BioCentury | Jul 10, 2020

How buysiders are sizing up commercial launches during the pandemic

Commercial launches were expected to be one of the biopharma activities hit hardest by the pandemic, but some new products have performed better than expected. The environment is not only pushing biotechs to new practices,...
BioCentury | Jul 10, 2020
Product Development

Evive meets in Phase III for chemotherapy-induced neutropenia; plus regulatory updates for Biogen, Eisai, Merck, AZ

Evive planning BLA, MAA for neutropenia therapy following pivotal trial readout  Evive Biotech Inc. said efbemalenograstim alfa met the primary and secondary endpoints in a Phase III study to prevent chemotherapy-induced neutropenia in breast cancer...
BioCentury | Apr 23, 2020

Market recalibrates Biogen’s valuation as aducanumab filing is delayed

Biogen’s aducanumab roller-coaster ride continued Wednesday as investors reassessed the risk for the Alzheimer’s therapy following a roughly six-month delay for the company’s BLA submission. Biogen Inc. (NASDAQ:BIIB) disclosed Wednesday plans to push back an...
BioCentury | Apr 4, 2020

Investors are seeking only one thing: a sign the pandemic tide is shifting

The usual clinical and commercial catalysts are taking a back seat in the second quarter as buysiders are almost solely focused on COVID-19 milestones that will stabilize the market. On the other hand, the virtual...
BioCentury | Apr 3, 2020
Product Development

COVID-19: manufacturing mAbs in patients

The urgency and scale of the coronavirus outbreak could drive progress in an emerging therapeutic strategy suited to rapid development and distribution -- encoding of antibodies in RNA or DNA. Neutralizing mAbs against SARS-CoV-2 have...
BioCentury | Mar 14, 2020
Politics, Policy & Law

Patient access to new Alzheimer’s drugs will depend on diagnostic innovation and payment reform

If Biogen’s Alzheimer’s disease therapy aducanumab gets approved this year, it will set off a payment time bomb given the huge patient population, and the fact it almost exclusively falls in the Medicare age group....
BioCentury | Feb 28, 2020

Biogen expands its modality toolkit in Alzheimer’s and Parkinson’s with Sangamo deal

In its latest CNS partnership, Biogen is doubling down on targets already in its pipeline with a gene regulation technology from Sangamo it hopes will shut down target expression altogether. By closing off target expression,...
BioCentury | Feb 27, 2020
Product Development

Neurimmune launches CV trial, first clinical antibody program outside the brain

As the first antibody out of Neurimmune’s reverse translation platform -- aducanumab -- heads for FDA submission this year, the biotech is looking beyond its core focus in CNS diseases. On Thursday, Neurimmune AG said...
BioCentury | Feb 11, 2020
Product Development

Alzheimer’s prevention replays the same amyloid failures as the treatment setting

The Phase II/III DIAN-TU trial of Lilly’s solanezumab and Roche’s gantenerumab was always a long shot, given the previous late-stage failures of both agents in Alzheimer’s trials. Perhaps more surprising is that both compounds remain...
BioCentury | Feb 5, 2020
Product Development

Biogen investors look ahead to Alzheimer’s after Tecfidera IP win

The U.S. Patent Trial and Appeal Board removed a major overhang for Biogen investors on Wednesday after ruling to uphold the validity of a patent covering blockbuster MS therapy Tecfidera dimethyl fumarate. The news sent...
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