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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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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 -
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 -
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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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Drug shortages, cost concerns and iffy access — how DTC and telehealth could even the playing field
Companies like UpScriptHealth led the charge with online prescriptions decades ago, and now the industry is catching on to solve some of healthcare’s most pressing issues.
By Michael Gibney • May 22, 2024 -
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OpinionThe judicial microscope on abortion meds puts FDA and industry in a precarious spot
The recent SCOTUS case involving mifepristone exposes the risk of drug safety determinations by judicial fiat.
By Meg Alexander • May 9, 2024 -
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Q&AAZ oncology chief says AI can help solve cancer’s ‘ZIP code lottery’ as health disparities persist
Partnerships have been key to building the company’s AI capabilities and patient-focused R&D, said AstraZeneca’s head of U.S. oncology.
By Michael Gibney • May 8, 2024 -
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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 -
Permission granted by Amylyx Pharmaceuticals
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 -
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Deep DiveUkraine 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 -
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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 -
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3 big recent trial flops
How these clinical setbacks impacted the companies, industry and patients.
By Meagan Parrish • April 12, 2024 -
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Deep DivePsychiatry 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 -
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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 -
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Alnylam turns to genealogy to find rare disease patients through family trees
A vastly underdiagnosed rare disease presents a challenge to Alnylam’s commercial team, but a family health road trip has patients talking about their hereditary risk.
By Michael Gibney • March 26, 2024 -
Permission granted by Gates MRI
ProfileThe pharma ‘fixer’ now helping Gates MRI’s tuberculosis battle
After getting her start as a nurse, Debra Weiss worked her way up the corporate ladder and is now COO of Gates MRI, which just launched its first phase 3 trial for tuberculosis.
By Alexandra Pecci • March 22, 2024 -
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Orchard sets out to sell world’s priciest gene therapy
Orchard is counting on the long-term data it’s accrued to convince insurers to cover Lenmeldy’s $4.25 million list price, the highest of any genetic medicine to come to market.
By Kristin Jensen • March 20, 2024 -
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After Amylyx drug failure, what’s next for ALS?
The company’s combo treatment Relyvrio was approved in 2022, but after failing a phase 3 trial, may be pulled from the market.
By Meagan Parrish • March 15, 2024 -
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Q&AFormer U.S. patent head on why federal march-in rights for drugs would be a ‘devastating’ mistake
A Biden administration proposal to seize patents for drugs deemed too pricey would have a ripple effect that cuts into the heart of innovation, says former U.S. PTO head Andrei Iancu.
By Michael Gibney • March 14, 2024 -
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As colorectal deaths rise among younger people, a screening tool could help pinpoint more patients
As colorectal deaths rise among younger people, a diagnostic could help pinpoint more patients.
By Alexandra Pecci • March 12, 2024 -
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Sponsored by MMITWhy pharma should prioritize the patient journey: A survivor’s story
One rare disease survivor’s diagnosis experience highlights the need for pharma companies to better understand the patient journey.
By Carolyn Zele, Solution Consulting Advisor, MMIT • March 11, 2024 -
Permission granted by Tarsus Pharmaceuticals
Q&AInto the unknown: Tarsus’ CEO on its launch strategies in a new disease category
The company scored a first-in-class nod for its eye med last year, which treats a common but frequently undiagnosed condition.
By Meagan Parrish • March 8, 2024 -
Permission granted by Amylyx Pharmaceuticals
Amylyx ALS drug fails crucial study, putting company’s future in doubt
The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.
By Jacob Bell • Updated March 8, 2024 -
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Could pharma’s legal attack on the IRA succeed in killing price negotiations?
An all-out blitz across U.S. courts is bolstering pharma’s goal to overturn Medicare drug price negotiations.
By Amy Baxter • March 6, 2024 -
Permission granted by Natalie Ferguson/American Gene Technologies
ProfileHIV isn’t ‘solved,’ but a doctor who treated some of the first patients hopes to finally deliver a cure
From San Francisco in the 80s to a gene therapy prospect, Dr. Marcus Conant looks back on his long fight against the virus — and if the industry is close to ending the epidemic.
By Michael Gibney • March 5, 2024 -
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After ‘tragic’ bacterial outbreak, lawmakers press FDA to step up foreign inspections
Impatience to fix long-held challenges to overseas drug facility inspections is growing on Capitol Hill.
By Amy Baxter • March 1, 2024
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