Drug Development
Taking an early proof of concept into preclinical and clinical development is a costly and complex process. But there are strategic ways to streamline the process and reduce risk and costs. In this webinar, you’ll hear directly from Nobel Laureate Sir Michael Houghton and experts from Applied Pharma, who bring decades of real-world success and deep scientific expertise.
FEATURED STORIES
Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.
Competing with giants like Takeda and Moderna, the plucky biotech believes it has unlocked a future with an easy, yearly oral vaccine.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
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THE LATEST
The retooled COVID-19 vaccine promised by GlaxoSmithKline and vaccine giant Sanofi is entering Phase IIb testing, with new antigen dosages it hopes will boost the lackluster immune response seen in adults 50 and over during its last Phase I/II trial.
Otonomy shares plunged 50.1% at news that its drug to treat Meniere’s disease failed to hit the primary endpoint in its Phase III trial.
Moderate to severe vasomotor symptoms (VMS), also known as hot flashes, have long been a problem by people facing menopause.
It was a busy week for clinical trial announcements. Here’s a look.
There’s plenty of COVID-19-related news today. Here’s a look.
The vaccine will be manufactured and distributed around the world by Novavax and Serum Institute of India (SII).
Shares in the company shot up 212.6% following the news it had isolated the potentially variant-neutralizing antibodies.
An open letter from a group of academics is urging the Biden administration to implement updates to guidance and standards that will better protect high-risk workers from the novel coronavirus that causes coronavirus disease 2019 (COVID-19).
Tapinarof’s potential remittive effects could hold even more value for long-term psoriasis suffers. For patients coming into the trial with a PGA score of 0 (n=78), median time to the disease worsening (defined as a PGA score of ≥2) after discontinuing treatment was approximately 115 days, or 4 months.
With distribution of COVID-19 vaccines being slow, public health officials and researchers are trying to develop schemes and rationales for delaying the dosing of the second shots.