Gilead’s lenacapavir shows promise for multi-drug-resistant HIV

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Gilead Sciences presented new results from its Phase 2/3 CAPELLA study focused on its investigational, long-acting HIV-1 capsid inhibitor, lenacapavir. 

The trial, which involved heavily treatment-experienced people with multi-drug resistant HIV-1 infection, showed that lenacapavir had substantial virologic suppression for 26 weeks. 

In November, the company had announced that 88% of lenacapavir recipients in the trial had at least a 0.5 log10 reduction in HIV-1 viral load after 14 days of functional monotherapy.

“The CAPELLA trial enrolled people who were failing their regimens with a detectable viral load and had very few remaining options due to multi-drug resistance, which presents a formidable barrier to treatment,” said Dr. Diana Brainard, senior vice president, virology therapeutic area at Gilead Sciences in a statement. “These interim results from the CAPELLA trial demonstra…

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Injectable anti-HIV therapies could see strong growth

Photo by Miguel Á. Padriñán from Pexels

The market for injectable anti-HIV therapeutics will be worth $28 billion by 2029, according to projections from the analyst and consulting firm GlobalData. 

GlobalData valued the broader HIV therapeutics market at $22.9 billion in 2019 across the U.S., France, Germany, Italy, Spain, U.K. and Japan. 

While the overall market is growing at a low single-digit rate, injectable therapies will likely see more brisk growth, GlobalData projects. 

To date, the majority of HIV therapies are orally-delivered antiretroviral drugs although a handful of injectable drugs have hit been introduced over the years. 

Future injectable anti-HIV therapies could be administered less frequently than oral drugs. 

One early injectable anti-HIV therapy, Fuzeon (enfuvirtide) from Roche (OTCMKTS:RHHBY), is administered multiple times per day, posing a challenge for adh…

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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 …

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MedTech 100 roundup: Another high as stocks tick up

For the third consecutive week, stocks in the medtech industry reached heights not yet seen since the COVID-19 pandemic began.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.65 points at the end of last week (Aug. 7). Overall, medtech stocks saw a 0.72% increase from the 89.01-point total at the same time a week prior (July 31).

On Aug. 5, the index reached 90.45 points, marking its highest point since that pre-pandemic high, with the previous mid-pandemic high (90.37) coming last week.

The most recent high mark represents just a -2% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Meanwhile, the S&P 500 Index saw a 2.5% increase from July 31 to Aug. 7, and the Dow Jones Index fared even better, positng a 3.8% rise over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13…

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Pfizer to make Gilead’s remdesivir COVID-19 treatment

Pfizer (NYSE:PFE) announced today that it entered into a multi-year agreement with Gilead Sciences (NSDQ:GILD) to manufacture and supply its antiviral remdesivir treatment.

The investigational antiviral remdesivir will be manufactured by Pfizer under the agreement as the company becomes one of the multiple external manufacturing organizations supporting efforts to scale up the supply of the investigational treatment for COVID-19. Pfizer will offer contract manufacturing services at its McPherson, Kan.-based facility to supply remdesivir for Gilead.

Get the full story at our sister site, Pharmaceutical Processing World.

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Insitro raises $143m Series B

Machine-learning-driven drug discovery and development company Insitro announced today that it raised $143 million in an oversubscribed Series B financing round.

San Francisco-based Insitro said in a news release that it plans to use the funds to build its foundations of technology and automation, enabling data generation at a larger scale, expanding its capabilities for creating predictive models of human disease.

Get the full story at our sister site, Drug Discovery & Development.

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Insitro raises $143m Series B

Machine-learning-driven drug discovery and development company Insitro announced today that it raised $143 million in an oversubscribed Series B financing round.

San Francisco-based Insitro said in a news release that it plans to use the funds to build its foundations of technology and automation, enabling data generation at a larger scale, expanding its capabilities for creating predictive models of human disease.

The company also plans to use the money for helping to identify patient segmentation biomarkers and advancing therapeutics in genetically-defined patient populations. Other uses of the funds include building partnerships along the R&D chain to accelerate drug discovery and development.

Insitro is working on applying bioengineering technologies to creating data sets that allow for machine learning methods to assist in pharmaceutical R&D.

“Since our founding, insitro has been focused on building a data-driven drug discovery and de…

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Gilead licenses remdesivir production to 5 generic drugmakers

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.

The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.

Get the full story on our sister site, MassDevice.

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Gilead licenses remdesivir production to 5 generic drugmakers

(Image from Gilead Sciences)

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.

The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.

The FDA gave remdesivir emergency use authorization May 1. State health departments are distributing it within their states.

Remdesivir is an intravenous drug that…

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