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  • FDA approves new formulation of Pfizer’s Lyrica

    SILVER SPRING, Md. — Pfizer’s Lyrica has an approved new formulation. The Food and Drug Administration on Thursday approved Lyrica CR (pregabalin) controlled-release tablets. 

    The tablets are indicated as a once-daily treatment for neuropathic pain associated with diabetic peripheral neuropathy and to manage postherpetic neuralgia. It was not approved for fibromyalgia management.

  • Lupin acquires Symbiomix Therapeutics

    MUMBAI, India — Lupin’s U.S. subsidiary’s latest acquisition is set to strengthen its pipeline for gynecologic drugs. The company has acquired Symbiomix Therapeutics for $150 million, which includes an upfront payment of $50 million and closed today.

  • Lilly launches Humalog Junior KwikPen

    INDIANAPOLIS — Eli Lilly’s latest introduction is making half-unit doses of insulin easier for patients with Type 1 and Type 2 diabetes. The company on Wednesday launched its Humalog Junior KwikPen, which it said is the only prefilled, disposable half-unit insulin pen. The Food and Drug Administration approved the product in June to treat diabetes.

  • FDA approves Novo Nordisk’s Fiasp fast-acting insulin

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new fast-acting mealtime insulin from Novo Nordisk. The agency granted approval to Fiasp to treat adults with diabetes.

    The drug is a formulation featuring the company’s NovoLog insulin aspart developed with the aim of achieving properties that more closely match the natural physiological insulin mealtime response of someone without diabetes.

  • FDA approves Lilly’s breast cancer drug Verzenio

    SILVER SPRING, Md. — Eli Lilly’s new treatment for certain breast cancers has been approved by the Food and Drug Administration. Verzenio (abemaciclib) was approved to as a treatment for patients with a hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that is advanced or metastatic and has progressed following endocrine therapy.

  • Merck gets FDA approval for new Keytruda indication

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Keytruda (pembrolizumab), the drug’s manufacturer Merck announced recently. The drug is now approved as a third-line treatment for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors test positive for a certain protein identified by an FDA-approved test.

  • Foundation Consumer Healthcare among buyers of Teva’s women’s health brands

    JERUSALEM — Teva has made two separate sales from its global women’s health business in an effort to repay term loan debt. The move follows its sale last week of its Paragard IUD.

  • FDA approves Symbiomix Therapeutics’ Solosec

    SILVER SPRING, Md. — The Food and Drug Administration has approved Symbiomix Therapeutics’ new drug Solosec (secnidazole) oral granules. The drug is the first approved single-dose oral therapy for bacterial vaginosis. 
     
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