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Latest From Jessica Merrill
AbbVie announced positive data from the first of two pivotal Phase III studies testing the GnRH receptor antagonist, but Allergan and Myovant are among the companies also looking to bring new drugs to market.
US FDA Principal Deputy Commissioner Rachel Sherman said during the BIO CEO & Investor conference that while investors and others would like to see complete response letters, the agency's hands are bound when it comes to their full release. Sherman also commented on FDA's focus for right-to-try legislation.
Bristol paid a handsome $1.85bn upfront for access to Nektar's lead immuno-oncology program NKTR-214 to study in combination with its own drugs, but the expense was viewed by some as a smart play versus buying Nektar outright.
Despite the recent volatility in the stock market, experts and industry insiders at the BIO CEO & Investor conference in New York said biotech remains a leading area to invest, predicting continued VC investment and more M&A ahead.
Novartis' generic drug unit confirmed the receipt of a complete response letter from the US FDA for a generic version of GlaxoSmithKline's Advair, following similar CRLs for Mylan and Hikma.
One of Teva's few bright spots is its leading position in the big new commercial opportunity for migraine, but its CGRP drug fremanezumab could now be delayed by an issue at third-party manufacturer Celltrion.