Linde says cryogenic fog can help freeze-dry biologics

31-Jul-2012 - Industrial gas supplier Linde claims its 'cryogenic fog' technology is the first commercially-feasible way of controlling ice-crystal formation during the lyophilisation of biologic drugs.

Granules India cites rising China API and intermediates prices as Q1 driver

31-Jul-2012 - Granules India saw API sales rocket in the fiscal first quarter due – according to the firm – to an efficiency drive and the impact of rising prices in China.

News in brief

US Rayos approval good news for Skyepharma says analyst

31-Jul-2012 - Reformulation and delivery tech firm SkyPharma is set for an earnings boost following US approval for rheumatoid arthritis (RA) drug developed by Horizon Pharma.

Lilly to double insulin capacity by 2017 without adding plants

31-Jul-2012 - Eli Lilly plans to double its insulin and device manufacturing capacity by 2017 without building any new production plants.

News in brief

BASF ups EOA prices again

30-Jul-2012 - BASF has changed what it charges for ethanolamines (EOA) in Europe for the third time this year. 

People on the move: jobs in pharma

30-Jul-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest chops and changes on the pharmaceutical careers ladder, including news from ABPI, Cubist and Oxford Pharmascience.

TGA to cut fees for manufacturers of low wholesale turnover drugs

30-Jul-2012 - Pharmas producing drugs for the Australian market may see manufacturing licence charges slashed if their products do not sell above a certain threshold according to a plan outlined by the...

SRI to develop bioadhesive HIV and HSV formulation

30-Jul-2012 - Researchers at SRI International say a bioadhesive-based platform delivery could help slow the spread of HIV and HSV in Africa.

News in brief

Teva makes first Indian forray with help of P&G

26-Jul-2012 - Teva Pharmaceuticals is set to build its first Indian production plant after finalising a pact with healthcare giant Procter & Gamble (P&G), according to local authorities.

People on the move: jobs in pharma

26-Jul-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest new hires in the pharmaceutical industry, including news from the FDA, Cipla and Array.

Regulatory pressures on microbial drug production means big wins for Cherwell Laboratories

26-Jul-2012 - Cherwell Laboratories has more than doubled the size of its Bicester, UK, plant that manufactures prepared media for microbial production after a boom in demand for its goods.

FDA mixed messages create QbD confusion; consultant

26-Jul-2012 - Variable understanding of QbD among US FDA reviewers is leading to mixed messages and confusion, a consultant said.

SAFC ensures modest growth for Sigma Aldrich in Q2

25-Jul-2012 - Sigma Aldrich’s fine chemicals manufacturing section SAFC ensured a modest growth for the company although its “weak” research business in the US and the EU has stunted any drastic figures, according to...

Aegis gets patent for peroxide-free stability excipient in MAb formulations

25-Jul-2012 - Aegis Therapeutics has been granted a US patent for a novel formulation method and excipient that it claims reduces the risk of oxidative damage during MAb production and storage.

EXCLUSIVE QUOTES

Stop online sales of counterfeit drugs, say industry big boys

24-Jul-2012 - Four of the biggest pharma manufacturing associations are calling for more patient awareness of the burgeoning issue of fake drugs sold on the internet.

Congress committee to mull sale of 1m banned inhalers

24-Jul-2012 - A House subcommittee has furthered legislation that would allow the sale of 1m CFC-propelled asthma inhalers.

Novasep latest firm to invest in ADC capacity

24-Jul-2012 - Novasep has joined the growing number of manufacturers betting on the antibody drug conjugate (ADC) market with a €3m investment at its plant in Le Mans, France.

Ideal Cures say new excipient tech can cut 3 months off costing development

23-Jul-2012 - Ideal Cures has launched a ‘ready-to-use’ ER excipient designed to help mid-sized Pharmas cut costs and save time.

Colorcon says IPEC review process would make Pharmas more likely to use new excipients

23-Jul-2012 - More support for IPEC Americas’ proposed excipient safety review process emerged last week with Colorcon saying it makes Pharmas more likely to use new excipients.

News in brief

Expo Technologies rebrands as Prozess Technologie

23-Jul-2012 - Expo Technologies has rebranded as Prozess Technologie and moved to a new HQ in St Louis, Missouri, US.

EXCLUSIVE

Invest in African R&D to boost manufacturing: WAPMA and PMGMAN's plea

23-Jul-2012 - WAPMA and PMGMAN are calling on African Governments to pump more money into R&D in order to boost the continent’s pharmaceutical manufacturing sector.

Industry tight-lipped on impact of FDA ER/LA opioid REMS

19-Jul-2012 - Manufacturers of extended-release and long-acting (ER/LA) opioids have declined to comment on the impact of a class-wide REMS.

Phyton gets CEP for paclitaxel production via plant-cell fermentation

19-Jul-2012 - API maker Phyton Biotech LLC has been granted a CEP for the production of paclitaxel using plant cell-based fermentation.

Indian API production takes hit as APPCB shuts 12 plants

18-Jul-2012 - API production in India will take a hit this week with plant closures for Aurobindo, Hetero Drugs, Divis Pharmaceuticals, and Sri Krishna Pharmaceuticals following allegations of environmental wrongdoing.

Beneo-Palatinit and Biogrund unveil new quick coating excipient

18-Jul-2012 - Biogrund and Beneo-Palatinit say new pill coating will help manufacturers cut process time.

Nanoshells could solve oncology dual delivery riddle

18-Jul-2012 - Hollow nano shells capable of holding both cancer fighting drugs and immune-system boosters could be the solution to oncology’s greatest delivery riddle, according to Yale University researchers.

Fine chemical earnings grow at Albemarle in Q2

18-Jul-2012 - Fine chemicals were one of few positives for Albemarle in the second quarter according to the US chemicals firm’s latest results.

Mozambique re-establishes national drug quality lab

17-Jul-2012 - Drug quality in Mozambique looks set to improve following the creation of a national QA/QC testing laboratory.

Religion plays big part in pharma gelatine shortage for India: Beroe

17-Jul-2012 - Religion is playing a big part in increasing gelatine woes for Indian drugsmakers, according to Beroe.

News in brief

GSK buys HGS and TGS buys Par

17-Jul-2012 - Two major takeovers dominate the headlines this week with GSK finally securing its takeover of HGS and Par Pharmaceutical agreeing to be bought by private-equity firm TGS.

People on the move: jobs in pharma

17-Jul-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceuticals, including news from Daiichi Sankyo, Galenea and Lannett.

Australian Govt to improve how TGA communicates with stakeholders after fee row

16-Jul-2012 - The Australian Government has announced a plan to improve how the TGA communicates with stakeholders just days after criticism about plans to increase fees.

Lonza stresses importance of IP protection in Asia

16-Jul-2012 - Lonza says the migration of major customers’ R&D operations to Asia made protecting IP for its new expression system a must.

Unilife bags US patent and targets customers in branded and generics sector

16-Jul-2012 - Unilife has been granted a US patent for its prefilled syringe technology just weeks after announcing a supply contract with an unnamed autoimmune disease-focused pharma.

News in brief

AstraZeneca buys brain drug candidates from Link Medicine

16-Jul-2012 - AstraZeneca has bought compounds being developed for brain disorders from US biotech firm Link Medicine.

News in brief

Lonza says new platform cuts 6 weeks off cell line development

12-Jul-2012 - Lonza has launched a new version of its gene expression system that cuts weeks off the cell line development and construction process.

Dishman abandons pharma SEZ plan

12-Jul-2012 - Dishman Pharmaceuticals has abandoned plans to set up a special economic zone (SEZ) citing law changes that make the project less attractive and unfavourable economics as the reasons for the decision.  ...

ICH move corrects regulator - industry power balance; expert

12-Jul-2012 - ICH has countered claims that industry influence is detrimental by cutting commercial interests' power over regulators, a consultant said.

BPTF says FDA safety and innovation act is good for safety and US industry

11-Jul-2012 - SOCMA’s BPTF says new fee laws under the FDA Safety and Innovation Act will improve drug quality and boost US manufacturing sector.

Prosonix teams with ICL to assess MCPs for COPD and asthma

11-Jul-2012 - Prosonix aims to develop new treatments for respiratory diseases though an R&D accord formed with Imperial College London (ICL).

Switzerland and Israel ask for exemption from EU API import 'written confirmation' rules

11-Jul-2012 - So far only Switzerland and Israel have asked to be included in the list of countries not required to provide written confirmation that plants making APIs destined for the EU...

Albemarle expands API capacity

10-Jul-2012 - Albemarle has increased production capacity at its plant in Michigan, citing demand for custom and generic APIs as the driver.

"Sleep driving" drug should remain on the shelves says TGA

10-Jul-2012 - An insomnia treatment linked to sleepwalking and sleep driving should stay on the market according to the Australian Therapeutic Good Administration (TGA).  

Less regulatory pressures, more growth: say top pharma execs

09-Jul-2012 - Pharma execs are now spending as much time dealing with increasing levels of regulations as they spend on growing their businesses, according to KPMG.

News in brief

Lipotec pharma units not included in Lubrizol takeover

09-Jul-2012 - The takeover of peptide-based actives developer Lipotec by industrial chemicals firm Lubrizol will not include the Spanish firm’s pharma business.

People on the move: jobs in pharma

09-Jul-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest chops and changes in the pharmaceutical industry, including news from the EMA, Cipla, and MethylGene.

UPDATE

‘Just add water’ for ease of cleaning HP production tech, says Bosch

05-Jul-2012 - ‘Just add water’ as a preparation for cleaning the stand-in-place tech used to produce HP compounds, says Bosh’s Johannes Rauschnabel.

EMA wants debate on clinical data extrapolation; new concept paper

05-Jul-2012 - The EMA wants a debate on the extrapolation of clinical data to see if a framework is needed to govern this potential approach to reducing unnecessary research and letting industry...

FDA publishes Celltex Therapeutics inspection 483

05-Jul-2012 - The US FDA has published a 483  detailing the violations it observed during an inspection of stem cell firm Celltex Therapeutics in April and the document does not make for comfortable reading....

EXCLUSIVE QUOTES - Updated article

GSK speaks to IPT about the “mistakes” that led to $3bn criminal charges

04-Jul-2012 - GlaxoSmithKline (GSK) tells in-Pharmatechnologist.com that it was 'mistakes' made a decade ago that led to this week's $3bn worth of criminal charges.

OLAW clarifies position on cost’s role in animal welfare after feedback

04-Jul-2012 - The US NIH has clarified its position on research animal welfare after its original statement raises concerns.

BASF sells chitosan biz to firm with eye on pharma

04-Jul-2012 - BASF has sold its chitosan biopolymers business to Norway-based Seagarden ASA continuing the divestiture of the non-core units it acquired as part of Cognis in 2010.

SFDA draft excipient guidelines place quality burden on pharmas

03-Jul-2012 - New Chinese SFDA draft guidelines make pharmaceutical firms more responsible for monitoring excipient quality and assessing suppliers.

The quest for more understanding is behind the single use boom: Pall and Thermo Fisher

03-Jul-2012 - The implementation of single use technology in the biopharmaceutical fill and finish process has seen a massive uptick recently because of better industry understanding, according to Pall’s Bruce Rawlings.

ScinoPharm to invest in cancer drug capacity

02-Jul-2012 - API maker ScinoPharm is to invest in cancer drug and injectables capacity, citing current global shortages as a driver for its decision.

News in brief

B-MS to buy Amylin for $5bn

02-Jul-2012 - Bristol-Myers Squibb will pay $5.3bn for Amylin Pharmaceuticals in a move that furthers it and partner AstraZeneca’s efforts in diabetes and may herald next wave of Pharma consolidation.

People on the move: jobs in pharma

02-Jul-2012 - in-PharmaTehcnologist.com presents its latest round-up of the new and changing faces of the pharmaceutical and biopharma world, including news from Transcept, Allegro and Sucampo.

Koslow launches hand-held passivation testing tech

02-Jul-2012 - A new hand-held testing device can help drugmakers determine if their stainless steel tech is prone to corrosion according to developer Koslow Scientific.