India's Semler sues FDA for $50M over suspicious spreadsheet

Semler is taking on the FDA over actions the CRO says were spearheaded by a disgruntled employee.

By Suzanne Elvidge • Feb. 1, 2018

Pharma tees up US capital spending, yet details remain vague

Pfizer, Merck and AbbVie have independently pledged to invest a combined $15.5 billion in domestic capital projects over the next five years.

By Ned Pagliarulo • Feb. 1, 2018

Baxter will import IV saline bags in wake of supplier difficulties

Hurricane Maria battered Puerto Rico's supply chains, making procurement of needed health supplies from the island's manufacturing facilities difficult.

By Rich Weissman • Feb. 1, 2018

FDA turns to drug packaging in bid to combat opioid crisis

The regulator aims to check abuse of Imodium by changing how the drug is packaged, and is considering similar approaches for immediate release opioids.

By Suzanne Elvidge • Jan. 31, 2018

FDA changes biologics inspections from biennial to risk-based

"While this means the inspection frequency for some establishments will be reduced, for some facilities it may increase," FDA chief Scott Gottlieb said.

By David Lim • Jan. 26, 2018

Chinese drugmakers tap GE tech, seeing biologic boom ahead

Zhejiang-based Clover BioPharmaceuticals is the latest to install GE Healthcare's "FlexFactory," aiming to ramp up GMP production of biologic medicines.

By Ned Pagliarulo • Jan. 25, 2018

Pfizer's EpiPen woes creep into Canada

A shortage of the epinephrine auto-injectors is the latest manufacturing issue to hit the big pharma.

By Jacob Bell • Jan. 25, 2018

FDA skewers Chinese API maker for lax quality control

Regulators noted that, by producing multiple drug products in the same space, there was a chance for "life-threatening" cross-contamination. 

By Jacob Bell • Jan. 18, 2018

Ipca Labs buys North Carolina manufacturer for $9.7M

Pisgah Labs specializes in production of API and intermediates, giving the Indian drugmaker new manufacturing capabilities in the U.S.

By Ned Pagliarulo • Jan. 18, 2018

With eye to Brexit, Almac to invest $42M in Ireland site

Located in Dundalk, Ireland, the CDMO's newly inspected facility is slated to be ready for operation by January 2019. 

By Ned Pagliarulo • Jan. 18, 2018

Flexion taps Thermo Fisher's flexible manufacturing for Zilretta

The biotech relies on the scientific instrument maker's Patheon unit as its sole supplier of finished drug product. 

By Suzanne Elvidge • Jan. 17, 2018

FDA works to ease IV shortages after Hurricane Maria

Saline and drug shortages triggered by the storm's effects still pose a challenge for U.S. hospitals and providers. 

By Suzanne Elvidge • Jan. 17, 2018

JPM18: Teva cutting up to 25 manufacturing sites within 2 years

It's the latest cost-savings move as the struggling Israeli drugmaker moves to rightsize itself.

By Jacob Bell • Jan. 11, 2018

Adaptimmune manufactures first dose of cell therapy, signs vector deal

The new facility can deliver cells for up to 300 patients a year, with potential expansion of up to 1,000 patients per year.

By Suzanne Elvidge • Jan. 11, 2018

Boehringer, BeiGene enter manufacturing pact for PD-1 drug

In a hookup with the German drugmaker, BeiGene gets a boost for tislelizumab production.

By Suzanne Elvidge • Jan. 11, 2018

As biopharma supply chains streamline, companies consolidate

An EY report details big changes — including the return of the "mega-merger" — coming to pharmaceutical companies and their supply chains.

By Kate Patrick Macri • Jan. 10, 2018

Distributors fire back against opioid lawsuits

Facing a wave of lawsuits, a pharmaceutical distribution group wants to correct the record on its role within the opioid supply chain.

By Edwin Lopez • Jan. 9, 2018

FDA aims to strengthen oversight of compounded drug manufacturing

While changes have been made since a 2012 meningitis outbreak, large-scale drug compounding still poses risks, an update from the FDA cautions.

By Ned Pagliarulo • Jan. 4, 2018

Fresnius Kabi's investigations aren't up to snuff, says FDA

The German drugmaker has repeatedly failed to identify what's causing sterility issues at its plants, pushing the FDA to issue two warning letters last month.

By Jacob Bell • Jan. 4, 2018

Shire seeks FDA sign-off on plasma manufacturing facility

Bringing the Covington, GA site on line will add 30% to Shire's plasma production capacity, helping support a growing immunology business.

By Suzanne Elvidge • Jan. 4, 2018

GSK taps Viant to test blockchain-based tracking

Blockchain developers believe the tech is ideally suited to serve the biopharma industry's supply chain needs.

By Jennifer McKevitt • Jan. 3, 2018

Fujifilm invests in gene therapy startup

The Japanese photography company has turned its focus to drugmaking in recent years, as illustrated by its new equity stake in EdiGene Corp.

By Jacob Bell • Dec. 21, 2017

MilliporeSigma tapped by bluebird for manufacturing

For bluebird, the deal is another step toward solidifying a stronger production process for its gene therapies.

By Jacob Bell • Dec. 21, 2017

Regulatory reforms unstick CMO market in China

A pilot scheme introduced by the Chinese government has given domestic biopharma companies more flexibility to tap CMOs for their manufacturing needs.

By Wang Fangqing • Dec. 21, 2017

Juno inks CAR-T supply deal with Thermo Fisher

Manufacturing is a key hurdle for cell therapy, pushing developers to be proactive in setting up production and supply chain processes during clinical development.

By Ned Pagliarulo • Dec. 21, 2017