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FDA approves first biosimilar for the treatment of certain breast and stomach cancers

The US Food and Drug Administration (FDA) today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the US for the treatment of cancer.
- Source: mdlinx
- 628
- December 5, 2017
breast cancer FDA herceptin New Approvals Ogivri stomach cancer
Astellas Takes Out Massachusetts’ Biotech Mitobridge in $390M Deal

Tokyo-based Astellas Pharma is buying Cambridge, Mass.-based Mitobridge for a total of $390 million. Astellas is pulling the trigger on an acquisition option from a partnership deal the two companies formed in 2013. Under that deal, the two companies collaborated on discovering and developing drugs that target mitochondrial function. The most advanced program from the collaboration is MA-0211, which is presently in Phase I clinical trials for Duchenne muscular dystrophy (DMD). Astellas is an equity investor in Mitobridge already, and is paying $165.5 million in cash in addition to the $60 million in equity it already owns. There is also an additional $225 million in potential milestone payments. John Carroll, with Endpoints News, writes, “For years now, Salk’s Ron Evans—a celebrated serial entrepreneur in scientific circles—has been concentrating on the potential of a new pathway for turning your average couch potato rodent into Mighty Mouse—without exercise…. A couple of ...
- Source: biospace
- 703
- December 5, 2017
acquisition Astellas Clinical Trials Duchenne muscular dystrophy Market Views Series
High-stress childhoods blind adults to potential loss

Adults who lived high-stress childhoods have trouble reading the signs that a loss or punishment is looming, leaving themselves in situations that risk avoidable health and financial problems and legal trouble.
- Source: medicalxpress
- 652
- December 5, 2017
high-stress childhoods Researches weigh gain and loss
Woman becomes first in US to give birth after uterus transplant, Health News

For the first time in the United States, a woman with a transplanted uterus gave birth, officials at a Dallas hospital said on Friday.
- Source: visionaryaline
- 415
- December 4, 2017
Researches uterus transplantation
Mouth bacteria linked to esophageal cancer

An analysis of microbes sampled from the mouths of more than 120,000 people has found that two types of bacteria that lead to gum disease are also linked to higher risk of esophageal cancer.
- Source: medicalnewstoday
- 617
- December 4, 2017
cancer mouth bacteria Researches
Is Mepolizumab an Effective Treatment for Asthma?

Researchers investigated whether mepolizumab is safer and more effective than triple-inhaled treatments for chronic obstructive pulmonary disease.
- Source: medicalnewsbulletin
- 670
- December 4, 2017
asthma COPD mepolizumab
FDA Clears First Medical Device Accessory for Apple Watch®

Atrial Fibrillation (AFib), is the most common heart arrhythmia, and a leading cause of stroke. AFib affects more than 30 million people worldwide, and one in four people over the age of 40 are at risk for developing it. Millions of people around the world are unknowingly living with AFib. Yet, two out of three strokes are preventable when AFib is detected and treated appropriately.
- Source: Prnewswire
- 542
- December 4, 2017
AI Apple Watch New Approvals
J&J-led coalition launches a landmark efficacy study for an HIV mosaic vaccine

For decades now, investigators have been drawn to HIV vaccine research — a Holy Grail in anti-viral research that would have an enormous impact in a world that still sees two million new infections every year.
- Source: Endpts;
- 519
- December 4, 2017
HIV Market Views vaccine virus
Gottlieb Says Faster Cancer Drug Approvals Coming for Secondary Indications

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office.
- Source: raps.org
- 686
- December 4, 2017
cancer FDA NIH Policy
Ddu Attended CPhI India

CPhI India was held from November 28th to November 30th, 2017 at the Bombay Exhibition Centre in Mumbai, India.
- Source: Ddu
- 1,441
- December 4, 2017
CPhI pharmaceutical

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