Eli Lilly scored another indication for its cancer drug Cyramza (ramucirumab) Wednesday, when the regulatory agency approved the cancer medication to be used in tandem with paclitaxel chemotherapy in addition to its primary indication as a standalone agent for patients with advanced metastatic gastric or esophageal junction adenocarcinoma. The company is exploring additional cancers, but announced in July that the drug failed to hit liver cancer targets. Analysts projected in April that gastric-only indications could equal around $600 million in peak sales.
GlaxoSmithKline submitted its monoclonal antibody mepolizumab to the FDA and EU authorities for approval Wednesday. PharmaTimes explains that GSK is seeking two different age groups for the injectable maintenance medication for patients with severe eosinophilic asthma: 12 and up in the US and adult patients in the EU. The company is in need of a respiratory success — recent earnings show that its new Ellipta franchise has been slow to take off, and investors, such as Leerink’s Seamus Fernandez have said that the respiratory business is the GSK division to watch.
Shire released AbbVie from the merger agreement, but investors are not so forgiving. Reuters reports that the Elliott Associates hedge fund is considering suing AbbVie for the failed deal because of what may be construed as misleading statements, since AbbVie’s board voted against the deal after months of saying it was for it. Reuters notes that Elliot Associates held around 7.85 million shares of then-takeover target Shire.
J&J’s HCV treatment Olysio (simeprevir) was approved by FDA for use in combination with Gilead’s Sovaldi, Bloomberg reported Thursday. HCV sufferers can now be treated with Olysio paired with Sovaldi rather than add-ons like ribavirin or interferon—both of which include material side effects. The Washington Post wrote Thursday that patients may face an uphill battle receiving insurance coverage for these new treatments. The paper explains that insurers are restricting access to only those patients with serious liver damage. Medicaid programs also require that patients demonstrate a commitment not to use drugs and alcohol, before allowing them to receive new drugs.
Allergan may be courting a new admirer—Bloomberg, citing unnamed sources, tells us. Generic giant Actavis has been in “active talks” on an alternative deal, as the Botox manufacturer works to obviate Valeant’s hostile takeover. Valeant formed a joint venture with William Ackman’s Pershing Square Capital to acquire 9.7% of Allergan back in February, and a legal battle has ensued on whether Ackman obtained those shares legally and how the shareholders should vote on the proposed deal.