Hospira has received a US FDA Warning Letter at an Australian injectables facility months after workers asked the firm not turn the site into “the new Rocky Mount.”
Including explosion protection in initial facility plans can save money in the long-term, according to Rembe, especially as drugmakers continue to work with more volatile ingredients.
Boehringer Ingelheim is investing more than €100m ($126m) at its Dortmund, Germany site to expand production capacity for its Respimat inhaler, which is the third time in the past four years that the company has made a capacity-expanding investment at...
China-based WuXi PharmaTech has acquired CRO XenoBiotic Laboratories (XBL) to bolster its bioanalytical and DMPK (Drug Metabolism and Pharmacokinetics)/ADME (absorption, distribution, metabolism, and excretion) services. Financial terms were not disclosed....
Catalent has urged industry and academia to share knowledge about delivery technologies to help improve drug efficacy as it signs a deal to develop ADHD treatments for Cingulate.
The Medicines Manufacturing Industry Partnership (MMIP) between the ABPI (Association of the British Pharmaceutical Industry), BIA (BioIndustry Association) and a number of companies aims to make the UK a more attractive destination for pharma manufacturing.
The market opportunity for each Indian drugmakers granted a license to manufacture Gilead’s hepatitis C drug Sovaldi could be worth over $600m, an analyst has calculated.
Hundreds of workers brought in to help fix manufacturing issues at a Boehringer Ingelheim facility will not be affected despite the firm looking to shave 600 jobs in a €450m ($580m) cost-cutting initiative.
Life science sector consolidation is a concern for some biomanufacturers, who say mega mergers like Merck KGaA’s $17bn acquisition of Sigma-Aldrich will limit their ability to negotiate on prices.
The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.
The US FDA has warned the public not to use any sterile medicines made by Downing-owned NuVision Pharmacy, Texas, which failed to comply with a recall order.
Hospira has invested 15m AUD ($14m) in a Victoria injectables plant it says will continue to make drugs for export despite the economic downturn and strong Australian dollar.
As contract manufacturers continue to consolidate, some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies.
Gilead has granted seven Indian drugmakers licenses to produce generic versions of its $1,000 a pill drug Sovaldi to increase access to hepatitis C medicines in 91 developing countries.
Almac has teamed up with Welsh Academics and industrial chemistry firm Hockley International to develop enzymes capable of making drug intermediates more quickly.
Relypsa has entered into a multi-year commercial manufacturing and supply agreement with CMO Patheon for the finished product manufacture of patiromer, Relypsa's potential treatment of hyperkalemia.
Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.
US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012.
CDMO (contract development and manufacturing organization) Catalent saw Q4 revenue rise 3% and income rise 66% thanks in part to an increase in its oral technologies segment.
Meda has sold a New Jersey facility dedicated to its intra-urethral erectile dysfunction drug Muse as part of a strategic review of its manufacturing network.
Xellia has agreed to invest $100m in equipment, retain staff and create 40 full time jobs at the plant it bought in Raleigh, North Carolina in return for business incentives.
ZMapp, the experimental Ebola therapy given to a handful of infected patients in West Africa, is being produced in tobacco plants for Mapp Biopharmaceutical by CMO Kentucky Bioprocessing in collaboration with drugmaker Defyrus.
Patheon has sliced four weeks off its Quick-to-Clinic service saying speedier supply of materials for first in human trials increases pharma’s return on investment.
Novo Nordisk has bought a biomanufacturing facility earmarked for closure by Olympus Biotech and begun rehiring staff in order to support its haemophilia product pipeline.
Pfizer is rumoured to be eyeing up Actavis three months after failing to woo AstraZeneca in a $120bn megamerger, but what would such a deal bring to the Pharma Giant? In-Pharmatechnologist investigates.
Patheon has acquired Gallus BioPharmaceuticals adding two US biologics plants and says with an industry shift towards medium sized bioreactors it now holds the market advantage.
Parallel deals to invest in Isofol Medical and manufacture the alternative chemotherapy agent Modufolin on its behalf are evidence of Recipharm’s ambitious growth strategy, the CDMO says.
Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.
Roche has bought InterMune for $8.3bn (€6.3bn) and says it will continue contracts with Catalent and two API suppliers for the manufacture of its lead product Esbriet (pirfenidone).
PSC Biotech plans to enter the US sterile injectables contracting space after buying a plant originally set up by J&J unit Mentor Biologics to make a Botox rival.
Recipharm will buy Corvette Pharmaceutical Services Group from private equity owners LBO Italia Investimenti to add much needed lyophilisation capacity and increase access to the Italian market.
Access to portable and flexible technology could be one way of containing transmissible diseases says G-CON as it launches a more readily deployable version of its ‘POD’ manufacturing suite.
GMP failures at an aseptic plant owned by SCM Pharma are part of a wider industry trend affecting several sterile sites in the UK, according to the ex-owner of the CDMO.
Recipharm AB will continue its spending spree of the past few years according to CEO Thomas Eldered, who reiterated the CMO’s plan to grow through takeovers in a results presentation earlier today.
