Maker of Pfizer med warned for continued testing issues

Tris Pharma has for years ruffled feathers at the FDA for not adequately investigating drug product failures.

By Jacob Bell • April 12, 2018

Sanofi boosts vaccine supply capabilities with Toronto investment

The Toronto site is the exclusive producer of the five-component pertussis, an antigen used to make pertussis combination vaccines.

By Randi Hernandez • April 12, 2018

Celltrion acknowledges CRLs in potential hurdle for Teva

Rejection by the FDA of the two biosimilar candidates Celltrion develops with Teva could also prove a headache for the Israeli drugmaker's migraine therapy.

By Randi Hernandez • April 9, 2018

Autolus pairs up with Miltenyi to manufacture T-cell therapies

Autolus aims to automate its cell processing steps utilizing Miltenyi tools, which could in theory make the complex manufacturing process more reproducible.

By Randi Hernandez • April 5, 2018

AGC in new expansion as biologics production heats up

With the industry's focus shifting more to large-molecule drugs, contract manufacturers are building out capacity to meet demand.

By Jacob Bell • April 5, 2018

Corning to build NC facility in pharma packaging expansion

The manufacturer plans to invest $200 million in the plant, which will produce the company's Valor Glass packaging.

By Ned Pagliarulo • April 5, 2018

Alnylam taps Agilent for commercial API supply

The five-year deal will help support Alnylam's planned market launch of its RNAi therapeutic patisiran.

By Ned Pagliarulo • April 4, 2018

Proposed China tariffs target dozens of medical products

Insulin products, vaccines and certain active pharmaceutical ingredients imported from China could face a new 25% tariff under the Trump administration's proposed plan. 

By Ned Pagliarulo • April 4, 2018

Eisai partners with Nichi-Iko in generics pact

Under the deal, Eisai will transfer ownership of its generics unit to Nichi-Iko, supplying its new partner with API from a manufacturing plant in India.

By Ned Pagliarulo • March 29, 2018

Fujifilm lays down $800M for Irvine Scientific

Snapping up niche bioprocessing companies furthers Fujifilm's goal of improved pharma manufacturing, and it's on the hunt for more buys.

By Randi Hernandez • March 29, 2018

Novartis sues Regeneron over manufacturing methods

The Swiss pharma claims the technology used to produce eye drug Eylea and cancer treatment Zaltrap infringes on one of its long-held patents.

By Jacob Bell • March 28, 2018

CROs team up to develop shared tech standards

Six contract research organizations have banded together in a bid to unify the industry around common standards and speed drug development.

By Lisa LaMotta • March 28, 2018

Daiichi taps Hitachi for regenerative medicine manufacturing

The deal will help Daiichi’s investigational candidate harness an accelerated regulatory pathway for regenerative products in Japan.

By Randi Hernandez • March 22, 2018

Thermo Fisher to grow European footprint with new supply chain site

A planned 86,000-square-foot facility could be completed by late-2019, and Thermo says there's the potential to double its size later on.

By Jacob Bell • March 22, 2018

Wuxi adds large-scale, single-use bioreactors

The contract manufacturer continues its expansion at its Wuxi city facility that it began in 2015. 

By Lisa LaMotta • March 22, 2018

FDA warns Indian drugmaker over open-air API production

Inspectors from the agency weren't thrilled to find birds and insects nearby equipment used for drug manufacturing.

By Ned Pagliarulo • March 22, 2018

J&J to sell Lifescan, dropping out of diabetes diagnostics

The pharma giant intends to divest its Lifescan unit to a private investment firm for $2.1 billion.

By Suzanne Elvidge • March 19, 2018

Oxford BioMedica aims to raise cash for bioprocessing expansion

The British cell and gene therapy company plans to sell shares to fund a facility expansion. 

By Lisa LaMotta • March 15, 2018

Novartis splits operations unit as part of leadership reshuffle

Steffen Lang will join the Swiss pharma's executive committee as head of technical operations, while current member André Wyss will step down.

By Ned Pagliarulo • March 15, 2018

Covance bets on biologics with new immunotoxicology testing arm

The unit will help manufacturers evaluate immune system-related risks associated with candidates in their biotherapeutic pipelines.

By Randi Hernandez • March 15, 2018

Novel uses for oral solid doses driving lifecycle management strategies

With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage (OSD) arena.

March 15, 2018

DHL wants to tap blockchain for life sciences, pharma

The shipper partnered with Accenture to investigate how blockchain can help a variety of industries, primarily from a logistics perspective.

By Kate Patrick Macri • March 13, 2018

WuXi Biologics, Adagene ally to address hard-to-manufacture antibodies

Conventional approaches to make drug product for antibody-based medicines is not always sufficient — a challenge the companies seek to address.

By Randi Hernandez • March 9, 2018

Two OTC drugmakers in China feel the sting of FDA warnings

Over a third of warning letters issued last year by the FDA's Office of Manufacturing Quality cited violations by OTC makers.

By Randi Hernandez • March 8, 2018

Charles River hones biologics business, adding lab space

Seeing rising demand for the large molecule drugs, the contract research and manufacturing firm aims to expand what services it can offer to drugmakers.

By Lisa LaMotta • March 8, 2018