Daré Bioscience Announces Publication of Phase 1/2 Pharmacokinetic, Safety and Pharmacodynamic Data for DARE-VVA1

Daré Bioscience has announced the publication of Phase 1/2 clinical study results for its investigational formulation, DARE-VVA1. The tamoxifen-based product is designed to treat vulvovaginal atrophy (VVA) in women without hormones and was found to be safe and well-tolerated in postmenopausal participants with moderate to severe VVA. Daré is developing DARE-VVA1 as a hormone-free option for pati..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms

Milla Pharmaceuticals and Alter Pharma Group Receive FDA Approval for Dexmedetomidine Hydrochloride Injection

Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, has received FDA approval for its generic version of Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, which is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. The drug should be administered by continuous infusion not to exceed 24..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms

Inspire Medical Systems, Inc. Announces FDA Approval for Apnea Hypopnea Index Indication Expansion and Increased Body Mass Index Labeling

Medical technology company Inspire Medical Systems has received approval from the US Food and Drug Administration for an expanded indication that increases the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index warning in labeling to 40 from 32. The update will provide a safe and effective treatment option for patients with moderate to se..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms

Sumitomo Pharma Oncology, Inc. Presents Updated Preliminary Data from Phase 1/2 Clinical Study Evaluating Investigational Agent TP-3654 in Patients with Myelofibrosis at European Hematology Association 2023 Hybrid Congress

Sumitomo Pharma Oncology, Inc. has presented updated preliminary data from a Phase 1/2 clinical study evaluating TP-3654 at the European Hematology Association 2023 Hybrid Congress. The investigational selective oral PIM1 kinase inhibitor is being tested in patients with myelofibrosis who were previously treated with or ineligible for JAK inhibitor therapy. Preliminary data showed spleen volume ..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms

ACROBiosystems Aneuro Partners with Diagnostic Biochips to Accelerate Neuroscience Drug Discovery

ACROBioSystems and Diagnostic Biochips have partnered to accelerate neuroscience drug discovery, according to a recent announcement. ACROBioSystems has launched in vivo electrophysiology solutions for neuroscience research under its Aneuro brand that will work without a headstage, reducing the physical burden on animal heads without compromising signal channels. The probes are designed to help r..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms

Stem Cell Therapy Market Size to Reach Around USD 31.41 BN by 2030

The global stem cell therapy market is projected to reach USD 31.41 billion by 2030, growing at a CAGR of 13.73% during the forecast period from 2023 to 2030. The market size was estimated at USD 11.22 billion in 2022 and is expected to expand to USD 24.29 billion by 2028. Factors driving the growth of the market include accelerated funding for stem cell therapies, rising interest in stem cell-b..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms

Biden Administration Imposes Penalties on 43 Drugs Due to Price Hikes

The Biden administration has implemented inflation penalties on 43 Medicare Part B drugs to reduce costs for older Americans, following the imposition of fines on 27 drugs in March. The Inflation Reduction Act (IRA) requires pharmaceutical manufacturers to justify price increases exceeding the inflation rate, with financial penalties imposed if justifications are found insufficient. Under the IR..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms

AstraZeneca and Sanofi's Pediatric RSV Antibody Receives Unanimous Backing from FDA Panel

AstraZeneca and Sanofi have received unanimous backing from the FDA’s Antimicrobial Drugs Advisory Committee for their respiratory syncytial virus (RSV) antibody, nirsevimab, for use in the pediatric setting. Nirsevimab is an investigational long-acting antibody that targets and binds to the part of the RSV virus that attaches to the host’s cells. If approved, nirsevimab would become the first i..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms

Gene Editing Race Between Editas and Vertex, CRISPR Heats Up

The gene editing race between Editas Medicine and Vertex Pharmaceuticals with CRISPR Therapeutics has heated up as both companies released positive data for their sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT) hopeful treatments. Editas Medicine unveiled early data from the RUBY and EdiTHAL trials on Friday, demonstrating the potential of its gene editor EDIT-301 in t..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms

FDA Adcomm Unanimously Backs Full Approval of Eisai, Biogen’s Leqembi

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has unanimously supported Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease. This indicates that the FDA is likely to grant full approval before July 6th, as it usually follows its advisory committee's recommendations. The FDA released briefing documents on Wednesday that showed agency staff be..

• format_list_bulleted BS
• · 2023. 6. 11.
• textsms