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CFDA and CMDE Issue Draft Guidance on Medical Devices for Rare Diseases

On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug and device reform—the Opinion on Strengthening the Reform of the Drug and Medical Device Review and Approval Process to Encourage Drug and Medical Device Innovation (“Opinion 42”).
- Source: National Law Review
- 703
- February 23, 2018
CFDA medical device Policy
PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2017 RESULTS PROVIDES 2018 FINANCIAL GUIDANCE

Pfizer Inc. (NYSE: PFE) reported financial results for fourthquarter and full-year 2017 and provided 2018 financial guidance.
- Source: Pfizer
- 528
- February 21, 2018
Company Insight Pfizer
Merck Announces Fourth-Quarter and Full-Year 2017 Financial Results

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2017.
- Source: Merck
- 527
- February 19, 2018
Company Insight Merck
Johnson & Johnson Reports 2017 Fourth-Quarter Results

Johnson & Johnson today announced sales of $20.2 billion for the fourth quarter of 2017, an increase of 11.5% as compared to the fourth quarter of 2016. Operational sales results increased 9.4% and the positive impact of currency was 2.1%. Domestic sales increased 9.8%. International sales increased 13.5%, reflecting operational growth of 9.0% and a positive currency impact of 4.5%.
- Source: Johnson & Johnson
- 519
- February 17, 2018
Company Insight Johnson & Johnson
GSK delivers improvements in sales, margins and cash flow in 2017

GSK delivers improvements in sales, margins and cash flow in 2017：Total EPS 31.4p, +67% AER, +36% CER; Adjusted EPS 111.8p, +11% AER, +4% CER
- Source: GSK
- 508
- February 15, 2018
Company Insight GSK
Medical device product development– 7 pitfalls you need to avoid

Managing your medical device product development project can be a daunting task. There are regulations and paperwork to manage, along with expectations such as deadlines or goals for getting the device to market.
- Source: medicaldesignandoutsourcing
- 623
- February 14, 2018
Market Views medical device
EKGs May Determine Major Depression or Bipolar Disorder

A groundbreaking Loyola Medicine study suggests that a simple 15-minute electrocardiogram could help a physician determine whether a patient has major depression or bipolar disorder.
- Source: bphope
- 635
- February 14, 2018
bipolar disorder Depression Researches
Could AI One Day Detect the Flu…Before You Even Feel Sick?

It’s flu season, and many of us find ourselves glancing nervously at anyone coughing or sniffling in our vicinity. But how, besides shielding ourselves from public sneezers, do we avoid coming into contact with infections?
- Source: smithsonianmag
- 635
- February 14, 2018
AI flu Market Views
Novartis receives FDA approval for Cosentyx® label update to include moderate to severe scalp psoriasis

Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis.1 The updated label includes Cosentyx data in moderate to severe scalp psoriasis – one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients.1-3 The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.6
- Source: pharma.us.novartis
- 560
- February 13, 2018
Cosentyx® FDA New Approvals Scalp psoriasis
Global Investors Back Rani Therapeutics With $53 Million As Company Moves To Clinical Trials

Rani Therapeutics, the developer of a pill designed to replace injectable drug delivery for patients suffering from chronic diseases, today announced that it has raised $53 million to invest in manufacturing in preparation for human clinical trials. This investment brings the total raised to $142 million in funding.
- Source: Prnewswire;
- 528
- February 13, 2018
chronic diseases Clinical Trials Series

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