P-Gels mean cheaper and more varied drug development, says Patheon

31-May-2012 - Patheon says its new soft gel platform is creating cheaper development opportunities for drugsmakers.

FDA alert drives cephalosporin sales drop at Aurobindo

31-May-2012 - A FDA import alert drove a double-digit drop in quarterly cephalosporin sales at Aurobindo and led to a one-third cut in full year earnings. 

Hospira asks FDA for critical drug list to cut shortages

31-May-2012 - Hospira has urged the FDA to create a list of critical drugs to limit the subjectivity of its draft guidance on drug shortages.

FDA's new User Fee Bill spurs hopes for safer overseas supply chain

30-May-2012 - The US drug industry has welcomed news that Senate has passed the FDA’s amended User Fee Reauthorization Bill in the hopes it will mean a safer global supply chain....

People on the move: jobs in pharma

30-May-2012 - In-PharmaTechnologist presents its weekly round-up of the latest new appointments in the pharma biz, including news from Pfizer, EMD Millipore and Jubilant.

Drop “outmoded” training to boost GMP compliance; study

30-May-2012 - Many biopharma firms can improve their GMP compliance efforts by dropping “outmoded” training measures, a report found.

USP replaces 'out of date' impurity testing standards

29-May-2012 - The US Pharmacopeial Convention (USP) has introduced new elemental impurity standards to replace what it says were outdated guidelines.

Mergers a “key problem” for regulatory compliance, drug quality expert says

29-May-2012 - Biopharma mergers are a “key problem” for manufacturing quality teams as the loss of focus can lead to regulatory actions, a compliance expert said.

MHRA sees cases of microbial contamination double in 2011

29-May-2012 - The number of microbial contamination deficiencies identified by MHRA GMP inspectors doubled in fiscal 2011.

FDA warns about Hospira's doubly-filled injectables

28-May-2012 - The US FDA has issued a warning about Hospira’s Carpuject prefilled cartridges after batches were found containing more than twice the amount of recommended dosage.

West eyes growth from FDA biosimilar delivery flexibility

28-May-2012 - West Pharmaceutical Services expects significant growth from biosimilars as manufacturers use novel delivery devices as a “key differentiator”.

EMA okays MabThera after contamination at Roche site

28-May-2012 - The EMA has cleared the Roche oncology blockbuster MabThera after concluding contamination of API bioreactors poses little threat.

UPDATE

Shortage of Indian gelatin makers could be "tremendous" opportunity for foreign firms, says IPEC

24-May-2012 - IPEC (International Pharmaceutical Excipients) Federation is calling on foreign gelatin makers to set up manufacturing plants in India in a bid to tackle an “acute” shortage of the excipient.

EDQM warns CEP holders of 'directory' scam

24-May-2012 - The EDQM has warned manufacturers that hold Certificates of Suitability (CEP) of a new scam that asks for a fee for inclusion in a directory.

New hot melt capabilities for Bend

24-May-2012 - Bend Research says the addition of a new 18mm extruder to its hot melt tech will cut costs and will allow it work with customers earlier in the drug development...

USP and FDA fattens-up QA standards for heparin

23-May-2012 - The US Pharmacopeial Convention (USP) and the FDA are calling for stricter quality standards for the production and supply of heparin.

Codexis strengthens relationship with Merck & Co

23-May-2012 - Industrial enzyme developer Codexis has had its supply contract extended by Merck & Co and been granted key patents for its Hep-C enzymes.

US Senate votes on FDA safety and innovation act

23-May-2012 - The US FDA will have more powers to inspect ‘risky’ overseas pharmaceutical plants according to supporters of a bill being considered by the US senate this week. 

UPDATE

A closer bond is key to inhaled delivery success: Prosonix

22-May-2012 - Prosonix says its new ‘smart’ excipient-free drug particles can improve the delivery of inhaled combination therapies.

Solvias adds 3D particle tech to PAT offering

22-May-2012 - Solvias’ PAT business unit has added particle characterization capabilities to its offering through an agreement with tech firm Innopharma lab.

Ideal Cures claims new DR coating better than shellac and starch

22-May-2012 - Ideal Cures has expanded its drug delivery tech portfolio with a new alginic acid-based, delayed-release coating that – it claims – has advantages over shellac and starch.

The single-use age has dawned, says ThermoFisher

21-May-2012 - Developments in single-use technology signals the end for clean-in-place biomanufacturing methods, according to ThermoFisher’s Bill Whitford.

News in brief

IPEC India to launch in June

21-May-2012 - IPEC India will be formally established by the end of June according to incoming chairman Ajit Singh of Mumbai-based ACG Worldwide.

EMD Millipore stresses ease of use and flexibility benefits of new bioreactor

21-May-2012 - EMD Millipore premiered a new single-use bioreactor at Interphex 2012, claiming the new design addresses industry demand for ease of use and flexibility.

Mitsubishi Tanabe Pharma to pull out of fine chemicals and rejig ingredients biz

21-May-2012 - Mitsubishi Tanabe Pharma (MTP) is to withdraw from the fine chemicals sector and transfer all pharmaceutical ingredient production to a subsidiary.

Round-up of new pharmaceutical manufacturing facilities

16-May-2012 - in-PharmaTechnologist.com presents the latest new facilities to spring up all over the world, including a plasma-based therapy expansion for Baxter, a North African foray for Julphar, and a supply chain...

USP and BPC harmonize first finished product monographs

16-May-2012 - Drug manufacturers will benefit from harmonisation of finished product monographs says the USP after a first of its kind collaboration with the BPC.

Dendreon to slash costs using production automation; CFO

16-May-2012 - Dendreon hopes to cut its cost of goods sold by two-thirds through automation of tasks at its cancer vaccine plants.

News in brief

Flamma adds commercial scale abilities for gas

15-May-2012 - Flamma now has the ability to use ammonia gas in commercial scale API production after buying a facility near Milan, Italy.

PTI stresses benefits of non-destructive testing at Interphex

15-May-2012 - PTI says its new non-destructive testing technology is uniquely positioned to help manufacturers reduce waste and save time and money.

Generic Lipitor drives jump in pharma revenues at Codexis

15-May-2012 - Codexis posted a jump in pharma sales after the Lipitor patent loss drove an uptick in demand for its atorvastatin intermediate.

Orchid net profit tumbles as traumatic 2012 ends on a low

15-May-2012 - Fourth quarter net profit at Orchid fell by two-thirds as the Indian API manufacturer ended a difficult year on a low.

News in brief

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.

FDA relaxes sterility test requirement for biologics

14-May-2012 - 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.

People on the move: jobs in pharma

14-May-2012 - in-PharmaTechnologist presents the latest job moves in the pharmaceutical industry including news from Incline, Tonix, and ABPI.

ICH sends Q11 guidelines to EU, US & Japanese regulators

14-May-2012 - The ICH has sent its Q11 guidelines on APIs to regulatory bodies in the US, European Union and Japan for adoption.

Fette's 'common sense' approach to boosting production

10-May-2012 - Reduce changeover time on oral solid dose machinery by cleaning equipment offline, Fette Compacting urged drugsmakers at this year’s Interphex.

in-Pharmatechnologist.com's review of Interphex 2012

10-May-2012 - 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....

People on the move: jobs in pharma

10-May-2012 - in-Pharmatechnologist brings you the lowdown of the latest new faces within the pharmaceutical industry, including news from Novo Nordisk, Generix, and Watson Pharma.

AMPAC Fine Chemicals posts loss despite anti-viral surge

10-May-2012 - The return of antiviral sales helped AMPAC Fine Chemicals grow sales in the second quarter but it still posted an operating loss.

Effective controls still lacking for continuous processing says Interphex panel

09-May-2012 - 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...

BASF buys omega-3 maker Equateq citing pharma potential

09-May-2012 - BASF has bought omega-3 fatty acid maker Equateq, citing its pharmaceutical and dietary supplements businesses as key beneficiaries.

New dry powder inhaler will improve delivery, says Aptar

09-May-2012 - 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 - The Indian government says multinational companies are running “a concerted campaign” against its generics industry.

EXCLUSIVE

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

07-May-2012 - Advancements in single-use equipment are crucial to the development of the biotechnology industry, according to experts at this year’s Interphex.

News in brief

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.

EMA outlines manufacturing quality docs for biologics trials

07-May-2012 - The EMA has published final guidelines on manufacturing quality documents needed for biologics entering clinical trials.

Generics rise sparks delivery tech need; Interphex speaker

07-May-2012 - The need for novel delivery technologies is greater than ever as firms scramble to extract maximum value from drugs, an Interphex speaker said.

Hospira ends shutdown after corrective steps at NC plant

03-May-2012 - Hospira thinks steps it took last week have fixed problems that disrupted contract manufacturing at a NC plant.

India plans $37m investment in vaccine cGMP compliance

02-May-2012 - The Indian government is to invest more than $37m to bring vaccine manufacturing plants in line with cGMPs.

Modular plants are “harbinger of change”; Interphex speaker

02-May-2012 - Modular plants are the “harbinger of change” in drug production and will allow for more flexible facility construction, a speaker at Interphex said.

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.