As supply shortages persist, ADMA relaunches immune globulin drug

Three of the plasma-derived therapies are currently in shortage, according to the FDA, putting pressure on hospitals and infusion centers.

By Ned Pagliarulo • Aug. 22, 2019

Pfizer injects $500M more into gene therapy manufacturing

The money is going toward a North Carolina plant that will make the inactivated viruses used to deliver gene therapies and employ 300 staff.

By Jacob Bell • Aug. 21, 2019

Technology permeates the cold chain warehouse — but has its limits

At DHL's cold storage facility in Chicago, technologies such as RFID are designed to withstand cold temperatures and help monitor shipments, including those for life sciences companies.

By Jen A. Miller • Aug. 13, 2019

Nektar battered over manufacturing issues and Bristol-Myers pullback

A study of skin, kidney and bladder cancer found disease progressed faster after patients received inactive doses of a Nektar drug paired with Opdivo.

By Jonathan Gardner • Aug. 9, 2019

PE firm to buy Cambrex for $2.4B amid flurry of CDMO acquisitions

Permira’s planned deal marks the third in the space topping $1 billion this year.

By Kristin Jensen • Aug. 7, 2019

Novo buys North Carolina plant from Purdue

Located near Novo's sprawling Clayton site, Purdue's facility gives the buyer capacity to manufacture oral drugs like its experimental version of semaglutide.

By Ned Pagliarulo • Aug. 6, 2019

Regenxbio inks viral vector rights deal with Pfizer

Pfizer gains non-exclusive rights to AAV9 vector technology from Regenxbio, a collaboration that supports one of the pharma's early gene therapy programs.

By Kristin Jensen • Aug. 1, 2019

Akorn takes $74 million charge to settle shareholder lawsuit

Investors accused the generics maker of knowingly ignoring data integrity issues at the company's manufacturing facilities — problems that eventually derailed a $4.3 billion deal with Fresenius. 

By Ned Pagliarulo • Updated Aug. 1, 2019

Pfizer may send EpiPen manufacturing to generics spinoff

The drug giant is in talks to transfer its troubled Meridian Medical Technologies unit to the merged business with Mylan.

By Kristin Jensen • Aug. 1, 2019

White House backs importing drugs from abroad

The Trump administration's latest drug price plan features ideas Republicans traditionally oppose and breaks with past claims about the FDA's ability to safely oversee importation.

By Jonathan Gardner • July 31, 2019

Lonza plans facility expansion amid pharma focus

While profit dipped over the first half of 2019, Lonza predicts strong sales growth driven by its pharma and biotech-facing unit.

By Kristin Jensen • July 25, 2019

Nonprofit US generics company secures supplier in Hikma

The hospital-created group Civica Rx signed a deal for production of 14 sterile injectables, aiming to alleviate drug shortages.

By Jonathan Gardner • July 23, 2019

Biohaven blames Apotex for FDA rejection of ALS drug

Biohaven said it is working with the FDA to solve the manufacturing-related problems that led to a Complete Response Letter for the experimental drug. 

By Andrew Dunn • July 22, 2019

Catalent to help make Novartis' Zolgensma at Maryland site

The gene therapy is currently produced at an AveXis facility in Illinois, but Novartis is expanding its capacity in anticipation of growing demand.

By Ned Pagliarulo • July 18, 2019

FDA warns Indian drug manufacturer Strides about document shredding

In a July warning letter, the regulator criticized the generics manufacturer for shoddy investigation of impurities and deficient quality practices.

By Kristin Jensen • July 17, 2019

Drone delivers Merck vaccines between islands using AT&T tech

The drone, which carried temperature-sensitive Merck vaccines over a 24-mile route, could potentially be used to bring drugs to remote locations.

By Morgan Forde • July 16, 2019

Kite building out manufacturing as next cell therapy inches to market

A new facility will span 67,000 square feet and be located in Oceanside, California, tucked into an existing Gilead site for biologics.

By Jacob Bell • July 16, 2019

Nexus to build $250M manufacturing facility in Wisconsin

The privately-owned drugmaker is planning a 10-year, multi-phase project in Pleasant Prairie, Wisconsin.

By Kristin Jensen • July 11, 2019

Sandoz widens launch of EpiPen rival as shortage continues

Manufacturing issues have kept EpiPen in shortage for more than a year, opening a window for Sandoz to build share for Adamis' Symjepi. 

By Andrew Dunn • July 10, 2019

Federal court bars stem cell sales by Florida company in win for FDA oversight

FDA leaders Ned Sharpless and Peter Marks said the legal action "sends a strong message to others manufacturing violative stem cell products."

By Andrew Dunn • June 27, 2019

Catalent picks up Novavax facilities, 100 employees

The contract manufacturer will use the two sites to further its gene therapy push, complementing a recent buy of Paragon Bioservices.

By Ned Pagliarulo • June 27, 2019

FDA warns Akorn on issues at New Jersey plant

The warning letter is the second issued by the agency to Akorn this year, following a notice for violations at a facility in Decatur, Illinois.

By Kristin Jensen • June 27, 2019

Aiming for price transparency, Civica Rx hits snag with bundled payments

The payment model, often opaque on specific drug costs, affects many of the medicines the hospital-led group is targeting, according to its commercial chief.

By Jacob Bell • June 27, 2019

Axovant signs Yposkesi as manufacturing partner

The small gene therapy developer, with no manufacturing capacity of its own, looks to Yposkesi for large-scale production.

By Kristin Jensen • June 20, 2019

DHL invests $150M to expand pharma, medical supply chain

The life sciences logistics market is highly fragmented, driving third-party companies to invest in temperature-controlled supply chains and specialized facilities.

By Shefali Kapadia • June 20, 2019