US Senator Bernie Sanders has called on the Secretary of Veteran Affairs to invoke a law which would break Gilead’s patent on Hepatitis C drug Sovaldi and allow cheaper generics.
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.
Adaptive clinical trial designs can be used in medical device studies as long as they are for “prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity,” the FDA says.
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.
Making sure candidate drugs are free of cardiac risks means drug industry demand for ion channel screening expertise is growing according to new CRO, Metrion.
Diabetes drugs made by J&J, AstraZeneca and Boehringer-Ingelheim are being investigated by the US FDA after 20 cases of acidosis resulting in hospitalisation were recorded.
The EMA's assessment of new drugs must be independent of pharmaceutical industry influence as an example to others, according to the Access to Medicines Foundation (AMF)
Dr Reddy’s has set out to build in the Japanese market days after revealing that higher generic and API sales elsewhere had been pegged back by currency fluctuations.
Experts across the sponsor-CRO spectrum seem to agree on at least one thing: the clinical trial process is ready for a major transformation, though how quickly and what types of innovations will be adopted the fastest remains to be seen.
Quintiles has completed its previously announced refinancing in which it entered into new senior secured credit facilities totaling $1.95bn, consisting of a $500m revolving credit facility and $1.45bn of term loans.
Western CROs with a presence in Japan are benefiting from growing demand from international pharma and local drugmakers interested contractors with global reach says PPD.
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.
The debate continues over how to optimize clinical trials, with some experts calling for incremental changes to combat inefficiencies while the FDA’s deputy commissioner says the industry is at a “tipping point.”
Sanofi's inhaled insulin drug Affrezza has generated lower than expected revenue due to marketing delays rather than low demand according to MannKind CFO, Matthew Pfeffer.
Analyzing data on previous study performance and the complexity and design of a trial can offer earlier insights on whether a protocol is feasible, Michelle Marlborough, VP of product strategy at Medidata, told Outsourcing-Pharma.com.
Toronto, Canada-based SB Medical Inc. and Barbados-based TC Medical Group, as well as Hanoch Stein of Baltimore plead guilty last week to a multi-year operation to smuggle and sell misbranded prescription pharmaceuticals and unlicensed wholesaling of...
The University of North Carolina at Chapel Hill and GlaxoSmithKline (GSK) are creating a new HIV research center and a jointly owned new company that will focus on discovering a cure for HIV/AIDS.
West Pharmaceutical Services expects annual revenues of up to $5m following the US FDA approval of a client’s product which uses West’s Crystal Zenith delivery system.
Recent US FDA approval of products containing the excipient HPC has driven demand, according to Nippon Soda (Nisso) which has expanded its production facility in Japan.
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.
Biopharma logistics provider Marken has opened its newest office and warehouse in Philadelphia, which is part of a global drug distribution network comprised of 10 cGMP compliant depots and more than 40 locations around the world.
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.
BASF says it remains committed to the pharma industry despite plans to divest its custom synthesis business and around 100 APIs and intermediates to Siegfried Holding.
Vaccines being developed using Catalent's oral Zydis platform would increase compliance and cut costs but Big Pharma is slow to get on board, the firm says.
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.
Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office...
As competition and pricing get fiercer for CRO Charles River Laboratories, the company is looking to save about $35m from new efficiencies in its RMS (Research Models and Services) business, Jim Foster, chairman, president and CEO of CRL, told investors...
Schott, Heuft and GEA have teamed up to offer drugmakers a serialisation service for primary packaging to help with EU anti-counterfeiting requirements.
