United States

Watchdog group files amendment to FDA Citizen Petition

Wednesday, March 30, 2016

With deaths in clinical drug trials every month since December 2015, Center for Responsible Science (CRS) has updated its July 2015 citizen petition. The petition urges the FDA to update 29 regulations to allow the preclinical test method most predictive of human response is used during drug testing. Current regulations mandate the use of animal models, despite great progress in more human relevant tests.

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Lilly’s Taltz (ixekizumab) receives FDA approval for plaque psoriasis

Friday, March 25, 2016

The FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.

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PTC Therapeutics cuts workforce 18%

Thursday, March 24, 2016

PTC Therapeutics is reducing its workforce by approximately 18%, which will primarily affect employees and contractors in the U.S. This reduction is part of PTC’s program intended to optimally manage operating expenses following its recent setback related to the Refuse to File letter received from the FDA for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). 

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FDA releases enhanced warnings for immediate-release opioid pain medications

Wednesday, March 23, 2016

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the FDA has announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. These actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

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FDA approves new treatment for inhalation anthrax

Wednesday, March 23, 2016

The FDA has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

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FDA Alert on Gilead Sciences’ Zydelig

Friday, March 18, 2016

The FDA has issued an alert for healthcare professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines.

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FDA grants Roche’s cancer immunotherapy Atezolizumab Priority Review

Friday, March 18, 2016

The FDA has accepted Roche’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease 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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