Novo Holdings Invests in SCHOTT Poonawalla to Strengthen Injectable Drug Packaging Capabilities in India
• Novo Holdings has made a strategic investment in SCHOTT Poonawalla, India's leading provider of injectable drug containment solutions, alongside TPG Growth to accelerate innovation and expansion.
• SCHOTT Poonawalla, a joint venture between SCHOTT Pharma AG and Serum Institute of India, operates three manufacturing facilities with an annual capacity exceeding 3 billion units and serves over 100 pharmaceutical customers.
• This marks Novo Holdings' first investment in India's medtech manufacturing sector, reinforcing its commitment to strengthening pharmaceutical infrastructure and supply chain resilience in Asia.
TPG Acquires 35% Stake in SCHOTT Poonawalla for $300 Million, Strengthening Drug Delivery Innovation
• US private equity firm TPG, along with co-investor Novo Holdings, has agreed to acquire a 35% stake in SCHOTT Poonawalla from Serum Institute of India (SII) for approximately $300 million, with the deal expected to close in the first half of 2025.
• SCHOTT Poonawalla, India's largest injectables-focused drug containment solutions company, will maintain its existing structure with SCHOTT Pharma retaining 50% ownership while SII will keep a minority stake following the transaction.
• The strategic partnership aims to accelerate SCHOTT Poonawalla's global expansion by combining TPG's healthcare investment expertise with the company's advanced drug delivery solutions portfolio, which includes prefillable syringes, cartridges, and vials for biologics and vaccines.
FDA Misses Deadline for Full Approval Decision on Novavax's COVID-19 Vaccine
• The U.S. Food and Drug Administration (FDA) has missed its April 1 deadline to decide on granting full approval to Novavax's protein-based COVID-19 vaccine, which currently has Emergency Use Authorization.
• The delay comes shortly after the resignation of Peter Marks, the FDA's top vaccine regulator who played a key role in COVID-19 vaccine approvals during the pandemic.
• According to reports, FDA senior leaders have indicated that Novavax's application needs more data, making approval unlikely in the near term, though the company maintains it has responded to all information requests.
FDA Grants ImmunityBio Authorization to Supply Recombinant BCG Amid TICE BCG Shortage
• ImmunityBio receives FDA authorization to provide recombinant BCG (rBCG) to urologists, addressing the critical TICE BCG shortage for bladder cancer treatment.
• Phase 1/2 clinical studies demonstrate rBCG's favorable safety profile compared to earlier BCG strains, showing tolerability similar to placebo when administered intravesically.
• The modified rBCG features two genetic enhancements designed to improve immunogenicity and safety, supported by data from multiple clinical trials including studies in bladder cancer patients.
Inventiva Restructures to Focus on MASH Drug Development, Reports €96.6M Year-End Cash Position
• Inventiva announces strategic pipeline prioritization, halting all preclinical research to focus exclusively on lanifibranor development for MASH treatment, with planned 50% workforce reduction.
• Company reports €96.6 million cash position at 2024 year-end, securing operations until Q3 2025, with potential additional funding of €116 million expected in Q2 2025.
• Last patient screening completed in NATiV3 Phase 3 trial of lanifibranor, with final patient randomization expected in first half of 2025 and topline results anticipated in second half of 2026.
Valneva's IXCHIQ Shows Sustained Immune Response in Adolescents and Positive Phase 2 Results in Children
• Valneva's IXCHIQ vaccine demonstrates a sustained 98.3% sero-response rate one year after single vaccination in adolescents, supporting potential label extension.
• Phase 2 trial data in children aged 1-11 years shows the vaccine is well-tolerated and highly immunogenic, paving the way for a Phase 3 study.
• The UK's MHRA has granted marketing authorization for IXCHIQ, making it available for adults, with plans for label extension applications.
• Valneva partners with CEPI and SII to expand access to the vaccine in low- and middle-income countries, addressing a significant unmet need.
Serum Institute of India Gains Approval for Typhoid and Yellow Fever Vaccine Trials
• Serum Institute of India (SII) has received CDSCO panel approval to proceed with Phase II/III clinical trials for its typhoid conjugate vaccine (bivalent).
• The typhoid vaccine trial will assess safety, immunogenicity, and lot-to-lot consistency in individuals aged 6 months to 65 years.
• SII also secured approval to conduct a Phase III clinical trial for its yellow fever vaccine, following positive interim results from the Phase II study.
• The yellow fever vaccine trial aims to further evaluate the vaccine's safety and immunogenicity based on a revised protocol.
ImmunityBio Advances Anktiva for Bladder Cancer Treatment in US and Europe
• ImmunityBio completed regulatory filings in the EU and UK for Anktiva with BCG for BCG-unresponsive NMIBC, with decisions expected by 2026.
• Anktiva, combined with BCG, received FDA approval in April 2024 for NMIBC in the US, showing broad availability through insurance programs.
• The company is preparing a supplemental Biologics License Application (sBLA) for Anktiva + BCG in papillary NMIBC, with submission planned for 2025.
• Clinical data showed a 55% disease-free rate at 12 months and a 93% cystectomy avoidance rate with Anktiva + BCG in NMIBC patients.
ImmunityBio's Anktiva Pursues European and UK Approval for BCG-Unresponsive Bladder Cancer
• ImmunityBio's Anktiva, combined with BCG, seeks approval in the EU and UK for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).
• The MAAs submitted to the EMA and MHRA are supported by Phase 2/3 QUILT-3.032 trial data, demonstrating a 71% complete response rate in patients with NMIBC with CIS.
• Regulatory assessments by both agencies are anticipated to conclude by Q4 2025, potentially leading to approval in Europe and the UK by 2026, expanding global access.
• ImmunityBio also plans to submit a supplemental BLA to the FDA in 2025, seeking approval for Anktiva in patients with BCG-unresponsive NMIBC in the papillary indication.
Novavax Achieves First $50 Million Milestone in Sanofi Partnership, Advancing COVID-19 and Influenza Vaccine Development
Novavax has reached a significant milestone in its partnership with Sanofi, triggering a $50 million payment related to its COVID-19 vaccine clinical trials in children. This collaboration also includes the development of combination vaccines for influenza and COVID-19, which have received Fast Track designation in the U.S. and are currently in Phase 1/2 trials. The partnership underscores Novavax's corporate growth strategy and its commitment to advancing vaccine technology.
Novavax Launches Phase 3 Trial for COVID-19-Influenza Combination Vaccine
Novavax has initiated a Phase 3 clinical trial for its COVID-19-Influenza Combination (CIC) vaccine and a stand-alone influenza vaccine, targeting adults aged 65 and older. The trial aims to evaluate the immunogenicity and safety of these vaccines compared to existing options. Novavax is also exploring an accelerated approval pathway with the U.S. FDA.
ANKTIVA Receives Permanent J-Code from CMS, Streamlining Reimbursement for Bladder Cancer Treatment
• The Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code (J9028) for ANKTIVA, effective January 1, 2025, to streamline billing.
• ANKTIVA, in combination with BCG, is FDA-approved for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).
• Clinical trial data shows ANKTIVA achieved a 71% complete response rate in patients with BCG-unresponsive NMIBC CIS, with durable responses up to 54 months.
Dengue Vaccine Landscape Evolves: New Candidates Show Promise in Clinical Trials
• Several dengue vaccine candidates are progressing through clinical trials, offering potential solutions for this widespread disease.
• Butantan-DV showed 67-79% efficacy in preventing dengue in a Phase 3 trial in Brazil and is awaiting regulatory approval.
• Panacea Biotech, in collaboration with ICMR, initiated a Phase 3 trial for their DengiAll vaccine in India after promising early-stage results.
• Codagenix Inc. received $5.88 million from the U.S. Department of Defense to advance its CodaVax-DENV tetravalent vaccine candidate.
HERVolution Therapeutics Secures $11.7 Million Series A to Advance HERV-Targeted Immunotherapies
• HERVolution Therapeutics raised $11.7 million in Series A funding to advance its immunotherapies targeting human endogenous retroviruses (HERVs).
• The funding will support clinical validation, cGMP manufacturing with Serum Institute of India (SII), and Phase 1 studies for lead asset IPT-001.
• HERVolution's approach focuses on reactivating dormant HERVs, which play a role in aging-related diseases like cancer, type 2 diabetes, and ALS.
• Lead candidate IPT-001, a dual adenoviral vector immunotherapy, is slated for clinical trials in 2025, with IPT-002 (mRNA vector) for prime-boost strategies.
FDA Approves Bavarian Nordic's Vimkunya, First Chikungunya Vaccine for Adolescents
• The FDA has approved Vimkunya, a chikungunya vaccine developed by Bavarian Nordic, for individuals aged 12 and older.
• Vimkunya is the first virus-like particle (VLP) single-dose chikungunya vaccine approved in the U.S., offering a new preventative option.
• Clinical trials showed Vimkunya induced neutralizing antibodies in up to 97.8% of vaccinated individuals within 21 days.
• Commercial availability of Vimkunya in the U.S. is expected in the first half of 2025, with launches in key European markets anticipated.
RH5.1/Matrix-M Malaria Vaccine Shows Promise as Blood-Stage Defense
• A Phase IIb trial of the RH5.1/Matrix-M vaccine shows 55% efficacy in preventing clinical malaria over six months in young children.
• The vaccine also demonstrated over 80% efficacy against high levels of malaria parasites, suggesting potential in preventing severe cases.
• RH5.1/Matrix-M targets the blood-stage of malaria, complementing existing vaccines that target the liver-stage of the parasite.
• The RH5.1/Matrix-M vaccine was well-tolerated, with mild adverse events, positioning it as a potential second line of defense against malaria.
Novavax Launches Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccines
• Novavax has initiated a Phase 3 trial for its COVID-19-Influenza Combination (CIC) vaccine and stand-alone influenza vaccine, evaluating immunogenicity and safety.
• The trial compares the CIC and stand-alone influenza vaccines to Novavax's updated COVID-19 vaccine and a licensed seasonal influenza vaccine in adults aged 65 and older.
• Novavax is collaborating with the FDA to explore potential accelerated approval pathways for both vaccine candidates, aiming for clarity by Q2 2025.
• The Phase 3 trial includes approximately 2,000 participants and builds upon positive Phase 2 data, with initial results expected by mid-2025.
FDA Halts Novavax's COVID-19 and Influenza Vaccine Trials Due to Safety Concerns
• The FDA has placed a clinical hold on Novavax's combination COVID-19 and influenza vaccine, along with its standalone influenza vaccine, following a serious adverse event report.
• The adverse event, motor neuropathy, was reported in a Phase 2 trial participant outside the U.S. who received the combination vaccine in January 2023.
• Novavax is collaborating with the FDA to provide necessary information and resolve the clinical hold, aiming to commence Phase 3 trials as soon as possible.
• The clinical hold does not affect Novavax's standalone COVID-19 vaccine, which remains available on the U.S. market.
© Copyright 2025. All Rights Reserved by MedPath