The deal, valued at up to $380m, includes upfront and milestone payments. Under the terms of the agreement, Cellares will streamline, automate, and transfer technology for selected BMS CAR T cell therapies onto its Cell Shuttle manufacturing platform. The collaboration will see the deployment of multiple Cell Shuttle and Cell Q systems, equipped with fully automated, high-throughput quality control, across Smart Factories of Cellares located in the US, European Union, and Japan. This partnership will aid BMS to expand its manufacturing footprint and cater to this increasing need through a scal ..read more

Merck, referred as MSD outside the US and Canada, has confirmed that Health Canada has approved a new indication for PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high risk adult kidney transplant recipients.   This approval is for cases where the donor is CMV-seropositive or the recipient is CMV-seronegative (D+/R-).  The decision by Health Canada was based on the results of a Phase III, double-blind, multi-centre, randomised, active comparator-controlled non-inferiority trial.   The trial, which is identified as P002 (NCT03443869), included 589 ad ..read more

This partnership follows the US Food and Drug Administration’s approval of ADSTILADRIN in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours. After technology transfer, SK pharmteco, a contract development manufacturing organisation (CDMO), will be responsible for manufacturing, testing, and release of the drug substance, subject to US FDA regulatory approval. The collaboration aims to diversify the supply and meet anticipated commercial growth. SK ..read more

This partnership is set to enhance the treatment options available to diabetes patients in Brazil. Under the agreement, Biocon will be responsible for the development, manufacturing, and supply of Semaglutide, while Biomm will handle regulatory approvals and commercialisation within the Brazilian market. Biomm, with a focus on biotechnology, aims to provide high-quality healthcare for chronic conditions and access to the latest treatments. It develops, manufactures and commercialises complex biotech and biosimilar drug products at its production facility in Nova Lima. Biocon CEO and managing d ..read more

A product of BioCryst Pharmaceuticals, Orladeyo’s registration, commercialisation and distribution are solely handled by Pint Pharma in Latin America. Hereditary angioedema (HAE) is a genetic disorder characterised by sudden, painful swelling of the skin, mucous membranes, and submucosal tissues. Patients with HAE have historically had limited treatment options, impacting their quality of life and leaving them at risk of severe attacks. Pint Pharma chief scientific officer Dr. Valnei Canutti said, “The approval of Orladeyo by ANVISA is excellent news for the hereditary angioedema patient commu ..read more

The designation is specifically for the characterisation of progressive or recurrent glioma using positron emission tomography (PET). TLX101-CDx is a PET imaging agent that targets membrane transport proteins LAT1 and LAT2, which could potentially be used as a companion diagnostic agent to TLX101, Telix’s investigational glioblastoma therapy. The designation will facilitate a more expedited review process and closer consultation with the FDA. The company is also in the final stages of preparing its New Drug Application (NDA) for TLX101-CDx for both adult and paediatric patients. Currently, ami ..read more

The company also plans to implement additional measures. This decision comes as the company seeks to extend its cash runway available and reassess its capital raising options in light of the current market conditions. Portage said that its board of directors decided to pause further enrolment in the ADPORT-601 clinical trial, which involves the study of PORT-6 and PORT-7, both adenosine antagonists. The company is actively exploring various strategic options, which may include partnerships, asset sales, mergers, restructurings, or even company wind down. The objective is to optimise value and ..read more

The recommendation, detailed in the final draft guidance, specifically targets patients whose B-cell ALL has been resistant to treatment, has recurred post stem-cell transplant, or has relapsed for the second time or more. Approximately 40 children and young adults in England are expected to be eligible for this treatment annually. Tisagenlecleucel has been accessible through the NHS Cancer Drugs Fund since December 2018, and the new guidance advocates for its standardised distribution across the NHS. The therapy, listed at £282,000 per infusion, will be offered to the NHS at a discounted rate ..read more

This collaboration aims to harness Invenra’s B-Body bispecific antibody platform to advance Astellas’ research and development in antibody discovery. Invenra CEO Dr Roland Green said: “We are honoured to partner with the Astellas team, one of the world’s foremost developers of therapeutics. We are excited by the potential of this partnership to yield profound benefits to patients in need.” As part of the agreement, Astellas will gain access to the B-Body technology. This collaboration is a strategic move to bolster Astellas’ efforts in developing bispecific therapeutic antibodies. Following th ..read more

This approval introduces a once-daily, oral, two-drug regimen for individuals aged 12 years and above, weighing a minimum of 25kg. Dovato, which combines dolutegravir (50mg) with lamivudine (300mg), is designed for patients with no history of antiretroviral (ARV) treatment or for replacing the existing, stable ARV regimen in individuals who are virologically suppressed. These patients should also not have failed treatment priorly and not have resistance to the individual Dovato components. The FDA’s approval is based on the data from the Phase IIIb DANCE clinical trial of Dovato in treatment-n ..read more