MiMedx is in trouble, again; Pfizer's Avastin biosimilar wins FDA approval
→ The controversial MiMedx has dug itself a deeper hole. Senior officials at the wound care company, which has long been criticized for its business practices, are aware of at least fifty instances of patient complications associated with the use of MiMedx’s skin grafts or injections, Bloomberg reported on Thursday, citing sources and documents. The Marietta, Georgia-based company, counts veterans and military hospitals as its customers and is still reeling from a 15-month long sweeping internal investigation that painted a sordid picture of MiMedx’s scandalous past, indicating the company’s former C-suite spied on employees, lied to regulators and misled investors.
→ Pfizer‘s $PFE biosimilar for Roche‘s blockbuster oncology drug Avastin has been approved by the FDA. The copycat, called Zirabev, can be used for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer. Amgen‘s $AMGN Avastin copy, Mvasi, was approved by the US agency in 2017.
→ After reporting positive data from its European pivotal study in March, Aimmune Therapeutics $AIMT submitted an application to market its peanut allergy therapy in Europe on Friday. The drug developer has essentially leapfrogged its arch-rival DBV Technologies $DBVT in the United States.