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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.

Podcast
Billions More in M&A, Another Bidding War and More FDA Drama
Merck has made a $9.2 billion play for Cidara, and there’s another bidding war afoot, this one for sleep biotech Avadel. Meanwhile, Rick Pazdur has taken the helm at CDER while tensions run high between FDA Commissioner Marty Makary and Health Secretary RFK Jr.
November 19, 2025
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1 min read
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Heather McKenzie
White plane in blue sky flies above clouds towards hot sun. Vector background
Approvals
Arrowhead Secures Maiden Approval, First FDA Nod for Rare Genetic Metabolic Disorder
The FDA approval of the siRNA drug Redemplo caps off a tumultuous 12 months for Arrowhead, whose partnership with Sarepta caused its own stock to drop during the gene therapy maker’s safety troubles this summer.
November 18, 2025
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2 min read
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Heather McKenzie
Richard Pazdur
FDA
Makary Got His Man in Pazdur—But Can He Last as CDER Director?
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
November 18, 2025
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6 min read
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Heather McKenzie
A contemporary artistic collage featuring a hand holding a trophy. The concept of victory and achievement.
Regulatory
Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
November 17, 2025
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6 min read
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Heather McKenzie
Paper red boat sailing in the ocean or sea, travel concept. Blue sea waves layers. Modern paper art style 3d render
Editorial
FDA’s Bad Rap: Pazdur Steps Up as Agency Continues To Take on Water
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
November 13, 2025
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8 min read
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Jef Akst
3d rendered illustration of hockey ice rink and goal. The puck is flying on goal.
Immunology and inflammation
Novartis, Vertex, More Optimizing Shots on Multiple Goals in Lucrative I&I Space
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
November 12, 2025
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6 min read
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Heather McKenzie
Podcast
Pfizer Wins Metsera, Trump Strikes GLP-1 Pricing Deal, FDA Awards More Priority Vouchers
Pfizer seals the deal with Metsera for $10 billion after Novo Nordisk bowed out; President Donald Trump welcomes executives from Novo and Eli Lilly to the White House to announce that the companies’ GLP-1 medicines would be sold at a reduced cost; and the FDA grants the second round of priority review vouchers—primarily to already marketed drugs.
November 12, 2025
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1 min read
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Heather McKenzie
Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.
FDA
FDA Stalwart Pazdur Named Tidmarsh’s Replacement as CDER Director
The appointment of Richard Pazdur, currently director of the FDA’s Oncology Center of Excellence, comes less than a week after he reportedly declined the post, and just nine days after his predecessor’s controversial exit.
November 11, 2025
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1 min read
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Heather McKenzie
FDA
FDA Removes Black Box Warning From HRT Products, Reversing Landmark Decision
After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
November 10, 2025
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2 min read
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Heather McKenzie
Amgen sign at its headquarters in Thousand Oaks, California, USA.
Cardiovascular disease
Amgen’s Repatha Cuts Risk of First Heart Attack by 36% in Phase III Trial
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
November 10, 2025
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4 min read
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Heather McKenzie
Eli Lilly's world headquarters in Indianapolis
Obesity
Lilly’s Amylin Agonist Headed to Phase III After Eliciting up to 20% Weight Loss
The highest dose of Eli Lilly’s eloralintide led to 20.1% weight loss after 48 weeks in a Phase II trial, exceeding analyst expectations and highlighting a “potentially best in class profile,” according to BMO Capital Markets.
November 6, 2025
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3 min read
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Heather McKenzie
Podcast
Pfizer and Novo Battle Over Metsera, Tidmarsh Fights FDA Exit, UniQure and Sarepta Face Setbacks
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
November 5, 2025
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1 min read
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Heather McKenzie
FDA CDER director George Tidmarsh speaking in an FDA video
FDA
UPDATE: Tidmarsh Waffles on Resignation, Will Fight To Clear Name
Less than 24 hours after resigning his post as the FDA’s head drug regulator, George Tidmarsh is reportedly reconsidering his decision and vowing to fight for his name and credibility amid a probe into his “personal conduct” at the agency.
November 3, 2025
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3 min read
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Tristan Manalac
Pictured: uniQure headquarters in Amsterdam
Huntington’s disease
FDA Does ‘About-Face’ on UniQure’s Huntington’s Gene Therapy
A month after sparking optimism for patients with Huntington’s disease with highly positive data for AMT-130, uniQure revealed Monday that the FDA may be changing its tune on the evidence required for an approval application, a change of direction Stifel called “very challenging” for uniQure.
November 3, 2025
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3 min read
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Heather McKenzie
Pictured: BMS sign on a building in San Diego, California/iStock, JHVEPhoto
Earnings
BMS Battles ‘Deeply Ingrained’ Prescribing Habits in Schizophrenia as Cobenfy Misses Q3 Estimates
Bristol Myers Squibb beat analyst and consensus estimates for the third quarter with $12.2 billion in sales, but executives on the company’s investor call faced questions about a sluggish uptake for schizophrenia drug Cobenfy as well as a highly anticipated Alzheimer’s psychosis readout for the product.
October 30, 2025
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3 min read
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Heather McKenzie
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