Drugs

The vaccine, mRNA-1273.214, has been granted conditional authorization in individuals aged 18+ as a booster dose by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Moderna announced yesterday. In each dose of the booster vaccine, half of the vaccine (25 micrograms) targets the original virus strain from 2020 and the other half (25 micrograms)

Like some of its peers, Novartis is both a developer of biosimilars, through its Sandoz unit, and the owner of branded biologics that will be threatened by the arrival of off-patent rivals when they lose intellectual property protection. Talking to investors on a second quarter results conference call on July 19, Novartis CEO Vas Narasimhan

Responding to the emergence of the omicron variant, Pfizer and BioNTech initially developed a version of their Comirnaty mRNA vaccine to protect against the BA.1 form of the virus. Clinical data shared earlier this year showed the vaccine neutralized BA.4 and BA.5, subvariants that emerged after development of the vaccine began, but to a lesser

Faced with a competitive market, Sanofi has sought to differentiate its influenza vaccines in recent years, winning US Food and Drug Administration approval for the high-dose trivalent and quadrivalent forms of its Fluzone for use in people 65 years and older. Fluzone High-Dose Quadrivalent, which won FDA approval late in 2019, is the only high-dose

The GMP certification of Charles River’s Memphis CDMO facility complements an existing GMP license for Investigational Medicinal Product (IMP) production. The new approval comes after an inspection by the cell and gene therapy experts from the Italian inspectorate, Agenzia Italiana del Farmaco (AIFA), performed on the EMA’s behalf. The Memphis site can now manufacture and ship drug products intended for European Union distribution.

AbbVie reported $17.3bn in Humira sales in the US in 2021, up 7.6% versus the prior year. Growth in the US has enabled AbbVie to continue increasing sales in the US even as off-patent competitors to the TNF inhibitor have caused revenues to contract internationally. Next year marks the arrival of biosimilar rivals to Humira

The two companies partnered up in 2015 on the joint development of biospecific cancer antibodies aimed at improving immunotherapy options for cancer patients. The expanded collaboration will see the German mRNA specialist and Denmark-headquartered biotech focus on researching, developing and commercializing novel monospecific antibody candidates for various cancer indications. “The expansion of our collaboration with

Recombinant human albumin is a critical component in the manufacture of biopharmaceuticals, particularly in modalities such as cell therapies, viral therapies and vaccines. Satorius will make the acquisition via its French subgroup Sartorius Stedim Biotech, acquiring 100% of Albumedix from private investors for £415m ($502m). Cell culture media business Founded in 1984, Nottingham-based Albumedix has

The platform enables biopharmaceutical companies to increase the speed to clinical manufacturing while reducing process development time and costs, says MilliporeSigma, which is the US and Canada life science business of Merck KGaA of Germany. “Cell and gene therapies offer the potential for curative treatments and can be commercialized in half the time compared to

Suzhou, Jiangsu headquartered Innovent has ‘strong clinical development capabilities and a broad commercial footprint in China’. The two companies will accelerate the development and commercialization of two Sanofi key clinical stage oncology assets: Phase III SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody-drug conjugate) and Phase II SAR444245 (non-alpha IL-2), combining with sintilimab, the leading checkpoint inhibitor in

Pfizer and Global Blood Therapeutics (GBT) have entered into a definitive agreement that sees the pharmaceutical company acquiring the biopharma for $5.4b USD. With the purchase, Pfizer brings into its rare hematology fold a company that offers expertise in the area, including a focus on sickle cell disease (SCD) and conditions that impact underserved communities.

The vaccine candidate, known as BNT162b5, is a bivalent vaccine that contains enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain and for an Omicron variant. In the announcement, the companies explained that by ‘enhanced’, it is meant that BNT162b5 the spike protein encoded from the mRNAs has been modified with the aim of increasing

The combined group will offer process development expertise and cGMP manufacturing for a broad range of autologous and allogeneic cell therapies, with ‘unparalleled expertise’ in gene editing and industry-leading induced Pluripotent Stem Cell (iPSC) capabilities. In particular, the group will benefit from significantly expanded capacity: with process and analytical development laboratories and cGMP manufacturing facilities

Noting rising global demand for cell culture media, Thermo Fisher Scientific announced today it is expanding the dry powder media manufacturing facility. The Grand Island expansion is part of a $650m multi-year investment from Thermo Fisher, which seeks to boost the company’s total manufacturing capacity in North America, Europe and Asia with flexible, scalable and

The H1 influenza vaccine uses the Cambridge, Massachusetts company’s MIMIX technology, with pre-clinical trials showing the system enhanced humoral and cellular immune responses in mice compared to vaccine intramuscular injection. The study​​ also showed that sustained release immunization promotes strong and long-lasting anti-influenza antibody responses, and enhanced protection against fatalities. Now the company is taking the

While not the first FDA-approved biosimilar for Roche’s blockbuster drug Lucentis – that being Biogen and Samsung Bioepis’ Byooviz​​, approved in September for three indications – it is the first and only biosimilar interchangeable with Lucentis across all five retinal disease indications. Cimerli – which becomes the 37th​ biosimilar approval in the US – is

Oxford Biomedica announced two separate partnership agreements on the same day, one that sees Orchard Therapeutics utilising the company’s LentiStable technology and another unspecified company that will leverage its LentiVector platform. The two latest deals arrive shortly after it had expanded an agreement with Juno Therapeutics for two new viral vector programmes, and after it

Synthego, a genome engineering company based in California, announced that it had begun work on a 20,000-square-foot manufacturing facility. The space, which will be located in the San Francisco Bay Area, will expand the company’s Halo platform to increase production of its gene editing tools. According to the company, Halo is a platform that provides

The two companies announced a strategic partnership in late 2021, with South Korean CDMO Samsung Biologics taking on manufacturing duties for Boston-based GreenLight Bioscience’s mRNA COVID-19 vaccine. Since then, tech transfer and scale-up from the lab bench to Samsung’s commercial facility has been completed in seven months, ‘demonstrating platform adaptability and scalability’. GreenLight’s process—from drug

The biotech is looking to progress its fully synthetic CD8+ T cell adaptive vaccine and announced that it had begun current good manufacturing practice (cGMP) production of the vaccine candidate. Emergex stated that its vaccine works differently to traditional influenza vaccines, by priming influenza-specific CD8+ T cells that are able to recognize the same peptides

Seagen is still being discussed as a target for Merck​, as the latter company looks to expand more extensively into antibody-drug conjugates (ADCs). However, regardless of any potential deal, the company continues to build out its pipeline in the area by signing a collaboration and exclusive license agreement with Sichuan Kelun Pharmaceutical, a Chinese biotech.

With the approvals of the final drug production, the company is now allowed to deliver drug product manufactured at its own site to the US and EU market, instead of using a third party, allowing it to achieve its ambitions of controlling the full manufacturing chain. The vaccine is known as Jynneos in the US