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

Gilead taps Sangamo to expand cell therapy after Kite buy

The big biotech is trying to expand its know-how and pipeline in its recently acquired area of cell therapies.

By Lisa LaMotta • Feb. 22, 2018

Biohaven teams up with Catalent on CGRP oral drug delivery

The drugmaker will use Catalent's fast-dissolving technology for rapid delivery of its migraine medication.

By Suzanne Elvidge • Feb. 22, 2018

CDER in warning letter frenzy as pharma struggles with quality control

While the FDA issued significantly fewer warning letters in 2017, the number coming from its CDER unit has nearly doubled since 2014, according to PwC.

By Jacob Bell • Feb. 21, 2018

Bayer plant flagged by FDA for poor GMP practices

As a result of the warning letter, the German giant expects a temporary effect on the supply of certain mature products.

By Jacob Bell • Feb. 15, 2018

Charles River boosts CRO chops with $800M deal for MPI

Acquiring MPI Research should raise Charles Rivers' profits as early as this year and expand its business with biotech.

By Ned Pagliarulo • Feb. 15, 2018

Bioverativ taps new manufacturer as it steps out of Biogen's shadow

The spinoff-turned-Sanofi-company could pay more than $100 million to Oxford BioMedica for lentiviral vector production.

By Jacob Bell • Feb. 15, 2018

LakePharma launches biomanufacturing center with new facility

The biologics specialist plans to add 100 jobs by 2020 to staff the new center, which will focus on supporting Phase 1 clinical trials. 

By Suzanne Elvidge • Feb. 15, 2018

Create brand sustainability with softgel technology

Three emerging trends that are shaping society and the pharmaceutical industry create a convincing argument for the use of softgel technology.

Feb. 13, 2018

FDA warning letter details violations at Celltrion plant

Issuance of the warning letter to Celltrion is causing a headache for Teva, which uses the Korean drugmaker to produce API for its biosimilar candidates and fremanezumab. 

By Ned Pagliarulo • Feb. 8, 2018

Citing lower tax rate, Amgen plans new biomanufacturing plant

The biotech says it will invest more in the U.S., although the $3.5 billion in total capital expenditures planned over the next five years is in line with past spending.

By Ned Pagliarulo • Feb. 8, 2018