Alnylam Pharmaceuticals
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FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder
Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.
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Roche Expands Into RNAi Through Alnylam Alliance on Hypertension Drug
Alnylam pioneered RNA interference drugs for rare disease. The biotech aims to bring RNAI to prevalent disorders and its alliance with Roche on the drug zilebesiran for hypertension better positions the company to achieve this goal.
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Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
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MedCity Influencers, BioPharma
A Dose of Innovation
As gene sequencing, machine learning, powerful imaging, sensors, gene and cell therapies make their way out of academic labs into everyday healthcare, our approach to healthcare is changing. For the first time, not only can we pinpoint the molecular and genetic causes of disease, but we also have the technologies to access them. On the back of this, prevention and cures are becoming possible. Can we afford them?
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Alnylam drug succeeds in heart study, setting stage for FDA filing and showdown with Pfizer
Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help the much larger group of patients suffering heart problems from the rare protein disease. An FDA submission is planned, which would pit the Alnylam drug in competition with a blockbuster Pfizer product.
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Alnylam sues Moderna & Pfizer, claiming Covid-19 vaccines infringe lipid patent
Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna and Pfizer infringe on a patent covering this LNP technology.
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Alnylam FDA submission aims to expand biotech’s franchise of gene-silencing drugs
Alnylam Pharmaceuticals has filed for FDA approval of vutrisiran, which could become the biotech’s fourth drug that works by RNA interference. Meanwhile the company is responding to a federal subpoena seeking documents related to the company’s marketing and promotion of its first RNAi drug, Onpattro.
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Let data – not politics – guide development of Covid-19 drugs, vaccines, biotech execs urge
In an open letter published by BIO, the executives emphasized the importance of science-driven evaluation of medicines and regulatory independence. The letter came amid growing concern about political pressure over the FDA, as well as lack of diversity in trials and companies being too quick to announce data that are inconclusive.
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Alnylam, Vir aim for year-end FDA filing to start Covid-19 antiviral drug trial
The companies said Monday they had identified the first candidate for clinical trials, a direct-acting antiviral RNA-interference drug that they plan to develop as an inhaled therapy against the SARS-CoV-2 virus.
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Alnylam gets $2B funding boost from Blackstone to develop drug pipeline
A key component of the deal includes a $1 billion purchase of 50% of royalties owed to Alnylam on sales of inclisiran, a drug for hypercholesterolemia that works by gene silencing. The company’s CEO said uncertainty and volatility due to Covid-19 meant the timing was right for the deal.
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Improving Communication Between Patients and Providers
Sarah Shillington, Chief Customer Officer notes how Artera’s omnichannel platform works.
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After decades of determined research, RNAi drugs have their day in the sun
A panel at Biotech Showcase last week provided an outlook for a new class of drugs that only entered the market two years ago, but was decades in the making.
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Novartis wraps up $9.7B Medicines Company buyout
The deal was originally announced in November. The Medicines Co.’s lead product candidate is inclisiran, an RNAi drug for reducing cholesterol, for which it submitted an FDA approval application in December.
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Foresight is 2020: A look at what’s ahead for biopharma
Executives from biopharma companies and an academic expert weigh in on what’s in store for areas like cell and gene therapy, precision medicine and drug pricing.
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The Medicines Co. studies produce further encouraging data on RNAi cholesterol drug
Although it hasn’t yet released details, the company announced positive data from two Phase III studies of inclisiran, which it is developing with Alnylam. The drug prevents production of PCSK9, the target of drugs made by Amgen and Sanofi/Regeneron.
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MedCo RNA-interference cholesterol drug shows positive Phase III data
Inclisiran, which The Medicines Co. is developing with Alnylam, prevents production of PCSK9, the same protein targeted by two drugs that were the subject of a major patent lawsuit ruling last week. The company plans regulatory filings starting later this year.
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Biotech execs criticize ‘atmosphere of intimidation’ amid actions against Chinese scientists
More than 150 people – including biotechnology and investment executives and academics – have signed a letter warning that actions dismissals of Chinese scientists create a hostile climate that threatens U.S. leadership in biomedical science.