Industry News

Impax Laboratories, Inc. announced that Impax has received tentative approval from the U.S. Food and Drug Administration (FDA) for its

Immunomedics, Inc. announced that its lead investigational antibody-drug conjugate, sacituzumab govitecan, or IMMU-132, has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer (TNBC) who have failed at least 2 prior therapies for metastatic disease.

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). EMEND has not been studied for the treatment of established nausea and vomiting.

Takeda Pharmaceutical Company Limited  and H. Lundbeck A/S announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that the companies presented substantial evidence to support the effectiveness of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD). Earlier today, the committee also discussed that cognitive dysfunction in MDD represents an appropriate drug development target.

Boehringer Ingelheim announced that SPIRIVA® RESPIMAT® is now available for the treatment of asthma by prescription in U.S. pharmacies. The U.S. Food and Drug Administration (FDA) approved a once-daily dose of 2.5 µg for the long-term maintenance treatment of asthma in people ages 12 and older.

Targovax has submitted a study protocol to the regulatory authorities in Spain to assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma (MPM), a rare type of lung cancer associated with exposure to asbestos.

Abbott and Alere Inc announced a definitive agreement for Abbott to acquire Alere, significantly advancing Abbott's global diagnostics presence and leadership. Under the terms of the agreement, Abbott will pay $56 per common share at a total expected equity value of $5.8 billion. Once the transaction is completed, Abbott will become the leading diagnostics provider of point of care testing. Abbott's total diagnostics sales will exceed $7 billion after the close.

Conatus Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company's emricasan development program for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).

Mersana Therapeutics and Takeda Pharmaceutical Company Limited  announced that they have entered a new strategic partnership granting Takeda rights to Mersana’s lead product candidate, XMT-1522, outside the United States and Canada. The deal also expands an existing collaboration between the companies to provide Takeda with additional access to Mersana’s Fleximer® antibody-drug conjugate (ADC) platform and grants Mersana an option at the end of Phase 1 to co-develop and co-commercialize one of these programs in the United States. In addition, the companies will co-develop new payloads for use with ADCs.

XMT-1522 is an investigational, Fleximer-based ADC therapy that targets HER2-expressing tumors, including breast, gastric and non-small cell lung cancers. Preclinical data suggest that XMT-1522 may have anti-tumor activity in patients with HER2 low-expressing cancers as well as in patients with HER2 high-expressing cancers that do not respond to currently available HER2-targeting therapies. Mersana anticipates filing an Investigational New Drug application (IND) for XMT-1522 with the U.S. Food and Drug Administration (FDA) in mid-2016.

AstraZeneca  announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).