Safe Biologics

FEBRUARY 4, 2025

Steqeyma is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older.

Biosimilars 130

Biosimilars Immunization Immunity 130

BioPharma Dive

JANUARY 9, 2025

Political and economic uncertainty hangs over the industry, while major bets on metabolic and immune disease drug research are set to play out.

Immunization 67

Immunization Immunity 67

Pharmacy Times

MARCH 23, 2025

Goad, PharmD, MPH, discusses the latest RSV vaccination guidelines and recommendations for 2025, highlighting vaccine options, target populations, timing considerations, evolving CDC policies, and the role of pharmacists in immunization efforts.

Vaccines 29

Vaccines Immunization Immunity 29

Pharmacy Times

MARCH 31, 2025

Effective management of immune checkpoint inhibitor-related toxicities requires early intervention, evolving guideline adherence, and multidisciplinary collaboration, with steroids remaining a key treatment.

Immunization 26

Immunization Immunity 26

pharmaphorum

JUNE 15, 2022

Cytokines have long been investigated for their potential as cancer treatments – selectively stimulate tumour-fighting immune cells – with varying levels of success. Trutino’s lead in-house asset is in early-stage development and scheduled to start clinical testing in solid tumours in 2025.

Immunization 98

Immunization Immunity Vaccines 98

Pharmacy Times

MARCH 29, 2025

PD-L1 immune checkpoint inhibitors are now standard for early-stage non-metastatic non-small cell lung cancer (NSCLC), with neoadjuvant, adjuvant, and perioperative strategies improving survival and outcomes.

Immunization 26

Immunization Immunity 26

Big Molecule Watch

SEPTEMBER 27, 2023

Sarepta and Catalent each subsequently filed answers denying infringement and asserting that they are “immune or otherwise protected from suit under the Safe Harbor provision of 35 U.S.C. § The parties will file dispositive motions on June 4, 2025, with responsive and reply briefing complete by July 2, 2025, and July 25, 2025, respectively.

Immunization 59

Immunization Immunity 59

Outsourcing Pharma

JUNE 20, 2023

A small molecule compound has shown to induce strong anti-tumor immune responses â an area where medical need is high.

Compounding 52

Compounding Immunization Immunity 52

Express Pharma

SEPTEMBER 4, 2024

Whilst most cases are mild and resolve within a few weeks, some people – particularly children, pregnant women, and those with suppressed immune systems – may endure more severe disease, which can be fatal. The SPRP covers a six-month period from September 2024 to February 2025.

Vaccines 104

Vaccines Immunization Immunity 104

Express Pharma

JUNE 26, 2024

The mRNA portion of these vaccines encodes a disease-specific antigen, prompting cells to display the antigen and stimulating an immune response. This product has now received the most review designations of all mRNA vaccines and is expected to launch commercially before the end of 2025.

Vaccines 111

Vaccines Immunization Immunity 111

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition.

Mayo Clinic 105

Mayo Clinic Dosage Biosimilars Immunization 105

pharmaphorum

DECEMBER 21, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

Biosimilars 126

Biosimilars Chemotherapy Immunization Immunity 126

Pharmaceutical Business Review

SEPTEMBER 2, 2024

The Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) [NVX-CoV2705] is now authorised for active immunisation against Covid-19. The CDC’s Advisory Committee on Immunization Practices unanimously recommended the use of the 2024-2025 COVID-19 vaccines for individuals as young as six months in June this year.

Vaccines 59

Vaccines Adverse Reactions Immunization Immunity 59

Big Molecule Watch

JANUARY 6, 2025

Ustekinumab is a monoclonal antibody that selectively inhibits human interleukin IL-12 and IL-23, cytokines that play a role in inflammatory immune responses. According to Celltrion, STEQEYMA is expected to be marketed in the United States beginning in February 2025.

Biosimilars 45

Biosimilars Immunization Immunity 45

Big Molecule Watch

FEBRUARY 17, 2025

On February 5, 2025 Valneva SE (Valneva) announced that the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valnevas chikungunya vaccine, IXCHIQ. Data has since shown this response can be maintained for at least three years in both younger and older adults.

Vaccines 45

Vaccines Immunization Immunity Labelling 45

The Thyroid Pharmacist

NOVEMBER 29, 2023

This product is designed to support the rapid reproduction of beneficial bacteria throughout the small and large intestines, to promote healthy gastrointestinal and immune function. Research has shown that the cat’s claw plant may have antiviral, anti-inflammatory, antioxidant, and immune-modulating properties.

Health and Personal Care Stores 73

Health and Personal Care Stores Immunization Immunity Labelling 73

Express Pharma

MARCH 3, 2025

The project is expected to get underway in March 2025, and is being supported by the Gates Foundation. Zydus will carry out early-stage development, animal immunogenicity studies and regulatory preclinical toxicology studies for this combination vaccine.

Vaccines 52

Vaccines Immunization Immunity 52

Pharmacy Times

FEBRUARY 21, 2025

The AACR Immunotherapy Conference 2025 will provide pharmacists with the opportunity to engage with cutting-edge cancer immunotherapy research, explore advancements in treatments, such as immune checkpoint inhibitors and CAR T-cell therapy, and connect with key leaders in the field.

Immunization 33

Immunization Immunity 33

Pharmaceutical Technology

DECEMBER 6, 2022

Until 2025, the companies will equally share the research and intellectual property licensing expenses under the partnership. Individuals with weak immune systems could have severe symptoms, and congenitally infected babies could suffer from an intellectual disability and vision and hearing loss.

Vaccines 52

Vaccines Immunization Immunity 52

pharmaphorum

JANUARY 10, 2022

Fellow big pharma company, Sanofi has also made a number of moves to bolster its R&D pipeline for mRNA vaccines – not least when it stated that it would invest €400 million each year into the development of mRNA vaccines, with the aim of developing six clinical candidates by the end of 2025.

Vaccines 111

Vaccines Immunization Immunity 111

European Pharmaceutical Review

SEPTEMBER 5, 2024

2 These are cells commonly found in the stroma of the tumour, which play an important role in inhibiting the body’s own immune response to the tumour, mediated through CD8+ T-cells (tumour-infiltrating lymphocytes). Research in the last few years has shown NOX4 in tumour cells is linked to the growth of cancer-associated fibroblasts (CAFs).

Immunization 59

Immunization Immunity Diabetes 59

Quality Matters

FEBRUARY 6, 2025

To understand monoclonal antibody drugs, its necessary to first know a little about how antibodies work in the bodys immune system. The immune system protects the body from harmful substances, microbes and abnormal cells that can cause diseases. Anything that triggers an immune response is called an antigen.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Immunization Immunity Biosimilars 52

pharmaphorum

AUGUST 22, 2021

Prior to CheckMate-274, no immune checkpoint inhibitor had shown efficacy as adjuvant therapy for these patients, and BMS could have some time on its own in the category. Cisplatin is sometimes used to reduce the tumour before surgery or as adjuvant treatment afterwards, but there isn’t much data to support its benefit in invasive UC.

Chemotherapy 78

Chemotherapy Immunization Immunity 78

pharmaphorum

SEPTEMBER 15, 2020

The UK has also taken an option on another 40 million doses in 2022, and between 30 and 90 million until 2025. The hope is that directly targeting the cells lining the airways may stimulate a more effective immune response against SARS-CoV-2. If exercised, that second phase would be worth €900 million to the French biotech.

Vaccines 80

Vaccines Immunization Immunity 80

Pharmaceutical Technology

JUNE 20, 2023

The project is supported by A$400m in funding from the Victorian government and A$250m from three founding partners, namely the Burnet Institute, the Peter Doherty Institute for Infection and Immunity, and the University of Melbourne.

Immunization 52

Immunization Immunity Vaccines 52

Pharmaceutical Technology

MAY 25, 2023

Apexigen discovers and develops a new generation of antibody therapeutics to treat cancer, along with new immuno-oncology products to harness the immune system to combat and eradicate cancer. Pyxis Oncology will issue 0.1725 shares of its common stock, with par value of $0.001 per share, for each Apexigen share.

Immunization 52

Immunization Immunity 52

pharmaphorum

OCTOBER 12, 2022

Similar to how we injected mRNA into people to trigger an immune response and train their immune system against COVID-19, genomic medicine repairs cellular or molecular mechanisms that are dysfunctional and cause disease.”. By 2025, pharma’s investment in AI is expected to reach $3 billion.

Drug Development 105

Drug Development Immunization Immunity Vaccines 105

pharmaphorum

JULY 28, 2021

Under the agreement, Calico is responsible for research and early development until 2025 and will take projects through phase 2a trials until 2030, with AbbVie having an option to take over projects once they reach later-stage development and lead commercialisation efforts.

Immunization 59

Immunization Immunity Drug Development 59

European Pharmaceutical Review

MARCH 14, 2024

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. Topline data from Vera’s ORIGIN Phase III trial of atacicept is expected in the first half of 2025. IgAN is the most common primary glomerulonephritis worldwide.

Diabetes 98

Diabetes Labelling Immunization Immunity 98

European Pharmaceutical Review

MARCH 14, 2024

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. Topline data from Vera’s ORIGIN Phase III trial of atacicept is expected in the first half of 2025. IgAN is the most common primary glomerulonephritis worldwide.

Diabetes 98

Diabetes Labelling Immunization Immunity 98

Big Molecule Watch

APRIL 29, 2024

Pfizer and BioNTech’s IPR petitions allege that the ‘127 and ‘600 patents are directed to “the use of mRNAs encoding any spike protein or spike protein subunit of any betacoronavirus, formulated in a broadly claimed lipid delivery system, to induce an immune response.” On April 12, 2024, Judge Richard G.

Immunization 65

Immunization Immunity 65

European Pharmaceutical Review

DECEMBER 19, 2023

Available from: [link] Vaccines and Immunization. Immunization coverage. Since vaccines can now be reformulated to meet the relevant WHO guidelines, the route to a future of fridge-free vaccines is open. A microneedle vaccine printer for thermostable COVID-19 mRNA vaccines. Nat Biotechnol. Injection Safety Fact Sheet. Internet] WHO.

Vaccines 111

Vaccines Communication Immunization Immunity 111

Express Pharma

JULY 3, 2023

The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025. The industry is looking for the identification of the right biologics or biosimilars to treat the next generation of auto-immune disorders, cancer, diabetes, rheumatoid arthritis, etc.

Biosimilars 95

Biosimilars Drug Development Generic Medicine Diabetes 95

pharmaphorum

SEPTEMBER 11, 2022

Analysts at Mizuho have suggested that competition from BMS’ drug could trim Otezla’s 2025 sales from $3 billion to $2 billion, although Amgen is attempting to defend its product by expanded the label of the drug to include mild psoriasis. Otezla was acquired by Amgen for $13.4

Labelling 52

Labelling Immunization Immunity 52

PharmaShots

JUNE 1, 2023

We are very pleased to demonstrate that our innovative immunotherapy platform can induce a strong immune response in humans. We reported at ESMO-IO the analysis of immune response of the first 3 cohorts of patients. Anti-PD-1 antibodies have recently become standard first-line treatments for melanoma and NSCLC. 2015; Zhu et al.,

Immunization 40

Immunization Immunity Vaccines Health and Personal Care Stores 40

Pharmaceutical Technology

JULY 29, 2022

The Omicron variant spreads more easily than earlier variants of the virus that cause Covid-19, including the Delta variant, and also has the ability to sometimes evade immunity from vaccines, previous infection, or both. Jubilant will double its injectable filling capacity in Spokane at a cost of $193m, to be completed by 2025.

Vaccines 52

Vaccines Packaging Immunization Immunity 52

pharmaphorum

JANUARY 13, 2023

Everyone agrees that cell and gene therapies are poised for an explosion, with far more drugs in the pipeline than are currently approved, and the FDA predicts it will clear 10 to 20 per year by 2025. These therapies have incredible potential to fight cancer and other diseases using the patient’s own immune system.

Drug Pricing 98

Drug Pricing Immunity Immunization Vaccines 98