Clinical Intelligence

FDA grants Genentech’s cancer immunotherapy Tecentriq (atezolizumab) Accelerated Approval

Friday, May 20, 2016

The FDA granted Accelerated Approval to Genentech’s Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

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Pfizer showcases results from two phase III TRUMENBA studies

Monday, May 16, 2016

Pfizer has announced results of two phase III studies demonstrating the immunogenicity of TRUMENBA (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe. The two studies, one in adolescents and one in young adults, met all primary immunogenicity endpoints. Also, secondary data presented show that TRUMENBA demonstrated similar immune responses against ten additional MnB strains, in both adolescents and young adults.

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Melinta’s Baxdela releases positive phase III results for hospital-treated skin infections

Friday, May 13, 2016

Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, today announced top-line results from the second phase III study (RX-3341-303 NCT01984684) of Baxdela (delafloxacin), an investigational anionic quinolone in development for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).

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FDA grants Priority Review for Lilly’s Olaratumab

Monday, May 9, 2016

The FDA has granted Priority Review for the biologics license application (BLA) for Eli Lilly’s olaratumab, a PDGFRα antagonist, in combination with doxorubicin, for the potential treatment of people with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.

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