Bosch plans to upscale its new X-ray capsule QC tech

28-Jun-2012 - Bosch Packaging says it is now developing a big batch version of its new X-ray capsule inspection tech.

FDA sends closeout letter to Cephazone after re-inspection

28-Jun-2012 - The FDA has sent a closeout to Cephazone Pharma after an inspection of changes made since last year’s warning letter.

A new easy way to "clean" pharma ingredients; study

28-Jun-2012 - Scientists have uncovered a new simple way to “clean” genotoxic impurities (GTIs) in drug ingredients by mixing the solution with contamination-eating scavengers.

EXCLUSIVE

Pakistan's re-joined health ministry still troubled, says PPMA

27-Jun-2012 - PPMA is fearful that the Government of Pakistan’s recent call for more foreign investment in the local pharma sector will go unheard because the industry is already overcrowded.

Round up of drug delivery news from academia

27-Jun-2012 - in-PharmaTechnologist.com presents a roundup of academic drug delivery news, including Pfizer working with Chinese researchers.

Particles in Hospira’s paclitaxel prompt Health Canada warning

27-Jun-2012 - Health Canada has warned of paclitaxel batches from Hospira that may have particles embedded in the vial or floating in the solution.

New filtration tech boosts biomanufacturing yields, says Sartorius

26-Jun-2012 - Sartorius Stedim says its new range of sterilising-grade filters can allow steam cleaning in dry conditions and minimises protein binding.

FDA says Amylin withheld data on extended-release drug

26-Jun-2012 - The FDA has accused Amylin of withholding cardiac safety information in its marketing application for an extended-release diabetes drug.

EMA adds Q&A on genotoxic impurities & residual solvents

26-Jun-2012 - The EMA has updated its quality documents with sections on genotoxic impurities, residual solvents, and heavy metal catalyst residues.

People on the move: jobs in pharma

25-Jun-2012 - in-PharmaTechnologist.com presents a very special round-up of the latest movers and shakers in the industry, including news from our very own Nick Taylor, as well as bulletins from BIA, Merrimack...

Drug delivery developers must simulate device drops; EMA

25-Jun-2012 - The EMA is advising manufacturers to simulate dropping a drug delivery device during development to test its robustness. 

Tighter GMPs a significant risk for Indian drugmakers; CARE

25-Jun-2012 - The manufacturing quality clampdown by regulators is a “significant risk” for Indian drugmakers, a credit rating agency said.

Is drug delivery by skin the solution to bioavailability woes? report from Achema

21-Jun-2012 - Drug regulators and the biomanufacturing industry need to embrace drug delivery via the skin to solve solubility problems with peptides and proteins, according to Across Barriers’ Udo Bock.

People on the move: jobs in pharma

21-Jun-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest comings and goings in the pharma industry, including news from BioAlliance, Cangene and Sucampo.

Price of water & corporate sustainability agendas pushing waste reuse; Veolia

21-Jun-2012 - The price of water and corporate agendas are driving pharmaceutical production plants to reuse and reclaim waste, Veolia said.

News in brief

West and Amgen sign Crystal Zenith evaluation deal

21-Jun-2012 - West Pharmaceutical Services has inked a deal with Amgen to evaluate its Crystal Zenith technology for drug containment.

India launches 'similar biologics' guidelines at BIO2012

20-Jun-2012 - New 'similar biologics' guidelines will curb the rising cost of innovation, attract overseas investment and ensure patients have access to drugs according to the Indian Government team which launched them...

News in brief

Unilife inks 7-year prefilled syringe European supply deal

20-Jun-2012 - Unilife has signed a seven-year contract to supply its Unifill prefilled syringe for use with a generic auto-immune drug.

Freeman updates powder analysis tech

20-Jun-2012 - Freeman Technology has added a new “intuitive” control system to its multi-purpose powder analysis system.

Expert backs global risk-benefit framework at BIO2012

20-Jun-2012 - A risk-benefit assessment framework for new drugs is a must for Pharmas, a leading industry expert told attendees at BIO 2012 in Boston.

Achema 2012: Safety, efficiency and single-use technology

19-Jun-2012 - Safety, efficiency, innovation and single-use tech are the buzz words at Achema 2012 in Frankfurt.

DSM inks antibody contract manufacturing deal for XD

19-Jun-2012 - DSM has signed an antibody contract manufacturing deal focused in its intensified cell culture process, XD.

HHS investing $400m to speed pandemic vaccine production

19-Jun-2012 - HHS is investing $400m (€318m) to create centres to speed development and production of medical countermeasures.

ATMI gears up for single-use "boom" for biotech industry

18-Jun-2012 - ATMI has added helium integrity testing of bioprocess vessels in response to what it says is a boom in the single-use technology arena.

Biologics stability fears make RFID too costly, GE tells EC

18-Jun-2012 - GE has told the EC the need to test how RFID affects biologic stability means it is too costly to use in anti-counterfeiting.

FDA sends closeout letter to end Akzo API plant warning

18-Jun-2012 - The US FDA has posted a closeout letter to an AkzoNobel Mexican API plant seven months after it warned the facility.

Mettler Toledo take track and trace offering to the US

14-Jun-2012 - Mettler Toledo is taking its ramped-up track and trace offering to the US in a bid to plug what it says is a sizeable gap in the market.

New modulator to boost protein production, says ProBioGen

14-Jun-2012 - ProBioGen has launched a new pathway modulator for mammalian cell lines that it says improves protein production efficiency.

Biogen preps for shrinking MS injectables market

14-Jun-2012 - Biogen Idec expects the market for injectable MS drugs to shrink as patients choose more convenient delivery forms.

Indian SMEs need Gov support to comply with GMPs; report

14-Jun-2012 - The Indian Government must better support modernisation efforts at small businesses to boost GMP compliance, a report found.

People on the move: jobs in pharma

13-Jun-2012 - in-PharmaTechnologist.com presents its latest line-up of the new appointments within the industry, including news from Abbott, Trophos and the NIH.

Lilly looks to drug delivery to win share in insulin market

13-Jun-2012 - Eli Lilly will use its drug delivery device capabilities to boost the competitiveness of its developmental basal insulins, the firm’s SVP said.

Bayer files patent for chewable dosage manufacturing process

13-Jun-2012 - Bayer is trying to protect its manufacturing process for a chewable drug delivery dosage form with a US patent application.

Submit good REMS proposals for FDA brownie points, says RAPS author

13-Jun-2012 - Submitting a REMS (Risk Evaluation and Mitigation Strategies) proposal for risky drug developments could earn companies brownie points, according to Quintiles’ Ed Tabor.

update

EFPIA calls for revision of German approval and pricing laws

12-Jun-2012 - German drug approval and pricing laws are prompting Pharmas to abandon the market says the EFPIA, which has called for ‘urgent action’ to protect innovation and access to medicines.

Chocolate drug delivery has NIH interest, Lycotec CEO says

12-Jun-2012 - The CEO of Lycotec says its chocolate formulation of a liver-targeted oral compound has attracted interest from the NIH and FDA.

FDA plans warning label for drugs produced with albumin

12-Jun-2012 - The FDA is proposing a warning to cover the “extremely remote risk” of viral disease spreading from drugs manufactured using albumin. 

More HIV drugmakers to stabilise the South African supply chain, says Aspen

11-Jun-2012 - The upcoming tender for antiretroviral meds (ARVs) in South Africa will be opened up to more companies in a bid to tackle shortages, an insider told us.

New ERP causes “self-inflicted disruption” of supply at Pall

11-Jun-2012 - Pall posted weaker than expected results after the switch to a new ERP system caused “self-inflicted disruption” of supply.

Open pharma – regulator talks “critically important” to ending shortages; FDA

11-Jun-2012 - Biopharma firms can overcome a hurdle to ending drug shortages by having transparent talks with the FDA, an Agency official said.

UPDATE

Pricing schemes stunts UK pharma manufacturing market's growth: report

07-Jun-2012 - The UK pharma manufacturing market is predicted to see a modest 2.7 per cent growth over the next five years largely due to pricing schemes set by the Government, according...

Indena on the environmental standard trail

07-Jun-2012 - Milan head-quartered plant extract specialist, Indena, has been granted the ISO14001 certification for its Tours production site in France, marking the second for its five production sites.

FDA warns 8 manufacturers for failing to register plants

07-Jun-2012 - The US FDA has sent warning letters to eight biopharma companies for failing to register production facilities.

Round up of drug delivery news

07-Jun-2012 - in-PharmaTechnologist.com presents a roundup of drug delivery news, including a FDA set back at Amylin and expansion at Particle Sciences.

News in brief

Pfizer confirms 177 job cuts at Irish API plants

06-Jun-2012 - Pfizer has confirmed 177 staff working for production facilities in Ireland will be cut.

People on the move: jobs in pharma

06-Jun-2012 - in-PharmaTechnologist.com presents its latest weekly line-up of the new faces and places in the pharmaceutical industry, including news from MorphoSys, Pinnacle and Catabasis.

Initial investment in REMS means big pay-put for pharma, says RAPS author

06-Jun-2012 - A bigger initial pay-out for REMS means long-term profitability for drugsmakers, says Quintiles Ed Tabor.

Lack of “horsepower” prompts sale of AMPAC aerospace biz

06-Jun-2012 - AMPAC is selling its aerospace business after deciding it lacked the “horsepower” to grow both it and the pharmaceutical unit.

US court rules failure to report 483s can mislead investors

06-Jun-2012 - A US appeals court has judged failure to report FDA Form 483s can mislead investors in its revival of a case against KV Pharmaceutical.

Quicker, safer vaccine production a reality thanks to hydrogen peroxide, according to study

05-Jun-2012 - Hydrogen peroxide could be the key to safer and more efficient vaccine production, according to researchers at Oregon Health & Science University.

EMA adds formulation, closure flexibility to biosimilar guidance

05-Jun-2012 - The EMA has joined the FDA in proposing to accept different biosimilar formulations and closures in revised draft guidelines.

EXCLUSIVE

GDUFA means a level playing field for generics makers, says SOCMA

04-Jun-2012 - The new Generic Drugs User Fee Act (GDUFA) means a “level playing field” for drugmakers, according to SOCMA members.

EMA posts draft guidelines on transgenic animal production

04-Jun-2012 - The EMA has published draft guidelines on ensuring drug quality when producing APIs in transgenic animals.

Aptar to enter injectable device components with €165m buy

04-Jun-2012 - AptarGroup is buying Stelmi for €165m ($205m) to expand into primary packaging components for injectable delivery devices.