Pharma: Page 6
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Permission granted by Eli Lilly
FDA approval is just the beginning. Now Lilly’s Kisunla faces the tough Alzheimer’s market.
Recent history suggests an Alzheimer’s approval doesn’t necessarily translate to market triumph. Perhaps for Eli Lilly’s Kisunla, this time could be different.
By Michael Gibney • July 9, 2024 -
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The FDA pushes concrete plans to further diversity in clinical trials
The long-awaited guidance offers a more detailed road map for pharma.
By Kelly Bilodeau • July 8, 2024 -
Explore the Trendline➔
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TrendlineCommercialization, marketing and social media
As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical.
By PharmaVoice staff -
Permission granted by BeiGene
Q&AHow BeiGene is taking on established blockbusters with an expanding blood cancer arsenal
BeiGene’s Brukinsa is the first in a hematology franchise that the company hopes will rival top-sellers and introduce a new lineup of medicines for patients.
By Michael Gibney • July 2, 2024 -
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The IRA will lower U.S. drug spending, CMS finds — but not for awhile
As the first 10 drugs undergo price negotiations with the U.S. government, the latest spending projections reveal soon-to-be-implemented price caps will have an impact by 2027.
By Amy Baxter • July 1, 2024 -
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Up-and-comers look for an edge in the bustling ADC field
The next wave of targeted ADC therapies is on the horizon, and these three potential rising stars could help carry the field forward.
By Meagan Parrish • June 28, 2024 -
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Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?
Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.
By Delilah Alvarado • June 27, 2024 -
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Don’t call it a comeback: Biotech’s CNS resurgence forges Big Pharma connections
Neuroscience pipelines are reawakening as biotechs prove to the pharma giants that the field is still worth the investment.
By Michael Gibney • June 27, 2024 -
Courtesy of Novo Nordisk
Will the real Ozempic please stand up? Lilly, Novo face uphill counterfeit battle
Weight loss market leaders are warning patients and healthcare providers about the risks associated with knockoff versions of their popular obesity meds — and taking legal action.
By Amy Baxter • June 26, 2024 -
Permission granted by Geron
After 33 years, Geron’s first approval marks a turn in Nobel-winning science
The decades-long story of how a first-in-class blood cancer treatment went from bench to bedside.
By Alexandra Pecci • June 26, 2024 -
Permission granted by Bristol-Myers Squibb
Ahead of its upcoming decision date, a competitor takes aim at KarXT
The FDA isn’t slated to render a decision about BMS and Karuna’s potential breakthrough schizophrenia med until September — but a biotech is already hoping to be hot on its heels.
By Kelly Bilodeau • June 25, 2024 -
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Q&ACan Moderna’s COVID-flu combo shot improve flagging vaccination rates?
A COVID and flu duo could ease manufacturing and administration, potentially driving higher vaccination rates, said Moderna’s VP of North American medical affairs.
By Michael Gibney • June 25, 2024 -
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Q&A // First 90 DaysAfter an obesity deal with Novo, Omega’s new business head is on the hunt for more partners
With a career focused on striking deals, Kaan Certel is hoping to lead the Flagship-backed biotech with an mRNA platform into its next phase of growth.
By Amy Baxter • June 24, 2024 -
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3 windows of opportunity in women’s health
Despite a recent surge of interest, the femtech and women’s health markets are far from reaching their full potential.
By Alexandra Pecci • June 21, 2024 -
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New data showcase promise, growing pains of CAR-T in autoimmune disease
One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.
By Ben Fidler • June 20, 2024 -
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NIH-funded trials fall flat on diversity goals
Many clinical trials aren’t meeting enrollment inclusion checkpoints — and some aren’t even setting targets, according to a recent OIG report.
By Amy Baxter • June 20, 2024 -
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Avoiding the pharma ‘junk pile’ with launch readiness, pipeline rigor and ‘quick kills’
Drug launches have underperformed expectations at a high rate, and pharmas need to get better at thinning the pipeline to make room for the real wins, says a life sciences consultant.
By Michael Gibney • June 18, 2024 -
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The hunt for the brain’s biomarkers
How Roche is finding better ways to diagnose brain conditions like Alzheimer’s and Parkinson’s disease.
By Kelly Bilodeau • June 17, 2024 -
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Pfizer’s Paxlovid flunks long COVID study as researchers uncover the condition’s deep toll
While researchers gain ground understanding long COVID’s impact, viable treatments could still be a long way off.
By Meagan Parrish • June 14, 2024 -
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Lilly’s adcomm win shows amyloid and tau will likely dominate Alzheimer’s — for now
Lilly is the latest to approach the coveted Alzheimer’s approval, but a slate of drugmakers are lining up clinical trials in amyloid and tau to take a shot at improving patient outcomes.
By Michael Gibney • June 13, 2024 -
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Behind the powerful computations, AI’s role in pharma is still beset by challenges
Small biotechs are saving time and money leveraging AI to develop new drugs, but incomplete data and disease complexity remain hurdles for the space.
By Amy Baxter • June 12, 2024 -
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FDA’s platform designation aims to ease R&D pain points
A new program creates approval pathways for multiple drugs developed on the same platform.
By Amy Baxter • June 11, 2024 -
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As Big Pharma places bigger bets on ADCs, here’s where the field is headed next
With more drugmakers getting into the antibody-drug conjugate game, emerging innovations signal a bright future for the technology.
By Michael Gibney • June 11, 2024 -
Permission granted by Bristol-Myers Squibb
Behind Big Pharma’s layoffs — is there an end in sight?
A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?
By Kelly Bilodeau • June 10, 2024 -
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Pharma’s R&D gamble: picking pipeline winners in a risky field
How leaders from biotech, Big Pharma and the investment world know when they've found the right candidate or company to back.
By Meagan Parrish • June 7, 2024 -
Permission granted by City of Hope
A ‘widening gap’ in access to new cancer meds drives efforts from City of Hope and Bristol Myers
Cancer care is improving so quickly that receiving newer medications can be difficult — City of Hope’s wide oncology network and a 10-year commitment from Bristol Myers Squibb offer some solutions.
By Michael Gibney • June 6, 2024
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