Deep Dive: Page 2
Industry insights from our journalists
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FDA ups the ante for copycats, antibiotics, orphan drugs. But is it working?
Regulators are using incentives to spur development of much-needed drugs. The results so far have been mixed.
Jacob Bell • Aug. 27, 2018 -
How Scott Gottlieb is upending FDA communication, one tweet at a time
The FDA commissioner has relentlessly pumped out tweets, statements and more. But how has that affected FDA communications and the agency overall?
Andrew Dunn • Aug. 27, 2018 -
Seeking to adopt AI, drugmakers search for right mix of talent
AI holds promise as a powerful new tool in the hunt for new drugs. Yet building a team that blends tried-and-true methods with AI remains a challenge.
Ned Pagliarulo • July 23, 2018 -
Payers, doctors weigh AI's disruptive prescribing potential
The disruption won't happen overnight, though, as big tech firms try to not only develop healthcare AI tools, but show they'll enhance, rather than upend, the doctor-patient relationship.
Jacob Bell • July 23, 2018 -
Immunotherapy advances spur new look at cancer vaccines
Researchers have long been intrigued by the idea of a cancer vaccine, drawn in by hints of an immune role in cases of "spontaneous" remissions to cancer. Now, the immunotherapy boom is opening up new areas of research.
Ned Pagliarulo • June 25, 2018 -
Why be a vaccine company?
Lower margins and pricey manufacturing are hallmarks of vaccine making. Yet the drugs can provide a steady, and often competition-free, source of revenue.
Jacob Bell • June 25, 2018 -
Garabedian has few regrets and is ready to be seen
The former embattled Sarepta CEO is attempting a comeback by exploring a different facet of an industry he knows well.
Lisa LaMotta • June 11, 2018 -
Pharma turn to NASH unlikely to mirror meteoric rise of hep C
Hopes of a hepatitis C-sized market could be dashed by the complexity of and challenges in diagnosing the lesser-known liver disease.
Ned Pagliarulo • May 21, 2018 -
After a flurry, NASH deals put on pause
After several years of dealmaking in the liver disease space, the industry waits for the next wave of assets to mature.
Lisa LaMotta • May 21, 2018 -
NASH drug pipeline headed toward uncertain market
The fatty liver disease has dozens of treatments in the global pipeline. But investors are treading lightly, casting doubt on the market opportunity.
Jacob Bell • May 21, 2018 -
3 market-busting hurdles to NASH commercialization
With the first NASH drugs expected to win approval over the next two to three years, drugmakers will face several major barriers to market entry.
Lisa LaMotta • May 21, 2018 -
Oncology boom spurs DTC advertising, and with it controversy
As the debate for and against direct-to-consumer advertising rages on, cancer drugmakers look poised to pump massive amounts of money into the practice.
Jacob Bell • May 16, 2018 -
Lilly's JAK woes set the stage for AbbVie, Gilead to jump ahead
An adcomm's iffy stance on baricitinib could mean one less thing to worry about for rivals looking to break into the fairly open JAK inhibitor market.
Jacob Bell • April 24, 2018 -
As India, China drug industries mature, FDA scrutiny an overhang
Rising numbers of warning letters have put production quality in focus, just as both countries turn further toward novel drug R&D.
Ned Pagliarulo • April 23, 2018 -
CAR-T ups challenges in pharma supply chain
New technology made it viable to ship the cell therapies. Now, stakeholders are pushing for more innovation to meet looming commercial demands.
Jacob Bell • April 23, 2018 -
Two years after cancer setback, Bristol-Myers' new biomarker bet pays off
The success of CheckMate-227 is a step toward validating tumor mutational burden, but questions remain about how easily the test could be adopted.
Ned Pagliarulo • April 16, 2018 -
I/O combos inch forward in pharma's lung cancer quest
An impressive survival benefit could lift Merck's Keytruda plus chemo regimen, while Bristol-Myers hopes its checkpoint inhibitor pairing can help it catch up.
Ned Pagliarulo • April 16, 2018 -
Gene therapy heavyweights talk next steps for CAR-T
Several big names in cell and gene therapy development discussed what's on the horizon at a meeting of the Alliance for Cancer Gene Therapy.
Lisa LaMotta • April 11, 2018 -
Abuse deterrents still finding their niche in the pain space
Hard-to-abuse opioids haven't been on the market for very long, and whether they have staying power amid a public health crisis remains an open question.
Jacob Bell • March 26, 2018 -
Lilly's bet on pain stands out amid bare pharma pipeline
Even as the opioid epidemic has heightened the need for non-addictive painkillers, few pharma companies have made pain a therapeutic area of focus.
Ned Pagliarulo • March 26, 2018 -
Incyte study could bring lessons for cancer immunotherapy
Merck has bet on the potential of Incyte's IDO blocker as a partner for Keytruda across five different cancer types. A Phase 3 trial in melanoma is first up.
Ned Pagliarulo • March 14, 2018 -
Despite crowded I/O field, pharma, VCs still eager to invest
Surging biopharma investment into cancer has raised concerns about duplicative research. Industry execs, however, see the opportunities as too great to pass up.
Ned Pagliarulo • March 09, 2018 -
For Cosentyx, Taltz, Siliq: A marketing race to differentiate
The IL-17 arena is getting pretty crowded, pushing drugmakers to explore various routes to market dominance.
Jacob Bell • March 07, 2018 -
Pharma taking liberties with DTC ads, says study
A new study analyzes current DTC ad campaigns and dissects whether disclosure of beneficial side effects could be misleading or interpreted as off-label promotion.
Randi Hernandez • March 07, 2018 -
Numbers show drugmakers are keeping RTFs under wraps
A BioPharma Dive analysis of company and FDA data show plenty of companies are not disclosing Refusal to File letters from the FDA.
Lisa LaMotta • March 05, 2018
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