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.
Pfizer will invest €90.5m ($95m) in French vaccine specialist Valneva, representing 8.1% of Valneva’s share capital. The investment will support the duo’s Lyme disease vaccine partnership.
Pharma industry organizations say they are deeply disappointed by the decision taken by World Trade Organization (WTO) at its ministerial conference, MC12, to endorse a TRIPS waiver for COVID-19 vaccines.
Following the adoption of a critical list of COVID-19 vaccines and treatments, European Union member states and pharma companies will communicate to ensure sufficient supply to meet evolving demand.
Measuring potency for gene and cell therapies is not so clear-cut, and some companies have hit roadblocks in their submissions to regulatory agencies as a result.
The BIO International Convention in San Diego this week heard the US-based Center for Breakthrough Medicines (CBM) is to speed up plans to build what it calls the largest cell therapy manufacturing operation worldwide.
Valneva has reached a settlement with the UK government over an abandoned COVID-19 vaccine contract. Meanwhile, the future of its COVID-19 vaccine in the EU could become clearer next week after an EMA committee vote.
San Jose, California-based ParkourSC says it has expanded its digital supply chain operations platform to help pharma companies address supply challenges.
A meeting of the FDA’s vaccines and related biological products advisory committee (VRBPAC) voted Tuesday to recommend that the agency grant Emergency Use Authorization (EUA) for Novavax’ COVID-19 vaccine.
The US Federal Trade Commission (FTC) announced on June 7 that it will examine pharmacy benefit managers’ role at the center of the US pharmaceutical system.
Johnson & Johnson (J&J) has officially informed Emergent BioSolutions Inc of its decision to terminate its agreement with the contract manufacturer in relation to the pharma group’s COVID-19 vaccine.
The US Food and Drug Administration (FDA) has approved GSK’s Priorix (Measles, Mumps and Rubella Vaccine, Live) for individuals 12 months of age and older.
Regeneron Pharmaceuticals will purchase Sanofi's stake in their collaboration on Libtayo (cemiplimab) for an upfront payment of $900m, giving Regeneron exclusive worldwide rights to the medicine.
GSK will acquire Affinivax, a US clinical-stage biopharmaceutical company, for a $2.1bn upfront payment and up to $1.2bn in potential development milestones.
Danish vaccine company Bavarian Nordic has entered several new supply contracts with countries for its smallpox vaccine, with deliveries set to start immediately.
