FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin)

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq® (atezolizumab) in combination with Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have […]

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Amgen and UCB receive positive vote from FDA Advisory Committee in favor of approval for EVENITY™ (romosozumab)

Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) for the approval of EVENITY™* (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture after reviewing safety and efficacy data from the pivotal Phase […]

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Abbott to acquire Cephea Valve Technologies, Inc.

Abbott (NYSE: ABT) announced today that it has exercised its option to purchase Cephea Valve Technologies, Inc., a privately held medical device company developing a less-invasive heart valve replacement technology for people with mitral valve disease. Financial terms were not disclosed. Abbott provided capital and secured an option to purchase Cephea in 2015. Cephea’s technology […]

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European Commission approves Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma

Bristol-Myers Squibb Company (NYSE: BMY) announced that the European Commission has approved the combination of Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (“low-dose”) for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).

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US FDA accepts regulatory submissions for review of tafamidis to treat transthyretin amyloid cardiomyopathy

Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to […]

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EVENITY™ (romosozumab) receives approval in Japan for the treatment of osteoporosis in patients at high risk of fracture

Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) announced that the Japanese Ministry of Health, Labor and Welfare has granted a marketing authorization for EVENITY™ (romosozumab) for the treatment of osteoporosis in patients at high risk of fracture.(1) Amgen and UCB are co-developing EVENITY worldwide, with development in Japan being led by Amgen Astellas BioPharma K.K., […]

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Boehringer Ingelheim initiates a collaborative partnership with Science 37 to accelerate patient centricity in the development of novel therapies

Science 37, an industry leader in virtual clinical trials, and Boehringer Ingelheim announced a technology enterprise collaboration agreement that will support Boehringer Ingelheim in running remote clinical trials. Science 37 is licensing access to its proprietary software platform, NORA® (Network Oriented Research Assistant), which leverages mobile technology and telemedicine capabilities, enabling patients to

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Sandoz and Pear Therapeutics announce US launch of reSET-OTM to help treat Opioid Use Disorder

Sandoz Inc., a Novartis division, and Pear Therapeutics, Inc., announced today the US commercial launch of reSET-O(TM) for patients with Opioid Use Disorder (OUD). reSET-O*, cleared by the US Food and Drug Administration (FDA) in December, is immediately available. The reSET-O prescription digital therapeutic (PDT) is a 12-week cognitive behavioral therapy intended to be used […]

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AstraZeneca announces organisational changes

AstraZeneca is today announcing organisational changes to support continued scientific innovation and commercial success in the main therapy areas as the Company enters a new phase in its strategic development. Included in the changes will be the arrival at AstraZeneca of the world-renowned oncology scientist, José Baselga, as well as the creation of:

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