TGaS Advisors' vice president Gary McWalters believes the drug industry must rethink its approach to regulatory compliance and how it works with healthcare professionals.
Shipments of drugs that do not violate patent rights in the exporting or importing countries should not be seized in transit or labeled as counterfeit, as occurred recently, according to health advocates.
The proposed FDA funding for 2009 has given a boost to the agency, with $300m more being offered than the agency requested to ensure the safety of products.
The Indian pharmaceutical and biotech sectors may see more M&A activity this year with rumours that GSK, Sanofi Aventis and Merck KGaA are on the look out for potential deals.
As the battle for Genentech continues, the US biotech has warned its shareholders that Roche may “seek to influence our business in a manner that is contrary to our goals or strategies”.
Alamac Clinical Services (ACS) has added a new cold-chain and supply storage facility at its site in Craigavon, Northern Ireland in response to what it describes as an “unprecedented increase in demand” from drug industry clients.
Barack Obama’s support for R&D tax credits to boost innovation is designed to assuage Big Pharma’s fears about a ban on “authorised generics,” and new “comparative effectiveness" tests, according to Datamonitor’s Sandra Reynolds.
MannKind, one of the inhaled-insulin market’s only remaining players, has posted higher than expected Q4 losses as costs for development of its lead product candidate Afresa increase ahead of its submission to the US FDA.
French drug major Sanofi Aventis is in talks about taking over market leading Brazilian generics firm Medley, according to reports the country’s Valor Economico newspaper.
Spanish drug regulators have ordered a temporary halt to use of a single batch of Merck & Co’s cervical cancer vaccine Gardasil after two girls became sick after receiving the injection, according to Reuters.
New Sanofi Aventis chief Christopher Viebacher has virtually ruled out major acquisitions, eschewing the trend started by Pfizer’s $68bn (€53bn) swoop for Wyeth in favour of an anti-mega merger stance like that adopted by UK rival GSK.
A filing with the SEC says that Roche is not prepared to continue in a relationship with Genentech in which it owns a majority of the biotech’s equity but has limited involvement in its governance.
TGaS Advisors has launched a new version of its commercial compliance benchmark (CCB), which aims to help companies adhere to the array of guidance affecting their operations.
Crucell and DSM Biologics have added fellow Dutch firm Bioceros to the PER.C6 vendor network to provide manufacturing and support capacity in line with increased demand for the cell line.
MD Logistics has added a 15,000 sq ft of cold-storage facility to its distribution operations in Indiana, US in response to the rising demand for biologics transportation services.
The strained relationship between Genentech and Roche has been revealed in a SEC filing, which details their differing valuations and accusations of misleading financial models.
Seidenader Vision is gearing up to launch a modular track and trace (T&T) solution which, it says, will give drug manufacturers the flexibility to adapt to the changing legislative landscape.
Merck & Co has earmarked nearly $1bn in investment funding to boost its quality and manufacturing capacity in vaccines, said chief executive Dick Clark on the firm’s fourth-quarter results call.
King Pharmaceuticals has unveiled plans to reduce its workforce by 22 per cent in a bid to further reduce costs after the US District Court decision to invalidate patents protecting its lead product, the muscle relaxant Skelaxin (Metaxalone).
Haupt Pharma has acquired Pfizer’s production facility in Latina, Italy, which moves the contract manufacturer into antibiotics and allows it to provide additional services to clients.
Regulators in India’s Maharashtra state have compiled a hit list of 110 drugmakers that they intend to prosecute for sub-standard manufacturing practices, according to media reports.
Dr Rajashekar Reddy, chief minister of Andhra Pradesh, India presided over the inauguration ceremony for Biological E’s new INR3bn ($61m) vaccine and biopharmaceuticals manufacturing campus.
Two months after the European Union (EU) released antitrust findings the FTC is suing Solvay Pharmaceuticals and two other companies for illegally agreeing to a delay generic’s release.
As the sophistication of counterfeit drug packaging continues to improve it is becoming harder and harder to tell real products from fake. in-PharmaTechnologist spoke with Alpvision's Roland Meylan about the company's approach to brand authentication.
Indian IT company Satyam continues to be rocked by the fraud scandal, with media reports claiming that GSK and Novartis are on the verge of taking their business elsewhere.
Within Obama’s $819bn economic stimulus package are numerous provisions relevant to the pharmaceutical industry, including funding to construct or renovate private manufacturing facilities.
Roche has stepped up its pursuit of Genentech, launching a hostile bid of $42bn after growing frustrated with the lack of progress over the past six months.
Pfizer’s $68bn swoop for Wyeth looks set to start an epidemic of merger madness according to comments by Frost & Sullivan (F&S) analyst Shabeer Hussain.
The WHO has delayed its controversial EB 124/14 amendment that would, according to some groups, broaden the organisation’s definition of “counterfeit” from its current focus on patient health to include infringements of intellectual property.
Pfizer’s fourth quarter results saw net income plummet by 90 per cent and revealed that the company is to close five manufacturing facilities, laying-off 10 per cent of its workforce.
Pfizer has confirmed it has entered into an agreement to buy Wyeth in a deal worth $68bn, which it hopes will strengthen its position in anticipation of a challenging few years.
Valois Pharma has informed in-PharmaTechnologist that it is developing a range of add-ons for its equadel nasal drug delivery device, which the company believes will help improve patient compliance.
A new report suggests the large numbers of fake drugs produced in China could drive CMO customers away and see Central and Eastern Europe (CEE) emerge as a contract manufacturing hotbed.
Late last week the US Department of Health and Human Services (HHS) awarded Novartis a $490m contract to continue work on its cell-culture influenza vaccine plant in Holly Springs, North Carolina, US. in-PharmaTechnologist spoke with Novartis spokesman...
The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations.
A Chinese citizen has been fined more than $1.2m and sentenced to over six years in a US prison for distributing counterfeit drugs that appeared “identical to authentic pharmaceuticals”.
Sanofi-Aventis is to sell its liquid drug manufacturing plant in Colomiers, southwest France, to industry specialist Unither for an as yet undisclosed sum.
BIOTECanada has warned the Canadian government that unless it supports biotechs 50 per cent could run out of money this year, resulting in thousands of people being made redundant.
Drug contract services specialist inVentive Health has selected a new office in Somerset, New Jersey, US which will house its patient outcomes, clinical, health and commercial division.
Despite criticism in certain quarters, joint GMP inspections represent the best use of resources in an increasingly globalised market, according to the EMEA.
US drugmaker Adventrx Pharmaceuticals is reducing its workforce to just 14 employees in a bid to preserve cash and refocus efforts on bioequivalence programmes for its lead candidates.
Sanofi-Aventis Canada has licensed I-many’s suite of software for managing pharmaceutical contracts, with the IT company also performing installation, maintenance and support.
An open house at GSK’s plant in Pennsylvania, US gave the world its first glimpse of the facility that the firm hopes will become the global hub of its vaccine packaging and filling business.
