The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
£5m
The Centre for Process Innovation has received £5m in funding from the UK Government to develop a ‘library’ of mRNA vaccines that can be used to help fight new Covid-19 variants.
87%
New trial data released by Eli Lilly showed that the company’s Covid-19 antibody combo reduced hospitalisations and deaths by 87%.
$86,040
The estimated monthly price of Zokinvy, a Hutchinson-Gilford progeria syndrome treatment that topped GoodRx’s list of the most expensive pharmacy drugs in 2021.
250,000
Italy has blocked the export of 250,000 AstraZeneca Covid-19 vaccine doses to Australia amid claims that the company failed to meet its EU contract commitments.
17.8 million
Since 24 February, COVAX has shipped more than 17.8 million Covid-19 vaccines to patients in lower-income nations around the world.
Approvals
J&J single-dose Covid-19 vaccine
The European Medicines Agency has recommended conditional marketing authorisation for Johnson & Johnson subsidiary Janssen’s Covid-19 vaccine.
Source: Pharmaceutical Technology
Azstarys
The US Food and Drug Administration (FDA) has approved Corium’s Azstarys (serdexmethylphenidate and dexmethylphenidate capsules) in three dosage strengths for treating attention deficit hyperactivity disorder symptoms in patients aged 6 years or older.
Source: BioSpace
Fotivda (tivozanib)
The US FDA has approved Fotivda for the treatment of adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies.
Source: Cancer Network
Zolgensma (onasemnogene abeparvovec)
Novartis Gene Therapies’ Zolgensma (onasemnogene abeparvovec) will be available for use in the UK’s National Health Service (NHS) following recommendations by regulators in England and Wales, as well as Scotland.
Source: Pharmaceutical Technology
Pepaxto (melphalan flufenamide) Injection
The US FDA has granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma
Source: FDA
Clinical Trials
Moderna doses first subjects in trial of Covid-19 booster vaccines
Moderna has dosed the first subjects in a Phase II clinical study with its modified Covid-19 vaccines designed to address the potential need for booster vaccine candidates. Enrolment is being carried out by amending the ongoing Phase II clinical study.
Source: Clinical Trials Arena
Novartis’ canakinumab fails to improve overall survival in lung cancer trial
Novartis has announced that its interleukin-1beta inhibitor canakinumab failed to hit the primary endpoint of overall survival in a Phase III non-small cell lung cancer trial.
Source: Pharma Times
Gilead’s lenacapavir maintains high virologic suppression rates in trial
Gilead Sciences has reported that additional results from the Phase II/III CAPELLA trial showed its investigational lenacapavir maintained high rates of virologic suppression in heavily treatment-experienced individuals with multi-drug resistant HIV-1.
Source: Gilead
Melior Pharmaceuticals to initiate trial of Covid-19 drug
Melior Pharmaceuticals is set to initiate a planned Phase II study of its novel, first-in-class lyn kinase activator, tolimidone, for Covid-19 treatment. Tolimidone is a repositioned drug that was shown to be safe and well-tolerated in prior clinical studies.
Source: Pharmaceutical Technology
NIH includes four potential Covid-19 drugs in ACTIV-2 trial
The US National Institutes of Health (NIH) has initiated enrolment in a Phase II/III ACTIV-2 trial to test four potential investigational drugs for treating Covid-19. The therapeutics are Synaigen’s inhalable beta interferon, SNG001, delivered by nebuliser, AstraZeneca’s long-acting monoclonal antibody combination, AZD7442, to be studied as both infusion and intramuscular injection and Sagent Pharmaceuticals’ orally administered serine protease inhibitor, Camostat mesylate.
Source: Clinical Trials Arena
Viriom, Chromis’ Avifavir reduces time to virus elimination in Covid-19 patients
Viriom and Chromis have reported that data from a study of directly acting antiviral drug, Avifavir (favipiravir) demonstrated reduced time to virus elimination in Covid-19 patients.
Source: Pharmaceutical Technology
