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Final FDA Rule Requires Medical Device Trials Outside US to Conform to GCP

The US Food and Drug Administration (FDA) on Tuesday finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
- Source: Regulatory Affairs Professionals Society
- 636
- February 24, 2018
FDA medical device Policies
How Precision Medicine is breaking off Chokehold on Healthcare with Big Data

Big data is showering its miraculous effects on a range of industries. And the healthcare industry is not left out of the bandwagon. Precision medicine is at the brink of a revolution in individualizing treatment, and healthcare professionals are devising ways to prevent and treat diseases with granularity down to a single patient’s genome.
- Source: dexlabanalytics
- 535
- February 23, 2018
big data healthcare Researches
Flu breath– sick people can spread the flu virus just by breathing

The flu is a bit of a stealth microbe. Infected people may shed significant amounts of flu virus simply by breathing, scientists have discovered.
- Source: cbc
- 581
- February 23, 2018
flu Researches
Merck’s ERK inhibitor shows promise in combo against resistant cancers

One-fifth of patients in a phase 1 study responded to an investigational ERK inhibitor from Merck, bolstering hopes that this type of drug could be used effectively in combination with other cancer drugs. ERK is a cell signal that is believed to drive the growth of many cancers.
- Source: fiercebiotech
- 543
- February 23, 2018
cancer drugs Company Insight inhibitor
Major study backs efficacy of antidepressants

A large-scale review of the most common antidepressants has found them all to be superior to placebo in treating major depression, potentially laying to rest questions over their effectiveness.
- Source: pharmatimes
- 422
- February 23, 2018
antidepressants Researches
NICE sticks with ‘no’ for earlier use of Halaven

Cost regulators for NHS treatments in England and Wales are sticking with their position that Eisai’s Halaven should not be funded by the NHS as a second-line of attack against a certain form of breast cancer.
- Source: pharmatimes
- 1,826
- February 23, 2018
breast cancer Market Views NHS
Siemens Healthineers is preparing to file IPO

Siemens AG has announced a plan for its Siemens Healthineers business to go public in the first half of the year, according to a company statement. It’s not the first time the German medical imaging and diagnostic business has made its intentions to file an IPO known, but perhaps the company is betting on a more receptive audience in the current market.
- Source: MedCityNews
- 613
- February 23, 2018
Company Insight diagnostics medtech
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
- 662
- 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
- 518
- 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
- 515
- February 19, 2018
Company Insight Merck

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