HIV

Addressing the HIV epidemic in Eastern Europe and Central Asia

Working in partnership will be key, says Alex Kalomparis, vice president, public affairs, international at Gilead Sciences. 2021 marks 40 years since the first cases of HIV were reported. In that time, over 79 million people have been diagnosed with HIV, with more than 36 million dying from AIDS-related illnesses, more than any other infectious …

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Pfizer’s RSV Vaccine; Forte Biosciences’ Atopic Dermatitis Asset; Bone Therapeutics’ Osteoarthritis Programme; JandJ’s HIV Vaccine Trial; Versanis Bio $70 M Series A Financing; AC Immune’s Alzheimer’s Antibody Drug

Pfizer’s RSV Vaccine enters in the late-stage of clinical trials  As the battle to get an effective Respiratory Syncytial Virus (RSV) vaccine on the market heats up, Pfizer is launching a critical late-stage study of its experimental vaccine against a severe version of a cold virus that may cause pneumonia and death in the young …

Pfizer’s RSV Vaccine; Forte Biosciences’ Atopic Dermatitis Asset; Bone Therapeutics’ Osteoarthritis Programme; JandJ’s HIV Vaccine Trial; Versanis Bio $70 M Series A Financing; AC Immune’s Alzheimer’s Antibody Drug Read More »

Gilead Collaborates with Merck to Jointly Develop and Commercialize Lenacapavir + Islatravir for HIV

Shots: The companies will co-develop & co-commercialize the combination of Gilead’s Lenacapavir and Merck’s Islatravir in long-acting oral & injectable formulations for HIV. Gilead & Merck will share global development & commercialization costs (60%/40%) respectively For oral products, Gilead will lead commercialization in the US & Merck will lead in the EU & ROW while …

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Gilead Present Results of Lenacapavir in P-II/III CAPELLA Trial for the Treatment of HIV at CROI

Shots: The P-II/III CAPELLA trial involves assessing lenacapavir (SC, every 6mos.) vs PBO in 36 participants in a ratio (2:1) with multi-drug resistant HIV-1 infection The study demonstrated virologic suppression @26wks., viral load reduction from baseline of ≥ 0.5 log10 copies/mL for 14days functional monothx. period (88% vs 17), low (150 mg/kg) and high dose …

Gilead Present Results of Lenacapavir in P-II/III CAPELLA Trial for the Treatment of HIV at CROI Read More »

ViiV Healthcare Presents Results of GSK3640254 (GSK’254) in P-IIa study for the Treatment of HIV at CROI

Shots: The P-IIa POC study involves assessing GSK3640254 (GSK’254, qd) in 34 treatment-naïve adults with HIV. The study is divided into 2 parts- in part 1, patients received GSK’254 (10/200mg) vs PBO for 10days and in part 2, patients got GSK’254 (40/80140 mg) vs PBO for 7days The study showed the antiviral activity b/w dose …

ViiV Healthcare Presents Results of GSK3640254 (GSK’254) in P-IIa study for the Treatment of HIV at CROI Read More »

ViiV Healthcare Present Results of Long- Acting Cabotegravir and Rilpivirine in P-IIIb ATLAS-2M Study for HIV at CROI 2021

Shots: The P- IIIb ATLAS-2M study involves assessing long-acting cabotegravir and rilpivirine regimen for the treatment of HIV The ATLAS-2M 96wks. data reinforce the 1EPs @48wks. demonstrated the efficacy of every 2mos. dosing (q8w) was non-inferior to monthly dosing (q4w) dosing with (2.1% & 1.1%) participants having HIV-1 RNA ≥50 c/mL. The 2EPs @96 wks. …

ViiV Healthcare Present Results of Long- Acting Cabotegravir and Rilpivirine in P-IIIb ATLAS-2M Study for HIV at CROI 2021 Read More »

Could CRISPR cure HIV? US biotech Excision raises $60m to find out

US biotech Excision BioTherapeutics has raised $60 million to test a potential HIV cure in the clinic, which would use CRISPR technology to snip out the viral code from human cells and tissues. Once someone is infected with HIV it stays with them for life thanks to the retrovirus’s ability to inject its DNA code …

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ViiV’s Rukobia cleared in EU as rescue HIV therapy

The European Commission has given a green light to the use of ViiV Healthcare’s Rukobia as a treatment for people with HIV that has developed resistance to other antiretroviral therapy (ART).  The first-in-class HIV attachment inhibitor is cleared for use as an add-on therapy to other ARTs in adults “for whom it is otherwise not …

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Horizon, Viela Deal; Concert Schizo Drug Flop; Gilead Deals with Arcus and Gritstone

Horizon Therapeutics Bolsters its Rare Disease Portfolio in a $3B Viela Bio Buyout Horizon Therapeutics has announced to acquire Viela Bio for about $3.1 billion to augment its portfolio and pipeline of treatments for rare diseases. The shares of Viela Bio skyrocketed more than 52% in premarket trading after the news was broadcasted.  The deal …

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Gilead Signs an Option and License Agreement with Gritstone for HIV Vaccine

Shots: Gristone to receive $60M at closing, including $30M up front and a $30M as an equity investment at a premium and is eligible to receive up to ~$725M as option exercise payments and milestones along with royalties on sales of therapy Gilead will be in charge of conducting a P- I study for the …

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ViiV/J&J’s long-acting HIV regimen finally approved in US

The FDA has approved Cabenuva, a long-acting HIV treatment from ViiV and Johnson & Johnson that keeps the virus at bay with a monthly injection instead of daily pill regimen. It follows a surprise rejection at the end of 2019, due to the information in the dossier related to chemistry, manufacturing and controls (CMC). The …

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ViiV launches digital triage service for HIV patients with London hospital

ViiV Healthcare and London’s Westminster Hospital NHS Foundation Trust have launched a digital triage service for HIV patients supported by a mobile app. ViiV, a joint venture majority owned by GlaxoSmithKline, with Pfizer and Shionogi as minority shareholders, has been working with Chelsea and Westminster Hospital NHS Foundation Trust on the service. The new service …

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Tivicay approved in Europe in new dispersible tablet for children with HIV

ViiV’s Tivicay is to become available in Europe in a new dispersible tablet form to treat children living with HIV. The joint venture, majority-owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, said the European Commission had granted a marketing authorisation for the new formulation. These tablets are used in combination with other antiretroviral agents …

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ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

Shots: The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety, tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while the second study assessed the 1L & 2L treatment in patients of the same age The approval includes updated dosing recommendations for Tivicay film-coated tablets (10/25/50mg) for children aged ≥6yrs. …

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV Read More »

Data sets up 2021 filings for Gilead’s twice-a-year HIV drug lenacapavir

Gilead Sciences has the data it was hoping for in a pivotal trial of lenacapavir, an HIV drug that only needs to be dosed by subcutaneous injection every six months, keeping it on course for regulatory filings next year. Lenacapavir (previously GS-6207) is the first in a new class of class HIV-1 capsid inhibitor that …

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ViiV could challenge Gilead with long-acting HIV PrEP shot

GlaxoSmithKline’s HIV joint venture ViiV Healthcare could mount a challenge to Gilead’s HIV pre-exposure prophylaxis (PrEP) medicines after the FDA granted Breakthrough Therapy Designation for its long-acting injectable drug cabotegravir. In the trial cabotegravir was injected every eight weeks in a formulation that the company hopes will be more appealing than Gilead’s daily Truvada pill. …

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ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Shots: This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020) Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing …

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Gilead got a boost from a newly approved PrEP drug. Now, a major insurer is dropping coverage

UnitedHealthcare sent a notice to plan members stating that it would no longer cover Descovy to prevent HIV, while Truvada – after it goes generic next month – will be covered for free. Gilead reported that Descovy for PrEP had offset a second-quarter fall in product sales.

ViiV’s twice-monthly injected PrEP drug superior in HIV prevention to Gilead daily pill, analysis shows

The company said Tuesday that a final analysis of its Phase IIb/III study of cabotegravir showed greater efficacy in HIV prevention than Gilead’s Truvada. The study, among men and transgender women who have sex with men, was stopped in May following an interim analysis.