In unusual step, FDA pushes back against reports on questionable generic drug quality

A statement from agency chief Scott Gottlieb and CDER head Janet Woodcock defended their oversight of generic drugs imported from abroad.

By Ned Pagliarulo • Feb. 22, 2019

FDA to accept drug plant inspections by Poland, Slovenia

So far, the regulator has recognized health authorities in 22 EU countries, trusting information those agencies gather through GMP inspections.

By Ned Pagliarulo • Feb. 21, 2019

Allogene inks lease for new cell therapy manufacturing facility

The 118,000-square-foot space should help the biotech be less reliant on its contract manufacturer and its partner Pfizer. 

By Jacob Bell • Feb. 21, 2019

AveXis adds new jobs in gene therapy manufacturing expansion

More jobs and money are on the table for an AveXis plant in North Carolina, showing acquirer Novartis' interest in building out its gene therapy capabilities.

By Suzanne Elvidge • Feb. 21, 2019

AstraZeneca adjusts supply chain for no-deal Brexit

The pharma will change some product packaging, duplicate batch testing and build inventory ahead of the impending Brexit deadline. 

By Matt Leonard • Feb. 19, 2019

Teva set to shed 11 manufacturing sites in 2019

The drugmaker's plans are part of a broad cost-cutting drive aimed at shrinking its spending base amid ongoing challenges in its generics business.

By Ned Pagliarulo • Feb. 14, 2019

Jazz set to lose rights to Erwinaze after partner cancels deal

While the lost rights would be a hit to Jazz's revenues, the company has a recombinant version of drug that analysts believe could cushion the blow. 

By Kristin Jensen • Feb. 13, 2019

Immunomedics, still searching for first approval, discloses forthcoming FDA re-inspection

The agency will re-inspect a New Jersey manufacturing facility as part of a regulatory resubmission for the company's lead drug candidate.

By Andrew Dunn • Feb. 8, 2019

Marken expands in Philadelphia, seeing higher biopharma demand

The biopharma-focused subsidiary of UPS will add a new GMP-compliant storage and distribution center near the Philadelphia airport.

By Kristin Jensen • Feb. 7, 2019

Tris Pharma's ibuprofen recall grows

The drugmaker is now recalling three more lots of product, adding to its production woes and the industry's larger problems with ibuprofen.

By Jacob Bell • Feb. 7, 2019

Pharma is shuffling around jobs, but a skills gap threatens the process

Drugmakers have found difficulty luring employees who can work with the latest technologies away from the likes of Amazon and Google, for instance. 

By Jacob Bell • Feb. 4, 2019

J&J inks deal with MeiraGTx for retinal disease gene therapies

The early-stage deal is a sign of growing interest from pharma in advancing gene therapy development, analysts said.

By Suzanne Elvidge • Feb. 1, 2019

Hitachi Chemical buys cell therapy-focused CDMO in Germany

The deal will add two manufacturing sites in Munich to Hitachi's portfolio, which already includes sites in the U.S. and Japan.

By Andrew Dunn • Jan. 31, 2019

Lonza promotes biopharma head to CEO spot

Marc Funk, currently COO of Lonza's Pharma and Biotech unit, will take over for Richard Ridinger in March.

By Ned Pagliarulo • Jan. 31, 2019

Novartis touts record year for manufacturing changes, but Kymriah still an overhang

Despite 16 plant transformations in 2018, Novartis foresees more work ahead as the company tries to strengthen production capabilities.

By Jacob Bell • Jan. 31, 2019

FDA zeroes in on potential causes of blood pressure med contamination

Scientists at the FDA have developed new tests to detect NDMA impurities contaminating some valsartan and other angiotensin II receptor blockers. 

By Suzanne Elvidge • Jan. 28, 2019

Lonza begins second-gen supply of Portola's Andexxa

Recent FDA approval of Portola's new manufacturing process for the reversal agent has allowed the biotech to launch the drug more broadly in the U.S.

By Ned Pagliarulo • Jan. 24, 2019

SAP debuts blockchain solution for counterfeit drugs

Manufacturers can store unique data via blockchain, and consumers can access the information by scanning the products with their smartphones.

By Matt Leonard • Jan. 23, 2019

How product recalls spread through the supply chain

Traceability and inventory planning can help supply chain managers weather the storm of a recall. 

By Barry Hochfelder • Jan. 22, 2019

Novartis, Novo Nordisk stockpile medicines as risk of no-deal Brexit rises

The Danish diabetes drugmaker is working to increase its stockpiles of insulin, while Novartis warned of "hugely impactful" disruption.

By Matt Leonard • Updated Jan. 25, 2019

Boehringer building out biologics manufacturing in China

The expansion of Boehringer's OASIS plant includes another bioreactor and the infrastructure to support two 2,000-liter single-use bioreactor production lines.

By Jacob Bell • Jan. 17, 2019

AmerisourceBergen subsidiary laying off hundreds at compounding plant

The company will cut about half its workforce at a Tennessee-based facility, which has been suspended due to concerns flagged by the FDA last year.

By Suzanne Elvidge • Jan. 17, 2019

EPA: Pharmaceuticals in reverse supply chain are hazardous waste

A new regulation could prompt uncertainty as players in the pharmaceutical supply chain evaluate compliance.

By Gary Wollenhaupt • Jan. 14, 2019

FDA expands excepted activities as government shutdown drags on

As days stretch into weeks, Commissioner Scott Gottlieb and his agency are battling to not let the shutdown hurt food and drug safety.

By Suzanne Elvidge • Jan. 14, 2019

Akorn's drug pipeline 'held hostage' with FDA warning letter

The agency detailed numerous violations against the generic manufacturer's plant in Decatur, Illinois.

By Kristin Jensen • Jan. 10, 2019