Health systems roll out generic manufacturing company to meet hospital needs

Catholic Health Initiatives, HCA and Mayo Clinic are just a few of the groups aiming to lower costs and increase access to generics through the newly-named Civica Rx.

By Jacob Bell • Sept. 6, 2018

As valsartan recall persists, FDA touts facility inspection transparency

FDA Commissioner Scott Gottlieb released a document detailing how the agency prioritizes which plants it inspects.

By Andrew Dunn • Sept. 6, 2018

Lupin's Tarapur facility gets clean bill of health from FDA

Amid widespread problems with valsartan production, a cGMP inspection has alleviated concerns at one of Lupin's Indian plants.

By Suzanne Elvidge • Sept. 5, 2018

BioPharma Dive's 10 hottest stories of the summer

Readers were drawn to news from big pharmas, like Pfizer and Roche, as well as a landmark biotech approval and new drug launches. 

By Jacob Bell • Sept. 4, 2018

FDA widens valsartan probe, warns more recalls could be coming

In a new announcement, the agency offered details about the ongoing investigation into impurities found in generic versions of the blood pressure drug.

By Suzanne Elvidge • Aug. 31, 2018

Catalent's growth blemished by weaker Softgel performance

Though investors seemed pleased with the contract manufacturer's most recent fiscal year performance, executives expect headwinds to the Softgel segment will continue in 2019.

By Jacob Bell • Aug. 30, 2018

FDA continues clampdown on compounders

The decision to turn down three prospective ingredients for outsourcing facilities now awaits public comment.

By Suzanne Elvidge • Aug. 30, 2018

Kyowa Hakko picks up warning letter from the FDA

Repeat failures call into question the Japanese pharma's data integrity.

By Suzanne Elvidge • Aug. 29, 2018

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