Neisseria meningitidis serogroup b nhba fusion protein antigen

NHS England Launches World-First Gonorrhoea Vaccine Amid Record Infection Rates

2 days ago

• England becomes the first country globally to implement a gonorrhoea vaccination program, targeting high-risk populations as infections reach record levels with over 85,000 cases reported in 2023. • The vaccine, repurposed from the meningitis B jab, offers 30-40% protection against gonorrhoea and will primarily be available to gay and bisexual men with multiple partners or previous STI history. • Public health officials hope the vaccination program will help combat the rising threat of antibiotic-resistant gonorrhoea strains, potentially preventing 100,000 cases and saving the NHS nearly £8 million over the next decade.

GSK and Novartis Complete $16 Billion Asset Swap Deal, Reshaping Both Companies' Strategic Focus

8 days ago

• GlaxoSmithKline and Novartis have completed their $16 billion asset swap deal, with GSK exchanging its oncology portfolio for Novartis's vaccines business, while also creating a joint consumer healthcare venture. • Analysts question GSK's decision to exit oncology—a high-growth therapeutic area where its portfolio showed 32% growth in 2014—while Novartis is praised for strengthening its position in the lucrative cancer market. • The strategic realignment allows both companies to focus on core strengths, with GSK concentrating on respiratory, HIV, vaccines and consumer healthcare, while Novartis enhances its prescription medicine portfolio with particular emphasis on oncology.

FDA Approves Zevtera for S. aureus Bacteremia, Marking First New Treatment in 15 Years

3 months ago

• Basilea Pharmaceutica's Zevtera (ceftobiprole) receives FDA approval for three indications, becoming the first beta-lactam antibiotic approved for Staphylococcus aureus bacteremia. • The approval addresses a significant medical need, with approximately 120,000 S. aureus bloodstream infections occurring annually in the US according to CDC data. • The drug's approval includes coverage for antimicrobial-resistant infections, particularly MRSA, targeting a market projected to reach $5.5 billion by 2030.

EMA Recommends Novartis' Meningitis B Vaccine for Approval

4 months ago

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended Novartis' meningitis B vaccine, Bexsero, for approval for patients aged 2 months or older. This vaccine represents a significant advancement in preventing meningococcus B bacterium, the leading cause of meningitis in industrialized countries. If approved, Bexsero could drastically reduce the incidence of childhood meningitis and septicemia.

FDA Approves Abrysvo for RSV Prevention in Adults Aged 18-59 at Increased Risk

5 months ago

• The FDA has approved Abrysvo, Pfizer's RSV vaccine, for adults aged 18-59 at increased risk of RSV-associated lower respiratory tract disease. • Abrysvo is the first RSV vaccine approved for adults younger than 50, addressing a crucial need for at-risk individuals in this age group. • Data from the pivotal Phase 3 MONET clinical trial supported the approval, highlighting the vaccine's efficacy in preventing RSV-related illness. • This approval marks a significant advancement in RSV prevention for younger adults with specific risk factors.

FDA Gears Up for Critical Decisions on Alzheimer's, Breast Cancer, and Neurological Therapies in Early 2025

5 months ago

• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.

GSK's Penmenvy Approved by FDA for Meningococcal Disease Prevention in Adolescents and Young Adults

6 months ago

• The FDA has approved GSK's Penmenvy vaccine for individuals aged 10-25, targeting five major serogroups of Neisseria meningitidis. • Penmenvy combines antigenic components from GSK's Bexsero and Menveo vaccines, offering broader protection against invasive meningococcal disease (IMD). • Clinical trials demonstrated a safety profile consistent with GSK's existing meningococcal vaccines, showing effective immune responses. • The CDC's Advisory Committee on Immunization Practices will vote on recommendations for Penmenvy's use in adolescents and young adults.

GSK Reports Sharp Decline in Vaccine Sales as RSV Shot Arexvy Falls 72% in Q3

7 months ago

• GSK's Q3 vaccine sales declined significantly, with RSV vaccine Arexvy experiencing a 72% year-over-year drop and shingles vaccine Shingrix falling 7%, leading to revised sales forecasts. • Narrowed CDC recommendations, COVID vaccination prioritization, and lower RSV infection rates contributed to Arexvy's sales decline, mirroring similar challenges faced by Pfizer's competing vaccine Abrysvo. • Despite current setbacks, GSK maintains market leadership in RSV vaccination and projects Arexvy's annual peak sales to exceed 3 billion pounds, emphasizing the vaccine's long-term potential.

Neisseria meningitidis serogroup b nhba fusion protein antigen

Drug Development Updates