With a more than 27 percent increase in revenue for Q3 of FY 2013 over the same quarter last year, CRO Parexel has raised its guidance for both the fiscal and calendar year.
In the war against counterfeits, regulators have concentrated on serialisation and ePedigree and missed an opportunity on product authentication, according to AlpVision.
Soon most new drugs will come with a biomarker or companion diagnostic says Almac, citing growing demand and a recently announced billion-dollar mergers as evidence for the trend.
Novo Nordisk says the $69 investment in its Danish plant will convert capacity ready for its new GLP-1 analogue and is a further commitment to Danish manufacturing.
Covance’s 10 percent growth in Q1 2013 compared to the same quarter last year was driven mostly by its central laboratories business and has caused a boost in its revenue targets for the rest of the year.
A push to root out antimalarial counterfeit drugs in Ghana will begin later this year or early 2014 as part of a pilot project to test an FDA-developed counterfeit detector.
Revised excipient guidelines expected from Brazilian regulator Anvisa this year will reduce confusion and further align standards with those in the US and EU says an industry expert.
Novartis says both its Swiss plant and third-parties will support its consumer health lines as it restructures its Nebraska facility following a FDA Form 483.
Manufacturing problems and costs associated with a new device-focused strategy hurt in Q1, but Hospira says efforts to fix troubled Rocky Mount facility are still on track.
Goodwin Biotechnology has teamed up with Coldstream Laboratories to offer clients ADC services as another example of biopharma demand driving contract manufacturing and development.
Following the completion of remediation efforts to deal with an FDA warning letter, Chris Phillips, AMRI's senior director of its Burlington, Massachusetts site, discusses what he considers to be a "new bar" in enforcement activity from...
Dispatches from Excipient Fest in Baltimore - UPDATE
As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and excipients, questions still remain on whether the manufacturers will be able to comply with the looming requirements.
China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have added another layer of safety requirements but challenges remain for the regulators in ensuring compliance, experts say.
Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax vaccine using its solid-dose injector – welcome to our needle-free drug delivery round-up.
With a ruling that could have implications for any CRO looking to understand its rights under a MSA (master services agreement) with a sponsor, a federal district court in Ohio has ruled against CRO Medpace.
CRO Quintiles and its shareholders are offering more than 19 million shares of common stock that will be priced between $36 and $40 per share, according to an updated S-1 filing with the US SEC.
Manufacturing disruptions at Lonza's Hopkinton, Massachusetts site are causing shortages of Ipsen Biopharmaceuticals’ growth failure treatment for children in both the US and EU, just as the company announces that it will shutter another manufacturing...
In a quarter that has seen the company divest its contract packaging and Canadian drug distribution arms, AmerisourceBergen’s Q2 results have been deemed “less than special” by analysts.
The US Department of Justice’s Attorney’s Office in Boston has sent subpoenaed documents related to AstraZeneca's UK manufacturing practices, which the company said it is complying with.
Icon’s first quarter FY2013 revenue increased 26% year on year, besting analysts’ expectations and resulting in a nearly 7% increase in the company’s stock price.
A clear timeline and stepwise approach to a US solution for tracking and tracing pharmaceuticals through the supply chain to root out counterfeits is necessary, stakeholders agreed.
Efforts to update SUPAC guidance on immediate and modified release dosage forms will end in faster approvals, if regulatory and financial hurdles can be overcome, says expert.
The US FDA is beginning to push CMOs and other manufacturers away from using real-time release testing as a shortcut to ensuring drug quality and reducing end product testing, experts said.
With backing from the Australian Government, DSM has opened a mammalian cell culture operation to fuel the growing demand in the Asia-Pacific biologics market.
The cash-strapped FDA is looking to cut corners any way it can, especially if it can hone in on which pharma manufacturing facilities and sites need to be prioritized for inspections.
A new bipartisan draft bill released by four US senators late last week seeks to establish a lot-level electronic system to track pharmaceutical products and further secure the US supply chain.
The FDA has finalised guidance on the manufacturing of antibiotics in order to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs.
The Kansas Bioscience Authority has awarded a $400,000 grant to the CRO PRA to create a new program to attract recent college graduates into the clinical research and CRO industries.
Despite a downturn in the number of clinical trials across all phases, CROs may still see a substantial increase in bookings as large pharma and biotech companies look to keep costs down, according to an analyst.
Despite offers from Amgen and Novartis reportedly worth up to $2bn, Hikma announced last week it will keep its profitable and growing injectable business.
The EMA’s upgrade to the EudraGMDP database aims to increase the safety of the EU supply chain by releasing GMP certificates and other data so companies can ensure supplier compliance.
DKSH has upgraded its cold chain infrastructure in Southeast Asia as both small and large manufacturers increase their access needs to emerging markets.
The inventor of a reagent recently found to be highly explosive says many drug production chemicals may have similar profiles and that knowing how to handle them is the key.
ATMI has started selling a new cGMP-compliant fill finish platform in a continuation of its focus on what it says is the growing single-use tech market.
Following its acquisition by Mayne Pharma, Metrics says it is to offer proprietary pellet form technology for advanced drug release and to increase bioavailability.
US regulators have rejected Allergan's candidate migraine drug Levadex for a second time, this time citing concerns about the CMO - Exemplar Pharma - the Californian drugmaker acquired earlier in the week for $20m.
GlaxoSmithKline’s contract manufacturer has experienced unspecified manufacturing issues that are expected to set back supplies of its restless leg treatment Horizant until June.
