All news

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 By Nick Taylor

The US FDA expects Merck KGaA to do a “comprehensive and global assessment” of its sites after sending a warning letter to three plants.

Ockham buys Nexus in bid to boost oncology trial offering

15-Feb-2012 By Natalie Morrison

Ockham has expanded its oncology trial services offering through its acquisition of Nexus Oncology.

GLP tox capacity constraining, but slowly, Charles River says

15-Feb-2012 By Nick Taylor

GLP toxicology capacity is filling up after repeated cuts but it will be years until more space is needed, the CEO of Charles River said.

Quality regulations lag behind modern understanding; FDA

15-Feb-2012 By Nick Taylor

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

News from Patheon, AmerisourceBergen and Premier Research – People on the move

14-Feb-2012 By Natalie Morrison

Outsourcing-Pharma presents its weekly round-up of the latest chops and changes within the pharmaceutical jobs market, with news from Patheon, AmerisourceBergen and Premier Research.

Agilent introduces service to cut cGMP lab validation timelines

14-Feb-2012 By Natalie Morrison

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

Private equity to buy SeraCare

14-Feb-2012 By Nick Taylor

SeraCare Life Sciences has accepted an $82m offer from a US private equity firm six months after it began searching for a buyer.

Flat Congress funding will make FDA more reliant on user fees

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.

FDA calls for audits of heparin suppliers in draft guidance

14-Feb-2012 By Nick Taylor

The FDA is asking companies to audit heparin suppliers in draft guidance intended to stop a repeat of the 2008 contamination.

Trade secret changes critical to regulatory sharing, FDA says

14-Feb-2012 By Nick Taylor

The FDA has said it is critical that trade secret laws are changed to allow it to share manufacturing information with other regulators.

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.

Catalent earnings jump as oral tech demand drives Q2 growth

13-Feb-2012 By Nick Taylor

Earnings at Catalent jumped in the second quarter as rising demand for its oral technologies offset weakness in sterile injectables.

Prismic hunting for anti-psychotic alliances

13-Feb-2012 By Natalie Morrison

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.

Layoffs possible as BASi looks to cut costs after weak Q1 results

13-Feb-2012 By Nick Taylor

BASi is looking at staffing levels to “sharply” cut costs after posting first quarter results a shareholder called “pitiful”.

Bend Research on the hunt for more SDD alliances

13-Feb-2012 By Natalie Morrison

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

Pfizer signs up Biologics Inc as cancer drug distributor

13-Feb-2012

US-based oncology services firm Biologics Inc will distribute a kidney cancer drugs being under a new contract with Pfizer.

FDA biosimilar guidance permits alternative drug delivery devices

13-Feb-2012 By Nick Taylor

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

Bioclinica says pricing in imaging sector has stabilised; expects 8% top line growth

09-Feb-2012 By Gareth Macdonald

Bioclinica says pricing in the clinical imaging sector has stabilised as Pharmas have opted to work with fewer service providers.

China healthcare spending up despite economic fears, BD says

09-Feb-2012 By Nick Taylor

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

AMRI says Burlington issues resolved, pending final FDA inspection

09-Feb-2012 By Gareth Macdonald

AMRI says the US FDA has no concerns about its sterile fill-finish facility in Burlington, Massachusetts and that the challenge now is to win back customers.

AMPAC sales jump 50% on return of antiviral revenues

09-Feb-2012 By Nick Taylor

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

Lilly teams with Bend over spray-dried dispersion tech

09-Feb-2012 By Natalie Morrison

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

GSK brings work in-house in bid to boost efficiency and cut costs

09-Feb-2012 By Nick Taylor

GSK is bringing outsourced work back in-house and placing manufacturing at existing sites in a bid to boost efficiency.

Celerion signs up to VCT's verified patient database project

08-Feb-2012 By Natalie Morrison

Celerion has teamed up with Verified Clinical Trials (VCT), a group aiming to stop ‘professional patients’ enrolling in multiple trials.

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

08-Feb-2012 By Gareth Macdonald

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

United Drug in €30m packaging services deal as rise continues

08-Feb-2012 By Nick Taylor

United Drug has inked a four-year, €30m packaging services deal as it continues to grow the division, particularly in the US.

BASi says "reduced-stress" animal testing provides more accurate results

08-Feb-2012 By Natalie Morrison

BASi says its new sampling tech will allow for quicker, cheaper and more accurate animal testing through its “low-stress” lab.

Cambrex on takeover hunt amid pharma fine chem consolidation

08-Feb-2012 By Nick Taylor

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 By Nick Taylor

GSK is developing tablets it can compress without excipients to cut the time taken to reach the clinic by up to nine months.

Jubilant posts unhappy Q3 earnings despite record sales

07-Feb-2012 By Gareth Macdonald

Foreign currency effects left Indian contractor Jubilant Life Sciences with a third quarter loss despite record sales.

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”.

Covance looking to win biz from distracted competitors; analyst

07-Feb-2012 By Nick Taylor

Covance is investing to win business from “distracted competitors” that have been part of mergers and buyouts, an analyst claims.

Australia mulls chemical supply chain actions to stop terrorism

07-Feb-2012 By Nick Taylor

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

Marken to build new China depot; denies reports of client loss

07-Feb-2012 By Gareth Macdonald

Logistics contractor Marken plans to ramp up its activities in China with a new Beijing depot set to open later this year.

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

06-Feb-2012 By Nick Taylor

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

New approvals and contracts at CMOs

06-Feb-2012

Outsourcing-pharma.com presents a round up the latest developments in the contract manufacturing sector – with news from Cambrex, Florida Biologix, SCM Pharma, Recipharm and OctoPlus.

Annual WHO meeting to tackle spread of substandard drugs

06-Feb-2012 By Nick Taylor

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

What’s in a name? Quite a lot say CROs and CMOs citing differing business fundamentals

06-Feb-2012 By Gareth Macdonald

The desire to be an all-encompassing ‘one stop shop’ may be common to both contract research organisations (CRO) and contract manufacturing organisations (CMO), but that does not mean the terms CRO and CMO are synonymous say industry leaders.

UPDATE

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

06-Feb-2012 By Natalie Morrison

The Indian Drug Manufacturers Association (IDMA) plans to amp up pharma business in Tamil Nadu by helping more companies meet WHO production standards.