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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.

Facade of the FDA's office in Maryland
FDA
6 Drugs Approved Despite Failed Trials or Minimal Data
Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
October 5, 2023
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6 min read
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Heather McKenzie
Right and left sides of the brain/iStock, Warrenra
Drug Development
Karuna Submits Highly Anticipated NDA for KarXT in Schizophrenia
If approved by the FDA, Karuna Therapeutics’ investigational agonist of muscarinic acetylcholine 1 receptors M1 and M4 would provide the first new mechanism of action for schizophrenia patients in decades.
September 28, 2023
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3 min read
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Heather McKenzie
Pictured: BrainStorm Co-CEO Stacy Lindborg
Policy
BrainStorm Withdraws BLA for ALS Therapy, Plans Phase IIIb Trial
After an FDA advisory committee voted 17-1 against approving NurOwn last month, BrainStorm executives Wednesday laid out a potential path forward for the experimental amyotrophic lateral sclerosis treatment.
September 27, 2023
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5 min read
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Heather McKenzie
Facade of the FDA's office in Maryland
Policy
FDA Takes BrainStorm to Task Over Efficacy, Manufacturing Ahead of NurOwn Adcomm
The FDA’s briefing documents found that BrainStorm’s BLA submission for its investigational cell therapy for ALS did not demonstrate evidence of effectiveness and that the manufacturing data was “grossly deficient.”
September 25, 2023
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5 min read
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Heather McKenzie
A patient consults with a doctor/iStock, Artit_fiz
Policy
Upcoming NurOwn Adcomm Highlights Regulatory Role for Patient Advocates
Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.
September 22, 2023
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10 min read
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Heather McKenzie
Facade of the FDA's office in Maryland
Policy
6 Key Regulatory Guidance Documents Issued in 2023
The FDA has issued more than 30 guidance documents related to drug development so far this year. BioSpace takes a closer look at six of them.
September 14, 2023
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5 min read
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Heather McKenzie
Pictured: Memory lapses in neurodegenerative disea
Drug Development
The Alzheimer’s Treatment Landscape: Leqembi vs. Donanemab
With a potential combined market value of $30 billion, BioSpace takes a deep dive into the Phase III data supporting Eisai and Biogen’s Leqembi and Eli Lilly’s investigational donanemab.
September 8, 2023
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8 min read
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Heather McKenzie
Pictured: Amgen's office in Tampa, Florida
Policy
FTC Agreement Clears Amgen to Proceed with $27.8B Horizon Deal
Under a consent order agreement announced Friday, Amgen is prohibited from bundling any of its products with Horizon’s Tepezza or Krystexxa, allaying the FTC’s primary concerns.
September 1, 2023
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2 min read
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Heather McKenzie
An MRI scan of the human brain/iStock, Photoprofi3
Drug Development
Coveted GLP-1 Drugs Show Early Promise in Alzheimer’s Disease
With a recent study yielding positive results, experts say GLP-1 drugs are making headway in treating Alzheimer’s and other neurodegenerative diseases.
August 31, 2023
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5 min read
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Heather McKenzie
DNA and genome editing concept/iStock, elenabs
Drug Development
CRISPR Shows Preclinical Promise in Treating Alzheimer’s, Challenges Persist
At AAIC, researchers presented studies using CRISPR-Cas9 in animal/organoid models of Alzheimer’s disease, but some experts doubt that such approaches will successfully translate to humans.
August 11, 2023
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6 min read
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Heather McKenzie
Right and left sides of the brain/iStock, Warrenra
Drug Development
The Neuropsychiatric Pipeline: 10 Late-Stage Therapies to Watch
With a potential $509 billion up for grabs by 2028, companies including Biogen, Sage, Karuna Therapeutics and Cerevel Therapeutics are vying to bring their drugs across the regulatory finish line.
August 9, 2023
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11 min read
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Heather McKenzie
FDA sign in front of its building in Maryland
FDA
Sage Hints at Difficult Decisions After Zuranolone’s Rejection in MDD
The FDA approved Sage and Biogen’s zuranolone Friday as the first oral medication for postpartum depression but declined to approve the application in major depressive disorder.
August 7, 2023
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3 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 Approves Biogen, Sage’s Zurzuvae as First Pill for Postpartum Depression
Partners Biogen and Sage Therapeutics had sought approval for the therapy in both postpartum depression and major depressive disorder, but the FDA rejected the application for the latter.
August 4, 2023
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3 min read
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Heather McKenzie
sad man hand in head with whiskey on desk
Drug Development
GLP-1 Drugs Show Promise in Alcohol, Opioid Use Disorders
Early research and anecdotal evidence indicate that the popular diabetes and obesity drugs could treat some patients with addictive disorders.
August 2, 2023
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5 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.
Policy
5 Highly Anticipated FDA Decisions for Rare Diseases Coming This Year
The first half of this year saw milestone approvals for rare disease therapies, and the FDA has several more such decisions on its calendar in the second half of 2023.
July 27, 2023
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6 min read
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Heather McKenzie
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