FDA sends warning letter to APP after insects found in vials

29-Feb-2012 - The US FDA has sent APP Pharmaceuticals a warning letter after insects were found in production areas and finished products.

EXCLUSIVE

Create painless devices for quicker regulatory approval, says BD

28-Feb-2012 - Reduced-pain injection systems are the key to gaining regulatory approval for new products, according to BD.

EMA calls for companies to trace their heparin to slaughterhouses

28-Feb-2012 - Marketing applications for heparin should cover traceability from slaughterhouses and other details of sourcing porcine mucosa, the EMA said.

Grindeks posts jump in API sales after expanding range by 50%

27-Feb-2012 - API sales at Latvia-based Grindeks jumped last year as it benefited from expanding its portfolio by 50 per cent.

Sole suppliers must alert FDA to CMO production interruptions

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.

FDA posts guidance on Phase I CMC for live biotherapeutics

27-Feb-2012 - The US FDA has published final guidance on the CMC data needed to support early phase trials of live biotherapeutics.

IPEC wants feedback on proposed 2015 Chinese Pharmacopoeia revision – Today!

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.

Unilife launches Autoinfuser range publically

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.

FDA guidance aims to stop drug shortages using supply alerts

23-Feb-2012 - The US FDA has published draft guidance on drug shortages to clarify when and how manufacturers should report possible supply disruptions.

Freeman sets up US subsidiary and plans to establish service lab

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.

update

BASF hikes EOA prices again

22-Feb-2012 - BASF has increased its European prices for ethanolamines (EOA) for the third time in as many months.

EXCLUSIVE

Bespak hunting development deals for nasal spray tech

22-Feb-2012 - Bespak is on the hunt for more development contracts for its new nasal delivery platform.

FDA allows temporary import of Sun’s Doxil alt to ease shortage

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.

GE Healthcare launches bioprocess training courses in Singapore

21-Feb-2012 - GE Healthcare has launched a new suite of bioprocess training courses in collaboration with a leading Singapore academic institution.

Exclusive interview

Aptar Pharma says new eDevices will speed up regulatory approval

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.

Abbott's extends in Sligo ready for its new API line

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.

Job cuts a factor in calculating GMP compliance risk; PIC/S

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.

Round-up of the new drug delivery devices on show at Pharmapack 2012

20-Feb-2012 - Pharmapack Europe 2012 saw a multitude of companies launching their new drug delivery devices into the pharmaceutical arena.

Another cancer drug recall at troubled CMO Ben Venue

20-Feb-2012 - Safety concerns prompt yet another recall at troubled US CMO Ben Venue with Bedford Labs pulling its leukaemia treatment cytarabine.

MHRA suspends license of Teva generic over dissolution fears

20-Feb-2012 - The MHRA has suspended the license for a Teva generic over suggestions its dissolution rate could affect interchangeability.

West proprietary delivery tech sales flat in the fourth quarter

20-Feb-2012 - West Pharmaceutical Services posted another flat quarter of proprietary delivery product sales but is predicting “notable increases” in 2012.

FDA wary of West-Ward warning letter’s effect on drug shortages

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.

Hospira aims for 2H ramp up at NC plant but challenges ahead

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.

Lonza denies completion of South African API plant deal

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.

Quality regulations lag behind modern understanding; FDA

15-Feb-2012 - Regulations have failed to keep pace with modern understanding about manufacturing and quality, a FDA director said.

News in brief

Genentech warns of fake Avastin

15-Feb-2012 - Genentech is warning patients that counterfeiters have distributed fake Avastin, which lacks the API bevacizumab, in the US.

FDA warning letter asks Merck KGaA to investigate all its sites

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.

Agilent introduces service to cut cGMP lab validation timelines

14-Feb-2012 - Agilent has introduced a compliance service to cut the time take to validate and begin production at cGMP laboratories.

Trade secret changes critical to regulatory sharing, FDA says

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.

FDA calls for audits of heparin suppliers in draft guidance

14-Feb-2012 - The FDA is asking companies to audit heparin suppliers in draft guidance intended to stop a repeat of the 2008 contamination.

News in brief

CoE launches smartphone tech to check drug authenticity

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.

Prismic hunting for anti-psychotic alliances

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.

Bend Research on the hunt for more SDD alliances

13-Feb-2012 - Bend Research is on the lookout for more collaborative development alliances with Big Pharma through its spray-dried dispersion (SDD) technology.

FDA biosimilar guidance permits alternative drug delivery devices

13-Feb-2012 - The FDA has said biosimilars can use different drug delivery devices than their reference products in its long-awaited guidance.

News in brief

OptiNose OKed for Phase III trial of nasal delivery tech

09-Feb-2012 - OptiNose has received US FDA approval to start Phase III trials of its nasal delivery device.

China healthcare spending up despite economic fears, BD says

09-Feb-2012 - BD posted double-digit revenue growth in China as government spending on healthcare continued despite economic pressures.

Lilly teams with Bend over spray-dried dispersion tech

09-Feb-2012 - Eli Lilly has licensed a spray-dried dispersion (SDD) technology from Bend Research, expanding its manufacturing capabilities.

AMPAC sales jump 50% on return of antiviral revenues

09-Feb-2012 - AMPAC Fine Chemicals posted a 50 per cent jump in revenues after the return of sales from its antiviral business.

AMRI posts Q4 loss but expects contracting revs to grow in 2012

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

News in brief

Rx-360 warns Pharmas of potential L-Arginine shortage

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.

Cambrex on takeover hunt amid pharma fine chem consolidation

08-Feb-2012 - Cambrex expects fine chemical consolidation to continue this year and is being “proactive” in its hunt for takeover targets.

GSK aims to cut time to clinic with excipient-free compression

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.

Shanghai Pharmaceuticals buys major stake in special API maker

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.

News in brief

BAC BV and Life Teschnologies team up on processing columns

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.

US consent decree act aims to stop “regulatory frenzy”

07-Feb-2012 - A proposed US act aims to impose limitations on consent decrees and stop the “regulatory frenzy in Washington”.

Australia mulls chemical supply chain actions to stop terrorism

07-Feb-2012 - Australia is considering steps to stop chemicals used in drug manufacturing from being diverted by terrorists to make explosives.

UPDATE

Tamil Nadu will be next manufacturing hit if makers meet WHO standards, says IDMA

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.

News in brief

Anti addiction API helps Johnson Matthey grow in Q3

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.

US act aims to end shortages by speeding post-approval changes

06-Feb-2012 - A US drug shortages act aims to make drug production more efficient by quickening review of post-approval manufacturing changes.

Annual WHO meeting to tackle spread of substandard drugs

06-Feb-2012 - The WHO is urging countries to collaborate on tackling substandard drugs and strengthening supply chains at a new annual meeting.

CMO news roundup – Foster, Excella, Catalent and RohnerChem

02-Feb-2012 - A round-up of news in the contract manufacturing space, with developments at Foster Delivery Sciences, Excella, Catalent and RohnerChem.

AstraZeneca to cut 1,350 ‘operations support’ jobs

02-Feb-2012 - AstraZeneca will cut 1,350 operations jobs in the next few years as part of wide ranging restructuring move.

EU plan to add APIs to pollutant watch list could raise costs

02-Feb-2012 - European Commission plans to add three APIs to its list of water polluting chemicals could result in costs to pharmaceutical companies.

FDA calls for more powers to adopt nationwide ePedigree

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.

SkyePharma: CEO departure not linked to European Flutiform delays

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.

Kerry to build new cell culture lab for biopharmas

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.

News in brief

Watson plans new R&D centre

01-Feb-2012 - Drugmaker Watson Pharmaceuticals has broke grounds on an R&D lab in New Jersey, US.

Encap lands long-term manufacturing contract

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.

Pfizer recalls birth control pills after blister packaging error

01-Feb-2012 - Pfizer is recalling 28 lots of contraceptives after a blister packaging error raised the risk of unintended pregnancy.