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.
GSK’s first quarter following the demerger of its consumer health business sees the company raise its 2022 sales guidance to between 6-8%, up from 5-7% on its previous estimation.
Avista Therapeutics, a University of Pittsburgh Medical Center (UPMC) spinout, is teaming up with Roche to develop novel AAV gene therapy vectors for eye diseases.
Sandoz said the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a natalizumab biosimilar, developed by Polpharma Biologics.
The European Commission has extended the marketing authorization for Bavarian Nordic’s smallpox vaccine, Imvanex, to include protection from monkeypox and disease caused by vaccinia virus.
The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.
US biotech, CAMP4 Therapeutics, has secured US$100m in a Series B financing round that it says will be used to accelerate expansion of its regulatory RNA (regRNA) platform.
Bavarian Nordic continues to sign contracts for its smallpox vaccine in response to the monkeypox outbreak, with the company again raising its financial guidance for 2022 and noting orders now stretch into 2023.
The EU Ombudsman has closed the inquiry into the EU Commission’s handling of a request for text messages between its president and the CEO of Pfizer, upholding the finding of maladministration.
Samsung Biologics says it is actively working to engage its suppliers to transition to net zero emissions in multiple areas and invest in renewable energy.
Novo Nordisk has announced positive results from a Phase 3 study assessing the efficacy and safety of concizumab, its prophylactic treatment of hemophilia A or B with inhibitors.
Vertex Pharmaceuticals will acquire ViaCyte, a privately held biotech focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320m.
The ECDC and the EMA are recommending second COVID-19 booster shots for people between 60 and 79 years old as well as for individuals with medical conditions putting them at high risk of severe disease.
Biotech supply chains face an uncertain future in 2022 and beyond: up against myriad challenges ranging from future pandemic outbreaks to geopolitical tensions – and, indeed, unforeseen threats. Communication and collaboration between policymakers and...
