BLA

Bavarian Nordic’s Chikungunya Vaccine Candidate Granted Accelerated Assessment by European Medicines Agency

Retrieved on: 
Friday, February 23, 2024
Marketing, EMA, Marketing Authorisation Application, Committee, MAA, Food, BLA, Nature, Vaccination, CHMP, European Medicines Agency, Public, Chikungunya, OMX, Ageing, CHIKV, Vaccine

Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.

Key Points: 
  • Bavarian Nordic is on track to submit its Marketing Authorisation Application for CHIKV VLP to EMA during H1 2024.
  • COPENHAGEN, Denmark, February 23, 2024 – Bavarian Nordic A/S (OMX: BAVA) (“the Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for CHIKV VLP, the Company’s investigational chikungunya vaccine.
  • Bavarian Nordic is on track and plans to submit its MAA for CHIKV VLP to the EMA during H1 2024.
  • “We are pleased to receive the accelerated assessment in recognition of our chikungunya vaccine candidate and our efforts to bring this novel product to the market.

Telix 2023 Full Year Results: Inaugural Profit Achieved, Strong Revenue Growth Underpins Investment in Late-stage Pipeline

Retrieved on: 
Thursday, February 22, 2024
Marketing, Crown, Growth, U.S. FDA, BLA, Soft-tissue sarcoma, TLX, Ethics, ASX, Commercialization, Webcast, AEDT, Patient, Biologics license application, NDA, Research, Depreciation, Prostate cancer, Pharmaceutical industry

MELBOURNE, Australia, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its results for the financial year ended 31 December 2023.

Key Points: 
  • MELBOURNE, Australia, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its results for the financial year ended 31 December 2023.
  • Dr Christian Behrenbruch, Managing Director and Group CEO commented:
    “This is an excellent result which demonstrates the strength of the Telix business model.
  • Full year revenue for 2024 expected range of US$445M to US$465M ($675M to $705M at current exchange rates), representing an approximate 35-40% increase on 2023.
  • Expected additional investment of 40-50% in R&D (compared with 2023), including both external and internal costs funded by operating cash flow and broadly in line with revenue growth.

Greenwich LifeSciences Flamingo-01 Manufacturing & Protocol Accepted by European Regulators

Retrieved on: 
Thursday, February 22, 2024
Clinical trial, Breast cancer, EMA, Patient, BLA, European Medicines Agency, Immunotherapy, CTIS, Pharmaceutical industry

The Company's application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA's Clinical Trials Information System (CTIS).

Key Points: 
  • The Company's application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA's Clinical Trials Information System (CTIS).
  • The Company was informed that the manufacturing, non-clinical, clinical, statistical, and regulatory sections of its application are acceptable and the regulators' requests for information have been addressed.
  • The regulators have thus approved the clinical trial, marking a major milestone for the Company.
  • Once an individual site has been activated patients can be screened and enrolled.

Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review

Retrieved on: 
Wednesday, February 21, 2024
Bone marrow, Marketing, FDA, Food, Regeneron Pharmaceuticals, BLA, Safety, European Medicines Agency, Patient, Priority, Disease, Biologics license application, Tissue, Cancer, Pharmaceutical industry

Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Key Points: 
  • Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
  • The BLA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023.
  • Earlier this month, the European Medicines Agency accepted for review the Marketing Authorization Application for linvoseltamab in the same indication.
  • Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Savara Reports Fourth Quarter/Year-End 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 7, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Research, Chemistry, Investment, GM, Pulmonology, BLA, APAP, Patient, Disease, Chair, Inc., Cryptocurrency

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2023 and provided a business update.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2023 and provided a business update.
  • Research and development expenses for the fourth quarter of 2023 and 2022 were $12.7 million and $7.6 million, respectively.
  • General and administrative expenses for the fourth quarter of 2023 and 2022 were $4.9 million and $3.2 million, respectively.
  • As of December 31, 2023, the Company had cash, cash equivalents and short-term investments of $162.3 million.

CEL-SCI Corporation Issues Letter to Shareholders

Retrieved on: 
Wednesday, March 6, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Head, Neck, EMA, Health Canada, ESMO, Condition, Neoadjuvant therapy, Plasma protein binding, Neoplasm, Immunotherapy, Physician, Marketing, SCCHN, FDA, Food, BLA, Letter, Risk, European, Patent, COVID, Patient, Policy, MHRA, NOCC, United, Survival, Congress, NIHR, Diagnosis, Pembrolizumab, CGMP, PD-L1, Radiation, Pharmaceutical industry

CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
  • This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting.
  • In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
  • These features make it easy to write a label for Multikine, which is essential for drug approval.

Indapta Therapeutics Receives U.S. FDA Fast Track Designation for Lead Clinical Drug Candidate IDP-023 for Non-Hodgkin’s Lymphoma and Myeloma

Retrieved on: 
Thursday, February 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Fast Track, CMV, BLA, Cell, Biologics license application, Cytomegalovirus, Interleukin, Safety, Therapy, Cytokine, Accelerated approval (FDA), Patient, NK, Clinical trial, Multiple myeloma, Rituximab, Lymphoma, Cancer, Priority review, Pharmaceutical industry

Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).

Key Points: 
  • Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).
  • “This designation highlights the promise of Indapta’s highly potent NK cell platform and will further accelerate clinical development of our lead drug candidate, IDP-023, for two of the largest unmet needs in B-cell driven blood cancers, non-Hodgkin’s lymphoma and multiple myeloma,” said Dr. Mark Frohlich, CEO of Indapta.
  • Patients being enrolled now in Indapta’s Phase 1 clinical trial are receiving up to three planned doses of IDP-023 with or without interleukin-2.
  • To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells, with low donor-to-donor variability.

Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, February 28, 2024
Health, Genetics, Research, Pharmaceutical, Science, Biotechnology, SRPT, Hart–Scott–Rodino Antitrust Improvements Act, Investment, Interest, Sarepta Therapeutics, Part, Sale, University, Trial of the century, Ageing, BLA, GAAP, Therapy, BioMarin Pharmaceutical, Income tax, PMR, Depreciation, Magnesium deficiency, Nationwide Children's Hospital, Hospital, Safety, Patent, Clinical trial, Biologics license application, Mutation, Priority review, Acquisition, PIN, Dystrophin, FDA, Food, DMD, Duchenne muscular dystrophy, U.S. FDA, Agency, Patient, PRV, PMO, Pharmaceutical industry

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2023.

Key Points: 
  • Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2023.
  • Beginning in the fourth quarter of 2023, amortization of in-licensed rights (formerly included within depreciation and amortization expense) and income tax (benefit) expense are no longer excluded from the non-GAAP results.
  • Non-GAAP financial results for the fourth quarter and full-year 2022 have been updated to reflect this change for comparability.
  • All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table “Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures.”

Ligand Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, MRK, Research, CRL, New Drug Application, Investment, Eisai, Growth, Sale, Parent, Novin, Focal segmental glomerulosclerosis, Streptococcus, LGND, FSGS, Breakthrough therapy, BLA, AED, GAAP, Therapy, NASH, Liver, NDA, Depreciation, Breast cancer, Total, Forecasting, Perampanel, Shanda, Telecanthus, ID, Retirement, PDUFA, Vaccine, Symantec Endpoint Protection, Type 2 diabetes, Safety, VRNA, Molluscum contagiosum, F2, Acquisition, Caregiver, Merck, AASLD, FDA, Telephone, Food, Pneumonia, Income tax, Hepatology, COVID-19, Element, Patient, SPA, Pharmaceutical industry

Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.

Key Points: 
  • Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.
  • Costs of Captisol sales were $1.6 million for the fourth quarter of 2023, compared with $21.6 million for the same period in 2022, with the decrease due to lower total Captisol sales during the fourth quarter of 2023 and $9.8 million in accelerated depreciation on Captisol manufacturing equipment during the fourth quarter of 2022.
  • Amortization of intangibles was $8.3 million for the fourth quarter of 2023, compared with $8.5 million for the same period in 2022.
  • Travere also announced fourth quarter 2023 results reporting that it received 459 new patient start forms for FILSPARI in the fourth quarter of 2023 and net product sales of $14.9 million for the fourth quarter.

BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA

Retrieved on: 
Tuesday, February 27, 2024
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Incidence, Progression-free survival, European Commission, Tislelizumab, Anemia, Quality of life, Food, File, ESCC, BLA, Nausea, Vomiting, BGNE, Platelet, Safety, Stomach, Civil service commission, Death, Patient, Survival, Biologics license application, Appetite, Cancer, Pharmaceutical industry

“In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.

Key Points: 
  • “In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.
  • Median progression-free survival for TEVIMBRA plus chemotherapy was 6.9 months vs. 6.2 months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]).
  • The safety profile for TEVIMBRA in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies.
  • A BLA for the treatment of patients with advanced or metastatic ESCC after prior chemotherapy is also under review by the FDA.