|« Previous month||Next month »|
29-Feb-2012 - The US FDA has sent APP Pharmaceuticals a warning letter after insects were found in production areas and finished products.
29-Feb-2012 - Researchers are calling for alternative excipients for vegetarians who are unwittingly consuming animal fats when physicians prescribe meds containing gelatin.
29-Feb-2012 - Eli Lilly says plans for a new €330m ($444m) manufacturing facility in Ireland are in preparation for the launch of a range of its pipeline molecules.
28-Feb-2012 - Reduced-pain injection systems are the key to gaining regulatory approval for new products, according to BD.
28-Feb-2012 - Marketing applications for heparin should cover traceability from slaughterhouses and other details of sourcing porcine mucosa, the EMA said.
28-Feb-2012 - Ingredients manufacturer Rousselot has announced a price increase on its gelatine portfolio to balance out spiralling raw material costs.
28-Feb-2012 - Almost 30 per cent of biopharma companies have insourced previously outsourced work in the past year, a PwC survey of CEOs found.
27-Feb-2012 - in-PharmaTechnologist presents its weekly round-up of the latest appointments within the pharmaceutical industry, including news from Biomatters, Seattle Genetics, and Permeon.
27-Feb-2012 - API sales at Latvia-based Grindeks jumped last year as it benefited from expanding its portfolio by 50 per cent.
27-Feb-2012 - Glenmark is recalling incorrectly packaged birth control pills from the US, less than one month after Pfizer took similar actions.
27-Feb-2012 - Sole suppliers that outsource manufacture must alert the FDA of interruptions at their CMOs, the Agency wrote in draft drug shortages guidance.
27-Feb-2012 - The US FDA has published final guidance on the CMC data needed to support early phase trials of live biotherapeutics.
23-Feb-2012 - The US FDA has issued import alerts against 22 Chinese heparin suppliers it claims ship adulterated product.
23-Feb-2012 - IPEC Americas has issued an urgent call for drug industry feedback on China Pharmacopoeia Committee plans to expand the number of excipients listed in the 2015 edition of the Chinese Pharmacopoeia.
23-Feb-2012 - Unilife is expanding its large dose delivery platform in a bid to meet a “growing industry need” for at-home drug administration in bigger scale.
23-Feb-2012 - The US FDA has published draft guidance on drug shortages to clarify when and how manufacturers should report possible supply disruptions.
22-Feb-2012 - Freeman Technology says growing Pharma demand for analytical data prompted the formation of US subsidiary and it behind its plans for a new laboratory.
22-Feb-2012 - BASF has increased its European prices for ethanolamines (EOA) for the third time in as many months.
22-Feb-2012 - Bespak is on the hunt for more development contracts for its new nasal delivery platform.
22-Feb-2012 - The US FDA is allowing Sun Pharma to import a version of Doxil to ease the drug shortage created by manufacturing failings at Ben Venue.
21-Feb-2012 - GE Healthcare has launched a new suite of bioprocess training courses in collaboration with a leading Singapore academic institution.
21-Feb-2012 - Aptar Pharma says its new eDevices can help companies gain quicker regulatory approval for their nasal drug products without having to re-do clinical trials.
21-Feb-2012 - Abbott Laboratories will pump €85m ($113m) into the expansion of its API production plant in Sligo, Ireland, in preparation of the launch of its pipeline products.
21-Feb-2012 - Pfizer and Mylan have settled patent litigation with Sanofi over a pre-filled drug delivery device used to treat allergic reactions.
21-Feb-2012 - Regulators should consider the impact of job cuts at manufacturing sites when drafting a risk-based GMP inspection plan, PIC/S said.
20-Feb-2012 - Pharmapack Europe 2012 saw a multitude of companies launching their new drug delivery devices into the pharmaceutical arena.
20-Feb-2012 - Safety concerns prompt yet another recall at troubled US CMO Ben Venue with Bedford Labs pulling its leukaemia treatment cytarabine.
20-Feb-2012 - The MHRA has suspended the license for a Teva generic over suggestions its dissolution rate could affect interchangeability.
20-Feb-2012 - West Pharmaceutical Services posted another flat quarter of proprietary delivery product sales but is predicting “notable increases” in 2012.
16-Feb-2012 - The US FDA has sent West-Ward Pharmaceuticals a warning letter and asked for forewarning of any actions that may worsen drug shortages.
16-Feb-2012 - Sterility fears have prompted Genzyme to recall 9,380 vials of Fludara manufactured by Ben Venue Laboratories.
16-Feb-2012 - in-PharmaTechnologist presents its weekly round-up of the latest appointments in the pharmaceutical industry, including news from Silence Therapeutics, Accorda, and Hospira.
16-Feb-2012 - Hospira hopes to ramp up output at its Rocky Mount facility in the second half of 2012 but warned it is “very difficult” to predict the remediation timeline.
15-Feb-2012 - Lonza has denied reports it has signed a deal with the South African government to build a $210m (€159m) API plant, saying it is merely “in discussions” over plans.
15-Feb-2012 - Regulations have failed to keep pace with modern understanding about manufacturing and quality, a FDA director said.
15-Feb-2012 - Genentech is warning patients that counterfeiters have distributed fake Avastin, which lacks the API bevacizumab, in the US.
15-Feb-2012 - The US FDA expects Merck KGaA to do a “comprehensive and global assessment” of its sites after sending a warning letter to three plants.
14-Feb-2012 - Agilent has introduced a compliance service to cut the time take to validate and begin production at cGMP laboratories.
14-Feb-2012 - President Obama’s budget for 2013 projects FDA funding of $2.5bn (€1.9bn), flat year-on-year, but user fees will give it more cash.
14-Feb-2012 - The FDA has said it is critical that trade secret laws are changed to allow it to share manufacturing information with other regulators.
14-Feb-2012 - The FDA is asking companies to audit heparin suppliers in draft guidance intended to stop a repeat of the 2008 contamination.
13-Feb-2012 - The Council of Europe (CoE) has launched an online service which will allow patients to check the authenticity of their medication using just a smartphone.
13-Feb-2012 - Prismic Pharmaceuticals is hunting for alliances to help it bring a more efficient anti-psychotic to the market after acquiring assets from drug manufacturer Scarista.
13-Feb-2012 - Bend Research is on the lookout for more collaborative development alliances with Big Pharma through its spray-dried dispersion (SDD) technology.
13-Feb-2012 - The FDA has said biosimilars can use different drug delivery devices than their reference products in its long-awaited guidance.
09-Feb-2012 - OptiNose has received US FDA approval to start Phase III trials of its nasal delivery device.
09-Feb-2012 - BD posted double-digit revenue growth in China as government spending on healthcare continued despite economic pressures.
09-Feb-2012 - Eli Lilly has licensed a spray-dried dispersion (SDD) technology from Bend Research, expanding its manufacturing capabilities.
09-Feb-2012 - AMPAC Fine Chemicals posted a 50 per cent jump in revenues after the return of sales from its antiviral business.
08-Feb-2012 - AMRI posted a Q4 loss on lower sales but predicts that contracting revenues and margins will increase in 2012 thanks to cost cutting measures and new contracts
08-Feb-2012 - Pharma supply chain consortium Rx-360 has advised drugmakers to check their L-Arginine stocks, warning that a recent surge in demand could limit supplies.
08-Feb-2012 - Cambrex expects fine chemical consolidation to continue this year and is being “proactive” in its hunt for takeover targets.
08-Feb-2012 - GSK is developing tablets it can compress without excipients to cut the time taken to reach the clinic by up to nine months.
07-Feb-2012 - Shanghai Pharmaceuticals has bought a 70 per cent stake in ingredients developer and manufacturer Changzhou Kony Pharm in a bid to boost its standing in the API market.
07-Feb-2012 - BAC BV and Life Technologies have launched a new range of affinity columns will ‘unlock’ high speed affinity HPLC for pharmaceutical processing.
07-Feb-2012 - A proposed US act aims to impose limitations on consent decrees and stop the “regulatory frenzy in Washington”.
07-Feb-2012 - Australia is considering steps to stop chemicals used in drug manufacturing from being diverted by terrorists to make explosives.
06-Feb-2012 - The Indian Drug Manufacturers Association (IDMA) plans to amp up pharma business in Tamil Nadu by helping more companies meet WHO production standards.
06-Feb-2012 - Johnson Matthey says sales of an anti-addiction API were the key to gains made by its fine chemicals business in Q3.
06-Feb-2012 - in-PharmaTechnologist presents its round-up of the latest appointments in the pharmaceutical industry, including news from Prosonix, Savient and Dendreon.
06-Feb-2012 - A US drug shortages act aims to make drug production more efficient by quickening review of post-approval manufacturing changes.
06-Feb-2012 - The WHO is urging countries to collaborate on tackling substandard drugs and strengthening supply chains at a new annual meeting.
02-Feb-2012 - A round-up of news in the contract manufacturing space, with developments at Foster Delivery Sciences, Excella, Catalent and RohnerChem.
02-Feb-2012 - AstraZeneca will cut 1,350 operations jobs in the next few years as part of wide ranging restructuring move.
02-Feb-2012 - European Commission plans to add three APIs to its list of water polluting chemicals could result in costs to pharmaceutical companies.
02-Feb-2012 - The US FDA has called for more authority to ensure any track-and-trace system is binding for industry and pre-empts state laws.
01-Feb-2012 - The resignation of CEO Axel Muller was a mutual decision and not linked to delayed efforts to win European approval for the asthma drug Flutiform says delivery tech firm SkyePharma.
01-Feb-2012 - Food ingredients and flavours firm Kerry Group is to build a cell culture and media development lab for the pharmaceutical biomanufacuturing sector.
01-Feb-2012 - Drugmaker Watson Pharmaceuticals has broke grounds on an R&D lab in New Jersey, US.
01-Feb-2012 - Encap Drug Delivery has won a contract manufacturing deal for a European licensed liquid-filled capsule product after the owner parted from its current CMO.
01-Feb-2012 - Pfizer is recalling 28 lots of contraceptives after a blister packaging error raised the risk of unintended pregnancy.
|« Previous month||Next month »|