Research & Development: Page 2
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Using the body as ‘a bioreactor’ — a regenerative medicine expert on where the field is headed
The director of the University of Pittsburgh’s McGowan Institute for Regenerative Medicine believes the industry is “turning a corner.”
By Alexandra Pecci • May 7, 2024 -
FDA’s new diagnostic rules draw pharma criticism
Tests frequently used in clinical trials will soon be regulated like medical devices — with some exceptions.
By Amy Baxter • May 6, 2024 -
Trendline
Clinical trial diversity
As pharma wises up to the fact that the current playbook for improving clinical trial diversity has yet to make a meaningful impact, the quest is on to refine that approach.
By PharmaVoice staff -
Takeover target? Activist investor believes Novavax tech would be in ‘better hands’ with Big Pharma
With its next earnings report looming, pushback from an investor is adding pressure on Novavax to boost performance.
By Meagan Parrish • May 3, 2024 -
As AI proliferates in pharma, regulators look to catch up in clinical trials
The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.
By Amy Baxter • May 1, 2024 -
4 offbeat biotechs making a splash in the life sciences
From resurrecting an extinct species to improving regenerative medicines with plant-based materials, these biotechs are on the leading edge of science.
By Alexandra Pecci • April 30, 2024 -
Profile
Now a biopharma powerhouse, Vertex’s R&D bedrock could deliver tomorrow’s blockbusters
From its landmark CRISPR approval to its potential breakthrough drug for pain, Vertex’s development approach, led by chief scientific officer Dr. David Altshuler, is paying off.
By Michael Gibney • April 30, 2024 -
Q&A
How a biotech exec is leveraging Big Pharma lessons to advance tRNA
Michelle Werner shares how the lessons from her resume — and personal experience — are driving her work with novel therapeutics.
By Amy Baxter • April 29, 2024 -
As BMS announces major cuts, its Karuna deal looks poised to drive growth
The company's schizophrenia drug picked up in its $14 billion acquisition of Karuna Therapeutics recently generated positive long-term data from its phase 3 program.
By Kelly Bilodeau • April 29, 2024 -
Q&A
Neuroscience has entered a new era. Now it’s time for a ‘moonshot’ approach.
Dr. Jeremy Levin, CEO of Ovid Therapeutics, explains how scientific advances have converged to create a new era of drug development potential.
By Meagan Parrish • April 26, 2024 -
Q&A
AbbVie and Regenxbio’s ‘multibillion-dollar opportunity’ in vision loss gene therapy
After a successful mid-stage study, the companies aim to upend traditional wet AMD treatments with a one-time gene therapy.
By Amy Baxter • April 24, 2024 -
Inside J&J’s strategy to de-gender clinical trials
Mark Wildgust, vice president of global medical affairs for J&J's oncology division, shares strategies for making clinical trials gender- and trans-inclusive.
By Alexandra Pecci • April 23, 2024 -
Vistagen’s on-demand nasal spray could provide a novel option for social anxiety
The fast-acting medication is one of a few new approaches being tested for the crippling condition.
By Kelly Bilodeau • April 22, 2024 -
Behind the ‘encouraging’ new results for Amylyx’s beleaguered drug
Where Amylyx ultimately failed in ALS, it could prevail in a rare disease. The doctor leading this research explains why.
By Meagan Parrish • April 19, 2024 -
Roivant spinoff tackles growing complexity of clinical trials
As precision medicine booms, all trials are starting to look like rare disease trials, the company said.
By Kelly Bilodeau • April 18, 2024 -
3 patent expirations in 2024 and how companies are pivoting
As the cliffs approach, pharma companies are tackling the sales hit with diverging strategies.
By Amy Baxter • April 17, 2024 -
Deep Dive
Ukraine was pharma’s ‘darling’ of clinical trials. As war drags on, will the industry come back?
New clinical trial starts are picking back up, but are still far below their bustling pre-war level.
By Meagan Parrish • April 16, 2024 -
Where the GLP-1 weight loss market goes will depend on data
As GLP-1s expand into new disease categories, their impact could be enough to overtake leading cardiovascular drugs.
By Amy Baxter • April 15, 2024 -
Biotech Spotlight
Traditional gene therapies are uber-niche. Ocugen hopes to change that.
The biotech is developing a ‘gene-agnostic’ approach to expand the patient pool for gene therapies.
By Alexandra Pecci • April 15, 2024 -
3 big recent trial flops
How these clinical setbacks impacted the companies, industry and patients.
By Meagan Parrish • April 12, 2024 -
Deep Dive
Psychiatry drugs finally have pharma’s attention. Can they keep it?
Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.
By Jacob Bell • April 10, 2024 -
Biotech Spotlight
What’s old is new: The revival of a one-time radiotherapy cancer treatment
TAE Life Sciences is bringing radiation-based cancer therapy to clinical trials globally in the coming years.
By Amy Baxter • April 10, 2024 -
Next-gen menopause treatments have blockbuster potential. Can women, doctors and payers be convinced?
The market is huge, but will companies overcome the triple hurdles of payer hesitance, prescriber reluctance and sluggish consumer demand?
By Alexandra Pecci • April 8, 2024 -
Women want to participate in clinical trials. Lack of flexibility is still a problem.
Underrepresentation of women in clinical trials affects the resulting drugs that are available down the line, but even small changes can fuel participation.
By Kelly Bilodeau • April 8, 2024 -
Viral return: 3 U.S. cases concerning experts
Infectious diseases that were “off the playing field” are now making a comeback.
By Meagan Parrish • April 5, 2024 -
Q&A // First 90 Days
With an ovarian KRAS combo ready for review, Verastem’s CEO is poised for the transition
As its FDA filing approaches, Verastem Oncology CEO Daniel Paterson wants to go from “The Little Engine That Could” to a major oncology player.
By Michael Gibney • April 4, 2024