Bionest

The Missing Piece in the Brexit Prep Jigsaw

After three years since the United Kingdom’s vote to leave the European Union and a number of extensions, the country is fast approaching the latest deadline of October 31, 2019. The new Prime Minister, Boris Johnson, and the leaders of the EU have been at loggerheads, and the possibility of a deal or no deal...

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Changing Policies for Kidney Care

More than 1 in 7 American adults has chronic kidney disease (CKD), with the majority of those affected unaware of it. CKD is associated with heart disease, stroke, kidney failure and early death. Chronic kidney care for patients who have progressed to end-stage renal disease (ESRD) or kidney failure — and thus require dialysis —...

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Focusing on NASH

Non-alcoholic fatty liver disease (NAFLD), the build-up of fat in the liver that is not caused by alcohol, affects almost 100 million people in the United States alone. With no drug therapies available for the condition, treatment has focused mostly on weight loss. The more severe form of NAFLD, non-alcoholic steatohepatitis (NASH), causes the liver...

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Gilead and Galapagos

With Gilead Sciences’ hepatitis C sales revenues from Solvaldi and Harvoni fading and lower than expected Yescarta sales, the company has been looking for new products to bolster its pipeline. In mid-July, Gilead addressed some of this need by deepening ties to an existing partner, Galapagos. The two companies have formed a 10-year, $5.1 billion...

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Zolgensma Launch “On Track,” but Significant Challenges Remain

On July 18, Novartis told analysts its Zolgensma launch was “on track.” Despite the gene therapy’s $2.1 million price tag, the company states the launch is “one of the most successful launches from an access standpoint in rare diseases.” Novartis said it had reached coverage deals with more than 20 commercial insurance plans, covering approximately 40%...

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The Rise of the Chief Digital Officer in Pharma Companies

Chief Digital Officer (CDO) is the latest title to become a standard within the pharmaceutical company C-suite, with Takeda, Bayer, GlaxoSmithKline, Novartis, Merck, Sanofi and others all making such appointments in recent years. As we’ve written before, this addition to the pharma senior management team reflects the growing importance of digital to pharma, which encompasses...

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New Excitement About Antibody-Drug Conjugates in Cancer

The ability to target malignant cells without damage to surrounding healthy ones has been a long-sought goal in cancer drug development. Antibody-drug conjugates (ADCs) have been investigated as one such solution aimed at delivering more targeted therapies. ADCs — an approach first envisioned by Paul Ehrlich in the early 20th century — combine the targeting...

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Breaking Out of the Bubble

X-linked severe combined immunodeficiency (X-SCID, or SCID-X1), is an orphan monogenic disorder popularly known as ‘bubble boy disease’ that affects 1 in 50,000-100,000 live births. The most serious of all primary immunodeficiencies, X-SCID causes severe failure of the immune system, including a lack of T cells, natural killer (NK) cells, or functional B cells. For...

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Next Generation Pills

Few people like injections, which can limit adherence to therapy and even cause some patients to avoid potentially beneficial treatments altogether. As a result, drug developers have commonly viewed oral delivery as the “gold standard” for many therapies, especially for common chronic conditions. Formulating protein therapeutics for efficient delivery in a pill or capsule, however,...

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FDA Fosters Innovation in Diabetes Care Through New Device Classification

Digital technologies are becoming an increasingly important part of modern healthcare. Medical devices  have the ability to connect to and communicate with other devices or systems. Not only are new types of devices being created, but many existing devices are being updated with digital capabilities. As a result, the U.S. Food and Drug Administration (FDA)...