Bionest

New Approvals for Tumor-Agnostic Cancer Treatments — and the Questions They Raise

On August 15, the U.S. Food and Drug Administration granted accelerated approval to Genentech/Roche’s Rozlytrek (entrectinib) for the treatment of adult and adolescent patients with solid tumors that exhibit neurotrophic tyrosine receptor kinase (NTRK) fusions and for whom there are no existing effective treatments. While NTRK fusions are rare, appearing in about 1% of solid...

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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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Applying Precision Medicine to Neuropsychiatric Disorders

Cancers were once looked upon as specific diseases, often defined by their tissue of origin, and drug treatments primarily aimed to kill rapidly growing tumor cells before harming slower growing normal ones. The result was often limited drug efficacy, accompanied by debilitating side-effects. Today, however, the growing understanding of the biology and genetics of particular...

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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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Blockchain and Pharmaceutical Supply Chain Security

Blockchain is a method to securely store digital information and create an accurate, verifiable, distributed record of individual transactions that is confidential, traceable and virtually uneditable. The first practical use of blockchain technology enabled bitcoin and other cryptocurrency transactions. Today, blockchain is being tested by a number of pharmaceutical companies, drug wholesalers, and at least...