Colossal Biosciences spins out Form Bio, which emerges with funding and a software platform that is designed to be used across drug discovery, cell and gene therapy, manufacturing, and academic research.
The UK company makes two announcements for its Jemperli (dostarlimab) treatment, after it successfully cleared a Phase II trial and is set to enter a new Phase III trial in combination with cobolimab.
The recent lecanemab trial read-out will have a sizeable impact on the path forward for other biopharma’s developing treatments for Alzheimer’s disease, says the chief executive of a company developing investigational therapies for rare peripheral amyloid...
The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.
A push toward multimodal businesses is encouraging greater reliance on contract development and manufacturing organizations (CDMOs), finds a new report.
Penn spinout, Verismo Therapeutics, says the FDA has granted Orphan Drug Designation (ODD) to its KIR-CAR T-cell immunotherapy drug, SynKIR-110, for the treatment of patients with mesothelin-expressing mesotheliomas.
Emercell has selected Cell-Easy as a long-term CDMO partner for the scale-up and manufacturing operations of its allogeneic NK cell-based product, NK-001.
iBio is jockeying for position as a leading player in AI-powered drug discovery while also expanding its immuno-oncology pipeline after closing on the acquisition of multiple assets from its partner, RubrYc Therapeutics.
The US regulator has given the green light for the distribution of doses of Moderna's COVID-19 booster shots from a manufacturing plant in Indiana run by Catalent.
The EU’s tailor-made centralised system for vaccine procurement was successful in procuring sufficient doses of COVID-19 vaccines, but a new report finds holes in the approach.
A new pilot training model, one using augmented reality (AR) and virtual reality (VR) to support learning, is aimed at individuals looking to boost their knowledge and skills so they can continue to progress the area of Advanced Therapy Medicinal Product...
The US Food and Drug Administration (FDA) has granted Accelerated Approval for bluebird bio’s Skysona (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral...
Ori Biotech (Ori) and the Cell Therapy Manufacturing Center (CTMC) have announced a collaborative partnership to develop industrial manufacturing processes for cell therapies.
A Series A financing round, led by Deerfield Management, is aimed at accelerating a new cell therapy modality for the treatment of neurological disorders, including Parkinson’s Disease.
A US federal judge ruling that a Californian clinic’s stromal vascular stem cell treatments do not fall under the FDA's regulatory jurisdiction is of significant concern, says the ISCT.
A collaboration between Touchlight and Lonza expands the Swiss CDMO’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material, the UK biotech’s doggybone DNA (dbDNA).
Emergence Therapeutics has become the tenth company to license ADC technology from Synaffix. The deal has a total potential value of up to US$360m, plus royalties on commercial sales.
The Asia-Pacific (APAC) region was the largest contributor to the global clinical trial landscape from 2017 to 2021, accounting for more than 50% of conducted trials during the analysis period, found research by GlobalData.
The US regulator has granted emergency authorization for Pfizer-BioNTech’s and Moderna’s Covid booster shots that target the highly contagious BA.5 omicron subvariant.
Luina Bio, an Australian biopharmaceutical CDMO, has been acquired by a biotech investor and a private equity group, namely Dr Glenn Haifer and Ampersand Capital Partners.
AstraZeneca's long-acting antibody combination Evusheld has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection: marking the first global marketing approval of...
A study has demonstrated the effectiveness and safety of adalimumab biosimilars Hulio and Hyrimoz in the therapy of patients with inflammatory bowel disease (IBD).
Employment in Greater Philadelphia among cell and gene therapy companies has more that doubled since 2019, while employees at contract manufacturing organizations have grown by nearly 40%. Continuing to build the workforce will be crucial as the area...
The World Health Organization (WHO) has published its first guidelines for Ebola virus disease therapeutics, issuing ‘strong recommendations’ for the use of two monoclonal antibodies.
Pfizer and BioNTech have completed their application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine: saying they stand ready to start shipping...
San Diego headquartered, Regen BioPharma, has filed a provisional patent application filing covering utilization of dendritic cell technologies to augment efficacy of its patented survivin mRNA cancer immunotherapeutic vaccine.
EMA has begun its review of the conditional marketing authorization application from South Korean developer, SK biosciences, for its COVID-19 vaccine, Skycovion, a recombinant protein-based vaccine with adjuvant from GSK.
The U.S. Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel), also known as beti-cel: a one-time gene therapy custom-designed to treat the underlying genetic cause of beta thalassemia in adult and pediatric...
The first Omicron bivalent COVID-19 vaccine has been authorized: with the UK’s regulatory agency giving the green light to Moderna’s Spikevax Bivalent Original/Omicron booster shot.
The purchase brings under the UPS Healthcare umbrella several temperature-controlled facilities in 14 countries situated throughout Europe and Latin America.
Novartis has set out how it expects biosimilars to affect its business in the coming years, identifying sales of $80bn that are open to its off-patent business and expressing confidence in the ability of some of its own products to weather the arrival...
Teva Pharmaceutical Industries has given a bullish assessment of its chances of claiming a big slice of the Humira biosimilar market, arguing it has “the best product profile of all companies coming to the market in 2023.”
The US Food and Drug Administration (FDA) has approved Coherus BioSciences’ Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis (ranibizumab injection) for all five indications.
