The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
92
As of 21 May, 92 laboratory-confirmed and 28 suspected cases of monkeypox with investigations ongoing, have been reported to the World Health Organization.
13%
As per discussions at the World Economic Forum Annual meeting, only 13% of people in low-income countries, mostly brown and black, are vaccinated.
$529
According to US Institute for Clinical and Economic Review (ICER), Pfizer’s Covid-19 antiviral Paxlovid, is priced reasonably at the $529 cost per treatment course.
85%
The Bavarian Nordic vaccine JYNNEOS, a licensed smallpox vaccine in the US, also confers 85% protection against the monkeypox virus.
$2.1bn
Eli Lilly and Company has announced plans to make an investment of $2.1bn to expand its manufacturing footprint in Indiana.
Approvals
CAMZYOS
Bristol Myers Squibb (BMS) has received US Food and Drug Administration (FDA) approval for Camzyos (mavacamten) to treat adult patients with symptomatic New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (HCM).
Source: PHARMACEUTICAL TECHNOLOGY
MOUNJARO
The FDA has greenlit Eli Lilly’s Type 2 diabetes and weight loss med Mounjaro (tirzepatide). In a head-to-head study last year, Mounjaro topped Novo’s blockbuster Ozempic in helping patients lose weight and keep their blood sugar levels in check.
Source: Fierce Pharma
COVAXIN
The Drugs Controller General of India (DCGI) has granted emergency use approval for Bharat Biotech’s whole-virion inactivated Covid-19 vaccine candidate, Covaxin (BBV152) for usage in children aged six to 12 years.
Source: Pharmaceutical Technology
RINVOQ
The US FDA has granted approval for AbbVie’s Rinvoq (upadacitinib; 15 mg, once daily) to treat adults with active ankylosing spondylitis (AS). Rinvoq is intended for AS patients who respond inadequately or are intolerant to one or more TNF blockers.
Source: Pharmaceutical Technology
CARVYKTI
The European Commission granted conditional approval of Carvykti, Janssen’s first cell therapy, for the treatment of patients with relapsed and refractory multiple myeloma who have received at least three prior therapies.
Source: Bloomberg
Clinical Trials
Hyundai Bioscience launches Phase II clinical trial of Covid-19 drug
Hyundai Bioscience has launched the Phase II clinical trial of a new broad-spectrum antiviral agent, CP-COV03, for the treatment of Covid-19 patients. The antiviral drug was developed in Korea as a universal treatment for diseases including Covid-19.
Source: Clinical Trials Arena
Glyscend concludes Phase I trial of oral type 2 diabetes therapy
A mucin-complexing polymer (MCP), GLY-200 boosts the natural mucus barrier in the duodenum or the upper small intestine. In the trial, GLY-200 was found to be well-tolerated across all tested dose levels without any safety signals detected.
Source: Clinical Trials Arena
Myeloid doses first patient in Phase I/II refractory PTCL therapy trial
Myeloid Therapeutics has announced the dosing of the first patient in the Phase I/II IMAGINE Study of its mRNA engineered CAR monocyte (CAR-M), MT-101, to treat refractory or relapsed peripheral T cell lymphoma (PTCL) patients.
Source: Clinical Trials Arena
Bavarian Nordic reports positive data from Phase II Covid-19 booster trial
In a Phase II study, participants inoculated priorly with approved messenger ribonucleic acid (mRNA) or adenoviral vaccines showed ABNCoV2 vaccine elicited a substantial improvement in neutralising antibodies against the Omicron variant of the SARS-CoV-2 virus.
Source: Clinical Trials Arena
Paradigm doses first subjects in Phase III knee osteoarthritis trial
Paradigm Biopharmaceuticals has randomised and dosed the first participants in the Phase III clinical trial of injectable pentosan polysulfate sodium (PPS/Zilosul) for treating pain linked to knee osteoarthritis (kOA) in the US.
Source: Clinical Trials Arena
Sen-Jam initiates subject enrolment in Phase II Covid-19 treatment trial
Sen-Jam Pharmaceutical has initiated subject enrolment in the Phase II clinical trial of its investigational oral Covid-19 therapy, SJP-002C, in Nepal. Subject enrolment is under a co-development deal with Duke-NUS and Duke University School of Medicine is underway.
Source: Clinical Trials Arena
