European drug industry groups have contrasted 'misguided' cuts to the Horizon 2020 budget with US plans to increase NIH funding for science R&D under the 21st Century Cures Bill.
The DCGI needs to clarify expiry date labelling rules for topical drugs according to an Indian trade group, which says some members’ products are being deemed to be ‘misbranded.’
The US FDA has lambasted two sterile compounders for violating cGMP in letters citing recent legislation brought in to ensure such companies are fully regulated.
Under the partnership, Nikon will have access to Lonza’s quality and operating systems, facility design and ongoing consulting services for the establishment of a wholly-owned Nikon cell and gene therapy contract manufacturing business.
Schott, Heuft and GEA have teamed up to offer drugmakers a serialisation service for primary packaging to help with EU anti-counterfeiting requirements.
WuXi PharmaTech subsidiary WuXi Biologics has begun construction on a new $150m biologics manufacturing facility in Wuxi, China, which is expected to be the largest mammalian cell culture manufacturing sire using disposable bioreactors in the world.
Hospira has recalled one lot of the anaesthetic Bupivacaine after a customer discovered orange and black particles floating and embedded in a glass vial.
Concerns climate change will see malaria, West Nile virus and chikungunya spread to the UK are legitimate according to Public Health England, even though no insects carrying such diseases have been detected to date.
The CMO (contract manufacturing organization) industry is ripe for consolidation as the rise in outsourcing continues and clients look to simplify their supply chains, DPx CEO James Mullen told Outsourcing-Pharma.com on Wednesday.
Tokyo-based CMIC Holdings Co., Innovation Network Corporation of Japan (INCJ), and JSR have agreed to acquire KBI Biopharma, a contract development and manufacturing organization with facilities in Durham and Research Triangle Park, North Carolina and...
Most pharmaceutical companies are already behind on preparations for the EU Falsified Medicines Directive’s serialisation requirements for 2018, says one services firm.
Big Pharma firms like AbbVie are partnering with delivery device makers to guard against biosimilar competition according to Unilife CEO, Alan Shortall.
CMO consolidation is resurrecting the ‘all-under-one-roof’ manufacturing model, but will firms fall into the same inefficiency pitfalls that drove pharma to outsource in the first place?
2015 is the year that AMRI loses its royalties for discovering the API of Allegra and the company is now looking to its string of recent acquisitions and new contract revenue to offset the loss.
AMRI has paid $60m for two Aptuit facilities including an aseptic manufacturing site in Glasgow, UK which the firm says will boost its presence in Europe.
Injectable-heavy drug pipelines and increased biotech funding are driving up US demand for sterile manufacturing, according to UK-based Symbiosis, which is looking to help fill the gap left by several high-profile exits from the space.
Patients and pharmacists can now use smartphones to check biologics are genuine with a new Merck Serono tech launched to combat counterfeiters' growing interest in high-value biopharma drugs.
German contract development and manufacturing organisation (CDMO) Vetter has built a facility for pre-clinical and clinical syringe filling in Chicago.
Catering for low value, high volume customers as well as the growing number of firms developing complex drugs will be a big challenge in the era of personalised medicine according to experts speaking at a London conference this week.
Biopharma companies are not likely to outsource a larger chunk of their manufacturing than they have in the past 10 years, according to a new report from PharmSource.
Investing in GMP compliance regulations is key to success in sterile manufacturing says UK-based Symbiosis which is looking to capitalise on gaps left by recent CMO pullouts.
Using encapsulation machinery that is well serviced and appropriate to the type of powder being used can save drugmakers hundreds of thousands of dollars, according to Capsugel
Sterigenics International has bought Italian gamma-ray sterilisation firm Gammarad in a deal that comes amid rumors that private equity owner GTCR is looking to offload the Illinois-based contractor.
India will ban PET packaging for liquid drug formulations for children, the elderly and women of reproductive age in November according to a Government statement.
The products, unveiled at BioProcess International in Boston this week, will help industry with their upstream and downstream processing and include an anti-CHO host cell protein detection kit, the first single-use fermentor, and a new mammalian expression...
Aesica has turned its back on sterile injectables manufacturing and, in an exclusive interview, told Outsourcing-Pharma.com there is now limited steriles capability in the UK following the exit of other key players.
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.
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.
West Pharmaceutical Services has confirmed it is evaluating potential expansions but says rumours that it plans to pay €100m ($130m) for a facility in Ireland are premature.
Dr Reddy’s Laboratories says accusations by the US Government’s Consumer Product Safety Commission (CPSC) that it violated childproof packaging rules could cause significant losses for the company.
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.
Big Pharma is still reliant on CMOs despite talk of returning in-house, says AMRI, which has launched into the top ten manufacturers in the US injectables sector following its recent acquisition.
Packaging Coordinators Inc (PCI) has announced its acquisition of Welsh contract development and manufacturing organisation (CDMO) Penn Pharmaceutical Services in a £127m ($215m) deal.
