All news

FDA relaxes sterility test requirement for biologics

14-May-2012 By Gareth Macdonald

The US FDA has changed its sterility testing requirements for biological products to give manufacturers greater flexibility and encourage use of ‘state-of-the-art’ analysis methods.

Manufacturing & lab demand help WuXi beat Q1 guidance

14-May-2012 By Nick Taylor

WuXi PharmaTech beat expectations in the first quarter as strong demand for manufacturing and laboratory services continued.

ICH sends Q11 guidelines to EU, US & Japanese regulators

14-May-2012 By Nick Taylor

The ICH has sent its Q11 guidelines on APIs to regulatory bodies in the US, European Union and Japan for adoption.

DSM says bids for maleic anhydride biz were too low

14-May-2012

DSM ended a five year search for a buyer for its maleic anhydride derivatives business last week after bids failed to meet expectations.

Marken mulls direct-to-study participant distribution

14-May-2012 By Gareth Macdonald

Marken is looking at setting up a home delivery service as a further expansion of its clinical trial and logistics offering. 

News from Incline, Tonix, and ABPI – People on the move

14-May-2012 By Natalie MORRISON

in-PharmaTechnologist presents the latest job moves in the pharmaceutical industry including news from Incline, Tonix, and ABPI.

in-Pharmatechnologist.com's review of Interphex 2012

10-May-2012 By Gareth Macdonald

in-Pharmatechnologist.com was at Interphex 2012 in New York, US to launch the revamped version of our website and speak to the pharmaceutical manufacturing and processing tech sector’s movers and shakers.

update

DSM’s says CMO sales up in Q1, but predicts challenging 2012

10-May-2012 By Gareth Macdonald

DSM saw some improvement for its CMO business in Q1 2012, but says the market will continue to be a challenge.

Fette's 'common sense' approach to boosting production

10-May-2012 By Natalie Morrison

Reduce changeover time on oral solid dose machinery by cleaning equipment offline, Fette Compacting urged drugsmakers at this year’s Interphex.

Patheon warns 400 jobs at risk as Swindon site trimmed

10-May-2012 By Nick Taylor

Patheon may lay off 400 staff at its Swindon, UK site as it moves forward with the restructuring of its facilities.

AMPAC Fine Chemicals posts loss despite anti-viral surge

10-May-2012 By Nick Taylor

The return of antiviral sales helped AMPAC Fine Chemicals grow sales in the second quarter but it still posted an operating loss.

News from Novo Nordisk, Generix, and Watson Pharma – People on the move

10-May-2012 By Natalie Morrison

in-Pharmatechnologist brings you the lowdown of the latest new faces within the pharmaceutical industry, including news from Novo Nordisk, Generix, and Watson Pharma.

USDA asks MPI to reconfigure enclosures after animal death

10-May-2012 By Nick Taylor

MPI Research must reconfigure its enclosures after they led to the death of a non-human primate, a USDA report obtained by animal rights activists shows.

Effective controls still lacking for continuous processing says Interphex panel

09-May-2012 By Gareth Macdonald

Continuous processing is still hamstrung by a lack of control systems and is not ready for specific FDA guidance according to an industry expert panel which met at Interphex last week.

New dry powder inhaler will improve delivery, says Aptar

09-May-2012 By Natalie Morrison

Aptar Pharma has launched a new twistable dry powder inhaler (DPI) which it says is a “cost effective” way to improve drug delivery as well as patient compliance.

Indian minister rails against anti-generics smear campaign

09-May-2012 By Nick Taylor

The Indian government says multinational companies are running “a concerted campaign” against its generics industry.

Know how your CMO will deliver its promises, says Baxter

09-May-2012 By Natalie Morrison

“Understand not only what your CMO can do, but how they can get it done,” was Baxter’s message during a speech at the year’s Interphex in New York.

BASF buys omega-3 maker Equateq citing pharma potential

09-May-2012 By Gareth Macdonald

BASF has bought omega-3 fatty acid maker Equateq, citing its pharmaceutical and dietary supplements businesses as key beneficiaries.

US biotech pursues Cetero for drug development delay costs

09-May-2012 By Nick Taylor

A US biotech is seeking $250,000 from Cetero to cover drug development delays caused by alleged breaches of contract.

FDA oversight driving closures of CMOs; Interphex speaker

09-May-2012 By Nick Taylor

Increased oversight by the FDA is causing some US-based CMOs to shut down, a speaker at Interphex said.

Marken buys sampling kit unit and bags LabCorp as a customer

07-May-2012 By Gareth Macdonald

Marken has bought the European kit building unit of LabCorp’s clinical trials division in a continuation of its efforts to grow into a full service contract logistics supplier.

EXCLUSIVE

Single-use is the future of biomanufacturing: report from Interphex

07-May-2012 By Natalie Morrison

Advancements in single-use equipment are crucial to the development of the biotechnology industry, according to experts at this year’s Interphex.

BASF to build formic acid plant in US

07-May-2012

BASF has announced plans for a new formic acid production plant in the US, citing the pharmaceutical industry among its key customer targets.

SGS adds formulation development services and expands US lab

07-May-2012 By Gareth Macdonald

SGS has added formulation development to its service offering through the expansion of its laboratory in Illinois.

Charles River CEO downplays interest in asset transfer deals

07-May-2012 By Nick Taylor

The CEO of Charles River said asset transfer strategic deals make little “rational sense” to clients or CROs.

People on the move: outsourcing jobs

03-May-2012 By Natalie Morrison

Outsourcing-Pharma brings you its weekly round-up of the latest appointments in the pharmaceutical industry – and this week we’re reporting from Interphex where exhibitors Covance and Aesica have introduced new faces. More new from Elsevier, ABPI and...

Hospira ends shutdown after corrective steps at NC plant

03-May-2012 By Nick Taylor

Hospira thinks steps it took last week have fixed problems that disrupted contract manufacturing at a NC plant.

People on the move: jobs in pharma

03-May-2012 By Natalie Morrison

This week, in-PharmaTechnologist brings you its weekly round-up of the latest changes on the pharmaceutical job ladder from Interphex in New York. We present news from exhibitors Aesica and Patheon, as well as AstraZeneca, Array and Elsevier.

Novartis to buy dermatology generic firm Fougera

03-May-2012

Swiss drug major Novartis aims to expand its generic drug business with the acquisition of US firm Fougera Pharmaceuticals.

Covance to close Arizona tox site as weak demand continues

03-May-2012 By Nick Taylor

Covance is to close its toxicology facility in Arizona after early development demand dipped at the start of 2012.

Medidata beats expectations as cross-selling activity ramps up

03-May-2012 By Nick Taylor

A doubling in the percentage of new clients buying more than one product helped Medidata beat first quarter expectations.

Round-up of CMO news

02-May-2012

Contract manufacturing organisations (CMOs) have been busy in the past week, with OsoBio expanding its plant and AMRI adopting a new relationship strategy.

Parexel posts huge bookings & begins another hiring spree

02-May-2012 By Nick Taylor

Gross bookings at Parexel topped $1bn in the third quarter but the need to accelerate hiring again led to a cut to earnings guidance.

India plans $37m investment in vaccine cGMP compliance

02-May-2012 By Nick Taylor

The Indian government is to invest more than $37m to bring vaccine manufacturing plants in line with cGMPs.

Chiltern sets up in Taiwan

02-May-2012 By Natalie Morrison

Chiltern has set up a legal entity in Taiwan that will allow it to establish its own local clinical research operations for the first time.

AmerisourceBergen sees Q2 revenue growth

30-Apr-2012

AmerisourceBergen’s commercial services arm was its key driver in Q2, offsetting the loss of key customer for its drug business.

West raises outlook as client conservatism drives sales

30-Apr-2012 By Nick Taylor

West has raised its outlook for 2012 after a shift in supply chain attitude by clients drove strong first quarter sales.

PhRMA speaks out against FDA biosimilar flexibility

30-Apr-2012 By Nick Taylor

PhRMA has spoken out against FDA plans to allow biosimilar manufacturers flexibility in delivery device and formulation choice.

FDA approves Merck & Codexis’ Januvia API production process

30-Apr-2012

The FDA has approved a process co-developed by Merck & Co and Codexis for manufacturing the Januvia API, sitagliptin.

How much does the chief earn – CEO pay at CROs fiscal 2011

30-Apr-2012 By Nick Taylor

Outsourcing-Pharma looks at the wages of the remaining big four public CROs and how they compare to operating income.

Penn Pharma adds packing capacity

30-Apr-2012 By Gareth Macdonald

Penn Pharma has added clinical and commercial packing capacity to cater for recently won European contracts.

Sub-Saharan is "attractive" emerging market, says Sandoz

26-Apr-2012 By Natalie Morrison

Sub-Saharan Africa is a “very attractive market” because of local leaders’ new focus on supporting generics makers, according to Sandoz.

Pharmas and CROs to meet to discuss quality management at Avoca summit

26-Apr-2012

Pharma sponsors and leading CROs will come together next week at a ‘Quality Summit’ held by consulting and research survey firm the Avoca Group.

Single-use bioprocess demand drives Sartorius’ sales jump

26-Apr-2012 By Nick Taylor

Bioprocess sales at Sartorius jumped 20 per cent in the first quarter on strong demand for single-use filters and bags.

Indian CRO weakness hits Q1 sales at Waters & Sigma-Aldrich

26-Apr-2012 By Nick Taylor

Pressures on Indian CROs hit first quarter instrument and research materials sales at Waters and Sigma-Aldrich.

IMS Health buys DecisionView to add enrolment planning tool

26-Apr-2012

IMS Health has bought DecisionView to add patient recruitment planning software to its healthcare unit.

Interactive map of fiscal 2011 FDA cGMP warning letters

26-Apr-2012 By Nick Taylor

In-PharmaTechnologist presents an interactive map showing the global distribution of US FDA cGMP warning letters in fiscal 2011.

Once a friend now an enemy: Over zealous EU regulators could hamper the CMO market, says analyst

25-Apr-2012 By Natalie Morrison

The European CMO industry could be blocked by over complex layers of regulation, says Frost & Sullivan analyst Aiswariya Chidambaram.

Therapure launches custom biologics offering

25-Apr-2012 By Gareth Macdonald

Therapure Biopharma says ‘long history’ of product development will help it compete in the custom biologics manufacturing sector.

Tamarisk Technologies claims to have solved the oral insulin puzzle

25-Apr-2012 By Natalie Morrison

Tamarisk Technologies is in licensing talks with several Big Pharmas over a tech which it claims could solve the oral insulin puzzle and “turn the industry upside down”.