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28-Mar-2013 - BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug.
28-Mar-2013 - Following its re-elevation to a ministerial level, the Chinese drug regulatory body has rebranded itself the China Food and Drug Administration (CFDA).
28-Mar-2013 - ACRO (Association of Contract Research Organizations) is calling on the FDA to clarify draft guidance attempting to mitigate the possible pitfalls in transitioning to electronic source data for clinical investigations.
27-Mar-2013 - As excipient suppliers are inundated with similar requests from users regarding quality and raw material sources, IPEC (International Pharmaceutical Excipients Council) is looking to streamline the exchange of information between...
27-Mar-2013 - Sale of medicines on trains and planes is just one reform being considered in a series of simplification measures aimed at increasing industry efficiency by the MHRA.
27-Mar-2013 - Pfizer’s Rifampin injections used to treat TB (tuberculosis) are in short supply as the company says manufacturing issues caused some vials and solutions of the drug to be possibly contaminated....
27-Mar-2013 - Two new nonreactive product contact components can control contamination and meet regulatory requirements according to their makers, Gore PharmBIO.
26-Mar-2013 - GSK is working on a low-cost manufacturing platform it will use to produce inactivated polio vaccines (IPV) for developing countries.
26-Mar-2013 - Both Teva and Hospira have pledged to restrict distribution of propofol as a lethal injection ingredient while production of the drug recommences.
26-Mar-2013 - Philadelphia-based CRO Frontage has received a Form 483 for “minor” issues related to its bioanalytical lab in Shanghai, China, a spokesman told us.
26-Mar-2013 - Shire says it is laying down a foundation into the specialty ophthalmology field following its second acquisition in a matter of weeks.
25-Mar-2013 - The FDA says compounding pharmacies need to be regulated under new legislation following a string of product recalls due to contamination threats.
25-Mar-2013 - Formulators still think of excipients first when faced with drug bioavailability difficulties judging by trends that emerged at our online event.
25-Mar-2013 - Micron Technologies’ new private-equity owner says it plans to grow the particle engineering firm through investment and acquisitions.
25-Mar-2013 - In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from AstraZeneca, Royal DSM and the FDA.
21-Mar-2013 - The US FDA listed failure to ensure product sterility or explain why some batches were only partially released among criticisms of Apotex in a warning letter published this week....
21-Mar-2013 - Health Canada says moving to an electronic filing system for regulatory submissions will reduce costs but warned drugmakers not to include their credit card details.
21-Mar-2013 - Drug industry groups welcomed corporate tax cuts and increased research credits set out in the UK budget last night suggesting they are good news for manufacturers.
20-Mar-2013 - Novo Nordisk says its long-acting oral insulin could become a lead product following the successful completion of an early-stage trial.
20-Mar-2013 - Planning for manufacturing scale up is a critical step that biotech drug developers often overlook according to US FDA Commissioner, Margaret Hamburg.
20-Mar-2013 - US-based particle engineering services frim Micron Technologies has been acquired in a private-equity backed management buyout.
20-Mar-2013 - Drugmakers Merck & Co and Eisai have both substantially cut internal data management costs through two unique off-shoring operations in China and India, respectively.
19-Mar-2013 - The US Environmental Protection Agency (EPA) says Teva still needs to address environmental issues at Missouri API plant landed with a $2.3m civil penalty.
19-Mar-2013 - The ‘R&D’ reorganisation announced by AstraZeneca yesterday will impact manufacturing and commercial operations as well drug development activities.
19-Mar-2013 - Manufacturing “delays” at an unidentified Sanofi-Aventis plant have caused a new shortage of a tuberculosis (TB) drug , according to the US FDA.
19-Mar-2013 - Marketed drugs will not need to be tested under final guidelines on 'tablet scoring' for branded and generic medicines issued by the US Food and Drug Administration (FDA) this week....
18-Mar-2013 - A High School is using mosquitos to deliver vaccines as part of a project to develop a ‘flying syringe.’
18-Mar-2013 - Proposed US government funding plans include $10m the FDA will use to increase oversight of drug manufacturing and research in China.
18-Mar-2013 - Drug solubility science, technology and solutions will take centre stage at “The Bioavailability Challenge” a free to attend online event in-Pharmatechnologist.com is hosting on Wednesday, March 20.
18-Mar-2013 - In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Glide, BASF and Pall.
14-Mar-2013 - Tokyo-based API Corporation, a unit of Mitsubishi Chemical Holdings Group, is making an investment in API and pharmaceutical manufacturer Neuland Laboratories’ facilities.
14-Mar-2013 - Cost competition and the financial crisis have slowed the growth of the global API marker over the past four years according to new data released by the CPA (Italian Chemical...
14-Mar-2013 - Shire has entered the neonatology market by acquiring Premacure and a new therapy and delivery technology designed to treat infant blindness.
14-Mar-2013 - Following an analysis of its global R&D business Actavis says it will close its Maltese R&D unit at a cost of 60 jobs.
13-Mar-2013 - The EC should add the US and Japan to list of countries exempt from new API import laws and intensify talks with China and India to prevent shortages according to EFPIA....
13-Mar-2013 - Vaccine developer Prokarium has been awarded £400,000 ($600,000) to help develop an oral vaccine.
13-Mar-2013 - Novo Nordisk says “there is still room for improvement” in the development and delivery of insulin as it awaits FDA approval of its challenge to Lantus.
13-Mar-2013 - Pfizer, GlaxoSmithKline, Roche and 26 other large pharmaceutical companies will provide about $5.85m (3.5m Euros) over three years to fund an Interpol initiative to combat pharmaceutical counterfeits and crime.
13-Mar-2013 - Catalent says it has acquired a Chinese softgel producer to expand its drug delivery offerings and expects more investments to come as part of a two-pronged plan into China.
12-Mar-2013 - Novozymes says a recombinant albumin product usually used to stabilize vaccines has been approved in Japan as part of a coating for medical devices.
12-Mar-2013 - Patheon says the shuttering of one of Banner’s manufacturing sites is necessary in integrating the recent acquisition into its global business structure.
12-Mar-2013 - South Korean regulators have cleared BASF to produce pharmaceutical grade omega-3 at its facility in Scotland.
11-Mar-2013 - MSD says plans to shutter an Irish API facility are not part of an outsourcing strategy and intends to relocate both staff and manufacturing.
11-Mar-2013 - Ashland says it is expanding its contract manufacturing business in order to offer its customers greater scope in drug solubilization.
11-Mar-2013 - The US FDA’s ability to inspect facilities, trial sites, and deal with all but its most pressing priorities will be restricted by mandatory government spending cuts according to the Alliance for a Stronger...
11-Mar-2013 - In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Merck, BASF and Tenex.
11-Mar-2013 - The European Commission (EC) says timelines for new laws requiring that risky drugs are marked for extra safety monitoring take industry practicalities into account.
07-Mar-2013 - Kyowa Hakko Kirin says commercial production of biopharmaceuticals will begin rolling out of its new plant in 2017.
07-Mar-2013 - Merck Serono says “fast progress” in its restructure programme helped double its net savings guidance for 2012 though headcount dropped by almost 2,000 with more cuts to come.
07-Mar-2013 - Pharmaceutical firms targeting the European market should expect drug review fees to increase by 2.6 per cent from April according to the European Medicines Agency (EMA).
07-Mar-2013 - A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.
07-Mar-2013 - A new partnership between a niche cancer drug discovery company and biotech powerhouse Celgene could pave the way for the future of cancer drug discovery and delivery.
06-Mar-2013 - Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.
06-Mar-2013 - Researchers say a synthetic ‘passport’ peptide may allow drugs to function with greater efficacy by evading the body’s immune system.
06-Mar-2013 - Ajinomoto says its flexible approach to tech licensing differs from rivals who are more focused on locking customers into manufacturing services contracts.
05-Mar-2013 - Chinese regulators want to improve how drugs are developed, reviewed and distributed in the country.
05-Mar-2013 - SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.
05-Mar-2013 - Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.
05-Mar-2013 - Sanofi has entered into an agreement to produce an API for French company DBV Technologies.
05-Mar-2013 - Endo says it will expand capacity at its generic manufacturing subsidiary Qualitest in light of quality lapses and product recall.
04-Mar-2013 - As many as 300 API manufacturing sites will need to be inspected to prevent drug shortages after new EU import regulations come into effect this summer according to pan-European group...
04-Mar-2013 - Mylan says its acquisition of Agila puts the generics company in a “leading position” in the injectables market.
04-Mar-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.
01-Mar-2013 - Capsugel says the acquisition of Encap is part of its recently announced Dosage Form Solutions (DFS) strategy.
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