Infectious Disease

FDA panel backs Takeda’s CMV drug for transplant patients

Takeda is closing on a first FDA approval in the treatment of refractory cytomegalovirus (CMV) infections in organ transplant patients, after agency advisors voted unanimously in favour of its antiviral maribavir. Maribavir (TAK-620) should be approved for refractory CMV infections in people with solid organ transplants as well as haematopoietic stem cell transplants (HSCT), regardless …

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GSK’s malaria vaccine gets WHO okay for mass rollout

The WHO has given a green light to widespread use of GlaxoSmithKline’s malaria vaccine in Africa, in what could be a major turning point in the fight against the disease. The RTS,S/AS01 vaccine – also known as Mosquirix – will be administered to children living in sub-Saharan Africa and other regions with moderate to high …

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Merck preps filings for oral COVID drug, but is it really a game changer?

Merck & Co is on the brink of plugging a gap in the coronavirus treatment armamentarium after its oral drug molnupiravir cut deaths and hospitalisations in mild or moderate COVID-19 in a phase 3 trial. Merck and partner Ridgeback Therapeutics have said they will see emergency use authorisation from the FDA for molnupiravir on the …

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Novartis drug raises hope of tackling malaria drug resistance

More than two decades ago , Novartis made a big contribution to the fight against malaria when it won approval for Coartem, the first artemisinin-based combination therapy (ACT), which has transformed care for people with the parasitic infection. Now – over a billion doses of Coartem (artemether-lumefantrine) later – the drugmaker thinks it may have …

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Booster data backs Pfizer, Valneva Lyme disease vaccine

Prospects for Valneva’s COVID-19 vaccine are up in the air, but another candidate partnered with Pfizer looks increasingly like it could fill the void of an effective shot for Lyme disease. New phase 2 data with their VLA15 vaccine shows that antibody responses from an initial three-dose regimen are initially high, although they start to …

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More malaria hope as antibody protects against infection

A single dose of a monoclonal antibody developed by scientists at the US National Institutes of Health (NIH) has provided protection for people exposed to malaria parasites for up to nine months. The results of the phase 1 trial suggest that antibodies could be used to protect travellers, military personnel and health care workers traveling …

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Sanofi swoops on partner Translate, buying the mRNA firm for $3.2bn

Sanofi has been forging ever-closer ties with its mRNA partner Translate Bio since the two started working together in 2018, and has now gone all in, offering $3.2 billion to buy the company outright. The $38-per-share deal – a 56% premium to Translate’s recent share price before an after-hours surge in the stock on rumours …

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Nestle gets closer to Seres, pledging $525m for microbiome C. diff drug

Swiss food giant Nestle has firmed up its five-year-old alliance with US microbiome specialist Seres, paying $175 million upfront for North American co-marketing rights to its lead drug for Clostridium difficile infections. Under the terms of the new deal, Nestle’s Health Sciences unit will pay Seres another $125 million if the FDA approves the drug …

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Cell-Mediated Therapies for Infectious Disease Summit

In the fight against emerging coronavirus variants and spike mutations, the need for long-lasting immunity is greater than ever. This is why the time is now to look beyond antibodies and capitalize on the long-term immune response of T cell therapies. The Cell-Mediated Therapies for Infectious Disease Summit is the first and only meeting focused on novel …

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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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EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed

UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed. Hertfordshire-based EUSA said recruitment has begun in phase 3 trial involving patients with COVID-19 previously treated with corticosteroids and other respiratory viruses associated with serious …

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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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Adult data back Merck’s challenger to Pfizer’s blockbuster Prevnar 13

Merck & Co has built more momentum behind its attempt to depose Pfizer’s blockbuster pneumococcal conjugate vaccine Prevnar 13, with two new phase 3 trials backing its rival shot V114. The two trials are both in adult subjects, a group that has been driving growth of Prevnar 13 in the last few years, and showed …

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Scynexis bids to end novel antifungal drought, filing ibrexafungerp in US

Scynexis has filed for FDA approval of its novel drug ibrexafungerp which – if approved – would be the first broad-spectrum antifungal to reach the US market for vaginal yeast infections in more than two decades. The Jersey City, US-based biotech has submitted ibrexafungerp (SCY-078) on schedule as a treatment for the vulvovaginal candidiasis (VVC), …

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Ionis deal delivers for GSK as HBV drug hits the mark in phase 2

An antisense drug developed by GlaxoSmithKline has been shown to suppress the hepatitis B virus (HBV) in a phase 2 trial, raising hopes of a “functional cure” for the widespread disease. HBV affects an estimated 260 million people worldwide, according to GSK. While drugs to treat it are available – such as Gilead’s polymerase inhibitor …

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Novo-backed $61m fundraising helps F2G prep for antifungal launch

Anglo-Austrian biotech F2G has raised $60.8 million in venture financing to help it bring a drug for life-threatening fungal infections through late-stage development and onto the market. While these infections remain fairly rare, there is still a pressing need for new antifungals to provide treatment options when established therapies fail, and F2G is one of …

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