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FDA issues draft guidance on topical drug ingredients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

Macrogenics taps AGC Biologics for commercial manufacturing

The CDMO will prepare to commercially supply Macrogenics' cancer drug margetuximab, which is making its way through Phase 3 study. 

By Suzanne Elvidge • May 14, 2018

What to expect from Trump's Friday drug pricing speech

The president is expected to lay out his administration's latest slate of proposals aimed at lowering the cost of drugs.

By David Lim • May 10, 2018

Avid CEO talks expansion, capacity and Asia

In an interview with BioPharma Dive, Avid's Roger Lias decribes the opportunities now open to the full-service biologics CDMO.

By Randi Hernandez • May 10, 2018

Proteon and Lonza extend manufacturing agreement

With Proteon's experimental drug moving through Phase 3, the biotech sought to secure long-term supply of the drug's active pharmaceutical ingredient. 

By Suzanne Elvidge • May 10, 2018

Ritter taps Medpace as CRO for Phase 3 microbiome study

Bringing on board a CRO moves Ritter a step closer to beginning pivotal trials for its microbiome booster.

By Suzanne Elvidge • May 9, 2018