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New Formulation of ONCASPAR®▼ (pegaspargase) Receives Marketing Authorization in Europe for Patients with Acute Lymphoblastic Leukemia (ALL)

Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, today announced that the European Commission (EC) granted Marketing Authorization for lyophilized ONCASPAR (pegaspargase), as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL) in pediatric patients from birth to 18 years, and in adult patients.1 The approval – which authorizes Shire to market lyophilized ONCASPAR in the 28 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway – follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12.
- Source: Shire
- 609
- December 15, 2017
ALL Antineoplastic New Approvals
Bayer’s rivaroxaban submitted to U.S. FDA for approval in patients with coronary and/or peripheral artery disease

The rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin 100 mg once daily, demonstrated a 24% reduction in the combined risk of stroke, cardiovascular death and heart attack / The application for marketing approval is based on the COMPASS study
- Source: press.bayer
- 611
- December 15, 2017
Bayer CAD/PAD Company Insight Janssen rivaroxaban
Ionis Pharmaceuticals Licenses IONIS-HTT Rx to Partner Following Successful Phase 1/2a Study in Patients with Huntington’s Disease

Ionis Pharmaceuticals, Inc. (IONS) announced today that Roche has exercised its option to license IONIS-HTTRx following the completion of a Phase 1/2a randomized, placebo-controlled, dose escalation study of IONIS-HTTRx in people with Huntington's disease (HD). Roche will now be responsible for all development and commercial activities. IONIS-HTTRx is the first therapy in clinical development designed to target the underlying cause of HD by reducing the production of the toxic mutant huntingtin protein (mHTT). In conjunction with the decision to license IONIS-HTTRx, Ionis earned a $45 million license fee from Roche.
- Source: finance.yahoo
- 485
- December 15, 2017
Clinical Trials Huntington’s Disease IONIS-HTTRx
11 Brilliant Ways Therapists Control Their Holiday Stress

Sometimes even the experts need a little help staying holly and jolly. Research shows holiday season stress can feel insurmountable. No one is immune. Mental health professionals, who are usually helping others manage emotions, put their own advice into practice as the year winds down.
- Source: msn
- 378
- December 15, 2017
holiday season stress Researches
Boehringer Ingelheim initiates real-world study of treatment sequencing in EGFR mutation-positive lung cancer

Boehringer Ingelheim has initiated GioTag, a real-world study to assess the impact of sequential therapy in patients with EGFR mutation-positive (M+) advanced non-small cell lung cancer (NSCLC). Data from approximately 190 patients who received tyrosine kinase inhibitors (TKI) – afatinib* in first-line, followed by second-line osimertinib**as part of standard clinical practice – will be analysed to determine total time on treatment.
- Source: boehringer-ingelheim
- 513
- December 14, 2017
EGFR NSCLC Researches
FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome

The U.S. Food and Drug Administration(FDA) expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA.
- Source: Prnewswire;
- 489
- December 14, 2017
EGPA New Approvals vasculitis
SwipeSense Lands $10.6M to Expand Location-Aware Hospital Apps

SwipeSense, a Chicago-based healthcare technology company has raised a $10.6 million in Series B2 funding led by Eclipse Ventures, with participation from Sandbox Industries and other existing technology and healthcare investors. The company plans to utilize the funding to improve its location-aware apps for healthcare platform, explore new use cases and expand its growing team.
- Source: hitconsultant
- 430
- December 14, 2017
HAIs healthcare Market Views Series
LSP closes $330M medtech fund, plots 15 investments

LSP has raised $330 million for its second medical technology fund. The big jump in size over the first fund tees up LSP to place bets on 15 companies with close-to-market devices, diagnostics and digital health tools.
- Source: fiercebiotech
- 684
- December 14, 2017
Company Insight diagnostics digital health
FDA suggests controls on interoperable devices

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.
- Source: massdevice
- 568
- December 14, 2017
FDA interoperable medical device Policy
Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

Approval based on data from the Phase III RESORCE study where Stivarga® (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib)
- Source: investor.bayer
- 702
- December 14, 2017
Bayer CFDA hepatocellular carcinoma Nexavar® Stivarga®

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