The Challenge of Change - Managing Excipients Control
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Stemedica Cell Technologies is seeking approval from the California Department of Health to begin the production of adult stem cells for Phase I and II clinical trials at its facility in San Diego, US.
Ranbaxy’s problems with the US FDA were ratcheted up a notch yesterday when the agency halted its review of products made at the firm’s plant in Paonta Sahib, India after uncovering “untrue statements” in ANDA’s and NDA filings.
It is not compulsory to respond to form 483s detailing deficiencies at a facility but the FDAs latest guidance fully recommends companies do so to avoid being issued with a warning letter.
Novartis has recalled two batches of meningitis C vaccine from the UK after the solvent used in their preparation was discovered to be contaminated with Staphylococcus aureus.
Equipment specialist Modular Process Constructors has been snapped up by Belgian biological testing firm Mach One for $500,000 (€388,746)
Pfizer’s primary care business unit has dropped two Phase III candidates, further reducing the drug giant’s product pipeline and raising more questions about its R&D decisions.
Pandemic influenza vaccine manufacturing technology will be made available to developing countries through a collaboration between the WHO and Schering-Plough.
An active pharmaceutical ingredient (API) pilot project, implemented by the Pharmacopoeial Discussion Group (PDG) last summer and aimed at harmonising API monographs, should generate its first results before the end of the year.
This week in-PharmaTechnologist's Pharma Phacts podcast focuses on a nanotechnology method that could produce more effective barrier packaging using less material.
The therapeutic index of Tekmira’s SNALP technology, which has been designed to deliver siRNA, has been improved by 5-10 times, according to new data.
MSD India, Merck & Co’s local subsidiary, plans to recruit an additional 300 staff this year to help it gear up for the launch of new vaccines for rotavirus, hepatitis A and herpes.
The US subsidiary of world leading generics firm Teva Pharmaceutical Industries has called in procurement specialist ICG Commerce to help it cut its outsourcing spend as part of ongoing cost reduction operations.
Wonderware has launched software to improve the management of batch processes, offering users the ability to easily install additional processing lines or manufacturing cells.
Shipments of drugs that do not violate patent rights in the exporting or importing countries should not be seized in transit or labeled as counterfeit, as occurred recently, according to health advocates.
The proposed FDA funding for 2009 has given a boost to the agency, with $300m more being offered than the agency requested to ensure the safety of products.
The Indian pharmaceutical and biotech sectors may see more M&A activity this year with rumours that GSK, Sanofi Aventis and Merck KGaA are on the look out for potential deals.
SGD launched its new lyophilisation vials at Pharmapack 2009, which Vincent Langlade, Marketing Director Pharmaceuticals, explained were well suited to capture the growing market.
As the battle for Genentech continues, the US biotech has warned its shareholders that Roche may “seek to influence our business in a manner that is contrary to our goals or strategies”.
The EMEA says that the two cases of status epilepticus reported in Spain last week are unlikely to be related to a batch of Merck & Co’s cervical cancer vaccine Gardasil that was withdrawn in the country last week.
Gerresheimer posted positive results for 2008, with operating income growing by over 13 per cent, but has acknowledged it will not be able to maintain this momentum in 2009.
Barack Obama’s support for R&D tax credits to boost innovation is designed to assuage Big Pharma’s fears about a ban on “authorised generics,” and new “comparative effectiveness" tests, according to Datamonitor’s Sandra Reynolds.
An Indian effluent treatment plant has been hit by a fine of Rs 23.3m ($470,000) for contaminating the water in the Andhra Pradesh region, according to local media reports.
Indian process technology firm ACE Technologies has won the contract to sell and service GEA Pharma Systems’ range of Courtoy tablet presses to local drug manufacturers as part of the latter company’s Asian expansion plan.
PII has expanded the range of drug delivery solutions it can offer clients through collaboration with NexMed, which gives the contract formulation company access to transdermal technology.
MannKind, one of the inhaled-insulin market’s only remaining players, has posted higher than expected Q4 losses as costs for development of its lead product candidate Afresa increase ahead of its submission to the US FDA.
Japanese chemicals firm Asahi Kasei has ramped up its bioprocessing operations with the acquisition of US industrial processing specialist TechniKrom’s biopharmaceuticals business.
Deacom has updated its ERP software, which allows a manufacturer to track raw materials through its facility and perform a range of business processes.
Work into solvents that can switch polarity from an ionic to non-ionic form, negating the need to remove them after each step, has won a researcher the John C Polanyi Award.
French drug major Sanofi Aventis is in talks about taking over market leading Brazilian generics firm Medley, according to reports the country’s Valor Economico newspaper.
Teva reported a 14 per cent fall in sales of active pharmaceutical ingredients (API) in the fourth quarter of 2008, taking the total to $339m (€268m).
IMA chief financial officer Sergio Marzo says that although demand for its machines has been strong so far this year, the number of orders it receives in the second quarter will provide a better reflection of the pharmaceutical industry’s position.
RxElite has pulled out of a move to its new facility, cut executive pay, sold a subsidiary and suspended SEC filings in an attempt to pay creditors.
Singapore’s pharmaceutical exports have tumbled since September, with drops of as much as 94 per cent a month witnessed in some key markets.
Outsourcing-pharma spoke to Amcor Flexibles about the future of the global flexible packaging market.
Oscient Pharmaceuticals is to reduce its workforce by 33 per cent as pharma industry uncertainty slows sales.
SAFC’s fourth quarter performance was hurt by dip in demand from big pharma in the US and Europe combined with lower sales to the chemical industry, according to parent company Sigma Aldrich.
Research into the development of cheaper, less environmentally damaging catalysts should be furthered by a grant awarded by the ACS Green Chemistry Institute.
Genzyme will launch the same biologic under two different names in the US after the FDA decided the drug produced at 2000L was considerably different to the 160L version.
Nigerian authorities have arrested 12 people accused of substituting glycerine in My Pikin Baby Teething Mixture for diethylene glycol, a chemical normally found in antifreeze, which has been linked to the deaths of 84 children.
Spanish drug regulators have ordered a temporary halt to use of a single batch of Merck & Co’s cervical cancer vaccine Gardasil after two girls became sick after receiving the injection, according to Reuters.
New Sanofi Aventis chief Christopher Viebacher has virtually ruled out major acquisitions, eschewing the trend started by Pfizer’s $68bn (€53bn) swoop for Wyeth in favour of an anti-mega merger stance like that adopted by UK rival GSK.
A filing with the SEC says that Roche is not prepared to continue in a relationship with Genentech in which it owns a majority of the biotech’s equity but has limited involvement in its governance.
An inspection system for sealing caps developed by Germany’s Vitronic could make the need for rotating pharmaceutical bottles and ampoules on the production line a thing of the past.
Crucell and DSM Biologics have added fellow Dutch firm Bioceros to the PER.C6 vendor network to provide manufacturing and support capacity in line with increased demand for the cell line.
India’s Sun Pharmaceutical Industries is worried about the FDA warning letter received by a Canadian manufacturing facility owned by its acquisition target Taro Pharmaceutical.
Compass Pharma Services is targeting contract drug developers and clinical research firms with a new microfilling offering that, it claims, helps reduce waste and may even make excipients unnecessary in some drugs.
The strained relationship between Genentech and Roche has been revealed in a SEC filing, which details their differing valuations and accusations of misleading financial models.
Australian packaging company Amcor is in talks with mining giant Rio Tinto about buying part of the latter’s Alcan Packaging Division, confirming speculation that emerged late last year.
KV Pharmaceutical Company has begun laying off 700 of its employees as it attempts to cut-costs in response to current difficulties.
The quality control systems in place at Isreali drugmaker Taro Pharmaceutical’s manufacturing facility in Ontario, Canada are the subject of a US FDA warning letter following an inspection carried out last year.
Seidenader Vision is gearing up to launch a modular track and trace (T&T) solution which, it says, will give drug manufacturers the flexibility to adapt to the changing legislative landscape.
Pliva is laying off 790 employees over the next 12 months following its acquisition by Teva but still intends to significantly increase API and finished product output over this period.
Researchers have raised concerns that wirelessly activated drug delivery devices could be hacked to steal personal information or release potentially fatal doses of a therapeutic.
Merck & Co has earmarked nearly $1bn in investment funding to boost its quality and manufacturing capacity in vaccines, said chief executive Dick Clark on the firm’s fourth-quarter results call.
New research suggests that deuteration, the replacement of hydrogen atoms with heavier forms, can alter an API's crystallisation properties and help drugmakers make better more effective drugs.
Millipore hopes its $23m (€18m) swoop for Guava Technologies will draw attention away from the underperformance of its bioprocess division, revenue from which fell 6 per cent in Q4 to $214m (€165m) and 2 per cent for 2008 overall.
Researchers have estimated that a pharmaceutical waste water treatment plant is pumping up to 45kg a day of ciprofloxacin into an Indian river, which could have grave consequences for the ecosystem.
Jared Wheat the owner of Hi-Tech Pharmaceuticals has been sentenced to four years in prison and fined $3m (€2.3m) by the US Courts for importing unauthorised and adulterated pharmaceutical products.
Almac Pharmaceutical Services has won the contract to produce packaging for physician samples of Middlebrook Pharmaceuticals antibiotic Moxatag (amoxicillin).
King Pharmaceuticals has unveiled plans to reduce its workforce by 22 per cent in a bid to further reduce costs after the US District Court decision to invalidate patents protecting its lead product, the muscle relaxant Skelaxin (Metaxalone).
Authentication and track and trace methods, like pedigree, should be combined to provide layers of protection against counterfeit drugs according to XStream Systems’ CEO Brian Mayo.
DSM is evaluating Micronit Microfluidics’ new microreactor, which has been developed to perform industrial scale fluid reactions of fine chemicals in a continuous process.
Haupt Pharma has acquired Pfizer’s production facility in Latina, Italy, which moves the contract manufacturer into antibiotics and allows it to provide additional services to clients.
Industrial processing giant Pall is stepping up global promotion efforts for its Allegro platform as the market for single-use drug manufacturing options, estimated to be worth around $400m (€308m), continues to expand.
Regulators in India’s Maharashtra state have compiled a hit list of 110 drugmakers that they intend to prosecute for sub-standard manufacturing practices, according to media reports.
Swiss Polytype Converting says it has completed the installation of one of its bespoke coating and lacquering systems at facilities owned by Austrian pharmaceutical foils specialist Constantia Patz.
Falling API sales and “an unprecedented negative economic environment” have forced Perrigo to cut its fiscal 2009 profit forecast and sent stock plummeting by 20 per cent.
Neopac has launched its Twist’n’Use single dose applicator, which it claims improves patient compliance, ensures administration of the correct dosage and prevents contamination.
A bill has been introduced to the US House of Representatives that would require pharmaceutical manufacturers pay a fee and have their facilities inspected more frequently.
Dr Rajashekar Reddy, chief minister of Andhra Pradesh, India presided over the inauguration ceremony for Biological E’s new INR3bn ($61m) vaccine and biopharmaceuticals manufacturing campus.
The EU has backed a €15.9m ($20.4m) research collaboration that will seek to develop drug delivery vehicles that can be tracked through the body with MRI and triggered using ultrasound.
Two months after the European Union (EU) released antitrust findings the FTC is suing Solvay Pharmaceuticals and two other companies for illegally agreeing to a delay generic’s release.
As the sophistication of counterfeit drug packaging continues to improve it is becoming harder and harder to tell real products from fake. in-PharmaTechnologist spoke with Alpvision's Roland Meylan about the company's approach to brand authentication.
The WHO’s review of comments during a discussion of plans to redefine “counterfeit” will focus on “public health impacts of substandard, spurious, and falsely labelled products,” according to the organisation.
Within Obama’s $819bn economic stimulus package are numerous provisions relevant to the pharmaceutical industry, including funding to construct or renovate private manufacturing facilities.
Roche has stepped up its pursuit of Genentech, launching a hostile bid of $42bn after growing frustrated with the lack of progress over the past six months.
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