Product Development

‘Modest’ expectations for ‘21 sales of Biogen’s Aduhelm

Biogen is seeing “strong indications of very high initial patient interest” in Aduhelm, CEO Michel Vounatsos said on the company’s 2Q21 earnings call Thursday, but the company expects modest revenues for...

Biopharmas leading orphan drug approvals: Data Byte

Though rare diseases can offer opportunities for small and mid-sized biotechs to retain ownership of their programs, pharmas still occupy eight of the top 10 spots for most orphan drug approvals. Bristol Myers Squibb Co....

What was left out of Sandrock’s Aduhelm letter

In an open letter to the Alzheimer’s disease community, Biogen’s Head of R&D Alfred Sandrock aimed to dispel what he called “extensive misinformation and misunderstanding” about Aduhelm circulating...

Round trip for Seres following Phase II UC miss

Seres is moving ahead with its next-in-line ulcerative colitis program SEC-301 following a Phase IIb failure for its lead UC candidate SER-287 that erased $1.2 billion from the microbiome company’s market cap.  On Thursday, Seres Therapeutics...

Mastering master protocols: lessons from COVID

Despite the success of the U.K.’s RECOVERY trial, master protocol trials on the whole were not the force for rapid, efficient drug development during COVID-19 that they should have been. But the failures...

Cytokinetics plans for commercial transition as CV programs progress

With its hypertrophic cardiomyopathy program slated to enter Phase III testing by year-end and a planned NDA submission for its heart failure candidate, Cytokinetics is actively building out its cardiovascular commercial workforce.  Top-line data from...

The growing siRNA pipeline: Data Byte

At least 37 companies are developing small interfering RNA (siRNA) therapies to treat genetic and rare diseases, with more than half moving into clinical trials. Of the products being explored by these companies, nearly 60%...

Nkarta looks to reduce manufacturing costs with new cell therapy plant

Nkarta announced Wednesday plans to build an integrated hub comprising manufacturing and R&D facilities and company headquarters in South San Francisco. Building a proprietary manufacturing capacity, and co-locating it with R&D, is critical to ensuring...

The ATTR pipeline: Data Byte

Competition continues to heat up in the rare disease transthyretin amyloidosis (ATTR), with at least a dozen preclinical and clinical programs coming up behind the three marketed agents, according to BioCentury’s BCIQ database. The indication...

July 12 Quick Takes: WHO gene editing recommendations go beyond germline to more immediate therapeutic applications; plus ProfoundBio, Incisive, EryDel, Inotrem and ReiThera

A pair of reports from the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing covers not only the hot-button issue of human germline editing, but also somatic...

The small but growing CD47 bispecific pipeline: Data Byte

Data presented at this year’s American Society of Clinical Oncology meeting showcased a growing pipeline of bispecific checkpoint inhibitors, including a handful targeting CD47.  Using a bispecific...

Comeback kid: Celldex gets latest lift from acquired urticaria program

Celldex’s latest revival is largely thanks to a 2016 acquisition that gave the company a KIT inhibitor that has now produced positive updated data in urticaria. The strength of Phase Ib data for anti-KIT...

Claudin 18.2 pipeline continues to grow: Data Byte

Following Astellas’ acquisition of the most advanced program targeting CLDN18.2 nearly five years ago, the pipeline of programs targeting the tight junction protein has grown to 27, making it one of the most sought after...

July 7 Quick Takes: Moderna launches flu trial of mRNA vaccine; plus Quidel recall, NIH, WHO, Boehringer-Lilly, Novartis and more

Moderna Inc. (NASDAQ:MRNA) dosed the first participants in a Phase I/II trial of quadrivalent seasonal mRNA influenza vaccine mRNA-1010 that will help determine whether the manufacturing and efficacy benefits of mRNA vaccines for COVID-19 translate...

Cancer still dominates orphan drug approvals: Data Byte

At the half-year mark, about half of the orphan drugs approved by FDA have been for rare cancer indications, continuing the trend of previous years. Orphan drug approvals in neurology, which has been the second...