MassBio: Massachusetts dominates IPO market, VC funding in 2017

While other states and cities have tried to make their mark in biotech, industry activity remains concentrated in Boston and California. 

By Andrew Dunn • Aug. 29, 2018

Novartis, Gilead CAR-T therapies approved in Europe, putting spotlight on global manufacturing

Kymriah and Yescarta are churned out in a matter of weeks — a production task that gets more difficult as approvals expand their geographic reach.

By Jacob Bell • Aug. 27, 2018

WuXi adds bispecific platform as business booms

The CDMO claims its bispecific technology can cut manufacturing costs and shorten development time by as much as 18 months.

By Suzanne Elvidge • Aug. 23, 2018

How TraceLink will use $93M to showcase the benefits of serialization

The data network plans to expand to help pharmaceutical supply chains tap into data that was unavailable prior to track-and-trace regulations.

By Edwin Lopez • Aug. 23, 2018

CSL's Seqirus expects to double flu vaccine production at NC plant

Coming off one of the worst U.S. flu seasons in the last decade, the FDA has approved a new process that Seqirus believes will improve the way cells are grown at its Holly Springs site.

By Jacob Bell • Aug. 23, 2018

Collaboration and knowledge transfer equals success for patients

The mentor relationship that led to long-term results through the transfer of critical knowledge.

Aug. 23, 2018

FDA extends EpiPen expiration date to ease shortages

Current shortages stemming from ongoing manufacturing delays could put children at risk as the school year approaches.

By Suzanne Elvidge • Aug. 22, 2018

EMA bars valsartan API made by second Chinese drugmaker

The EMA has revoked Zhejiang Tianyu's authorization to make the heart drug ingredient for EU medicines after finding traces of a carcinogen in batches produced by the manufacturer. 

By Suzanne Elvidge • Aug. 21, 2018

GSK will close manufacturing plant in Ireland, cutting 165 jobs

It's the second such announcement this month for GSK, which earlier said it would shutter a Bangladesh plant resulting in more than 1,000 layoffs.

By Barbara Boughton • Aug. 21, 2018

Trump seeks federal opioid lawsuit, DOJ aims to slash manufacturing quotas

The president said he'd like Attorney General Jeff Sessions to launch a federal suit in addition to ongoing state legal actions. Meanwhile, the DOJ and DEA proposed further cuts to quotas on opioids for 2019.

By Andrew Dunn • Aug. 17, 2018

Mylan's EpiPen supply woes drag on

In the midst of a strategic review, Mylan is still having problems with EpiPen supplies. The new approval of Teva's generic only makes the situation even more dire.

By Suzanne Elvidge • Aug. 16, 2018

After a hiring blitz, where is Mustang's CAR-T manufacturing headed?

On the heels of a new plant opening and licensing deal, Chief Technology Officer Knut Niss discussed lessons learned and the road ahead for Mustang.

By Jacob Bell • Aug. 16, 2018

Roche's Genentech planning to lay off 223 employees

Genentech already cut 365 total workers last November and now plans to eliminate hundreds more as Roche braces for biosimilars to erode some of its top brands.

By Andrew Dunn • Aug. 16, 2018

FDA sends Apotex warning letter for Indian manufacturing violations

Another warning heads out to an Indian facility in what is becoming a bumper year for Asian manufacturing violations.

By Suzanne Elvidge • Aug. 16, 2018

Catalent completes $130M acquisition of Juniper

The deal is the latest in the CDMO space aimed at beefing up services for pharmaceutical companies.

By Barbara Boughton • Aug. 15, 2018

With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season

Manufacturing delays at a Pfizer-owned EpiPen plant have created an opportunity for Kaléo.

By Nick Paul Taylor • Aug. 15, 2018

Torque touts modular approach to T cell manufacturing

Dubbed "Slipstream," Torque's platform is designed to be scalable and less labor-intensive than current cell manufacturing methods.

By Suzanne Elvidge • Aug. 9, 2018

Boehringer, Oxford BioMedica join on CF gene therapy project

Securing Oxford BioMedica's participation is indicative of the manufacturing hurdles present in gene therapy, particularly involving lentiviral vectors. 

By Suzanne Elvidge • Aug. 9, 2018

Manufacturing problems leave Jazz with 'extremely limited' Erwinaze supply

Issues at the drug's single-source provider, Porton Biopharma, have begun to impact Jazz's commercialization of the drug.

By Jacob Bell • Aug. 9, 2018

J&J, Bayer to shutter production plants in South Korea: report

The shutdowns are due to rising labor costs and shifting demand in the pharmaceutical market, writes The Korea Times. 

By Barbara Boughton • Aug. 9, 2018

Teva confident migraine drug will launch this year despite new manufacturing woes

On Tuesday, contract manufacturer Celltrion disclosed it received a Form 483 for its plant in Incheon, South Korea, which makes Teva's fremanezumab.

By Jacob Bell • Aug. 7, 2018

Changing clinical trial protocols to ensure success

The "eureka moment" that helped a small company make a big impact.

Aug. 6, 2018

Success for ADMA as Bivigam inspection file closes

ADMA Biologics has given Biotest's Bivigam a new lease on life by optimizing the production process and getting a manufacturing go-ahead from the FDA.

By Suzanne Elvidge • Aug. 2, 2018

GSK cuts 1,000 jobs with Bangladesh plant closure

Shuttering of pharmaceutical operations in Chittagong will take effect by year's end and impact employees in marketing and commercial operations.

By Suzanne Elvidge • Aug. 1, 2018

3 blockchain applications to watch in logistics

Complex supply chains make the logistics industry a prime proving ground for blockchain — a technology that could also be useful for pharmaceuticals.

By Deborah Abrams Kaplan • July 30, 2018