Product Show to Attract Thousands on Sept 26th

Posted by ISPE Boston
On September 19, 2018

Join your friends, colleagues, clients and suppliers – and over 350 exhibitors – at the Chapter’s 27th Anniversary Product Show on Wednesday, September 26 at Gillette Stadium. Why attend? Gather Insights – Learn from the industry’s recognized experts during a day-long series of educational programs in four topic areas: Risk Management & Quality, The Future […]

Broad Institute’s CRISPR Patent Affirmed

Posted by ISPE Boston
On September 12, 2018

[The following post has been excerpted from “For Journalists: Statement and Background on the CRISPR Patent Decision” by Lee McGuire, Chief Communications Officer, Broad Institute of MIT and Harvard.] A federal panel has again confirmed that the patents granted by USPTO to the Broad Institute, MIT and Harvard concerning CRISPR editing of eukaryotic genomes do […]

Alnylam Wins EU Approval of Onpattro

Posted by ISPE Boston
On September 12, 2018

Alnylam Pharmaceuticals has announced the European Commission (EC) has granted marketing authorization for Onpattro (patisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy. The approval was granted less than three weeks after Alnylam won FDA approval for Onpattro. The drug is based on Nobel Prize-winning science […]

Massachusetts Biotechs Dominated the IPO Market in 2017

Posted by ISPE Boston
On August 29, 2018

The Massachusetts Biotechnology Council (MassBio) today released its 2018 Industry Snapshot report, which shows that Massachusetts biotechs dominated the IPO market in 2017, accounting for 48% of all US-based biotech IPOs, up from 30% in 2016. 2018 has already outpaced 2017 in terms of total Massachusetts IPOs at 15, which accounts for nearly 40% of […]

About RNAi & Alnylam

Posted by ISPE Boston
On August 15, 2018

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel […]

Alnylam’s RNAi Therapeutic Approved by FDA

Posted by ISPE Boston
On August 15, 2018

RNAi therapeutics company Alnylam Pharmaceuticals has announced that the FDA has approved Onpattro (patisiran) lipid complex injection, a RNA interference (RNAi) therapeutic for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Onpattro is the first and only FDA-approved treatment for this indication. “Alnylam was founded on the vision of harnessing the […]

bluebird bio and Regeneron Announce Collaboration on New Cell Therapies for Cancer

Posted by ISPE Boston
On August 9, 2018

bluebird bio and Regeneron Pharmaceuticals have announced a collaboration to apply their respective technology platforms to the discovery, development and commercialization of novel immune cell therapies for cancer. The collaborators will specifically leverage Regeneron’s VelociSuite® platform technologies for the discovery and characterization of fully human antibodies, as well as T cell receptors (TCRs) directed against […]

Biogen Announces Positive Phase II Results for Alzheimer’s Treatment

Posted by ISPE Boston
On July 19, 2018

Biogen and its partner Eisai have announced positive topline results from the Phase II study with anti-amyloid beta protofibril antibody BAN2401 in 856 patients with early Alzheimer’s disease. The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score or ADCOMS, a measure of […]

Pfizer to Organize into Three Businesses

Posted by ISPE Boston
On July 19, 2018

Pfizer has announced it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business. These changes will be […]

Visterra to be Acquired by Otsuka Pharmaceutical for $430M

Posted by ISPE Boston
On July 19, 2018

Otsuka Pharmaceutical, headquartered in Tokyo, and Waltham-based Visterra have announced that Otsuka will acquire Visterra for approximately $430M in an all-cash transaction. The Otsuka and Visterra boards of directors have approved the transaction which is expected to close in the third quarter of 2018. Visterra’s Hierotope platform, comprised of novel computational and experimental technologies, enables […]

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