The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
$6bn
Under a deal to develop, manufacture and commercialise oncology, immunology and inflammation targets, IGM is set to receive $150 million in upfront and $6bn in milestone payments from Sanofi.
₹225
Serum Institute of India cut the prices of its Covid-19 vaccine to ₹225 ($2.96) from ₹600 for private hospitals in India.
829,000
Diarrhoeal diseases caused by polluted water and poor sanitation are the cause of 829,000 deaths every year, as per the WHO.
7.7%
Drug expenditures in the US grew by 7.7% in 2021 compared to the previous year, as per a recent report published by the American Society of Health-System Pharmacists.
12
The Affordable Care Act in the US completed 12 years in March. Among several other advances, the Act provided has provided $11 billion in funding to bolster and expand community health centers.
Approvals
BeiGene has obtained approval from the China National Medical Products Administration (NMPA) for its tislelizumab to treat patients with locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC), a type of oesophageal cancer.
Source: PHARMACEUTICAL TECHNOLOGY
The European Commission’s authorisation to Bristol Myers Squibb’s chimeric antigen receptor (CAR) T-cell immunotherapy, Breyanzi (lisocabtagene maraleucel; liso-cel) is based on data from TRANSCEND NHL 001 study of Breyanzi in adult individuals with R/R DLBCL, PMBCL and FL3B.
Source: PHARMACEUTICAL TECHNOLOGY
The US FDA approved Amneal’s BLA for bevacizumab-maly, a biosimilar referencing Avastin (bevacizumab). The product will be marketed under the proprietary name ALYMSYS and represents the third bevacizumab biosimilar approved in the U.S.
Source: BLOOMBERG
The US FDA approved the first drug to treat an ultra-rare cluster of conditions called PIK3CA-Related Overgrowth Spectrum (PROS) caused by mutations in a specific gene, granting an accelerated clearance to a Novartis therapy that's already in use for advanced breast cancer.
Source: BIOPHARMA DIVE
Gilead Sciences’ subsidiary Kite has secured approval from the US FDA for Yescarta (axicabtagene ciloleucel) CAR T-cell therapy to treat adult individuals with large B-cell lymphoma (LBCL). Yescarta is a genetically modified autologous T cell immunotherapy directed at CD19.
Source: PHARMACEUTICAL TECHNOLOGY
Clinical Trials
PHOSPLATIN DOSES FIRST SUBJECT IN PHASE II THYMIC EPITHELIAL TUMOUR TRIAL
Phosplatin Therapeutics has dosed the first subject in a Phase II clinical trial of its lead therapeutic candidate, PT-112, to treat specific individuals with recurrent thymic epithelial tumours (TETs), thymoma and thymic carcinoma.
Source: Clinical Trials Arena
MODERNA DOSES ADOLESCENTS IN COVID-19 VACCINE STUDY
Moderna has dosed the first adolescents in a phase 2/3 clinical trial designed to position its COVID-19 vaccine for use in children as young as 12 years old before the start of the 2021-22 school year.
Source: Fierce Biotech
FDA ISSUES NEW DRAFT GUIDANCE TO BOOST CLINICAL TRIAL DIVERSITY
The US FDA has issued guidance on how to develop plans for enrolling more subjects from underrepresented racial and ethnic populations in the country into clinical trials. Under the new guidance, medical product sponsors should submit a Race and Ethnicity Diversity Plan to the FDA.
Source: Clinical Trials Arena
AMGEN REVEALS NEW LONG-TERM DATA FOR LUMAKRAS AT AACR22
Amgen attempted to further pull away from Mirati Therapeutics in the KRAS space, touting a new batch of long-term non-small cell lung cancer data at AACR for its approved drug Lumakras.
Source: businesswire
AKEBIA REVEALS VADADUSTAT PARTIAL CLINICAL HOLD AFTER FDA SNUB
Akebia revealed that the FDA has slapped a partial clinical hold on its U.S. trials of vadadustat in kids with anemia due to CKD. After safety concerns derailed an approval of Akebia Therapeutics’ blockbuster hopeful vadadustat late last month, the company warned that a restructuring was in the cards.
Source: Fierce Pharma
SYNEURX COMPLETES ENROLMENT IN PHASE II TRIAL OF COVID-19 ORAL ANTIVIRAL
The trial for the company’s new Covid-19 oral antiviral candidate, SNB01 (Pentarlandir) will enable the selection of the optimal dose for the Phase III trial study, anticipated to commence soon. Pentarlandir acts on the main protease, or 3CL-protease and hinders TMPRSS2 for entry of the virus.
Source: Clinical Trials Arena
