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Pharma news

The FDA grants approval of orphan drug Haegarda to Behring

CSL Behring LLC, has gotten the FDA’s approval of Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.

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LEADER trial data included in Novo Nordisks Saxenda in Europe

Novo Nordisk got the right from the European Medicines Agency’s committee (EMA) to include data from the LEADER trial to Saxenda to the results from the trial showed the long-term effects of Victoza for type 2 diabetes and established cardiovascular disease patients.

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Novartis’s certain cancer combination approved by FDA; fourth actionable genomic biomaker in metastatic NSCLC

Novartis was cleared on Thursday by the US Food and Drug Administration (FDA) for combination of Tafinlar (dabrafenib) with Mekinist (trametinib) for treating metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express the BRAF V600E mutation, which is fourth actionable genomic biomaker in metastatic NSCLC

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Novartis’s large heart attack realted study meets endpoints

Novartis’s Phase III Cantos study of ACZ885 (canakinumab), one of the largest in the company’s history, combined with standard of care in people with a prior heart attack and inflammatory atherosclerosis has met the primary endpoint.

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ValiRx forms advisory board

ValiRx’s has formed an Advisory Board to support its main board in new strategic guidance and technical advice.

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Herantis announces initial plans for continued development of Lymfactin

Herantis Pharma’s clinical study with its investigational gene therapy product Lymfactin for treating secondary lymphedema has advanced to the last patient cohort, owing to good reported safety, the company said Thursday.

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Breast cancer patients testing Enzychem’s cheaper Mosedipimod, hopes for FDA’s approval

Announcing the phase 2 testing on Monday, the company said that the multicenter study of EC-18 (Mosedipimod), the world’s first oral medicine candidate to prevent and treat Chemotherapy-Induced Neutropenia (CIN), will begin dosing its first patient in the Asan Medical Center of Seoul, Korea. Enzychem also said it hopes to have EC-18 be approved by the FDA.

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Enable Injections presents syringe transfer system in a conference

Enable Injections debuts the first multi-vial/multi syringe system for biologics delivery. The small, handheld device can also be used for variable dosing based on patient’s weight, providing maximum flexibility and ease of use with a minimum of waste.

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Sanovas expands in China, $75 million in capitalization

Sanovas, Inc., a Life Science technology company will establish a venture capital fund and Innovation Center at the Suzhou Institute of Nanotechnology and NanoBionics (SINANO) at the Chinese Academy of Sciences to advance the company’s innovations and sales in China.

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Texas becoming big player in life science and biotech industry

Texas is headed to San Diego this week to showcase the state’s thriving biotechnology and life sciences sector at the world’s largest biotechnology conference, BIO International. More than 16,000 biotechnology and pharmaceutical leaders are expected to attend the annual conference, said Texas Economic Development Corporation.

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