Despite increased scrutiny from regulators, one third of Indian pharma manufacturers and CMOs have yet to conduct a review to assess potential gaps in the assurance of data integrity, according to a new EY survey.
AstraZeneca has partnered with two Algerian companies, AHT Health and Hasnaoui Finance, to create a joint venture with the aim of building a new $125m manufacturing facility in Algeria.
Teva has been accused of "playing games" with Mylan by acquiring a 1.35% stake in the generics firm weeks after having a $40bn (EUR36bn) takeover bid snubbed.
Pluristem Therapeutics will set up manufacturing sites and find local partners to make cell therapies for the Chinese, Korean, Mexican, Russian and Israeli markets after securing various patents this week.
Albany Molecular Research Inc. (AMRI) has signed a three-year collaborative agreement with biotechnology company HarkerBIO to co-market their drug discovery services to clients.
Merck KGaA is confident it will close the $17bn acquisition of Sigma-Aldrich in mid-2015 despite competition concerns from the European Commission (EC).
The strategic partnership between Baltimore-based CMO Cognate BioServices and Florida-based Akron Biotechnology will offer clients a more complete package of cGMP manufacturing services and regulatory support to develop regenerative medicines and cell-based...
From new service offerings to manufacturing deals to more formal strategic partnerships, the world of contract research and manufacturing organizations has been busy as of late. Here’s a roundup of some of the deals and new offerings:
Lonza shipped a sample batch of a drug for resistant cancers this week and is set produce commercial supplies if the Phase I candidate goes on to be approved says Sunshine Biopharma.
Biologics and focused R&D spending are driving the market for lyophilisation according to Symbiosis Pharmaceutical Services, which says its freeze-drying tech investment reflects this surge in demand.
Reliance on CMOs and CROs has allowed the flexibility to make Gilead a top 10 pharma firm, and the use of third-parties will remain part of its strategy according to the CFO.
Access to yeast strains modified to produce opiates for cheaper, more effective pain meds must be strictly controlled according to researchers who warn that stopping criminals using such API manufacturing routes to make illegal narcotics is vital.
Despite pharma being “highly regulated and slow to change,” continuous manufacturing will soon be realised, says Rutgers University which has received an R&D grant from J&J.
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.
Symbiosis Pharmaceutical Services has launched a bulk freeze drying offering for APIs and intermediates, citing new contracts as a driver for the investment.
Endo’s $8bn takeover of Par Pharmaceutical is expected to shake-up the generics sector, while Lupin is expanding its South American network – welcome to In-Pharmatechnologist’s M&A round-up.
With WuXi pushing full steam ahead in its bid to go private, one expert says that the company may be envious of a competing CRO -- Hangzhou Tigermed, which is smaller than WuXi but valued at a higher price on the Shenzhen stock exchange.
A lack of scientific talent will hold pharma back from adopting continuous manufacturing despite the imminent opening of regulatory pathways, says an MIT Professor.
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.
Compounding pharmacies must show they can produce high-quality medicines in order to overcome their safety stigma, according to Fagron which is opening a sterile facility in Kansas.
Hospira’s closure of its manufacturing facility in Clayton, North Carolina, which it says is a cost rather than a quality issue, will result in the laying off of 100 employees, according to a WARN notice posted Wednesday.
Schott, Heuft and GEA have teamed up to offer drugmakers a serialisation service for primary packaging to help with EU anti-counterfeiting requirements.
Persuading API manufacturers to seek prequalification is a challenge according to the WHO, which wants to raise awarness about the process and the positive impact it has on a suppliers' reputation.
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.
Indian generics firms see opportunities in the Japanese drug market according to a trade delegation that visited Tokyo last week seeking supply contracts.
Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma manufacturers and CMOs should begin to consider the switch as in the long-run it will end up saving companies time, money and space, FDA’s...
Lonza has predicted that revenues and profits will grow in 2015 despite the strong franc, citing pharma portfolio optimization and demand for outsourced manufacturing services.
Biotech giant Amgen has begun hiring about 100 more research scientists and production engineers as part of an expansion at its office in Cambridge, Massachusetts at the same time as laying off more than 2,000 employees at other sites.
AstraZeneca has inked a development and commercialisation deal with Celgene for its haematology programmed cell death ligand 1 (PD-L1) candidate, MEDI4736.
Cheaper disposable manufacturing techs and increased demand for outsourced production will see more CMOs enter the contracting sector according to HighTech Business Decisions
Agilent Technologies has launched a quadrupole-time of flight (Q-TOF) mass spectrometry system for applications including food safety and pharmaceuticals.
