New Approvals – Page 8 – media

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
- 165
- January 23, 2018
Avastin Mvasi New Approvals Roche
Aspyrian Therapeutics Inc. announces successful advances in RM-1929 clinical development

Aspyrian Therapeutics Inc. announces successful advances in RM-1929 clinical development in recurrent Head and Neck Cancer, including Fast Track designation granted by the FDA, initiation of clinical studies in Japan, and plans to start pivotal studies, which will incorporate the evaluation of anti-cancer immune responses, in early 2018.
- Source: Prnewswire
- 191
- January 19, 2018
anti-cancer immune New Approvals RM-1929
Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL

Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review.
- Source: Novartis
- 77
- January 18, 2018
DLBCL New Approvals sBLA
EU nod for Shire’s longer-acting haemophilia A therapy

Shire’s Adynovi has been approved for use in Europe for on-demand and prophylactic use in patients 12 years and older with the rare bleeding disorder haemophilia A.
- Source: Pharmatimes
- 108
- January 18, 2018
Adynovi haemophilia A New Approvals
Afatinib Approval Expanded for Rare Lung Cancer Treatment

Boehringer Ingelheim announced the approval of a new indication for afatinib (Gilotrif), as the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
- Source: Raredr
- 134
- January 17, 2018
afatinib DNA FDA New Approvals NSCLC
AstraZeneca’s PARP inhibitor gains market edge with breast cancer approval

AstraZeneca still enjoys the perks of being first to market with its PARP inhibitor. Lynparza (olaparib) sales were $81 million from July to September, whereas net revenues were $16.8 million and $39.4 million for Clovis Oncology Inc.'s Rubraca (rucaparib) and Tesaro Inc.'s Zejula (niraparib), respectively.
- Source: Biopharmadive
- 113
- January 17, 2018
inhibitor Lynparza New Approvals
NHS Adopts Early Warning Sepsis System

NHS officials have surmised that a system that identifies seriously ill patients would save approximately 2,000 lives a year. They have also estimated that 627,000 ‘bed days’ could be saved as a result.
- Source: Celebrity Angels
- 162
- January 17, 2018
New Approvals NHS sepsis
GBT Receives FDA Breakthrough Therapy Designation for Voxelotor for Treatment of Sickle Cell Disease (SCD)

Global Blood Therapeutics, Inc. (GBT) (GBT) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to voxelotor (previously called GBT440) for the treatment of sickle cell disease (SCD). Voxelotor is being developed as a disease-modifying therapy for SCD and previously received European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of SCD.
- Source: finance.yahoo
- 155
- January 16, 2018
FDA New Approvals SCD Voxelotor
Teva Announces U.S. FDA Approval of TRISENOX (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide
- Source: finance.yahoo
- 95
- January 16, 2018
APL arsenic trioxide FDA New Approvals Teva TRISENOX
Newly FDA-Approved Platform Will Rapidly “Manufacture” Stem Cells to Repair Our Bodies

Stem cells have the unique capability to transform into any sort of specialized cell needed in the body, making them especially promising for medicine that replaces nonfunctional or dead cells.
- Source: Futurism
- 105
- January 16, 2018
FDA New Approvals stem cells

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