Business & Industry News
Bayer and Onyx Provide Update on Phase III Trial of Nexavar®
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. announced that a Phase III trial evaluating Nexavar® (sorafenib) tablets in patients with non-small cell lung cancer (NSCLC) was stopped early following a planned interim analysis, when the independent Data Monitoring Committee (DMC) concluded that the study would not meet its primary endpoint of improved overall survival. Trasylol® - One Thousand Lives A Month
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EUSA Pharma Out-Licenses Preclinical-Stage Human Antibody to GlaxoSmithKline
FDA grants fast track designation for Boehringer Ingelheim's BIBW 2992
Boehringer Ingelheim's investigational cancer treatment BIBW 2992 has recently received a Fast Track Designation status by the FDA. Under this designation, Boehringer Ingelheim will conduct a pivotal trial programme studying BIBW 2992 in a non-small cell lung cancer (NSCLC) patient group where prior treatment with reversible EGFR inhibitors has failed. Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin)
Abbott received U.S. Food and Drug Administration (FDA) approval for SIMCOR(R), the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan(R) (Abbott's proprietary niacin extended-release) and simvastatin. SIMCOR is approved for use along with diet to lower levels of elevated total cholesterol, LDL "bad" cholesterol and triglycerides, and to raise HDL "good" cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate. Pharmion and MethylGene Announce U.S. Orphan Drug Designation
Pharmion Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Companies' histone deacetylase (HDAC) inhibitor, MGCD0103, as an Orphan Drug for the treatment of acute myelogenous leukemia (AML) in the United States. More Pharma News ...
Business & Industry
- CPHI Pharma Awards open to global innovators, scientists, entrepreneurs and social leaders
- Insilico Medicine brings AI-powered "ChatPandaGPT" to its target discovery platform
- BlueRock Therapeutics to incorporate wearable and invisible contactless digital health technologies from Rune Labs and Emerald Innovations in Parkinson's disease clinical trial
- Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma
- AstraZeneca launches call for entries to the 2023 global R&D Postdoctoral Challenge
Research & Development
- 'Biohybrid' device could restore function in paralysed limbs
- Scientists use tardigrade proteins for human health breakthrough
- DNA treatment could delay paralysis that strikes nearly all patients with ALS
- Scientists reveal a potential new approach to treating liver cancer
- Normalizing tumor blood vessels may improve immunotherapy against brain cancer
- Engineered bacteria find tumors, then alert the authorities
- First nasal monoclonal antibody treatment for COVID-19 shows promise for treating virus, other diseases
Conferences & Events
- SAE Media Group proudly presents the 4th Annual AI in Drug Discovery Conference
- SAE Media Group's 6th annual 3D Cell Culture Conference
- CPHI Frankfurt returns to pre-pandemic strength as pharma industry booms again
- 14th Annual RNA Therapeutics: Investigating the next generation of genetic medicine through RNA based therapies
- CPHI Excellence in Pharma Award Winners 2022
- CPHI Frankfurt Report predicts huge funding overhang to drive contract services growth
- CPHI Frankfurt 2022: Global pharma confidence hits record high in the annual CPHI Pharma Index
Regulatory Affairs
- FDA grants Accelerated Approval for Alzheimer's disease treatment
- FDA approves new HIV drug for adults with limited treatment options
- FDA approves first gene therapy for the treatment of high-risk, non-muscle-invasive bladder cancer
- FDA approves first gene therapy to treat adults with Hemophilia B
- FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease