FDA: Page 22
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Courtesy of Eli Lilly
Lilly wins FDA approval for new kind of diabetes drug
Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and was shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.
By Jonathan Gardner • Updated May 16, 2022 -
Sarah Silbiger via Getty Images
BridgeBio sale of FDA voucher good news for Bluebird, other biotech sellers
The drugmaker was able to get $110 million for its voucher, a kind of regulatory fast pass. Other vouchers have sold for similar amounts, boding well for Bluebird, which plans to sell two that it hopes to get this year.
By Ned Pagliarulo • May 13, 2022 -
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With spotlight on FDA, Congress weighs reforms to accelerated drug approvals
The proposed changes could have a notable impact on cell and gene therapy developers, many of which are advancing rare disease therapies that rely on speedy approval pathways.
By Jonathan Gardner • May 10, 2022 -
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Sponsored by CorEvitasTraditional and bespoke registries
In order to truly understand the lived experience of a patient with a given condition or disease, several types of real-world data sources should be analyzed.
May 9, 2022 -
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FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect
The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake.
By Ben Fidler • May 6, 2022 -
Jacob Bell/BioPharma Dive
AstraZeneca and Daiichi set to broaden use of breast cancer drug, challenging Roche
The FDA cleared Enhertu for second-line use in HER2-positive disease, the latest inroads the partners have made against Roche’s dominant portfolio of breast cancer medicines.
By Ben Fidler • May 5, 2022 -
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Spero to lay off 75% of workforce, change strategy after FDA challenges study results
Agency statisticians took a different view of the Phase 3 results the biotech was relying on to support approval of a new antibiotic, an announcement that triggered the sector's latest restructuring.
By Ben Fidler • May 4, 2022 -
Sarah Silbiger via Getty Images
FDA rejects two China-developed cancer drugs
The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.
By Jonathan Gardner • May 2, 2022 -
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Sponsored by CorEvitasUnderstanding real-world data in the real world
Real-world data (RWD) and real-world evidence (RWE) are valuable across the entire pharmaceutical product lifecycle, from examining patient outcomes to supporting disease education and awareness and beyond.
May 2, 2022 -
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Moderna seeks FDA clearance for COVID-19 vaccine in young children
The biotech's shot would become the first available to children under 6, the last remaining age group currently ineligible for vaccination.
By Kristin Jensen • April 28, 2022 -
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FDA panel supports agency push to raise approval bar for certain cancer drugs
Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.
By Jonathan Gardner • April 22, 2022 -
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GSK to test FDA's tough stance on anemia pills
Unlike treatments from Akebia and FibroGen, GSK's drug hasn't been tied to a higher risk of heart problems, potentially easing the agency's concerns.
By Ben Fidler • April 19, 2022 -
Jacob Bell/BioPharma Dive
Troubling data leads a biotech to pull its prized drug from market and FDA review
Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.
By Jacob Bell • April 18, 2022 -
Courtesy of Pfizer
Pfizer, BioNTech to seek FDA OK for booster dose in 5- to 11-year-olds
A third shot sparked a strong immune response in clinical testing, positioning the companies to make boosters available to the roughly 28 million kids in the U.S. who became eligible for their first two doses late last year.
By Kristin Jensen • April 14, 2022 -
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FDA clears Gilead to restart some studies of top cancer drug
The agency's OK is a needed reprieve for Gilead, whose dealmaking strategy in oncology has come under scrutiny from analysts and investors.
By Ben Fidler • April 12, 2022 -
Sarah Silbiger via Getty Images
'Where's the patient?': Experts question FDA's device recall guidance
While the guidance encouraged the use of electronic communications in recalls — a change experts have advocated for — some questioned why the agency did not address more problems with the system.
By Ricky Zipp • April 6, 2022 -
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FDA advisers grapple with how to update COVID-19 vaccines
About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.
By Ned Pagliarulo • Updated April 7, 2022 -
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FDA halts Vir, GSK antibody use in response to COVID subvariant's spread
The COVID-19 treatment had a brief time in the spotlight as one of the few drugs that's potent against the omicron variant. A substrain called BA.2 is now dominant in the U.S., however.
By Kristin Jensen • April 6, 2022 -
Novartis breast cancer drug approved for ultra-rare condition
The FDA's decision was based on real-world study data that indicated Novartis' Piqray could treat a cluster of conditions known collectively as PROS.
By Ned Pagliarulo • April 6, 2022 -
Courtesy of Gilead Sciences
CAR-T treatment moves earlier as FDA widens approval of Gilead's Yescarta
Yescarta, previously cleared only for use in treating late-stage lymphoma, can now be used after initial treatment has failed, a first for the cellular drugs.
By Ned Pagliarulo • April 4, 2022 -
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5 FDA decisions to watch in the second quarter
While a market downturn has weighed on the biotech industry, FDA approvals for drugs from Bristol Myers Squibb, Bluebird bio and Amylyx Pharmaceuticals could help the sector regain its footing.
By Ben Fidler , Ned Pagliarulo , Jacob Bell • March 31, 2022 -
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FDA rejects Akebia drug, dealing another blow to anemia pills
The biotech's experimental medicine, meant to be a convenient alternative to widely used injectable drugs like Aranesp, is the second of its kind to be knocked back by the agency due to safety concerns.
By Jonathan Gardner • March 30, 2022 -
Sarah Silbiger via Getty Images
FDA advisers narrowly side against an experimental ALS drug, likely lowering its approval chances
The panel of independent experts found clinical trial evidence generated by the drug's developer, Amylyx Pharmaceuticals, insufficient to establish the treatment's effectiveness.
By Jacob Bell • Updated March 30, 2022 -
Jens Schlueter via Getty Images
FDA clears second COVID booster for older adults, immunocompromised
"This was a relatively straightforward decision," top FDA official Peter Marks told reporters. The agency plans to discuss booster use more broadly with an advisory panel next month.
By Ned Pagliarulo • Updated March 29, 2022 -
Sarah Silbiger via Getty Images
Deep Dive // ALS drug development
How a long shot ALS drug came before the FDA
A negative vote from independent experts appears to lower the chances of Amylyx's medicine winning FDA approval. Still, FDA officials have cited flexibility and noted the difficulty of its forthcoming decision.
By Jacob Bell • March 28, 2022
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