The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
57,995
There are 57,995 confirmed monkeypox cases reported in the world, as per a 13 September Centers for Disease Control and Prevention (CDC) update
$1.4 billion
Over $1.4 billion in financial commitments have been pledged to the World Health Organization (WHO)’s financial intermediary fund (FIF) for pandemic prevention, preparedness, and response (PPR)
12.58 billion
As of 11 September, 12,589,972,108 Covid-19 vaccine doses have been administered, as per the WHO.
38
After 38 years as the director of the National Institute of Allergy and Infectious Diseases (NIAID), Dr. Anthony Fauci announced he will be leaving the position in December
$1.29 billion
The drug wholesale company AmerisourceBergen entered into a definitive agreement to acquire specialized services provider PharmaLex for $1.29 billion
Approvals
SPIKEVAX BIVALENT ORIGINAL/OMICRON
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above.
Source: PHARMACEUTICAL TECHNOLOGY
ROCTAVIAN
The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). It is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).
Source: PHARMACEUTICAL TECHNOLOGY
SUNLECA
Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The MAA for lenacapavir is based on data from the Phase II/III CAPELLA clinical trial.
Source: Pharmaceutical Technology
TECARTUS
The European Commission (EC) has granted marketing authorisation for Gilead Sciences subsidiary Kite’s CAR T-cell therapy Tecartus (brexucabtagene autoleucel) to treat relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukaemia (ALL).
Source: Pharmaceutical Technology
Clinical Trials
83bar and Virgo collaborate to introduce patient recruitment platform
83bar has entered a strategic collaboration with Virgo Surgical Video Solutions for launching a new Constellation Platform to recruit patients into clinical trials. The Constellation platform will aid practice managers and trial sponsors in connecting different aspects of the recruitment process.
Source: Clinical Trials Arena
Ideaya reports positive Phase II data for MUM combination therapy
Ideaya Biosciences reported positive interim Phase II clinical trial data of a darovasertib (IDE196) and crizotinib-synthetic lethal combination for patients with metastatic uveal melanoma (MUM). Of the any-line MUM patients, 89% and 83% had tumour shrinkage and disease control rate, respectively.
Source: Clinical Trials Arena
Dynavax doses first subject in Phase II plague vaccine trial
Dynavax Technologies dosed the first subject in a Phase II clinical trial of a recombinant plague (rF1V) vaccine, along with the company’s CpG 1018 adjuvant. The vaccine is being developed by the US Department of Defense (DoD).
Source: Clinical Trials Arena
FDA authorises Edgewise’s Phase II duchenne muscular dystrophy trial
The US FDA granted authorisation for Edgewise Therapeutics’ Phase II clinical trial of EDG-5506 for treating duchenne muscular dystrophy (DMD) in children. Named LYNX, the trial is expected to begin dosing subjects in the fourth quarter of this year.
Source: Clinical Trials Arena
Synairgen enters partnership to support viral infection trial
Synairgen has entered a partnership to support the UNIVERSAL trial being led by the Clinical Trials Unit of the University of Southampton in the UK to potentially develop antivirals for viral infections. The trial plans to recruit 1,000 subjects who will be assessed for a period of 12 months.
Source: Clinical Trials Arena
Astellas reports Phase III data of fezolinetant for menopause-linked VMS
Astellas Pharma has reported topline findings from the Phase III MOONLIGHT 3 clinical trial of fezolinetant to treat moderate to severe vasomotor symptoms (VMS) linked to menopause in women in mainland China. The adverse events were generally in line with those seen in prior Phase III trials of fezolinetant.
Source: Clinical Trials Arena
