Cambrex expands at Milan site

The generic API manufacturer will add a new lab in an effort to meet demand. 

By Suzanne Elvidge • June 13, 2018

Sun Pharma gets reprieve as FDA clears key Halol plant

India's largest generic drugmaker said the regulator had concluded violations found in a damaging 2015 warning letter to the facility were resolved.

By Ned Pagliarulo • June 12, 2018

WuXi Biologics plans first production facility in the US

The CMO will commit $60 million to build the plant, its latest project in a string of investments aimed at building a global manufacturing network.

By Suzanne Elvidge • June 11, 2018

Abeona opens commercial cell and gene manufacturing plant

The Elisa Linton Center in Ohio will manufacture cGMP-grade gene and cell therapies for clinical trials and commercialization.

By Suzanne Elvidge • June 7, 2018

How Fujifilm became a contract manufacturer

BioPharma Dive sat down with the head of Fujifilm Diosynth Biotechnologies at the BIO meeting to talk about manufacturing changes underway in the industry.

By Lisa LaMotta • June 7, 2018

TxCell turns to Lonza for CAR-T manufacturing

Anticipating increased demand, Lonza has been busy scaling up capacity to make cell and gene therapies for biotechs like TxCell.

By Suzanne Elvidge • June 7, 2018

UK launches new research institute tasked with improving drug discovery

The Rosalind Franklin Institute hopes to tap AI, robotics and new imaging techniques in a search for better methods to uncover new drug targets.

By Suzanne Elvidge • June 7, 2018

FDA working to mitigate critical drug shortages

Drug shortages can impede access to important drugs — something the agency aims to prevent in the future.

By Suzanne Elvidge • June 1, 2018

How to overcome drug sensitivity issues during development

By some estimates, 20-30% of drug formulations now have sensitivity issues. A glass container dedicated to biologics drugs has proven successful in de-risking switches from one container to another.

May 31, 2018

Ultragenyx taps Rentschler for Mepsevii commercial supply

The collaboration will give Ultragenyx access to fill and finish capabilities for its rare disease biologic.

By Suzanne Elvidge • May 31, 2018

GE Healthcare supports cell therapy scale-up

A partnership between DiscGenics, CCRM and GE Healthcare could help streamline manufacturing for the disc disease cell therapy.

By Suzanne Elvidge • May 31, 2018

Allergan recalls Taytulla contraceptive capsules

A packaging error could make the birth control ineffective and lead to unintended pregnancy.

By Suzanne Elvidge • May 30, 2018

EU refines IP rules to boost biosimilars and generics

The European Commission is loosening an IP law to improve the competitiveness of EU drugmakers in the global generic and biosimilar market.

By Suzanne Elvidge • May 29, 2018

FDA warns Florida-based Cerno about manufacturing and branding issues

Cerno's inadequacies in its cGMP manufacturing require consultant support to meet the FDA's needs.

By Suzanne Elvidge • May 25, 2018

Cleveland Clinic launches new biorepository

Increased access to tissue sample storage and improved patient consent could speed up translational research.

By Suzanne Elvidge • May 24, 2018

FDA issues draft guidance on topical drug ingredients

The agency is taking a closer look at how API are absorbed through the skin now that better technologies allow for more accurate monitoring. 

By Suzanne Elvidge • May 24, 2018

AstraZeneca raising profile in Bay Area

A new facility in South San Francisco will serve to consolidate the pharma's Bay area operations.

By Lisa LaMotta • May 23, 2018

Bioasis signs manufacturing deal with WuXi Biologics

Partnering with the Chinese CDMO should help Bioasis move one of its preclinical drug programs into the clinic.

By Suzanne Elvidge • May 23, 2018

Right to Try bill clears House, headed for Trump signature

FDA chief Scott Gottlieb had expressed reservations about the impact on agency authority.

By David Lim • May 22, 2018

11 technologies set to shape smart manufacturing

New tools like 3D printing and AI have already led to technological shifts, revealing a new wave of supply chain efficiencies yet to be unlocked.

By Jordan Branch , Edwin Lopez • May 21, 2018

Senate Dem says raising drug prices abroad won't help US

The generic drug lobby has concerns that tariffs proposed by the Trump administration, including on pharmaceutical ingredients and products from China, would lead to increased manufacturing costs and higher drug prices.

By David Lim • May 21, 2018

GE boosts cell culture media production tenfold

The manufacturing giant hopes the expansion in Austria and the U.S. will meet growing demand from industry. 

By Suzanne Elvidge • May 18, 2018

Cambrex expands high potency API capabilities

Work on a pilot plant in North Carolina has wrapped, while construction is underway of a new facility in Iowa. 

By Suzanne Elvidge • May 17, 2018

FDA issues warning letter to India's Goran Pharma

The agency suggests the company get help to sort out its facility issues.

By Suzanne Elvidge • May 16, 2018

Gilead finds new home in Europe for CAR-T manufacturing

By leasing a facility near the Amsterdam airport, Gilead will be better positioned to support commercialization in Europe of its cancer cell therapy, Yescarta.

By Ned Pagliarulo • May 15, 2018