Knowing about manufacturing innovations as soon as possible is more important for BioPharmas than for their small molecule counterparts according to an MIT Professor interviewed by our new sister site BioPharma-Reporter.com
Sanofi has inked a multimillion dollar licensing deal with Unilife for its prefilled syringes that will simplify its Lovenox and Clexane supply chains.
Clinical trial sponsors are now asking CROs to do more as an industry and as the top contracting companies build teams of scientists and physicians as varied as some hospital chains, sponsors’ reliance on outsourcing may have yet to peak.
The CMO market remains highly fragmented with thirty percent of active players likely to exit the business in the next ten years, according to a Frost & Sullivan report.
The global pharma packaging market - worth $47.5bn (Eur35.87bn) in 2011 - is expected to grow to $73bn in 2018, with a CAGR of 5.6%, according to a report by Transparency Market Research.
inVentiv Health company Adheris filed a lawsuit against the US Department of Health and Human Services (HHS) last week claiming that a new regulation imposes unconstitutional restrictions on part of its patient reminder business.
Covance’s IT expenses are expected to taper off in 2014, which could contribute to driving wider margins for the CRO, Covance CFO Alison Cornell said Monday.
As questions continue to be raised over the policies governing clinical trials in India, new regulations and amendments to the country's pharmaceutical laws are now coming to light.
GlaxoSmithKline is in talks with a number of companies interested in buying its Romanian manufacturing facility that was recently earmarked for closure.
CRO Covance has partnered with the Indiana Clinical and Translational Sciences Institute (CTSI) to conduct more Phase I research in the Midwestern state.
Mylan announced on Tuesday that it received approval from Indian regulators to acquire Agila for $1.6B just as a recent report from India’s Parliament criticizes foreign companies’ increasing control of the industry in the country.
The EU’s CHMP(Committee for Medicinal Products for Human Use) will delay the application of a guideline that would set limits on metal catalysts or metal reagent residues until the ICH finalizes its own guideline on the issue.
Bioreliance has launched an updated version of its mutagenicity service after conducting studies that confirmed its Big Blue Mouse assay still meets OECD standards.
The US Biomedical Advanced Research and Development Authority (BARDA) has awarded Novan $7.8 million to aid the development of what the company hopes will be the first FDA-approved drug with a burn healing indication.
The US FDA has sent a warning letter to CRO Drug Research and Analysis Corp. founder and president Henry Frazer for failing to adhere to the agency’s regulations governing clinical trials.
Biofocus says it is literally bringing its scientists closer together to aid its drug discovery services with a new 60,000 square foot facility in Cambridge, UK.
Chinese Police say GSK China rather than individual salespeople organised alleged bribery of doctors that is currently being investigated by the country's authorities.
The drug business launched by Becton, Dickinson and Company's (BD) earlier this year has had a third generic injectable approved by the US Food and Drug Administration (FDA).
The US FDA and EMA still disagree on some aspects of QbD, but collaborations like their recent pilot scheme can only be a good thing for industry according to a former MHRA assessor.
Cubist is issuing a nationwide recall of four lots of its antibiotic injection Cubicin after one of the company’s CMOs had a manufacturing issue that caused glass particulates to contaminate the lots.
An anti-abuse formulation developed by Acura Pharmaceuticals is gaining in popularity in the US with Ohio-based Fruth Pharmacy becoming the latest firm to say it will stock the Sudafed rival Nexafed.
Rapid growth in demand for pharmaceutical storage solutions could lead to Yusen working with its competitors, the firm says as it opens a 40,000m2 warehouse in Thailand.
CROs across the board saw revenue increase by more than 10% between 2011 and 2012, which was largely fuelled by Quintiles' growth, according to a new report.
Haupt says it will become Europe’s second largest manufacturer of contraceptive pills as it gets set for production after winning a contract from a “large group” in Ireland.
Being pipped to the post by the cast of Sesame St is rarely a positive, but when it means Outsourcing-pharma.com's tech team has the time it needs to develop an iPhone App as good as the one launched this week then it's OK.
Many physicians would switch migraine patients from oral treatments if the same drugs were available as a nasal inhalation, topical, or transdermal patch according to a new report.
CROs may see an uptick in sponsors requesting expedited pediatric trials as the US FDA has decided this week to begin posting online letters to sponsors that don’t meet deadlines for the trials.
Amgen spent $10.4bn (€7.8bn) this week on Onyx Pharmaceuticals, but AstraZeneca and Johnson & Johnson have also opened up their wallets this week – welcome to in-Pharmatechnologist.com’s merger & acquisition round-up.
The US FDA has released a Q&A to offer more clarity to GPhA, Cipla, Akorn and other drug and API manufacturers who responded to the initial stability draft guidance for ANDAs.
CRO Pharmaceutical Product Development (PPD) on Tuesday announced it has acquired Acurian to help build its clinical trial patient enrollment and retention tools.
Aoxing Pharmaceuticals reported increased sales and lower operating expenses for Q2 2013 one year on from the chromatin-tainted gelatin scandal that led to suspension of sales by China’s regulators.
