Tag: breast cancer

FDA Encourages Drugmakers to Enroll Male Patients in Breast Cancer Clinical Trials

clinical trials
The US Food and Drug Administration (FDA) issued new draft guidance encouraging drugmakers to enroll male patients in breast cancer clinical trials. While men account for less than one percent of b...

EMA to Review MAA for First China-Developed Trastuzumab Biosimilar

First trastuzumab developed in China following the National Medical Products Administration (NMPA) technical guideline for biosimilar with the New Drug Application (NDA) received the acceptance for re...

PhoenixMD and WuXi STA Produced Multikilogram Drug Supply for TNBC Treatment

PhoenixMD and WuXi STA have produced a multikilogram drug supply for PMD-026 under GMP manufacturing practices. Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designi...

Celgene Cancer Treatment Therapy Not Reach Endpoint

Top-line results announced from the international Phase 3 study evaluating adjuvant therapy with ABRAXANE in combination with gemcitabine vs. gemcitabine alone for patients with surgically resected pa...

FDA Approved Pfizer’s First Oncology mAb Biosimilar

Pfizer Inc. announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab), for the treatment of human epide...

Accelerated Approval for Roche Breast Cancer Treatment

Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® ) for the treatment of adults with unres...

EU Advisors Recommend AstraZeneca and Merck’s Tablets

AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positi...

Genentech Announced FDA Approval for Breast Cancer Treatment

Genentech, a member of the Roche Group, announced the U.S. Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) inj...

NICE Recommends Roche’s Breast Cancer Drug for Post-Surgery

NICE has published final draft guidance recommending pertuzumab (Perjeta, Roche) for treating early HER2-positive breast cancer in people whose disease has spread to their lymph nodes. This positiv...

Roche Plans to Expand Use of its Breast Cancer Drug

Roche has submitted a supplemental biologics license application in the US seeking to expand the use of Kadcyla (trastuzumab emtansine) to include the adjuvant treatment of people with HER2-positive e...

First China’s P4P Program for Cancer by Pfizer

Pfizer Inc. launched a pay-for-performance insurance program for its breast cancer drug Ibrance palbociclib in China. The program is the nation's first pay-for-performance insurance for oncology and c...

NICE Recommended Lilly’s Breast Cancer Drug

NICE has published draft guidance that now recommends Eli Lilly’s breast cancer drug Verzenios for use on the NHS. The guidance concludes that Verzenios (abemaciclib) is as effective as its rivals,...

Knight Therapeutics to Commercialise US Cancer Drug in Canada

Canada-based Knight Therapeutics signed an exclusive licence agreement with Puma Biotechnology to commercialise Nerlynx (neratinib) medicine in the country. Nerlynx is intended for the extended adj...

Novel Way to Treat Breast Cancer

Angle’s liquid biopsy system has been used in new cancer research that could provide a novel way to treat breast cancer and other tumours, by stopping or suppressing their spread from the original sit...

FDA Approved Breast Cancer Drug of Celltrion and Teva

The FDA has approved Celltrion and Teva’s biosimilar of Roche’s breast cancer drug Herceptin, the second potential competitor to the cancer blockbuster in the US. Herceptin is due to go off patent ...