United States

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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MedImmune receives FDA Fast Track for influenza treatment

Thursday, March 10, 2016

AstraZeneca’s global biologics R&D arm, MedImmune, has received Fast Track designation from the FDA for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalized with type A strain influenza. The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.

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