Research & Development: Page 9
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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 -
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 -
Explore the Trendline➔
Stock via Getty ImagesTrendlineClinical 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 -
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 -
Biotech Spotlight
Regenerative cell therapy biotech uses IPO to blast into human trials
Bucking conventional fundraising, FibroBiologics’ CEO Pete O’Heeron explains why the biotech company bet on themselves in the public market.
By Amy Baxter • June 5, 2024 -
Merck and Moderna’s cancer vaccine snags a clinical win in a field decades old
Cancer vaccines are taking off in the clinic, and a partnership between Merck and Moderna is at the forefront of a new wave of immunotherapy.
By Michael Gibney • June 3, 2024 -
After two Big Pharma deals, Nimbus looks to keep the hits coming
With the billion-dollar-plus deals under its belt with Gilead and Takeda, the biotech’s CEO explains where the company is going next.
By Kelly Bilodeau • June 3, 2024 -
Biotech Spotlight
Mythic Therapeutics aims to overcome one of ADC’s long-standing challenges
By developing ADCs that bind more directly to the target, Mythic Therapeutics believes its technology could deliver a step change for efficacy and safety.
By Alexandra Pecci • May 30, 2024 -
As weight loss booms, drugmakers look for an edge with oral options
Supply of GLP-1 medications falls well short of demand, and oral versions of the drugs loom over Eli Lilly and Novo Nordisk’s dominance.
By Amy Baxter • May 28, 2024 -
Where competition is heating up in pharma
The stage is set for potential blockbuster-level showdowns targeting these three indications.
By Meagan Parrish • May 24, 2024 -
After Vyvanse patent loss, Takeda’s neuroscience division looks to enter a new era
Heather Dean discusses the company’s neuroscience pipeline in epilepsy and narcolepsy and moving from a mass market to a rare disease mentality.
By Alexandra Pecci • May 21, 2024 -
3 up-and-coming US biotech hotspots
These three U.S. cities are putting themselves on the biotech map as unsung hubs of the industry.
By Alexandra Pecci • May 21, 2024 -
Execs from Bayer, Kite and Orca sound off on their launch strategies for cell and gene therapies
Planning early, staying nimble and approaching commercialization as a team sport should be top priorities, the leaders said.
By Amy Baxter • May 20, 2024 -
Why AlphaFold 3 is stirring up so much buzz in pharma
The “Nobel Prize-worthy invention” could be worth hundreds of billions commercially — and have a deep impact on drug R&D.
By Kelly Bilodeau • May 20, 2024 -
Why H5N1 has scientists and regulators on edge
While the H5N1 threat to humans is still low, the recent influenza outbreak in cattle is presenting strange and challenging hurdles for containment.
By Meagan Parrish • May 17, 2024 -
Investors put $400M into biotech licensing obesity drugs from China
The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.
By Gwendolyn Wu • May 16, 2024 -
5 trends impacting drug spend in the U.S.
Key factors changing how much Americans spend on prescriptions.
By Kelly Bilodeau • May 13, 2024 -
Sponsored by SmartLabs
Thinking inside the box: How SmartLabs is transforming laboratories for modern science and accelerating innovation
SmartLabs offers the first integrated platform combining re-configurable lab infrastructure, operations and scientific expertise.
May 13, 2024 -
Q&A
The Enhertu effect: Daiichi’s plan to build on the success of its crown jewel
The CEO of Daiichi Sankyo’s American business explains why it could be poised to become a “top 10” cancer company.
By Meagan Parrish • May 10, 2024 -
Lilly’s donanemab will face an Alzheimer’s adcomm in June, setting the stage for a Leqembi showdown
The FDA announced a June advisory committee date, potentially introducing a new Alzheimer’s treatment to compete with Eisai and Biogen’s Leqembi.
By Michael Gibney • May 9, 2024 -
Opinion
The 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 -
Q&A
AZ 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 -
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 -
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