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Celgene shaken again after the FDA kicks back their marketing application on blockbuster hopeful ozanimod

Celgene has been slammed with a refuse-to-file letter from the FDA for ozanimod, the biggest late-stage drug it has in the pipeline.
- Source: endpts
- 684
- March 2, 2018
Celgene FDA multiple sclerosis ozanimod
Galera Therapeutics Receives FDA Breakthrough Therapy Designation for GC4419 for the Reduction of Severe Oral Mucositis

Designation Based on Positive Results of Phase 2b Trial of GC4419 Severe Oral Mucositis Affects 70 Percent of Head & Neck Cancer Patients Receiving Radiotherapy
- Source: 4-traders
- 467
- March 2, 2018
FDA New Approvals severe oral mucositis SOM
Stem cell therapy offers hope for spinal cord injuries

Scientists have brought the prospect of spinal cord injuries being able to be treated with stem cells one step closer, after research in monkeys showed improvement post-stem cell graft.
- Source: pharmafile
- 417
- March 1, 2018
motor function NPCs Researches
FDA Approves SYMDEKOTM (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene

Vertex Pharmaceuticals Incorporated (VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor. SYMDEKO is Vertex’s third medicine approved to treat the underlying cause of CF. Vertex is ready to launch SYMDEKO and will begin shipping it to pharmacies in the United States this week.
- Source: finance.yahoo.
- 562
- March 1, 2018
cystic fibrosis FDA New Approvals SYMDEKO™
Lilly’s Verzenio bags third breast cancer nod

Eli Lilly’s Verzenio has been given another green light in the US for breast cancer, significantly expanding the drug’s treatment scope.
- Source: Pharmatimes
- 608
- March 1, 2018
breast cancer New Approvals
Viela Bio Spins Out of MedImmune; Raises Up to $250 Million in Series A Financing, 6 Dimensions Capital Leads Investment

Viela Bio announced today that it has incorporated as an independent, inflammation - and autoimmunity - focused biotechnology company after spinning out from MedImmune, the global biologics research and development arm of AstraZeneca. Viela Bio will primarily focus on developing medicines for severe autoimmune diseases by targeting critical pathways that are the root cause of the diseases.
- Source: finance.yahoo
- 475
- March 1, 2018
autoimmunity inflammation Market Views
Scandinavian Real Heart selects AdaCore software for artificial heart

Medical technology company Scandinavian Real Heart has announced that it will be using a range of AdaCore software solutions to develop reliable embedded software for its Total Artificial Heart device.
- Source: Verdict Medical Devices
- 595
- March 1, 2018
healthcare technologies and innovations medical device Researches
Cipla Partners With Roche Pharma India To Create Greater Access To Key Medicines

Cipla Ltd. and Roche Products (India) Private Limited have signed a distribution agreement for the promotion and sale of tocilizumab and the 2nd brand of bevacizumab.
- Source: Cipla
- 696
- March 1, 2018
Cipla Company Insight India Roche
Navigating the Legal Complexities of a Digital Health Transaction

Whatever the long-term future for life sciences, in house lawyers and their business counterparts as well as outside advisors who are able to navigate the convergence of business and legal issues surrounding the life sciences and technology industries will have a competitive advantage over those who ignore the parallel convergences that are taking place, continuing to focus instead on life sciences and technology as distinct and separate fields.
- Source: Corporate Council - Law.com
- 538
- March 1, 2018
big data digital health healthcare technologies and innovations Market Views
Japan Just Approved a New Drug That Can Kill the Flu Virus In Just One Day

As the worst flu season in a decade rages on, a potentially groundbreaking new drug that can kill the flu virus in just one day has won regulatory approval—in Japan.
- Source: Fortune
- 704
- February 28, 2018
flu New Approvals virus

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