Novo stands up stem cell manufacturing site in California

Licensed from Asterias, the plant will supply stem cell-based therapies for clinical research by the Danish drugmaker.

By Suzanne Elvidge • Oct. 4, 2018

Our formulation of heart and science is the key to our success

Angie will never forget the day she got a call from a client with a distribution and logistics challenge of global proportions.

Oct. 4, 2018

Hemophilia pressures have Bayer laying off 227 at California plant

While the German pharma sees growth for its three hemophilia therapies, the job cuts indicate growing pains will be part of the process.

By Jacob Bell • Oct. 3, 2018

The safety imperative for prefilled syringes

The increasing concern of several organizations to prevent needlestick injuries has led to the conception of the EZ-Fill® Integrated Safety System, a groundbreaking, fully-passive needle shield that requires no assembly of add-on safety system.

Oct. 2, 2018

Rare case of CAR-T resistance underscores manufacturing hurdles

Unintentional inclusion of a single leukemic cell in clinical production of a CAR-T treatment led to a fatal relapse in a case reported by Penn researchers.

By Ned Pagliarulo • Oct. 2, 2018

FDA bans Zhejiang Huahai imports as valsartan review continues

The China-based manufacturer remains under the microscope for tainted supplies of the heart drug.

By Suzanne Elvidge • Oct. 2, 2018

What you need to know about continuous manufacturing

Drugmakers are still figuring out exactly how to embrace more modern production methods — or if they even want to, in some cases.

By Ned Pagliarulo , Jacob Bell , Andrew Dunn • Oct. 1, 2018

EMA expands valsartan review to include 4 other sartan APIs

The net is being spread wider as regulators attempt to track down the cause of the potentially harmful contaminants.

By Suzanne Elvidge • Sept. 27, 2018

Novartis taps Cellular Biomedicines to supply Kymriah in China

The biotech will be in charge of manufacturing the CAR-T therapy, while Novartis helms distribution, regulatory and marketing efforts in China.

By Jacob Bell • Sept. 27, 2018

FDA's Woodcock on drug companies' sluggish march toward manufacturing's future

The CDER chief said the agency won't force companies that want to stay "in the 1940s" with traditional methods — as long as they meet FDA standards.

By Andrew Dunn • Sept. 24, 2018

Pharma's slow embrace of continuous manufacturing

On the whole, drugmakers remain wedded to traditional production methods that have served for decades. Some, however, are shifting to newer technology.

By Ned Pagliarulo • Sept. 24, 2018

For CDMOs, continuous manufacturing isn't an 'if,' but a 'how'

Contract services providers are receiving more interest from drugmakers keen on the technology's potential cost-savings and better efficiency.

By Jacob Bell • Sept. 24, 2018

As FDA and pharma warm to continuous manufacturing, generics stay skeptical

Generics companies worry continuous manufacturing could become another tool for branded drugmakers to protect their products.

By Andrew Dunn • Sept. 24, 2018

J&J still has much to explore with continuous manufacturing

More than two years after getting an OK to switch Prezista manufacturing from batch to continuous, the big pharma has no intention of backing away from the increasingly turned-to method of production.

By Jacob Bell • Sept. 24, 2018

One bottle of hope for one amazing kid

How Fisher Clinical Services, by Thermo Fisher Scientific worked with a drug company to create a special clinical trial to save a patient with late stage brain cancer.

Sept. 24, 2018

Prescriptions, outpatient care drive healthcare spending growth: report

The Health Care Cost Institute found employer-sponsored insurance spending increased by 44% over the decade through 2016. 

By Les Masterson • Sept. 20, 2018

BeiGene grabs GE facility, continuing manufacturing buildout

Part of GE Healthcare's KUBio business, the facility includes FlexFactory biomanufacturing and is set to be operational — at least in part — by 2019.

By Suzanne Elvidge • Sept. 20, 2018

Florence squeezes drug supply chains

Pharmacies, which don't always stockpile inventory, possess few options when massive storms disrupt logistics.

By Rich Weissman • Sept. 19, 2018

Thermo Fisher licenses CRISPR tech from Broad Institute

The instruments maker aims to meet the growing demand for contracting services from companies using CRISPR in drug R&D. 

By Suzanne Elvidge • Sept. 19, 2018

AdvaMed supports FDA combination product GMP plan

The agency wants to streamline quality compliance mechanisms for drug-device combinations.

By Nick Paul Taylor • Sept. 18, 2018

FDA finds another carcinogen in valsartan products

The impurities continue a summer-long effort by regulators to assess the risk from tainted API of the heart drug.

By Suzanne Elvidge • Sept. 14, 2018

Next generation bioprocessing advances with innovation, collaboration and education

"Existing bioprocessing methods have pushed us as far as we can go," says Merrilee Whitney, head of next generation bioprocessing at MilliporeSigma.

Sept. 14, 2018

Sun's Halol plant back under FDA's magnifying glass

An August inspection of the key manufacturing facility flagged six observations, although it's not clear whether the new issues will hamper operations. 

By Suzanne Elvidge • Sept. 13, 2018

UK accelerator secures cell and gene therapy production licenses

Autolus, Cell Medica, Adaptimmune and Freeline are some of the companies already working with the accelerator.

By Suzanne Elvidge • Sept. 13, 2018

As Florence approaches, Pfizer pauses operations at North Carolina plant

Erring on the safe side, Pfizer is suspending normal operations at the sterile injectables plant ahead of the expected impact from Hurricane Florence.

By Suzanne Elvidge • Sept. 12, 2018