The Challenge of Change - Managing Excipients Control
Colorcon
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European facilities owned by Israel’s Teva Pharmaceuticals and French drugmaker Servier are among the firms raided by the EC’s competition unit earlier this week, according to media reports.
Janssen-Cilag’s quality control unit has found a defect in certain batches of its Ionsys (fentanyl hydrochloride) management system that could lead to a potentially life-threatening overdose.
The possible sell-off of Enzon Pharmaceuticals’ biotechnology drugs business has come under fire by one of the firm’s shareholders, DellaCamera Capital Management, which says it is opposed to the move.
Questions about the safety in children of a number of azo dye food colourings which are routinely found in pharmaceutical products could be answered within the next 18 months, according to the European Food Safety Agency (EFSA).
The US Food and Drug Administration has opened offices in three Chinese cities – Beijing, Shanghai and Guangzhou – to help improve the safety of medicines and ingredients imported into the US.
Tris Pharma has launched its new drug delivery platform, NoBuse, which it claims provides a way to administer effective pain relief or ADHD products that are nearly impervious to abuse.
Nanoparticles have been guided by a magnet to deliver their active agent when they reach a tumor, reducing the toxic effect on the rest of the body.
Reaxa CEO Dr Peter Jackson explains why the firm added a nickel catalyst to its EnCat range.
Watson Pharmaceuticals has paid Israeli generics firm Teva $36m (€27.6m) for 17 products that the latter firm is selling under the terms of its $7.5bn acquisition of Barr Pharmaceuticals.
Contract development firm Azopharma has established a new laboratory facility in Welwyn Garden City, UK, which it hopes will facilitate its move into the European market.
New UK biopharmaceuticals firm RCP Therapeutics has added mitochondrial targeting nanotechnology expert Volkmar Weissig to its scientific advisory board.
Taiwanese API maker ScinoPharm has been granted a US patent for new crystalline forms of irinotecan which are designed to allow for easier filtration during production processing.
King Pharmaceuticals’ $1.6bn (€1.2bn) acquisition of Alpharma heads a busy week of deals that has seen J&J agree to pay $438m for Omrix and India’s Sun further its presence in the US narcotic APIs sector through the purchase of Chattem Chemicals.
A member of the US Congress has called on the GAO to launch an investigation into the FDA’s handling of the heparin crisis, citing “unanswered questions concerning [the] deaths”.
Members of the Committee on Energy and Commerce have said that recent actions by the FDA have been politically motivated and insufficient, although they did acknowledge the moves were necessary.
Sepha has launched PakScan, its new leak testing machine that the company claims can quickly and non-destructively test for holes in sachets and sealed pouches.
After collecting the drug delivery award at this year's AAPS, John Santini, CEO of MicroCHIPS, was on hand to explain what the gong meant to the company.
Animas has recalled several of its insulin pumps and glucose management systems on concerns that some cap units used by the products are not maintaining contact with the battery compartment.
Eli Lilly has bought ImClone for around $6bn (€4.6bn), gaining access to the blockbuster cancer therapy Erbitux (cetuximab) and significantly expanding its portfolio of Phase III oncology candidates, including IMC11F8 which is viewed as a potential Erbitux successor.
Pfizer’s Exubera failure need not be the final nail in the coffin for inhaled biopharmaceuticals as long as developers focus on proving “healthcare value” and addressing payer needs, according to Bruckner Group’s David Balekdjian.
Irish oral dosage specialist Merrion Pharmaceuticals is to develop and commercialise Novo Nordisk’s range of insulin analogues as the Danish firm seeks to tighten its grip on the $9bn (€7bn) a year diabetes market.
in-PharmaTechnologist.com presents its latest round up of personnel moves in pharmaceutical manufacturing.
MicroCHIPS scooped the drug delivery technology award at this year’s AAPS, after which CEO John Santini spoke to in-PharmaTechnologist.com about the device and what the future holds for the company.
Cargill discusses its C*PharmDex and Zerose Erythritol excipients at this year's CPhI in Frankfurt, Germany.
AstraZeneca is to cut 1,400 jobs and close more manufacturing facilities by 2013, as it attempts to slim down in preparation for impending generic competition for some of its cornerstone drugs.
The US Food and Drug Administration (FDA) has issued draft guidance on process validation, updating its 1987 document to incorporate advances in manufacturing technology and thinking.
The pharmaceutical industry’s vigilance in ensuring the safety of raw materials was criticised at this year’s AAPS, with significant, challenging alterations needed to improve the system.
Patheon has signed a slew of agreements to boost its portfolio of contract drug development and manufacturing services, forging new alliances with Omnicare, Depomed, Senopsys and Solvias.
Canada’s Orbus Pharma has decided to exit the contract manufacturing business, saying that the division “posed a distraction to the core business and generated low or negative margins.”
German chemical giant BASF chose this year’s AAPS meeting in Atlanta, US to showcase its growing library of USP excipient verification certificates, making good on its commitment to apply the highest manufacturing standards to this area of its business.
Contract research group Recipharm has leased AstraZeneca Biotech Laboratory (ABL) in Sodertalje, Sweden, bolting on recombinant protein and monoclonal antibody development capabilities to its offering.
Philips’ new intelligent pill (iPill) technology, which combines a sophisticate sensor array with a precise delivery mechanism, was one of the most talked about innovation presented at this year’s AAPS meeting in Atlanta.
Manufacturers of ingredients used as excipients in pharmaceuticals have faced some regulatory problems with a series substances known as 'atypical actives'.
The US authorities are turning up the heat on Icelandic generic drugmaker Actavis over manufacturing problems at the New Jersey plant which makes its recalled Digitek brand of the cardiac drug digoxin.
DSM Deretil, the chemical side-chain manufacturing operation of DSM's anti-infectives unit, is to go it alone through a management buyout.
The UK Royal Commission has issued a report on the spread of nanomaterials, stating that “urgent action [is] needed on testing and regulation”.
EyeGate Pharma has been received an award from Frost & Sullivan recognising its development of ocular drug delivery technology.
PharmaForm's new EPAS particle engineering technology, launched at this year's AAPS in Atlanta, US, may help drugmakers improve the solubility of insoluble actives without some of the costly and time consuming processing steps used by traditional methods.
New Zealand has approved clinical trials of Living Cell Technologies (LCT) type 1 diabetes treatment, which uses porcine cells encapsulated in a seaweed based gel.
Alpharma moved a step closer to bringing its morphine product Embeda to market after a US Food and Drug Administration advisory panel agreed that it is less susceptible to abuse than other opioid analgesic products.
Chinese drug regulators have ordered Sichuan-based drugmaker Vital Pharmaceutical Holdings to withdraw its hemorrhoid medicine Zhixue on concerns that it could cause liver damage.
US contract packaging firm Compass Pharma Services has reshaped its service and process organisation divisions to provide customers with a single point of contact.
US company BioLife Solutions has filed for approval of a Drug Master File in the HypoThermosol, a preservation media for biological materials.
Demand for glycerin as an ingredient in pharmaceuticals, personal care and other products is expected to show brisk growth out 2015, when demand around the world is expected to reach 3.39 billion pounds, according to market research firm Global Industry Analysts.
UPS is planning on building a new facility in Puerto Rico to help establish a reliable cold-chain delivery service, suggesting a brighter future for the island’s industry.
Cost cutting has sustained pharma profits in the faltering global economy, however top executives are starting to realise that reducing R&D capacity may not have been the smartest move in an era of weak pipelines and impending patent expiry, according to a new report by Ernst & Young.
Merck Serono has begun work on the expansion of its Swiss biotech facility, with the additional capacity being used to meet rising demand for Erbitux (cetuximab).
SAFC's Mike Harris explains bench top continuous processing at this year's CPhI
A Terre Haute, US resident has filed a lawsuit against Pfizer alleging that the company “negligently or recklessly” maintained its dam, resulting in the release of PCB.
GlaxoSmithKline (GSK) has proposed that it will close its facility in Dartford, UK in 2013, as the loss of patents for key drugs makes its operation uneconomical.
A Californian appeals court ruling may have altered product liability in the state, which could lead to numerous court cases being brought against big pharma.
Robert Sexauer, CEO of biopharmaceuticals group RCP Therapeutics, says the R&D investment deal signed with FirstPoint Biotech shows the attractiveness of the firm’s nano-medical pipeline, particularly given the current economic climate.
American Association of Pharmaceutical Scientist's (AAPS) president Dr Karen Habucky sets out the programme for the group's forthcoming annual meeting and exposition, which is being held in Atlanta, US between November 16- 20.
Danish drugmaker Novo Nordisk has unveiled an ambitious plan to build an insulin plant in China, tapping into a major new market for diabetes treatments.
Daiichi Sankyo has completed its $4.5bn (€3.5bn) purchase of Indian generics giant Ranbaxy Laboratories, quashing speculation that the Japanese firm would withdraw as a result of Ranbaxy’s ongoing problems in North America.
Ethex has initiated its third recall of the year as yet again the spectre of dangerous oversized tablets casts its shadow over the St Louis-headquartered company’s manufacturing operations.
Dr Thomas Rosen discusses Cognis' new excipient TPGS, a water soluble form of vitamin E, and its applications in increasing bioavailability.
Pfizer is likely to lose its crown as the world’s largest pharmaceutical company and by 2012 will be usurped by GlaxoSmithKline, according to a report from Urch Publishing.
US Marshals have entered Celsus Laboratories to seize 11 lots of heparin, which contain contaminated material from China according to the US Food and Drug Administration (FDA).
Honeywell has entered into a three-year agreement to supply its Aclar brand moisture-barrier films to Shanghai Haishun Packaging Material.
The publication Pharmaceutical Substances has been given its most comprehensive update since its launch, with revisions to half of the entries.
Senator Chuck Grassley has written a letter to Andrew von Eschenbach alleging systemic mismanagement of employee pay and benefits at the US Food and Drug Administration (FDA).
A deal to jointly market electronic patient monitoring service packaging has been signed by Stora Enso and Medixine.
Covidien is recalling half a million ReliOn single-use insulin syringes after it was uncovered that some had been mislabelled, creating the potential for fatal overdose.
The Indian government is planning on establishing pharmaceutical zones at major international airports to facilitate exports, according to local media reports.
Delays to US ePedigree and serialization laws, which will now not be implemented until 2015, could provide an unexpected windfall for US software firm Systech International and its PES platform.
Tim Bölke, head of the excipient taskforce at the European Fine Chemicals Group, discusses certification and the heparin scandal.
UK drug major GSK is cutting approximately 1,000 US sales jobs by the end of 2008 as it reorganizes to compete in the increasingly tough pharmaceutical market.
Following Barack Obama’s victory in the race to the White House, in-PharmaTechnologist.com examines what this could mean for the pharmaceutical industry.
The new MabDirect MM Fixed D column, launched by Denmark’s Upfront Chromatography, could be a boon for CMO’s and pilot plants working in the expanding bio-processing sector.
RCP Therapeutics, a developer of regenerative medicine, hopes that its new HQ in the UK will benefit from the country’s status as a financial centre and proximity to cost effective trial sites in Eastern Europe.
Printing technology specialist Domino, which develops labelling machines for the drug, food and beverage industries, is cutting 200 jobs in a bid to reduce expenditure by £10m (€12.4m) a year.
Caraco Pharmaceutical Laboratories, in which India’s Sun Pharmaceuticals holds a 76 per cent stake, has joined the list of generics manufacturers issued with an FDA warning on quality control issues.
Fred Eshelman, CEO of PPD, has funded a conservative political group that has produced a controversial last minute campaign advert.
MonoSol Rx has entered into a partnership with Midatech to develop new drug formulations using the companies’ respective expertise in thin film delivery and biocompatible nanocells.
NeoStem has agreed to acquire China Biopharmaceuticals Holdings in an attempt to capitalise on the manufacturing and marketing opportunities in the nation.
All the breaking news across the pharmaceutical manufacturing and outsourcing sectors.
The inauguration has taken place of Italy-based Stevanato’s packaging production facility in Cienega de Flores, Mexico.
The FDA has awarded a $1.19m contract for the development of quality by design (QbD) guidance for pharmaceutical manufacturers.
Disposable bioreactor specialist Wave Biotech AG of Switzerland has been snapped up by its commercial and development partner Sartorius-Stedim for an undisclosed sum.
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