Bristol Myers Squibb agrees nearly $6bn oncology merger
In an agreed merger with Mirati Therapeutics, Bristol Myers Squibb will gain rights to a best-in-class treatment for advanced non-small cell lung cancer (NSCLC) with a KRASG12C mutation.
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India joins mission to harmonise pharmacopoeial standards
As a “major manufacturer of the world’s medicines”, the Indian Pharmacopoeia Commission (IPC) has joined the Pharmacopoeial Discussion Group (PDG) to contribute to the harmonisation of quality standards.
Moderna reveals optimistic data for influenza-COVID-19 vaccine
Strong influenza and COVID-19 immunogenicity compared to approved standalone vaccines has been demonstrated in Moderna’s combination vaccine, interim Phase I/II trial data shows.
FUJIFILM Diosynth recruits new Quality leader
An ex-Biogen executive has been appointed as CDMO FUJIFILM Diosynth Biotechnologies’ new Chief Quality Officer.
Stem-cell therapy delivers potential in Alzheimer’s
Top-line Phase IIa data has demonstrated an allogeneic stem-cell therapy facilitated a lack of deterioration in cognitive signals in mild Alzheimer’s.
Sanofi and Teva to develop novel IBD treatment
Under a new agreement with Sanofi, Teva could receive up to $1.5 billion for its novel anti-TL1A therapy, a potential best-in-class option for inflammatory bowel disease (IBD).
Novartis completes Sandoz spin-off
As a newly independent company, Sandoz will concentrate on developing generic and biosimilar medicines, while its former parent company Novartis plans to drive its business forward with a strategic focus on innovative medicines.
Lilly agrees $1.4 billion radiopharma acquisition
Two late-stage radioligand therapies for oncological indications are planned to be developed through an acquisition agreement between Eli Lilly and POINT Biopharma Global.
WHO recommends second malaria vaccine
Newly recommended by the World Health Organization (WHO), the new “safe, effective and affordable” malaria vaccine has potential to reduce deaths "by up to a third”.
Increasing efficacy in extractables and leachable testing
Researchers have proposed a read-across methodology for pharmaceutical extractables and leachable (E&L) testing as a time-saving alternative to toxicity testing.
Sanofi-Janssen collaboration to advance novel E. coli vaccine
A potential first-in-class extraintestinal pathogenic E. coli (ExPEC) vaccine set to be jointly developed by Sanofi and Janssen, could help to abate a pathogen that is key in driving global antimicrobial resistance (AMR).
EMA validates MAA for novel telomerase inhibitor
Following European validation of its Marketing Authorisation Application (MAA), imetelstat has potential to become a standard of care in lower risk myelodysplastic syndromes (MDS), according to Geron’s CEO.
mRNA researchers awarded 2023 Nobel Prize
The Nobel Prize in Physiology or Medicine 2023 has been awarded to two researchers who were instrumental in helping to curb the COVID-19 pandemic, through their discoveries in mRNA base modifications.
Will novel antibiotic become front-line for C. difficile?
Based on positive Phase II data, the first-in-class antibiotic candidate ibezapolstat for C. difficile is expected to advance to Phase III trials more quickly.
FDA approves first-in-class antidepressant
The first antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor has been approved for major depressive disorder (MDD) by the US Food and Drug Administration (FDA).
