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...
CureVac has filed a lawsuit in a German regional court against BioNTech SE: seeking ‘fair compensation for infringement… of CureVac’s intellectual property rights’ regarding tech used in the manufacture of the Pfizer/BioNTech COVID-19 vaccine. BioNTech,...
The EU Ombudsman calls the EC's defense of its right not to keep records of text messages linked to COVID-19 vaccine negotiations between its president and the Pfizer CEO as “problematic”.
UK pharma group, Croda International, has inked a deal with the US government in which it will receive up to US$75m to expand its US manufacturing capacity for lipid systems.
MSD will supply Keytruda (pembrolizumab) in a phase 1/2a clinical trial for the treatment of patients with solid tumors, as part of an agreement with Transgene and BioInvent.
The European Commission (EC) has approved Kite’s CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
The industry had over 50 new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in both 2020 and 2021, up from an annual total of 29 a decade ago.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) made several recommendations for approval of drugs and therapies at its June 2022 meeting.
Merck has doubled its high-potent active pharmaceutical ingredients (HPAPI) production capacity with the expansion of its facility in Verona, Wisconsin, US.
BIO, the world’s largest trade association for the biotech industry, has responded to the US Food and Drug Administration's draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells.
The developer says it is harnessing parvovirus vectors that can deliver larger gene therapy payloads with enhanced tissue specificity and with minimal neutralizing immunity.
If new restrictions are placed on the FDA’s Accelerated Approval pathway, as many as two thirds of the treatments that use this pathway would never reach patients, according to research released at the BIO International Convention last week.
