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  • FDA approves Lilly, BMS drug for KRAS wild-type colorectal cancer

    NEW YORK — The Food and Drug Administration has approved a drug made by Eli Lilly and Bristol-Myers Squibb for treating a form of colorectal cancer, the two companies said.

    Lilly and Bristol announced the approval of Erbitux (cetuximab) for treating colorectal cancer that is KRAS mutation-negative, expresses the epidermal growth factor receptor and has spread to other parts of the body, also known as metastasis. The drug is approved for use alongside a chemotherapy combination containing irinotecan, 5-fluorouracil and leucovorin, also known as FOLFIRI.

  • FDA gives priority review to J&J drug

    RARITAN, N.J. — The Food and Drug Administration has given priority review to a drug as a treatment for blood-clot disorders, the manufacturer said Monday.

    Johnson & Johnson subsidiary Janssen Research & Development said the FDA had given the priority review status to its applications for Xarelto (rivaroxaban) as a treatment for deep-vein thrombosis — a condition in which clots form in one of the large deep veins, usually in the legs — and pulmonary embolism, which occurs when a DVT clot dislodges and is carried to the lung via the heart.

  • FDA accepts NDA for Agile's contraceptive patch

    PRINCETON, N.J. — The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.

  • Amgen completes Kai acquisition

    THOUSAND OAKS, Calif. — Amgen has completed its acquisition of Kai Pharmaceuticals, a privately held company based in South San Francisco, Calif.

    The deal, first announced in April, is valued at $315 million. The deal also includes the acquisition of KAI-4169, an experimental drug Kai is developing for secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. KAI previously reported compelling mid-stage clinical results for KAI-4169 in this indication.

  • Lilly gains U.S. pediatric exclusivity for Cymbalta

    INDIANAPOLIS — Eli Lilly announced that it has met Food and Drug Administration requirements for pediatric exclusivity for its antidepressant medication.

    Based on this decision by the FDA, Lilly has gained an additional six months of U.S. market exclusivity for Cymbalta (duloxetine hydrochloride), which now will expire in December 2013.

  • FDA orders unapproved oxycodone drugs off market

    SILVER SPRING, Md. — The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

  • Bristol-Myers Squibb buys Amylin for $5.3 billion

    NEW YORK — Bristol-Myers Squibb is acquiring Amylin Pharmaceuticals, the drug maker said Friday.

    Bristol announced that it would acquire Amylin for $5.3 billion, or $31 per share. The total value of the acquisition is about $7 billion, including $1.7 billion in Amylin's contractual payment and debt obligations.

  • Gilead seeks approval for HIV drug-boosting agent

    FOSTER CITY, Calif. — Drug maker Gilead Sciences has submitted a regulatory approval application to the Food and Drug Administration for a drug designed to increase the blood levels of certain drugs for HIV.

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