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

Parexel finds new CEO in INC Research vet

With more than two decades of CRO experience, Jamie Macdonald takes the top spot at Parexel on the heels of its private equity buyout.

By Jacob Bell • March 8, 2018

FDA recognizes GMP inspections by 4 more EU states

The move expands the number of EU regulators the FDA says can reliably conduct inspections of drug manufacturing facilities to 12.

By Ned Pagliarulo • March 8, 2018

TaiMed's HIV biologic secures FDA nod

The approval showcases how China-based manufacturers of biologic drugs are moving up value chains to produce novel drugs. 

By Randi Hernandez • March 7, 2018

Pfizer Hospira plant faces another recall

The McPherson, Kansas facility has been plagued by problems, resulting in potentially unsafe medicines being sold to hospitals.

By Lisa LaMotta • March 1, 2018

Kodak touts study to lure pharma manufacturing

The photography giant seeks a reinvention after digital innovation crippled traditional film companies.

By Jacob Bell • March 1, 2018

Regeneron links rise in Eylea safety reports to syringes

A recent spate in cases of intraocular inflammation among patients taking the eye drug led the biotech to conduct a review of its production processes.

By Ned Pagliarulo • March 1, 2018

Merck KGaA injects $47M into Asian manufacturing efforts

Capacity expansions in Asia could help speed up drug production timelines for both the domestic and foreign biologics markets.

By Randi Hernandez • March 1, 2018

Drug compounding oversight rises, but spotty: Pew

A new report highlights the challenges and safety issues still prevalent in compounding pharmacies.

By Jacob Bell • Feb. 26, 2018

Lonza adds new technology to Tampa facility

The CRMO adds further encapsulation capabilities to its Florida site, greatly increasing its capsule-filling expertise. 

By Lisa LaMotta • Feb. 22, 2018

Avid tapped to produce Enzyvant's rare disease candidate

It's Avid's latest move aimed at building a presence in the CDMO space.

By Jacob Bell • Feb. 22, 2018