The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
89%
Clinical trial results suggest that Pfizer’s experimental Covid-19 pill cuts the risk of hospitalisation or death by 89% in vulnerable adults.
$42bn
In H1 2021, global vaccine exports surpassed $42.5bn, hitting a record high over the last decade, according to a new report published by IndexBox.
87%
Results from a UK study of real-world data shows that the human papillomavirus vaccine is cutting cases of cervical cancer by 87%.
20
Swiss pharma powerhouse Novartis is set to end its 20-year-long investment into rival company Roche.
$1.3bn
Eli Lilly’s previously sidelined Covid-19 antibody treatment, bamlanivimab and etesevimab, is on track for a comeback thanks to a $1.3bn supply agreement ordered by the US Government.
Approvals
NVX-CoV2373
Biotechnology Novavax has been granted emergency use authorisation for its Covid-19 vaccine by drug regulatory authorities in Indonesia.
Source: AP News
molnupiravir
The UK’s Medicines and Healthcare products Regulatory Agency has authorised Merck’s molnupiravir, making it the first approved oral antiviral treatment for Covid-19 in adults.
Source: Washington Post
Covaxin
The World Health Organization (WHO) has granted emergency use listing to Indian company Bharat Biotech’s Covid-19 vaccine, Covaxin, for use in individuals aged 18 years and above.
Source: Pharmaceutical Technology
Vuity
The US Food and Drug Administration (FDA) has approved Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults.
Source: Abbvie
Scemblix
The US FDA has authorised the use of Novartis Scemblix (asciminib), with novel mechanism of action for the treatment of chronic myeloid leukaemia.
Source: Novartis
Clinical Trials
UK launches trial of drug to tackle fatigue in long Covid patients
The first trial of a drug to target the fatigue and muscle weakness experienced by more than half of people with long Covid has been launched in the UK. It is also the first drug trial in long Covid patients who were not hospitalised during their initial infection.
Source: The Guardian
Amylyx doses first subjects in Phase III ALS treatment trial
Amylyx Pharmaceuticals had dosed the first subjects in the Phase III clinical trial of its AMX0035 in amyotrophic lateral sclerosis (ALS) patients. An experimental product, AMX0035 has sodium phenylbutyrate and taurursodiol (TURSO; ursodoxicoltaurine) active agents.
Source: Clinical Trials Arena
Traditional Samoan medicine found to be as effective as ibuprofen at reducing inflammation
A team of researchers from Samoa, New Zealand and the US has found that the leaves of the Samoan tree, matalafi, are as good at relieving inflammation as ibuprofen.
Source: National Academy of Sciences
Aggrastat injection meets primary goal in coronary intervention trial
Medicure has reported that its Aggrastat (tirofiban hydrochloride) injection met the primary goal of combined efficacy and major bleeding in the shortened Aggrastat versus Integrilin in percutaneous coronary intervention clinical trial.
Source: Clinical Trials Arena
Novartis’ iptacopan hits endpoints in mid-stage study
Novartis’ investigational treatment iptacopan – also known as LNP023 – has met the primary endpoints in both patient cohorts in a Phase II C3 glomerulopathy clinical trial.
Source: Pharma Times
Inovio obtains approval for Phase III trial of Covid-19 vaccine in India
The Drug Controller General of India of the Central Drugs Standard Control Organization has granted authorisation to advance the Phase III portion of Inovio’s international Phase II/III clinical trial for its Covid-19 vaccine candidate, INO-4800, in the country.
Source: Clinical Trials Arena
