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the world’s largest trade association for the biotech industry, has responded to the US Food and Drug Administration's draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells.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.
As part of a wider expansion project, Merck commits to expanding an existing facility and building an entirely new one, as part of its strategy to focus on investment in Ireland.
The DATAcc has released a collection of open-access resources that are intended to help users build inclusivity into digital health measurement products.
Inceptor Bio, a biotechnology company advancing cell therapies for difficult-to-treat cancers, recently closed a US$37m Series A financing round led by Kineticos Ventures.
Northway Biotech, a contract development and manufacturing organization (CDMO) based out of Vilnius, Lithuania, is set to open a facility in Boston, US.
The World Health Organization (WHO) has today issued an emergency use listing (EUL) for Convidecia, a vaccine manufactured by CanSino Biologics, bringing the total number of COVID-19 vaccines validated by the organisation to 11.
Locus Biosciences says the US$35m in funding it has raised from a mix of old and new investors is further validation of its novel approach to treating bacterial diseases.
South Korean multinational, Lotte Corporation, is to acquire Bristol Myers Squibb's manufacturing facility in East Syracuse, New York. The deal is reportedly worth US$160m.
