Drug Development
Biopharma’s obsession with the weight loss sector—projected to exceed $130 billion in revenue by 2035—shows no signs of slowing down as analysts gear up for a year that will test the oral market and provide key data on novel mechanisms.
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After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
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AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.
Lisa Stockman Mauriello was diagnosed with ALS in January and is seeking access to Biogen’s tofersen (BIIB067) through the Right to Try Act. Her case has reinvigorated the ALS community and its fight for expanded access to investigational therapies for this cruel, always fatal disease.
A research collaboration among UCLA investigators and Merck KGaA, has pointed to the drug as showing promise for COVID-19. It is also being touted for its unusually broad effect in treating a range of cancers.
Between the Moderna and Pfizer-BioNTech COVID-19 vaccines, there are two mRNA therapeutics on the market … the only two.
With the ongoing global pandemic, BioNTech and Pfizer announced that they will be boosting their manufacturing capacity of the COVID-19 vaccine to 2.5 billion for 2021.
Vaccine passports are an interim step that can speed the return of some semblance of normality by allowing the rapidly growing numbers of vaccinated people to travel more easily and to attend typically crowded sporting events, concerts and religious services.
A new readout from a Phase IIb/III trial showed intravenous RLF-100 (aviptadil) met the primary endpoint of improving survival and recovery at 60 days post-treatment for respiratory failure in critically ill patients with COVID-19.
Humanigen, the biotech briefly run by “Pharma Bro” Martin Shkreli under the name KaloBios up until his arrest, is back in the game with an antibody that is keeping COVID-19 patients off of ventilators and improving survival.
The report listed four scenarios in order of likelihood, with the top being from bats through another animal.
Orphazyme announced its Phase II/III clinical trial of arimoclomal for inclusion body myositis (IBM) failed to hit both its primary and secondary endpoints.