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Third Rock debuts immunometabolism startup Rheos with $60M launch round

Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.

Source: pharmacompass
636
March 30, 2018

Merck KGaA adopts Medisafe medication adherence tool for patients with chronic conditions

Patients can access their record through a code for their iPhone. The idea is to help patients better understand their medical history, improve the quality of interactions with their physicians and family members, and make more informed decisions about their care.

Source: MedCityNews
575
March 30, 2018

Company Insights digital health EHR

Alnylam Presents New Clinical Results from the APOLLO Phase 3 Study of Patisiran at the 16th International Symposium on Amyloidosis

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced that the Company presented new results from the APOLLO Phase 3 study of patisiran, an investigational, RNAi therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis at the 16th International Symposium on Amyloidosis (ISA), being held March 26-29, 2018 in Kumamoto, Japan. In addition, the Company presented new data from the Phase 1 study of ALN-TTRsc02, an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis.

Source: biospace
589
March 30, 2018

ATTR amyloidosis Clinical Trials hereditary ATTR

Bigfoot brings in $55M Series B to propel integrated diabetes platform

This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval(PMA) from the FDA.

Source: MedCityNews
810
March 30, 2018

Company Insights diabetes FDA funding

FDA clears Medtronic’s smartphone-connected CGM for MDI users

Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016.

Source: mobihealthnews
816
March 30, 2018

FDA Guardian Connect insulin Medtronic New Approvals

China’s Adagene raises $50M to take anticancer antibodies into the clinic

Sequoia China has powered Adagene to a $50 million series C round. The investment positions the Chinese antibody discovery shop to move the most advanced assets in its oncology pipeline into human testing.

Source: FierceBioTech
601
March 30, 2018

Clinical Trials Company Insights oncology

Mylan Introduces Symfi™ Triple Combo Once-Daily HIV Treatment in the U.S.

Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.

Source: finance.yahoo
541
March 29, 2018

HIV-1 New Approvals Symfi™

Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia

Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).

Source: Novartis
631
March 29, 2018

FDA New Approvals Ph+ CML-CP Tasigna®

U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review

Bristol-Myers Squibb Company (BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation.

Source: drugdu
589
March 29, 2018

FDA MBS New Approvals Opdivo

Bluebird Bio and Celgene Corporation Enter into Agreement to Co-Develop and Co-Promote Anti-BCMA CAR T Cell Therapy bb2121 in the United States

Bluebird Bio, Inc. (Nasdaq: BLUE) and Celgene Corporation (Nasdaq: CELG) today announced that the companies have entered into an agreement to co-develop and co-promote bb2121, an investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States.

Source: investor.bluebirdbio
463
March 29, 2018

bb2121 Celgene multiple myeloma T cell therapy

Third Rock debuts immunometabolism startup Rheos with $60M launch round

Merck KGaA adopts Medisafe medication adherence tool for patients with chronic conditions

Alnylam Presents New Clinical Results from the APOLLO Phase 3 Study of Patisiran at the 16th International Symposium on Amyloidosis

Bigfoot brings in $55M Series B to propel integrated diabetes platform

FDA clears Medtronic’s smartphone-connected CGM for MDI users

China’s Adagene raises $50M to take anticancer antibodies into the clinic

Mylan Introduces Symfi™ Triple Combo Once-Daily HIV Treatment in the U.S.

Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia

U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review

Bluebird Bio and Celgene Corporation Enter into Agreement to Co-Develop and Co-Promote Anti-BCMA CAR T Cell Therapy bb2121 in the United States

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