On Friday, November 17, Genentech, a Roche company, sued Pfizer in a federal court in Wilmington, Delaware, over Pfizer’s biosimilar for Genentech’s Herceptin. Genentech is claiming that Pfizer’s proposed biosimilar infringes 40 of its patents. Genentech also is demanding compensation for lost sales if Pfizer launches its copycat version before the Herceptin patents expire.
Metastatic cancer is responsible for the vast majority of cancer deaths, but our limited understanding of how metastasis begins makes finding ways to stop it hugely challenging. A new study may provide some insight, however.
Researchers at Stanford University School of Medicine with the National Cancer Institute (NCI) have identified another cancer-surface molecule, CD22, and begun trials on B-cell acute lymphoblastic leukemia (ALL) patients using an immuno-oncology approach similar to CAR-T. In the Phase I trial, 15 of the 21 patients who had previously relapsed or did not respond to anti-CD19 CAR-T, were treated with an anti-CD22 CAR-T therapy. Ten of the 15 patients had already received treatment for CD19-targeted treatment.
Twice on Thursday, Genentech, scored two approvals from the U.S. Food and Drug Administration(FDA) – a new medicine for hemophilia and an expansion for its cancer drug Gazyva.
Remarkable progress is being made on HIV treatment. Ahead of World AIDS Day, UNAIDS has launched a new report showing that access to treatment has risen significantly. In 2000, just 685 000 people living with HIV had access to antiretroviral therapy. By June 2017, around 20.9 million people had access to the life-saving medicines. Such a dramatic scale-up could not have happened without the courage and determination of people living with HIV demanding and claiming their rights, backed up by steady, strong leadership and financial commitment.
Biopharma™, Inc., an immunotherapy company developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system to treat cancer and autoimmune diseases, announced a strategic research collaboration and license agreement with Merck, known as MSD outside of the United States and Canada.
The U.S. Food and Drug Administration(FDA) approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.
Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration(FDA) has approved a new indication expanding the use of SUTENT® (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). The approval was based on results from the S-TRAC trial that demonstrated a significant reduction in the risk of a disease-free survival (DFS) event (defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause) for patients at high risk of RCC recurrence who received SUTENT compared to placebo in the adjuvant setting.
Infants with the most severe form of spinal muscular atrophy (SMA) were more likely to show gains in motor function and were 47 percent more likely to survive without permanent assisted ventilation support when treated with a new medication, according to a study published today in the New England Journal of Medicine. The drug, nusinersen, performed so well that the study was stopped early and the treatment was approved shortly thereafter by the U.S. Food and Drug Administration (FDA) for all patients with this progressive neuromuscular disorder.
Sangamo Therapeutics, Inc. (SGMO) today announced treatment of the first patient in the Phase 1/2 clinical trial ("the CHAMPIONS study") evaluating SB-913, an investigational in vivo genome editing therapy for people with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome.
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