After several diabetic patients received a sham version of Roche's Avastin and lost their sight, the Drug Regulatory Authority of Pakistan (DRAP) is halting the sale or distribution of the drug until it can verify quality, the agency said in a release Sunday.
Roche has detailed Tecentriq’s performance in early-stage liver cancer from a positive phase 3 trial. But a negative sign of patient deaths might raise some eyebrows, and it could force the company to delay a potential FDA filing.
Combining Roche’s cancer immunotherapy Tecentriq with the company’s older medicine Avastin helped people with liver cancer live longer without relapsing after surgery compared to no treatment, Roche said Thursday. The company claimed it’s the first time such a drug combination has shown a benefit in this setting.
Avastin has attracted quite the crowd of biosimilars in recent years, and one more pharma company has elbowed its way in.
Genentech`s Biologic AVASTIN(Bevacizumab) Receives Approval in the U.S.
The European Commission (EC) has granted approval for Celltrion Healthcare’s Vegzelma (CT-P16) to treat metastatic breast cancer, advanced and/or metastatic renal cell cancer, non-small cell lung cancer, ovarian cancer, metastatic carcinoma of the colon or rectum and cervical cancer.
Outlook Therapeutics withdrew its BLA for bevacizumab, the active compound in Roche/Genentech’s Avastin cancer therapy, after the FDA requested additional information to complete the application, the biotech said Tuesday. Outlook plans to resubmit its BLA by September of this year.
Celltrion said that it has completed the preliminary work for launching CT-P16, an Avastin (Ingredient: bevacizumab) biosimilar, after signing a global patent agreement for the biosimilar product with Genentech, the original developer of Avastin.
The German healthcare group said on Thursday it would acquire a 55% stake in mAbxience, a maker of affordable biosimilar versions of cancer drugs MabThera and Avastin, for 495 million euros ($553 million), plus milestone payments contingent on commercial and development targets.
Specifically, House Speaker Nancy Pelosi’s bill would tweak the wording around the section of the law, moving from, “Testing must be related to use for rare disease or condition,” to the newer version of, “Testing must be related to first use or indication for rare disease condition.”