An expert speaking during the industry event offers insight and perspective on the flurry of CDMO deal-making in recent months, and what might lie ahead.
Contract data analysis can help predict pharma demand: Agiloft
The process management solutions firm says drug companies could use contract data to get a better handle on predicting demand and adjusting product output.
Aetion aims to advance the adoption of and standards for real-world evidence backed by a strategic investment from several global biopharma and health care companies.
The Republic of Ireland will move its population from short-acting to extended half-life haemophilia therapies, under an exclusive two-year deal with Sobi.
IQVIA has been contracted to expand the safety and efficacy monitoring of biologic products as part of a novel alliance with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER).
Emergent BioSolutions says it is looking to expand auto-injector manufacturing capacity due to growing demand for its nerve agent antidote product Trobigard.
Recipharm has acquired a Spanish manufacturing plant and signed a supply deal with former owner Roche for a range of solid dose products worth €35m a year.
BASF SE has selected the Icertis Contract Management (ICM) platform to automate its contracting processes and improve visibility into contractual obligations and deviations.
SQI Diagnostics Inc. has signed an agreement to commercialize a custom multiplexed assay for a Waltham, MA-based global biotechnology company's blood disorder drug program.
Avista Pharma Solutions, Inc. has been contracted to manufacture an opioid-derived small molecule, which is a component of a conjugate vaccine being developed to treat opioid addiction.
IntelGenx Corp. and Tetra Bio-Pharma Inc. have signed a binding term sheet for the development and commercialization of a drug product containing dronabinol.
After buying two CMOs, Japanese glassmaker AGC has made “a full-fledged launch” into the biologics manufacturing space and says it will consider further M&A opportunities.
A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.
Agilent Technologies has contracted the original creators of its RapidFire 365 High-throughput Mass Spectrometry System to further develop new applications.
MSM Poly LLC has signed a non-binding agreement to buy IP that underpins Ineos’ Barex resins, which are used to make pharmaceutical and food packaging.
After much speculation, Pfizer has confirmed it will renew its service agreements with its largest contract research organization customers – as analysts suspected.
This month marks the renewal period for Pfizer’s contract research organizations’ Icon and Parexel, and while revenues have been declining, analysts believe the pharma giant will renew with both companies.
As pharma sells off manufacturing capacity and outsources to large and specialist CMOs, smart contract houses will have an opportunity to grab market share in a currently fragmented sector, say experts.
WuXi PharmaTech has signed a strategic partnership deal to provide exclusive laboratory testing services to Hong Kong-headquartered Lee’s Pharmaceutical.
Novasep has signed two partnership agreements for the Japanese markets. The agreements were with Allied Laboratories, a life science and chemical consulting company, and with AR Brown, which will represent Novasep’s CMO services in the Japanese market.
As part of efforts to reduce clinical trial start-up times, WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for human research, said it will encourage the 1,200 members of its research network to...
Strategic relationships with contract manufacturers are becoming the standard, but big and small pharma demands differ considerably according to the two largest CDMOs, DPx and Catalent.
Efficient relationships with contract manufacturers are being held back by Big Pharma’s ‘intellectual arrogance’ and ill-defined operational teams, according to an ex-Director at GlaxoSmithKline.
Unilife says it is confident future revenue from current contracts could total $1bn and is scaling up manufacturing capacities despite no product sales in the third quarter.
CRO and sponsor payment service provider Clinverse announced a record first quarter to start 2014, with the addition of four significant new clients, as well as strong additional repeat business from existing clients.
Pernix Therapeutics will no longer be a CMO as it has signed a definitive agreement to divest its Houston, Texas-based manufacturing operations to Woodfield Pharmaceutical to cut costs.
Boehringer Ingelheim (BI) has warned that latest efforts to ensure continued Doxil production at Ben Venue's troubled sterile injectables plant in Bedford, Ohio must still be approved.
Catalent says it is creating dedicated space and possibly jobs at its Missouri facility in order to service a commercial contract for Pharmacyclics’ oncology drug Imbruvica.
Pfizer, GlaxoSmithKline, Sanofi, and at least ten other big pharma companies, CMOs and industry groups are criticizing aspects of the recent FDA draft guidance governing quality agreements.
CRO Covance is looking to help its biopharmaceutical and medical device clients manage their contract terms and associated payments better as some companies are losing almost 5% of US revenue from insufficient processes and contract management systems.
Although written quality agreements are not required under cGMP regulations, the US FDA is recommending that pharma companies and CMOs adopt the agreements to delineate responsibilities.
With a ruling that could have implications for any CRO looking to understand its rights under a MSA (master services agreement) with a sponsor, a federal district court in Ohio has ruled against CRO Medpace.