Search Results for “Amgen ” – Page 13

Patient death forces FDA to slap a hold on study using combo from Advaxis, AstraZeneca — biotech’s shares plunge

The FDA has slapped a clinical hold on a combo therapy using Advaxis’$ADXS axalimogene filolisbac along with AstraZeneca’s approved PD-L1 Imfinzi following the death of a patient in their Phase I/II trial.

Source: endpts
625
March 15, 2018

Four health systems and VA plan to create nonprofit drug company

Four health systems — Intermountain Healthcare, Ascension, SSM Health and Trinity Health — and the U.S. Department of Veterans Affairs will launch a nonprofit generic drug company.

Source: Medcitynews
412
March 7, 2018

generic drug Market Views

Viela Bio Spins Out of MedImmune; Raises Up to $250 Million in Series A Financing, 6 Dimensions Capital Leads Investment

Viela Bio announced today that it has incorporated as an independent, inflammation - and autoimmunity - focused biotechnology company after spinning out from MedImmune, the global biologics research and development arm of AstraZeneca. Viela Bio will primarily focus on developing medicines for severe autoimmune diseases by targeting critical pathways that are the root cause of the diseases.

Source: finance.yahoo
474
March 1, 2018

autoimmunity inflammation Market Views

EMA accepts MAA for romosozumab in the treatment of osteoporosis

The EMA has accepted the Marketing Authorization Application for romosozumab in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.

Source: europeanpharmaceuticalreview
883
February 2, 2018

Amgen EMA Evenity (romosozumab) osteoporosis romosozumab

AstraZeneca’s PARP Inhibitor Lynparza Gets Approval in Japan

AstraZeneca AZN and partner Merck MRK announced that the Japanese Ministry of Health, Labour and Welfare has granted approval to its PARP inhibitor, Lynparza, as a maintenance therapy for relapsed ovarian cancer, irrespective of BRCA mutation status in patients who have responded to their last platinum-based chemotherapy.

Source: finance.yahoo
678
January 26, 2018

cancer inhibitor New Approvals ovarian

Biosimilar Avastin wins EU approval

European regulators have issued a green light for Amgen and Allergan’s Mvasi, marking the first biosimilar of Roche’s Avastin to be approved in the region. The drug has been cleared to treat a range of indications spanning carcinoma of the colon or rectum, breast cancer; nonsquamous non-small cell lung cancer, renal cell cancer; platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer. The companies noted that the approval came after trial data showed a high degree of similarity between Mvasi (biosimilar bevacizumab) and its reference drug, “with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products”. Mvasi is the first product borne out of an alliance between Amgen and Allergan to bag marketing authorisation from the European Commission, “highlighting the success of our joint commitment to developing cancer biosimilars,” noted David Nicholson, chief research and development officer at ...

Source: Pharmatimes
567
January 23, 2018

Avastin Mvasi New Approvals Roche

Pandion Therapeutics Announces $58 Million Series A Financing to Advance Tissue-Specific Immune Modulator Drugs

Pandion Therapeutics, Inc., a biotechnology company developing bispecific antibody therapeutics to achieve localized immunomodulation, today announced the completion of a $58 million Series A financing. This funding will be used to advance its initial drug programs for autoimmune and inflammatory diseases toward the clinic, as well as to continue building the company’s technology platform and pipeline. Polaris Partners, the founding investor that provided the initial seed funding, co-led the Series A financing along with Versant Ventures and Roche Venture Fund. SR One and BioInnovation Capital also participated in the round.

Source: finance.yahoo
898
January 22, 2018

antibody Company Insight immunomodulation

Scholar Rock scoops $47M to trial SMA drug

Scholar Rock has raised $47 million to take its treatment for spinal muscular atrophy (SMA) into the clinic. The series C tees up Scholar Rock to find out whether its myostatin blocker can best the underwhelming performance of one-time rivals from companies including Novartis.

Source: fiercebiotech
493
January 4, 2018

blocker Company Insight myostatin SMA

Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

Approval based on data from the Phase III RESORCE study where Stivarga® (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib)

Source: investor.bayer
701
December 14, 2017

Bayer CFDA hepatocellular carcinoma Nexavar® Stivarga®

Obsidian Therapeutics Announces $49.5 Million Series A Financing to Develop Controllable Cell and Gene Therapy Products

Obsidian Therapeutics, Inc., a biotechnology company dedicated to the development of next-generation cell and gene therapies with pharmacologic operating systems, announced the completion of a $49.5 million Series A financing to further build its technology platform and advance its lead programs toward clinical development.

Source: Businesswire
557
December 8, 2017

CAR–T Market Views Series

Patient death forces FDA to slap a hold on study using combo from Advaxis, AstraZeneca — biotech’s shares plunge

Four health systems and VA plan to create nonprofit drug company

Viela Bio Spins Out of MedImmune; Raises Up to $250 Million in Series A Financing, 6 Dimensions Capital Leads Investment

EMA accepts MAA for romosozumab in the treatment of osteoporosis

AstraZeneca’s PARP Inhibitor Lynparza Gets Approval in Japan

Biosimilar Avastin wins EU approval

Pandion Therapeutics Announces $58 Million Series A Financing to Advance Tissue-Specific Immune Modulator Drugs

Scholar Rock scoops $47M to trial SMA drug

Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

Obsidian Therapeutics Announces $49.5 Million Series A Financing to Develop Controllable Cell and Gene Therapy Products

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