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

Sun Pharma recalls metformin tablets after finding contamination

In response to reports that one metformin HCl tablet had a piece of rubber glove in it, the Indian pharma's U.S. arm is recalling more than 2,500 bottles.

By Suzanne Elvidge • July 30, 2018

FDA puts clinical hold on Sarepta's DMD gene therapy program

The biotech has already created a plan to address the issue, with the aim of dosing patients by the end of 2018 pending an FDA go-ahead.

By Suzanne Elvidge • July 27, 2018

Pfizer to invest $465M in Michigan plant

A new sterile injectable manufacturing facility in the state is expected to start production in 2024, adding jobs to the area.

By Lisa LaMotta • July 26, 2018

Rubius buys manufacturing facility, to invest $155M

The Massachusetts-based biotech made the facility announcement the same week it raised $277 million through its IPO.

By Andrew Dunn • July 26, 2018

WuXi and Antengene sign cancer manufacturing agreement

In a deal focusing on China and the Asia-Pacific, WuXi will provide CMC services from preclinical to commercial.

By Suzanne Elvidge • July 26, 2018

FDA increases regulation on compounded drugs, issues new warning

The agency continues to increase its oversight of compounding, alerting the public to the risk of using cesium chloride as a bulk drug substance. 

By Andrew Dunn • July 26, 2018

Cambrex builds CDMO offerings with $425M Halo buy

By buying Halo, the API maker will add capabilities in specialized dosage forms as well as acquire two manufacturing plants. 

By Lisa LaMotta • July 23, 2018

Novartis hits CAR-T manufacturing snag as Kymriah sales disappoint

Details were scant on "variability in production specifications," but the pharma said it was still able to deliver final product to most patients.

By Ned Pagliarulo • July 19, 2018

Regulators recall valsartan after finding impurity tied to cancer risk

EU authorities linked the impurity to manufacturing changes made six years ago by a Chinese producer of the drug's active pharmaceutical ingredient.

By Suzanne Elvidge • July 19, 2018

Hikma ramping up injectable opioid output after shortages

The AMA declared drug shortages to be a national public health emergency last month, and the stream of opioids available to providers has continued to dry up.

By Rebecca Pifer • July 19, 2018

FDA creates task force to combat drug shortages

The group will look at factors such as payer reimbursement policies and incentives to encourage investment in manufacturing.

By Suzanne Elvidge • July 13, 2018

WuXi adds to its dealmaking hot streak

A new manufacturing agreement with Immune Therapeutics tasks WuXi with supplying the biotech's lead antibody.

By Suzanne Elvidge • July 12, 2018

Endocyte expands supply deal for VISION prostate cancer trial

A German specialist will produce the clinical and commercial supply of a radioactive isotope needed for Endocyte's therapy.

By Suzanne Elvidge • July 12, 2018

Novartis partners with French CDMO to bolster CAR-T supply

A deal with Cell for Cure is aimed at complementing the pharma's existing CAR-T production sites in New Jersey and Germany.

By Ned Pagliarulo • July 12, 2018

New FDA guidance aimed at advancing gene therapy

A suite of new and updated agency documents brings the prospect of more gene therapy approvals closer.

By Suzanne Elvidge • July 12, 2018

Sanofi shuts down French facility due to pollution complaint

Work at the Mourenx plant was immediately halted to sort out pollution problems associated with Depakine production.

By Suzanne Elvidge • July 11, 2018

Boehringer increases manufacturing capacity in China

By adding a new fill-and-finish line at its Shanghai site, the German drugmaker aims to be a "one-stop shop" for GMP contract manufacturing.

By Suzanne Elvidge • July 6, 2018