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

Pfizer, BioNTech in final talks to supply EU with coronavirus vaccine

The companies, which are among the furthest along in testing, would deliver up to 300 million doses of their shot to EU countries under a proposed deal.

By Kristin Jensen • Sept. 9, 2020

FDA scolds Mylan for 'repeated' manufacturing problems

Though it once had a glimmering manufacturing record, Mylan now finds itself in the crosshairs of the FDA. The agency is advising the company to quickly and comprehensively assess its global operations.

By Jacob Bell • Updated Sept. 4, 2020

Catalent, seeing rising demand, to expand Indiana production plant

The planned $50 million infusion is the third investment in Catalent's Bloomington facility in two years, reflecting the need for vial filling for biologic drugs and vaccines.

By Kristin Jensen • Sept. 3, 2020

CanSino, Canada abandon plans for a coronavirus vaccine trial

Canada was set to help CanSino produce its experimental shot as part of a deal to run what would've been the country's first coronavirus vaccine study.

By Kristin Jensen • Aug. 27, 2020

AstraZeneca broadens coronavirus vaccine manufacturing deal with Catalent

Catalent, which is already helping the British pharma make its vaccine, will now add key services from a Maryland gene therapy plant.

By Kristin Jensen • Aug. 26, 2020