Search Results for “FDA” – Page 181 – media

Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

The China Food and Drug Administration (CFDA) has announced new and updated regulations for medical device registration, testing and clinical trial requirements in the early days of 2018.
- Source: Emergo
- 804
- January 10, 2018
CFDA Clinical Trials medical device polices
Illumina and KingMed to develop oncology diagnostics in China

US-based gene sequencing firm Illumina has signed an agreement with Guangzhou KingMed Diagnostics Group to co-develop new oncology and hereditary disease testing applications in China.
- Source: Verdict Medical Devices
- 640
- January 9, 2018
cancer CFDA Company Insight digital health
US awards Novartis’ Kisqali ‘Breakthrough’ status

Novartis’ CDK4/6 inhibitor Kisqali has picked up Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer.
- Source: pharmatimes
- 557
- January 4, 2018
inhibitor Kisqali New Approvals
After disappointing 2016, new drug approvals roared back to life in 2017

New drug approvals all but screeched to a halt in 2016, with a measly 22 new OKs after a pair of bountiful years. But the FDA wasted no time in 2017, signing off on 12 drugs in the first quarter alone—besting its record for the same period of any year in recent history.
- Source: fiercebiotech
- 623
- January 4, 2018
CAR-T therapy FDA New Approvals new drug
The Healthcare Technology Winners of 2017

It’s been a big year in healthcare technology. Healthcare Analytics News™ reached out to experts across our 8 coverage areas to determine which companies, people, and projects made the biggest waves. The winners of 2017 ushered in advances that have turned heads, resulted in measurable improvements, and given reason to believe that this high-speed sector is not built on hype alone.
- Source: hcanews
- 492
- January 1, 2018
healthcare technology Market Views
Roche snags another Perjeta combo nod, but will ‘weak’ data limit its use?

Analysts and investors think Perjeta’s end-of-the-year indication may not be as lucrative as they once hoped. The FDA green-lighted the drug in tandem with giant Herceptin and chemo for HER2-positive, post-surgery breast cancer patients with a high risk of recurrence. Patients should receive up to 18 cycles of the regimen over the course of one year, according to the indication.
- Source: fiercepharma
- 558
- December 28, 2017
breast cancer Company Insight FDA HER2-positive
Mallinckrodt inks $1.2B Sucampo buy, ending rough 2017 on a high note

Mallinckrodt, which has landed in hot water multiple times this year, is diversifying beyond its controversial lead seller.
- Source: fiercepharma
- 440
- December 28, 2017
chronic Company Insight constipation Market Views
Increased Demand for 3D Printed Medical Device Products

3D printed medical device products are very high-end devices that are engaged in the process of utilizing digital models to develop a three-dimensional object.In the healthcare industry, many academic institutes make use of this technology for patient-specific treatment.The key 3D printed medical devices companies are working on strategies that would increase their market share.
- Source: Ddu
- 744
- December 27, 2017
Market Views medical device products
Roche and Ignyta Reach Definitive Merger Agreement

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ignyta, Inc. (NASDAQ: RXDX) today announced they have entered into a definitive merger agreement for Roche to fully acquire Ignyta at a price of US$ 27.00 per share in an all-cash transaction. This corresponds to a total transaction value of US$ 1.7 billion on a fully diluted basis. This price represents a premium of 74% to Ignyta’s closing price on 21 December 2017 and a premium of 71% and 89% to Ignyta’s 30-day and 90-day volume weighted average share price on 21 December 2017, respectively. The merger agreement has been unanimously approved by the boards of Ignyta and Roche.
- Source: Roche
- 529
- December 25, 2017
Ignyta Market Views Roche
3 Amazing Advances in Pharmaceutical Drugs in 2017

As 2017 draws to a close, we look back at a year where advances in pharmaceutical drug therapies brought new hope to people from across the globe. These steps forward bring with them a sense of suspense as we wait for more ground-breaking work to be accomplished in 2018. Here is Drugdu.com’s list of medical advances that amazed.
- Source: Ddu
- 641
- December 25, 2017
Market Views pharmaceutical drugs

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