By Kevin Dunleavy
An interesting and varied group of drugs—ranging from two first-in-class cancer therapies to a treatment that removes frown lines—face target dates for approval this month. Many of the decisions bear watching as their status could have far-reaching implications in the industry and for patients.
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By Nick Paul Taylor
The long wait for phase 3 data on Inovio’s COVID-19 vaccine just got longer. With DNA vaccine INO-4800 generating significantly lower antibodies against omicron than original SARS-CoV-2, Inovio has paused enrollment and asked regulators to change the primary endpoint to prevention of severe disease.
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By Andrea Park
According to a report from the U.S. commerce department’s International Trade Administration, the market for medical equipment in Russia totals more than $5 billion.
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By Max Bayer
SAB Biotherpeutics' COVID-19 antibody treatment SAB-185 is no longer following in the footsteps of AstraZeneca’s Evusheld as the National Institutes of Health has axed a sponsored phase 3 trial citing low COVID-19 hospitalizations.
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By Conor Hale
Johnson & Johnson’s Acuvue Theravision lenses are laden with ketotifen, the same drug used in a variety of eye drops for taming reactions to pollen, grass, pet dander or dust.
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By Annalee Armstrong
Pfizer already got a major boost for its maternal RSV vaccine this week, when trials for GlaxoSmithKline’s rival shot were halted. And now the FDA has granted Pfizer a breakthrough therapy tag, which could allow the New York pharma to put the pedal to the metal and leave its U.K. peer in the dust.
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By Anastassia Gliadkovskaya
Black patients were more likely to be diagnosed at a more severe stage of the disease and waited an average of eight days longer than white patients for treatment.
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By Andrea Park
COVID-19 case numbers may be plummeting, but the demand for fast-acting and easily accessible PCR-quality diagnostics—for the coronavirus and beyond—shows no sign of slowing down.
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By Kyle LaHucik
Finch Therapeutics' phase 3 trial for a C. difficile med has been placed on clinical hold by the FDA as the agency requests more information on how the biotech screens the donor-derived microbiome therapy for the virus that causes COVID-19.
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By Angus Liu,Eric Sagonowsky,Kevin Dunleavy,Fraiser Kansteiner,Sophia Sorensen
A study from France shows that Johnson & Johnson vaccine recipients were five times more likely to be hospitalized from COVID-19 than those who received the Pfizer-BioNTech jab. Pfizer will supply the U.S. with 1 million courses of its antiviral pill this month and double that supply in April. Brazil has produced its first batch of COVID-19 vaccines made entirely in the country. And more.
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By Andrea Park
Nearly two full years into the COVID-19 pandemic, the FDA is still rooting out sales of unauthorized tests and so-called treatments for the coronavirus.
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By Dave Muoio
After years of restructures and underwhelming offers, Tenet's board has decided to stick with Conifer for the long haul.
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By Angus Liu
That was fast. Just three weeks after touting a late-stage clinical trial win, a defeated Karyopharm Therapeutics now says the FDA doesn’t think the data support a label expansion for cancer drug Xpovio.
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