US buys another 650,000 doses of Lilly's COVID-19 drug as outbreak surges

The U.S. government has ramped up spending on Lilly's and Regeneron's antibody-based COVID-19 treatments, but each remain in short supply.

By Kristin Jensen • Dec. 3, 2020

Cell therapy commercialization: How to achieve positive customer experience

What are the critical needs your commercial model must address to deliver a best-in-class experience?

By Curt Kugel, Sankalp Sethi and Meghan McDonald • Dec. 3, 2020

CDC panel recommends giving first coronavirus vaccines to healthcare workers, nursing home residents

Advisers on the CDC panel cited risk and disease burden as reasons for setting their priority list for the first vaccine doses to become available, supply of which will be extremely limited.

By Jonathan Gardner • Dec. 1, 2020

Bluebird faces delay for sickle cell gene therapy as rivals inch closer

The setback for Bluebird's LentiGlobin comes amid a string of manufacturing-related delays for gene therapy developers.

By Kristin Jensen • Nov. 5, 2020

Chinese biotech partnered with GSK gets funding boost for coronavirus vaccine

Clover Biopharmaceuticals, one of several China-based groups advancing a coronavirus shot, has now received one of the largest investments to date from the vaccine development alliance group CEPI.

By Kristin Jensen • Nov. 3, 2020

Axovant shares sink on manufacturing delay for Parkinson's gene therapy

A longer-than-expected timeline for developing a new manufacturing process means a key study for Axovant's top gene therapy likely won't begin until 2022.

By Ned Pagliarulo • Oct. 30, 2020

Novartis, Molecular Partners partner to develop a scalable COVID-19 drug

The two Swiss firms will develop protein drugs that are meant to have similar effects as coronavirus antibodies, but would be easier to mass produce.

By Ben Fidler • Oct. 28, 2020

Lilly hires consultant to help fix issues at COVID-19 drug manufacturing plant

The New Jersey facility that ran afoul of FDA manufacturing standards is one of several Lilly is using to produce coronavirus antibody drugs.  

By Kristin Jensen • Oct. 22, 2020

Roche joins the COVID-19 antiviral drug race, betting $350M on a startup

A deal with Atea Pharmaceuticals gives Roche rights to an oral antiviral for coronavirus disease that would compete with emerging therapies from Pfizer and Merck.

By Ben Fidler • Oct. 22, 2020

An Indiana startup aims to join the US drug manufacturing push

Incog BioPharma Services has become the latest entity to sprout up as part of a concerted U.S. effort to onshore production of pharmaceuticals.

By Kristin Jensen • Oct. 21, 2020

Fujifilm to help Lilly make COVID-19 antibody drug

Lilly has asked the FDA for emergency clearance of the therapy, although a study safety review and an unrelated manufacturing inspection could complicate the request.

By Ned Pagliarulo • Oct. 15, 2020

EU stocks up on coronavirus vaccine, drug supplies with J&J and Gilead deals

Agreements with the companies will help the EU catch up with the U.S. and the U.K. in securing advance stores of in-demand treatments.

By Kristin Jensen • Oct. 8, 2020

Regeneron follows Lilly in asking for emergency approval of COVID-19 antibody drug

The two antibody treatments are now being reviewed by the FDA, although limited supply could mean their impact won't be felt for months, even if they are cleared for use.

By Ben Fidler • Oct. 8, 2020

Gilead to distribute COVID-19 drug Veklury in US, taking over from federal government

Supplies of the once scarce drug now exceed demand, leading the Trump administration to step back from controlling distribution.

By Ned Pagliarulo • Oct. 2, 2020

Solid gets all-clear from FDA to restart gene therapy trial

Worrisome immune responses had led the FDA to halt Solid's study. Now, the agency will permit Solid to continue after the biotech made adjustments to its manufacturing and patient enrollment procedures.

By Jonathan Gardner • Oct. 1, 2020

Arranta Bio set to boost manufacturing for growing pipeline of microbiome drugs

The contract manufacturer aims to capitalize on progress for microbiome-based therapies, a field that's been buoyed by recent clinical successes.

By Kristin Jensen • Sept. 30, 2020

Data, supply chain constraints still dog COVID-19 testing, NIH officials say

Former heads of BARDA and NESTcc highlighted a need for comparing test types and protocols as the U.S. seeks to boost point-of-care options for asymptomatic and pre-symptomatic people.

By Maria Rachal • Sept. 29, 2020

FDA delays testing of Inovio's coronavirus vaccine

The FDA has suspended the planned start of a late-stage trial of Inovio's experimental shot, dealing another setback to one of the most advanced DNA-based vaccine programs in development.  

By Jonathan Gardner • Sept. 28, 2020

Drugmakers push forward on large-scale production of coronavirus vaccines

HHS Secretary Alex Azar said six vaccine developers involved with Operation Warp Speed had begun commercial manufacturing of their experimental shots. 

By Ned Pagliarulo • Sept. 24, 2020

AstraZeneca turns to Samsung Biologics to help fuel Asia drugs push

The British drugmaker struck a manufacturing deal with Samsung to expand its ability to supply drugs to the Asia Pacific region, an area that's been key to its recent growth.

By Kristin Jensen • Sept. 24, 2020

BioNTech to buy Novartis manufacturing plant to bolster vaccine supply

The site, set to be one of the largest mRNA manufacturing plants in Europe, will help BioNTech and partner Pfizer make 750 million more doses of their coronavirus shot per year.

By Kristin Jensen • Sept. 17, 2020

Takeda adds to cell therapy push with new manufacturing site

The Japanese drugmaker has made cell therapy a focus, advancing three experimental cancer treatments into clinical testing with plans for two more.

By Ned Pagliarulo • Sept. 15, 2020

Novavax boosts coronavirus vaccine manufacturing capacity as key trial nears

The Serum Institute of India, a go-to partner for coronavirus vaccine makers, will help Novavax boost capacity to levels matching its larger rivals.

By Jonathan Gardner • Sept. 15, 2020

Catalent to invest $130M in gene therapy plant near Baltimore airport

The contract manufacturer is riding a boom in demand for both its gene therapy and vaccine manufacturing services.

By Kristin Jensen • Sept. 10, 2020

FDA wants more details on Sarepta gene therapy, potentially delaying final test

A new request from the regulator could tighten the race between Sarepta and Pfizer to prove out a gene therapy for Duchenne muscular dystrophy. 

By Ben Fidler • Sept. 10, 2020