An expression system developed by Cevec Pharmaceuticals has achieved 'very high' titres and bypassed problems that beset other platforms, moving the possibility of a commercial respiratory syncytial virus (RSV) one step closer.
Catalent has increased its stake in Redwood Biosciences telling us it is committed to the development of antibody-drug conjugates (ADCs) and the SMARTag technology platform.
AmerisourceBergen (ABC) plans to buy a minority stake in a Brazilian drug wholesaler and outlined plans for a $100m distribution services joint-venture in the rapidly expanding market.
The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new drug applications (INDs) and new drug applications (NDAs).
AMRI will acquire Cedarburg Pharmaceuticals for $38.2m (€27.7) in cash, plus $2.8m of assumed liabilities, to expand its API and drug development offerings.
The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.
Evotec AG has bought an asset management company that specialises in bringing academic discovery and development innovations to the attention of pharma and biopharma sponsors.
Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.
Efforts to cut industrial energy bills in the UK's 2014 Budget have been welcomed by the Chemical Industries Association (CIA), a group whose members include drug and ingredient makers.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a scheme next month to allow doctors to prescribe medicines without a marketing authorisation to patients with life-threatening conditions.
Drugmakers were replaced by buyers of cosmetics, hygiene and material protection ingredients as Lonza’s biggest customers in 2013 according to a report released by the Swiss CMO today.
Patheon and DSM’s Pharma Products merger is “highly complementary” with crossover limited to North American oral solid manufacturing growth, says DPx as it targets further growth opportunities.
Parexel has enlarged its clinical trial supply network with the opening of a distribution centre in Singapore and expansion of its Massachusetts facilities.
Recipharm has given investors a sneak peak at its finances ahead of its IPO next month that establishes the firm as a mid-tier CMO with plans to grow through acquisitions.
US pharmaceutical firms ‘fear change’ and need guidance on assessing safe excipient supply to become more like their European counterparts, says a senior IPEC expert.
Aegis Therapeutics claims a technology developed to improve the bioavailability of drugs delivered through the nose has a similar solubility enhancement effect in a solid dosage form.
‘Podular’ manufacturing systems will dominate facility design within five years, say G-CON and GEA who have teamed with Pfizer to create a flexible, repurposable and portable facility.
Shire has recalled one batch of its Gaucher’s disease drug VPRIV in the US after problems at its fill finish contractor resulted in particulate matter ending up in the vials.
New EU laws safeguarding national ownership of ‘genetic resources’ may delay production of seasonal influenza vaccines according to EFPIA, which wants stakeholders to discuss the issue.
The Board of Directors at Indian firm Orchid has approved the sale of its API business to Hospira, bringing the acquisition a step closer to completion.
Pharmaceutical companies need to change their attitudes to contractors, says the former director of Shire’s relationships with its 100 outsourcing partners.
Aesica has predicted that CMO sector consolidation will continue and hinted that it is considering strategic acquisitions as a part of a bid to generate $1bn revenue.
The Indian Supreme Court has been asked to cancel Ranbaxy’s manufacturing license in the wake of quality problems that earned the firm a US import ban.
CROs Clinical Research Management (ClinicalRM) and PPD were awarded contracts by the Biomedical Advanced Research and Development Authority (BARDA) to develop medical countermeasures.
CFS Clinical has selected C3i to provide global 24x365 multilingual technology support services for their site activation and investigator payment services.
Patheon brings fill/finish capabilities to DSM’s biomanufacturing services, President of Biopharma at the recently merged company DPx told Biopharma-Reporter.com in an exclusive interview.
Australia may lose its status as the leading supplier of pharma grade opium if it does not comply with Big Pharma requests and allow cultivation of the crop on the mainland.
In an exclusive interview, Patheon Executive Mike Lehmann talks DSM integration, further growth and how consolidation amongst CMOs may be driving strategic alliances with pharma.
As part of an effort to increase transparency, the EMA (European Medicines Agency) has published the first summary of a risk-management plan (RMP) of a newly authorised medicine.
Cloud-based community provider Exostar has selected Parexel as the latest CRO to become a member of its life science community, which aims to reduce the cost and burdens of collaborations between companies.
Sun Pharma’s antibiotic facility import alert is the latest blow to the Indian drug industry but is unlikely to impact revenues or cause US shortages, the firm says.
The UK Government has set out to make Britain a more attractive place from which to source drugs and ingredients by awarding a series of taxpayer funded grants to supply chain focused innovation projects.
Access to mixed hydrocodone painkillers such as AbbVie’s Vicodin will be restricted and production limited if plans by the US Drug Enforcement Administation (DEA) are cemented later this year.
WuXi PharmaTech is partnering with Pacific Biomarkers to gain access to its menu of validated biomarker assays to support WuXi's integrated clinical trial testing services.
Patheon has merged with Royal DSM's pharmaceutical products business to form DPx in a $2.65bn (€1.9bn) deal that analysts believe has created the world's second biggest CMO.
FDA guidance on product design has driven demand by pharma for tailored designs for tablet colour, size and shape, specialist consultancy Colorcon told Outsourcing-Pharma.com.
Ireland remains a significant small molecule drug manufacturing hub the Industrial Development Agency (IDA) says, despite a number of API plant closures.
Nearly a quarter of drugs made in Jammu & Kashmir and 10% of those produced in Himachal Pradesh are substandard according to new testing data published by CDSCO.
