Tag: Business and Industry

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

January 21, 2019 todi0

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 […]

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

January 17, 2019 todi0

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 […]

Abbott to acquire Cephea Valve Technologies, Inc.

January 16, 2019 todi0

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 […]

Merck welcomes ten new startups to its Innovation Center

January 16, 2019 todi0

Merck, a leading science and technology company, today announced the ten startups that will be joining the seventh intake of its Accelerator program at the Merck Innovation Center in Darmstadt. The teams come from nine different countries, making 2019 the most international intake in the Merck Accelerator’s history. They were chosen from a total of […]

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

January 15, 2019 todi0

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).

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

January 14, 2019 todi0

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 […]

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

January 10, 2019 todi0

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., […]

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

January 8, 2019 todi0

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

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

January 7, 2019 todi0

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 […]

AstraZeneca announces organisational changes

January 7, 2019 todi0

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: