Non-EU regulators can use EMA/FDA data for API export letters

31-Oct-2012 - Regulators in Non-EU countries can use results of previous inspections of API plants by EU or equivalent authorities in written confirmations, according to the European Commission.

Lonza cuts jobs at Visp API and biomanufacturing plant

31-Oct-2012 - Lonza will cut jobs at its facility in Visp, Switzerland and may enact similar 'productivity improvement programmes’ at other sites. 

Boehringer Ingelheim invests in inhaler tech plant

31-Oct-2012 - German drugmaker Boehringer Ingelheim (BI) plans to double production capacity at its inhaler plant in citing demand. 

News from CPhI

Optimism is returning to the pharma fine chemicals sector, says analyst

31-Oct-2012 - The positive impact drug industry demand for quality is having on the fine chemicals sector was evident at industry trade show CPhI last month according to expert Jan Ramakers. 

News in brief

NZ and Taiwan join PIC/S; API inspection scheme makes progress

31-Oct-2012 - New Zealand regulator Medsafe and the Taiwan FDA will join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) next year.

News in brief

EMA calls for submission of Type-1 MA variations before end of November

30-Oct-2012 - Pharmaceutical firms should let the EMA know about minor variations to marketing authorisation (MA) by the end of next month if they want to avoid delays over the festive period.

Collective responsibility at heart of India biologics GDP guide

30-Oct-2012 - All parties involved in the distribution of biologics in India must take responsibility for quality and keep seasonal temperature variations in mind says the CDSCO.

Menarini forms ADC manufacturing deal with OBT

30-Oct-2012 - Menarini has committed millions of euros to an antibody drug conjugate (ADC) clinical development and manufacturing pact with Oxford BioTerapeutics (OBT). 

Novartis says banned flu jabs safe and that 'particles' common in vaccines

29-Oct-2012 - Novartis says two seasonal influenza vaccines temporarily banned by several European countries on quality concerns are safe.

News in brief

C4C sets up cell therapy factory in France

29-Oct-2012 - A group combining government agencies and biotechnology firms have established what it claims is the first cell therapy development facility in France.

New device should reduce risk posed by high-dose insulin

29-Oct-2012 - A new delivery device should reduce the risk posed by the availability of high-dose insulin in Europe say regulators, but vigilance is still needed.

Lonza tweaks E.coli expression system; denies takeover rumours

29-Oct-2012 - Lonza claims a new selection technology to its microbial protein expression system will improve yields and boost efficiency.

Big Pharma contributions favour Romney

25-Oct-2012 - Big Pharma firms want a Republican in the White House judging by contributions received by the two US parties during the current campaign.

Rx360 wants feedback on new EU API import rules

25-Oct-2012 - Rx360 wants industry feedback on import requirements for active pharmaceutical ingredients (API) due to be introduced next year.

update

UK patent laws hamper drug development in according to IPO

24-Oct-2012 - The UK Intellectual Property Office (IPO) wants to make it easier to develop drugs in the country by changing the rules relating to patent infringement in clinical trials.

Evonik hikes amino acid prices in face of rising maize and sugar costs

24-Oct-2012 - Evonik has raised the price of its pharmaceutical amino acids as a result of rising maize and sugar costs.

Canada wants industry feedback on plans to extend GMP to APIs

24-Oct-2012 - Regulator Health Canada has started a consultation on plans to extend GMP requirements to active pharmaceutical ingredients (API).

EMA wants to revise BVDV testing requirements for bovine serum

23-Oct-2012 - The EMA wants feedback on its plans to revise testing requirements for bovine serum used to manufacture biologics.

News from AAPS

Motion sickness chewing gum gives platform for active ingredient formulation – researchers

23-Oct-2012 - A medicated chewing gum prototype that combats motion sickness could give a platform to incorporate other active ingredients with objectionable tastes into gum.

News from AAPS

Low API and excipient volumes vital to win authorisation under EU PIP says EMA

23-Oct-2012 - Pharmas should use lower API and excipient volumes if seeking authorisation under the EU Paediatric Investigation Plan  (PIP) says the EMA.

News in brief

Rubicon and Avantor team on excipient development

23-Oct-2012 - Rubicon Research and Avantor have teamed up to develop a gastro-retentive excipient for pharmaceutical applications.

People on the move: jobs in pharma

23-Oct-2012 - in-PharmaTechnologist.com presents its weekly round-up of career changes in the pharmaceutical industry, including news from Heptares, Cerecor and Dyax Corp.

Motion sickness chewing gum gives platform for active ingredient formulation – researchers

23-Oct-2012 - A medicated chewing gum prototype that combats motion sickness could give a platform to incorporate other active ingredients with objectionable tastes into gum.

US FTC forces Watson and Actavis to sell to rivals Sandoz and Par

22-Oct-2012 - Watson and acquisition target Actavis must sell 18 drugs to rivals Sandoz and Par Pharma under conditions imposed by the US Federal Trade Commission (FTC).

Octoplus to be stand alone R&D unit says Dr Reddy's; no job cuts planned

22-Oct-2012 - Indian drugmaker Dr Reddy’s wants to buy Netherland’s-based formulation services firm Octoplus to expand its drug delivery technology portfolio.

Aurobindo confident of FDA OK for banned API plant by year end

22-Oct-2012 - Aurobindo Pharma is still waiting for US FDA re-approval for its Indian cephalosporin plant, but is confident of a decision by the end of the year.

Merck Millipore announces 2013 price hike

18-Oct-2012 - Merck Millipore has announced plans to increase what it charges for chemical and biopharmaceutical processing solutions, citing rising costs.

Samsung halts biosimilar rituximab trial on regulatory concerns

18-Oct-2012 - Reports suggest that Samsung Biologics has halted a trial of a biosimilar version of Roche and Biogen Idec's Rituxan (rituximab).

Disptaches from AAPS

Eliminate scale up by using R&D equipment for commercial production: GSK

18-Oct-2012 - Using the same equipment from R&D to scale up will cut costs, time and improve efficiency, according to GSK.

Global pork shortage will impact heparin supplies, says Rx360

17-Oct-2012 - Heparin could be in short supply next year with higher feed prices and welfare costs forcing pig farmers to reduce the size of their herds.

Dispatches from AAPS

Remember regional Biosimilar regs and ref drugs differ, says Pfizer

16-Oct-2012 - Manufacturers trying to prove the similarity of their biosimilars must consider that regulations and reference medicines differ in different markets says Pfizer.

News from CPhI conference

Piramal looking for injectables capacity but wont overpay

16-Oct-2012 - Piramal Healthcare wants to add sterile injectables to its offering but is unwilling to overpay for facilities owned by 'value focused' private equity groups.

Dispatches from AAPS

Peru's GMP requirements mean delayed approvals, says expert

16-Oct-2012 - Stricter GMP requirements in Peru are increasing the time it takes to get drugs approved and may not be giving regulators any useful additional information. 

People on the move: jobs in pharma

15-Oct-2012 - in-PharmaTechnologist.com presents its weekly round up of the latest movers and shakers in the world of pharmaceuticals, including news from Cytos, Ablynx and Baxter.

Indian pharma regulations should not change to suit others, says the Government

15-Oct-2012 - Indian regulations should not change to suit Western GMP standards, according to the country’s Deputy Drug Controller.

BASF wants a share of pharma omega-3 market

15-Oct-2012 - BASF wants a share of the $1.5bn global market for drug grade omega-3 and expects the plant it is building to start shipping product early next year. 

Independent panel to grant access to GSK trial data

12-Oct-2012 - A new independent review panel will decide to grant access to GSK’s clinical trial data based on scientific merit.

People on the move: jobs in pharma

12-Oct-2012 - in-PharmaTechnologist.com presents its weekly round-up of the new faces and changing places in the pharma biz, including news this week from BIA, Tolera and Alexar.

Albemarle sees pharma ‘flight to quality’

12-Oct-2012 - Albemarle says it is seeing a flight to quality as pharmaceutical fine chemical customers begin to return to western suppliers.

Novasep to invest €30m in large-scale API production plant

12-Oct-2012 - Novasep plans to build the ‘world’s largest’ chromatography-based API production plant with backing the French government, banks and gas firm Total.

update

Piramal on the lookout for CMOs in the US and EU

10-Oct-2012 - Indian contractor Piramal Healthcare is on the lookout for acquisitions in the US and Europe that will expand its CRAMS business.

Mutual recognition agreements will solve global GMP woes, says EFCG

10-Oct-2012 - Mutual recognition agreements between Western regulators would help ensure a safe API supply chain, according to the EFCG.

Encap teams with academics on HME

09-Oct-2012 - Encap Drug Delivery (EDD) wants to develop hot melt extrusion capabilities to differentiate its service offering.

BASF to build biocatalysis line in India

09-Oct-2012 - BASF will add a catalyst production line at its largest facility in India to cater for growing demand from the country's API manufacturing sector.

Almac's API expansion on track; biocatalysis deal with DSM

09-Oct-2012 - Almac sees larger-scale, sustainable API manufacturing capacity as a way of retaining customers' projects if developments this week are an indication. 

CPhI Worldwide 2012: Networking, up-coming countries and bioavailability

08-Oct-2012 - in-Pharmatechnologist.com is going to Madrid, Spain to meet API and excipient makers, Biopharma firms, processing tech developers and contract services organisation gathered for one of the drug industry's biggest trade shows....

Sumitomo showcases combined coating and contamination assessment tech

08-Oct-2012 - Sumitomo Electric has launched a new tech that combines tablet coating assessment with organic materials detection capabilities.

3M patch tech under assessment for osteoporosis drug delivey

08-Oct-2012 - A transdermal patch technology developed by 3M Drug Delivery could lead to new injection free, compliance-boosting treatments for postmenopausal osteoporosis.

Symbiosis opens new injectables plant for APIs and biologics

08-Oct-2012 - Symbiosis has opened a new sterile manufacturing facility in Scotland for production of both pharma and biopharma products.

EXCLUSIVE

EMA biosimilar guidance welcomed but has further to go, say EGA, Aptuit and Charles River

04-Oct-2012 - Latest EMA biosimilar guidance on reference products is a “major breakthrough” but there is still work to do, say industry experts.

News in brief

US anti drug price gouging bill goes to committee

04-Oct-2012 - A US Bill designed to stop price gouging during drug shortages has progressed to the Committee stage.

People on the move: jobs in pharma

04-Oct-2012 - in-PharmaTechnologist.com presents its weekly bulletin detailing the latest career moves in the pharma and biopharma industries, including news from Sanofi, InVivo and Soligenix.

EMA will accept reference meds made outside Europe under biosimilars guidelines

03-Oct-2012 - The EMA plans to accept reference medicines sourced from outside the European Economic Area (EEA) under its updates biosimilar guidance.

Lonza to produce Phase 2b enzyme-replacement therapy

03-Oct-2012 - Lonza will produce trial supplies of an enzyme-replacement therapy being developed by Celladon Corp for heart failure.

News in brief

Medichem passes FDA inspection for 2nd time this year

03-Oct-2012 - A manufacturing plant operated by Spanish API maker Medichem has passed an inspection by the US FDA for the fifth time in a row.

Pakistan drugmakers need Govt action on DRA says PPMA

03-Oct-2012 - Drugmakers in Pakistan are suffering and parliament needs to implement on the proposed Drug Regulatory Authority (DRA) according to the Pakistan Pharmaceutical Manufacturers Association (PPMA).

final update

SAFC invests in powder media capacity in Scotland

02-Oct-2012 - SAFC will add powder media manufacturing capabilities at its plant in Irvine in a move supported by the Scottish Government. 

Quadro Engineering believes it has solved the "wet milling problem"

02-Oct-2012 - Quadro Engineering says its new wet milling tech will improve API production by operating at speeds previously thought impossible.

Dishman will launch 60 APIs over next two years

02-Oct-2012 - Dishman Pharma has followed its deal with UK drug repurposing firm Redx Pharma with plans to launch 60 generic APIs over the next two years.

News in brief

US FDA issues new BE guidelines for 50 APIs

02-Oct-2012 - The US FDA has issued draft bioequivalence guidelines for nearly 50 active pharmaceutical ingredients (API) in a notice in the Federal Register.

Lonza to make antibody conjugates for preclinical trials

01-Oct-2012 - Lonza will use its facility in Visp, Switzerland to make preclinical trial supplies of an antibody-drug conjugate (ADC) being developed by Intellect Neurosciences.

Deeper than ever bio images thanks to new nanotech

01-Oct-2012 - Drug delivery developers could get a boost from a new nanoparticle that can provide deep-tissue imaging.