as AstraZeneca, J&J clean up
The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.
July 9, 2026
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1 min read
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Heather McKenzie
Illustration Of Yacht Competing In Sailing Event
Rare diseases
Saol boards FDA’s resubmission boat, armed with new survival data
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
July 9, 2026
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3 min read
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Heather McKenzie
One red lottery winner or rare disease, multi-level personification, power, reverse search, secret sample, special spy, close-up. Company leader
Rare diseases
Through flux and fluidity, FDA keeps coming back to rare disease
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
July 8, 2026
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6 min read
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Heather McKenzie
Podcast
Vertex carries M&A uptick into H2, IPOs and VC raises also grow, FDA on pace despite turmoil
A surprising deal from Vertex Pharmaceuticals adds to Big Pharma’s acquisitive streak as Crinetics folds into the cystic fibrosis drugmaker. Meanwhile, IPOs and venture capital raises trend upward, but mostly for derisked companies. Plus, FDA decisions slow only slightly as the hunt for a permanent leader drags on.
July 8, 2026
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1 min read
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Jef Akst
Killer Whale, orcinus orca, Adult Leaping, Canada
Approvals
Orca opens up Treg cell therapy with FDA nod for allogeneic blood cancer treatment
The approval of Tregzi—the first regulatory greenlight for Orca Bio—was based on a Phase 3 study in which patients on the therapy were twice as likely to survive without cancer relapse and without chronic GVHD compared with conventional allogeneic transplant.
July 1, 2026
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2 min read
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Heather McKenzie
Podcast
Sentiment at BIO soars as FDA resets, dealmaking evolves; Amgen’s Tavneos in hot water
The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
July 1, 2026
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2 min read
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Jef Akst
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Huntington’s disease
Skyhawk CEO hopes FDA’s new uniQure position will translate to Huntington’s pill
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
June 30, 2026
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4 min read
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Heather McKenzie
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Duchenne muscular dystrophy
Capricor thrown for another loop as FDA sets adcomm for DMD cardiomyopathy therapy
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
June 26, 2026
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4 min read
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Heather McKenzie
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FDA
FDA’s uniQure, REGENXBIO reversals could bolster other near-term rare disease applications
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
June 25, 2026
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6 min read
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Heather McKenzie
This 3D render features human icons arranged side by side and in a line. Among them, one icon at the front shines brightly, symbolizing leadership and innovation. The visual presents a powerful metaphor for leadership, innovation, and making a difference, making it ideal for themes related to leadership and inspiration in the business world.
FDA
BIO CEO Crowley, DOD doctor Overton are top candidates for FDA commissioner: RBC
A new report from RBC Capital Markets lists Biotechnology Innovation Organization chief executive John Crowley and military physician Heidi Overton as potential candidates for the role of FDA commissioner—in addition to the agency’s current acting leader, top food regulator Kyle Diamantas.
June 24, 2026
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3 min read
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Heather McKenzie
Podcast
AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more
AbbVie scooped up immunology player Apogee Therapeutics for nearly $11 billion in one of the year’s top deals to-date, while Sanofi made a big play to survive its upcoming Dupixent patent cliff; FDA uncertainty continues as the agency changes direction on gene therapies by uniQure and REGENXBIO; and Jef Akst and Annalee Armstrong report back from San Diego.
June 24, 2026
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1 min read
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Jef Akst