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Incyte wins second FDA indication for FGFR inhibitor Pemazyre

FDA has approved the selective fibroblast growth factor receptor (FGFR) inhibitor Pemazyre (pemigatinib) to treat adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

The drug, developed by Incyte (Nasdaq:INCY), first won approval for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma.

The latest indication, MLNs with FGFR1 rearrangement, covers an extremely rare and aggressive form of blood cancer.

A 2019 article in Frontiers in Oncology noted that there had been approximately 100 cases of the cancer reported to date.

“The approval of Pemazyre represents an important treatment advancement for people living with MLNs with FGFR1 rearrangement who currently have limited treatment options,” said Hervé Hoppenot, Incyte CEO, in a news release. “These are complex hematologic malignancies with a range of presentations, and this approval highlights Incyte’s continued…

FDA approves Olumiant for treating some hospitalized COVID-19 patients

[Olumiant image courtesy of Lilly]

The JAK inhibitor Olumiant (baricitinib) from Incyte (Nasdaq:INCY) and Lilly (NYSE: LLY) has scored FDA approval to treat hospitalized COVID-19 patients who need help breathing.

In particular, the new indication covers adult patients needing supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.

Olumiant first won FDA approval in 2018 for treating moderately-to-severely active rheumatoid arthritis.

Lilly began testing the drug in hospitalized COVID-19 patients in June 2020. It won emergency use authorization (EUA) for such patients in November of that same year when used with remdesivir.

FDA broadened the EUA in July 2021 to allow its use with or without remdesivir.

Olumiant is the first immunomodulatory therapy to score FDA approval for a COVID-19 indication.

The drug continues to be avail…

34 of the most innovative pharmaceutical products

Photo by Myriam Zilles on Unsplash

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.

The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021.

In terms of pharmaceutical agents, the organization selected the following 34 nominees:

Company Drug name

AbbVie Inc.

Rinvoq (upadacitinib)

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma

Adhansia XR (methylp…

Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

Get the full picture from our sister site, Drug Discovery & Development.

Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]

The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

3 notable types of innovative drugs from 2020

Chemical structure of the COVID-19 therapy remdesivir. Image is from Wikipedia.

Last year, FDA approved 53 drugs, leading the industry to describe 2020 as “a strong year for new drug therapy.”

There are several drugs that stand out, according to Todd Wills, the co-author of a study that analyzes how innovative drugs are based on their structure.

The drugs that follow are examples of notable innovative therapies.

[Related: Here’s what molecular shape can tell you about pharma innovation]

1. COVID-19 therapies

One of the prominent drugs that stands out as structurally novel is remdesivir from Gilead Sciences (NSDQ:GILD). The first COVID-19 treatment to win FDA approval, remdesivir (Veklury), was first developed as an Ebola treatment. But the broad-spectrum antiviral also showed promise against the SARS-CoV-2 virus.

Gilead recently announced that sales of remdesivir beat …