Cryoport, in pursuit of smoother cell therapy logistics, opens new facility

Located in Livingston, New Jersey, the center is in close proximity to major cell therapy players like Novartis and Celgene.

By Jacob Bell • Oct. 24, 2018

Lonza plans to lay off 60 workers at Maryland plant beginning in December

As Lonza refocuses its manufacturing on four cell and gene therapy centers, a plant in Walkersville, Maryland, will see more than 100 workers affected and dozens expected to be laid off.

By Suzanne Elvidge • Oct. 23, 2018

Merck to create 170 jobs with new Ireland expansion

The big pharma has invested in its manufacturing network as demand climbs for vaccines and biologics.

By Suzanne Elvidge • Oct. 18, 2018

Acacia Pharma pitches quick path to refiling Barhemsys

A Complete Response Letter from the FDA earlier this month derailed Acacia's plans for its lead drug, but it hopes to soon get back on track.

By Suzanne Elvidge • Oct. 18, 2018

Managing inventory: What retail can learn from pharma

Retail and pharma are vastly different industries. But the tightly controlled world of drug supply still holds lessons for consumer goods. 

By Gary Wollenhaupt • Oct. 18, 2018

Shire debuts plasma facility in boost to manufacturing

Earlier this year, the biotech secured FDA approval for Gammaguard Liquid produced at the site.

By Suzanne Elvidge • Oct. 18, 2018

Expansion gives Almac room to grow in North Carolina

The CDMO opened a fourth building at its Durham campus, with space to add more than 100 employees over the next three years.

By Ned Pagliarulo • Oct. 11, 2018

Regulators wary of how McKesson handles illegitimate drugs

A Form 483 issued in July found the drug distributor didn't have proper systems for addressing illegitimate products when they came through its facilities.

By Jacob Bell • Oct. 11, 2018

Lonza boosts ADC manufacturing with new investment

Antibody-drug conjugates have occupied a corner of the biologic market for years. Lonza, though, is betting on faster growth.

By Suzanne Elvidge • Oct. 10, 2018

Manufacturers cite a 'workforce crisis' as the top threat to business

One in four manufacturers have turned down new business due to problems getting "quality" labor, a National Association of Manufacturers survey found.

By Edwin Lopez • Oct. 9, 2018

Sarepta builds out gene therapy manufacturing with latest CDMO deal

The biotech is thinking ahead, inking partnerships in recent months with Paragon Bioservices and Brammer Bio to support its gene therapy pipeline.​

By Suzanne Elvidge • Oct. 9, 2018

Dr Reddy's sells off Tennessee antibiotics facility in restructuring push

By 2021, the Indian drugmaker hopes to shift the majority of its North American business from solid oral dosages to injectables.

By Suzanne Elvidge • Oct. 4, 2018

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

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

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

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