Roche’s Tecentriq (atezolizumab) cancer immunotherapy has gained a new indication in the US after the FDA granted it a license in a difficult to treat the form of lung cancer in combination with chemotherapy. The regulator granted the new indication as a treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide in previously untreated patients. Approval is based on results from the phase 3 Impower133 study, showing Tecentriq in...
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Merck’s Keytruda has a new indication, and with it, immunotherapy has moved into a new frontier. With a Monday FDA green light for certain previously treated cervical cancer patients whose disease has worsened on or after chemotherapy, Keytruda became the first drug in its class to win a nod to treat those with the disease.Regulators gave their stamp of approval after 14.3% of recurrent or metastatic cervical cancer sufferers with tumors testing positive for the PD-L1 biomarker showed resp...
FIERCEPHARMA
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QED Therapeutics today announced that it has entered into an agreement with Foundation Medicine to develop a companion diagnostic for infigratinib, an FGFR1-3 selective tyrosine kinase inhibitor, in patients with cholangiocarcinoma. The companion diagnostic, which will include detection of activating FGFR2 fusions, is expected to be incorporated into FoundationOne®CDx, Foundation Medicine's FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that includes multip...
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It's spring, finally—and in the tree branches a battle is brewing. A robin returns to her nest with an earthworm. Her nestlings all beg, but only one will get this meal. And while Mom has an interest in making sure that all of her babies thrive, each little bird is more selfish. So the baby opens his beak again and again: give me more! Now picture a similar clash playing out in flowers of the same tree. A new study from Washington University in St. Louis reveals the surprising way that...
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The FDA hit Ei, a CDMO, with a warning letter for manufacturing pharmaceuticals in the same building and with the same equipment it uses to produce pesticides.In its letter posted to the regulatory agency’s website, the FDA outlined poor manufacturing procedures at the company’s facility located in Kannapolis, North Carolina. The plant, which produces finished pharmaceuticals like liquid and semisolid topical drugs, was inspected in early October 2017.The agency said inspectors found...
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After months of wrangling, the EMA finally has a solution to the £500 million financial liability it has faced over the tenancy to its former home in Canary Wharf. The EU regulator – now based in temporary accommodation in Amsterdam – has sub-let the entire 284,704 square feet (26,450 m2)accommodation at 30 Churchill Place to WeWork, a fast-growing shared office-space group. As a result of the deal, the EMA has also now settled its litigation with the Canary Wharf Group. Faced ...
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