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JCS Volume 15 Issue 4
 
Regional News

Roche’s aim to widen Evrysdi’s label nabs speedy FDA review in young spinal muscular atrophy patients

Now poised for a speedy trip through the FDA's regulatory review, Roche’s oral challenger in spinal muscular atrophy (SMA) could soon pick up a nod to cover all patie...
26 January 2022 Regional News atrophy | disorder
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Regional News

Idorsia scores FDA go-ahead for insomnia drug Quviviq to rival Merck’s Belsomra, Eisai’s Dayvigo

The FDA blessed Idorsia's Quviviq (daridorexant), a sleeping pill for those with insomnia. Because the FDA has recommended Idorsia to register Quviviq as a controlled...
11 January 2022 Regional News diagnosed | FDA
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Regional News

Bristol Myers Squibb’s Opdivo posts another win in early lung cancer, but debate over treatment approach likely remains

Bristol Myers Squibb has expanded Opdivo’s first-in-class win in pre-surgery non-small cell lung cancer, teeing up a potential FDA filing. Opdivo added to chemothera...
10 November 2021 Regional News BMS | Bristol Myers Squibb
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Regional News

With Merck’s oral COVID-19 med molnupiravir set for authorization, U.S. spends another $1B for 1.4 million courses

With molnupiravir, Merck & Co. and Ridgeback’s oral treatment for COVID-19, apparently on the doorstep of authorization, the U.S. has moved to secure additional d...
10 November 2021 Regional News COVID-19 | FDA
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Regional News

Biogen’s Aduhelm records one patient death. Is the controversial Alzheimer’s drug to blame?

Doctors already have reservations about Biogen’s controversial Alzheimer’s disease drug, Aduhelm. Now a reported death will likely trigger more doubts around its use....
10 November 2021 Regional News Aduhelm | Alzheimer
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Regional News

Pfizer’s COVID vaccine for younger kids meets FDA bar, with CDC panel next week being key to wide rollout

Kids ages 5-11 in the United States are now eligible for vaccination against COVID-19. On Friday afternoon, the FDA authorized the Pfizer-BioNTech mRNA vaccine, Comir...
2 November 2021 Regional News clinical trial | COVID-19
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Regional News

Novartis keeps the leukemia innovation coming with FDA approval for Gleevec follow-on Scemblix as Tasigna patent cliff nears

About two decades ago, Novartis transformed leukemia treatment with the introduction of Gleevec. Now, the Swiss pharma has ushered a third-generation therapy targeted...
2 November 2021 Regional News FDA | Gleevec
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Regional News

Novo Nordisk casts Queen Latifah in TV-themed awareness campaign for obesity

Novo Nordisk takes a page from three popular TV genres—medical drama, '90s sitcom and procedural crime show—by casting actress Queen Latifah in a new video series awa...
2 November 2021 Regional News clinical | FDA
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Regional News

FDA greenlights Genentech’s eye implant for macular degeneration. Will it be a tough sell?

Two treatments per year as opposed to 12, what’s not to like? In two words—surgical implants. That’s the stigma Genentech will potentially face as it attempts to con...
26 October 2021 Regional News age-related macular degeneration | AMD
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Regional News

Pfizer’s COVID-19 vaccine is safe, effective in kids ages 5 to 11, setting up possible FDA nod

Amid the nationwide COVID-19 vaccination campaign, youngsters 11 and under have been ineligible for shots—even though millions are back in school. With new Pfizer dat...
26 October 2021 Regional News COVID-19 | FDA
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