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Orphan drugs
Orphan Drug Act and Its Criticism

The Orphan Drug Act of 1983 was created to encourage pharmaceutical companies to develop drugs for so-called rare or ultra-rare diseases. The National Institutes of Health (NIH) defines rare diseases as afflicting as fewer than 200,000 individuals. Generally speaking, it has worked. Many companies are willing to inv...

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astellas
Commercial

NICE Rejects Gilead Sciences’ Yescarta on Cost Concerns The United Kingdom’s government-funded health service isn’t being so nice to Gilead Sciences’ CAR-T blood cancer treatment Yescarta. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for th...

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cancer
Clinical

Use of Placebo is Necessary Only in Certain Types of Oncology Trials: USFDA In a new draft guidance released, the USFDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary. The FDA said sometimes the use of a placebo can present practical or ethical co...

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FDA
AbbVie Receives Approval; Kymriah Approved; Shire Gets USFDA Approval; NICE Rejects; Bristol-Myers Squibb’s Opdivo; Eisai and Merck Get USFDA Approval

AbbVie Receives USFDA Approval for Imbruvica Plus Rituximab as First Chemotherapy-Free Combination Treatment for Waldenström's Macroglobulinemia Adults AbbVie announced that the USFDA approved Imbruvica (ibrutinib) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström's macroglobulinemia (W...

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Digital Pills
Digital Pill: A new frontier in digital healthcare all set to take-off

A digital pill is a tablet or capsule with embedded indigestible sensors that communicate about data outcomes related to when the medication is taken to a mobile application for access by the patient and treating their physicians. The novel digital pill system is designed to facili...

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Delveinsight
Outset Medical captures; Wright Medical Group to takeover Cartiva; Y-mAbs Therapeutics prepares for IPO; Biotech boom remunerates analysts

For all-in-one dialysis system, Outset Medical captures USD 132 Million to extend U.S. expansion Outset Medical bagged USD132 Million in series D capital. This ensued in encouraging the production capabilities and accelerating the commercial expansion for all-in-one dialysis system. The FDA cleared the Tablo Hemodia...

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Cancer
Snippet

National health authorities, U.K.'s NICE determines Gilead's cancer cell therapy exorbitant The National Institute for Health and Care Excellence (NICE) found Gilead's cancer cell therapy, Yescarta to be clinically efficacious for treating a type of lymphoma, but no ample evidence is present to estimate the benefit...

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transthyretin amyloidosis
Notizia

Novartis sends out orphan disease drug to LifeMax Labs LifeMax Laboratories, biotech based in San Francisco is given an authorization of a treatment by Novartis for Netherton syndrome, an orphan genetic disorder. Focus of treatment is on managing symptoms and avoiding skin infections and other complications. Life...

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Novo Nordisk
China Preparing for Pharma Big Bang: Is this Alarm Bell for US, Euro Pharma Giants?

As part of its “Made in China 2025” industrial plan, China hopes to reinvent its pharmaceutical industry. President Xi Jinping has identified his country’s reliance on foreign drug imports as a critical concern. China’s enormous population, coupled with the rise of disease and illness, make the country a prime marke...

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HCC
Japan Manages to Stand Apart from Global Hepato Cellular Carcinoma Crowd

Hepato Cellular Carcinoma (HCC) Not all deadly battles are lost. Some are won too.It is without the slightest doubt that the ones won are the typical examples of smart management, involving implementation of prudent steps, guided by the knowledge of every nook and corner. Undoubtedly, these examples not only serve ...

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