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30-Apr-2012 - PhRMA has spoken out against FDA plans to allow biosimilar manufacturers flexibility in delivery device and formulation choice.
30-Apr-2012 - West has raised its outlook for 2012 after a shift in supply chain attitude by clients drove strong first quarter sales.
30-Apr-2012 - The FDA has approved a process co-developed by Merck & Co and Codexis for manufacturing the Januvia API, sitagliptin.
30-Apr-2012 - Penn Pharma has added clinical and commercial packing capacity to cater for recently won European contracts.
26-Apr-2012 - Sub-Saharan Africa is a “very attractive market” because of local leaders’ new focus on supporting generics makers, according to Sandoz.
26-Apr-2012 - Bioprocess sales at Sartorius jumped 20 per cent in the first quarter on strong demand for single-use filters and bags.
26-Apr-2012 - Amgen is to buy Turkish generics company Mustafa Nevzat (MN) for $700m to build its business in the country’s rapidly expanding drug market.
26-Apr-2012 - In-PharmaTechnologist presents an interactive map showing the global distribution of US FDA cGMP warning letters in fiscal 2011.
25-Apr-2012 - Tamarisk Technologies is in licensing talks with several Big Pharmas over a tech which it claims could solve the oral insulin puzzle and “turn the industry upside down”.
25-Apr-2012 - Fluctuating raw material prices mean market knowledge is a must for companies competing in the intermediates and ingredients space according to Granules India.
25-Apr-2012 - Sandoz is supplying APIs to a Cameroonian generics firm as part of an alliance to raise standards and boost production in sub-Saharan Africa.
25-Apr-2012 - Half the pharma firms sent FDA GMP warning letters sent fiscal 2011 were criticised for failing to thoroughly investigate the failure of a batch.
25-Apr-2012 - Amgen has told the FDA that draft biosimilar guidance risks inhibiting manufacturing improvements and burdening industry.
24-Apr-2012 - Royal DSM NV has confirmed that Percivia – its biosimilars joint venture (JV) with Crucell - is to cease in-house product development after failing to agree on future investment and...
24-Apr-2012 - E.coli can be used as a cheaper and quicker way to make industrial quantities of “human-like” glycoproteins, according to new research.
24-Apr-2012 - In-Pharmatechnologist.com has chosen Interphex - the drug industry’s biggest production and processing technology show – as the launch event for our new look, refocused news website.
24-Apr-2012 - in-PharmaTechnologist presents its weekly round-up of the latest climbers on the pharmaceutical career ladder, including news from Novasep, BioTime and Syndax.
24-Apr-2012 - Merck Serono has spared its Swiss manufacturing facilities from the most severe of its cuts but will reduce headcount.
24-Apr-2012 - The FDA sent 40 per cent more GMP warning letters to biopharma facilities outside the US in fiscal 2011 than the previous year.
23-Apr-2012 - The SFDA has closed down 10 gel capsule factories and revoked two licenses after finding 23 batches of products tainted with “excessive levels” of the toxic metal chromium.
23-Apr-2012 - Indian contract manufacturer Surya Pharmaceutical has received an EDQM Certificate of Suitability (CEP) for an antibiotic API and approval for its Banur plant from Teva.
23-Apr-2012 - The American Business Council (ABC) has warned US drugsmakers working in Pakistan to brace themselves for supply chain disruptions as the Government imposes heavy delays on the process used to...
23-Apr-2012 - Copley Scientific says new ‘breath simulator’ will let developers predict real world DPI and MDI performance more accurately.
23-Apr-2012 - Albemarle posted surging fine chemistry operating profits as a result of positive pharma trends and other tailwinds.
19-Apr-2012 - The European Commission is offering a €2m prize to anyone who can keep vaccines stable at any ambient temperature.
19-Apr-2012 - CRO Spinnovation Biologics says new media analysis service will help developers answer culture scale-up questions faster and more cheaply than currently available methods.
19-Apr-2012 - South Africa aims to boost its pharmaceutical production sector by developing a 70-strong list of oral solid dose drugs that it will only buy from local manufacturers.
18-Apr-2012 - in-PharmaTechnologist presents its weekly round-up of the latest new appointments within the pharmaceutical industry including news from Centerstone, Bellicum and PhRMA.
18-Apr-2012 - The United States Pharmacopoeia (USP) has agreed to work with the South Korea Food and Drug Administration (KFDA) on the quality of medicines under an MOU signed this week.
18-Apr-2012 - CSL Biotherapies and Hospira are both separately recalling drugs due to contamination and syringe overfilling respectively.
18-Apr-2012 - The EMA is seeking industry comments on its draft template for written confirmation of API imports from outside Europe.
18-Apr-2012 - The US FDA IT system for improving oversight of regulatory compliance needs “considerable work”, a GAO report found.
17-Apr-2012 - Bosch Packaging Technologies has completed the acquisition of Eisai’s machinery business, expanding its inspection technology portfolio.
17-Apr-2012 - More post-acquisition integration in the pharma excipients space this week with Ashland launching a new product line combining its own techs with coatings it bought with International Specialty Products (ISP) in...
17-Apr-2012 - The EMA has released draft continuous process verification guidelines to bring its policies in line with ICH Q8, Q9 and Q10.
17-Apr-2012 - Novo Nordisk has told the FDA allowing alternative delivery devices for biosimilars creates “significant safety implications”.
16-Apr-2012 - RNA therapeutics developer Arrowhead Research has bought Alvos Therapeutics in the hope that peptide targeting technology will help it overcome delivery challenges.
16-Apr-2012 - The EMA has released guidelines extending use of real-time release testing (RTRT) beyond terminally sterilised products.
16-Apr-2012 - Merck & Co has asked the FDA for a “clear and unambiguous” definition of crude heparin to improve draft guidance.
12-Apr-2012 - BASF has developed a new naming scheme for the solubilisation and dermatology excipients it gained with the acquisition of Cognis .
12-Apr-2012 - Demand for insulin pens and ready-to-fill syringes helped Gerresheimer post double-digit first quarter sales growth and raise its outlook.
12-Apr-2012 - Lonza and Agennix have made a tactical alliance over the Phase III production of a non-small cell lung cancer therapy in the hopes it will improve the chance of joint manufacturing after the...
12-Apr-2012 - in-PharmaTechnologist brings you a round-up of the latest new facilities and expansions for drugsmakers, including added cytotoxic capabilities for BTL, Jubilant’s launch of a special economic zone in India and plans...
12-Apr-2012 - The EMA has collated its biosimilars advice into one document to tell firms when to expect a GMP inspection and other events.
11-Apr-2012 - Malaysian drugmaker Pharmaniaga wants to buy an API plant in Indonesia, touting the country as the most “promising” of the pharmerging economies.
11-Apr-2012 - in-PharmaTechnologist brings you its weekly round-up of the latest chops and changes on the pharmaceutical career ladder, including news from J&J, Sirona, and Ova Science.
11-Apr-2012 - The US FDA has posted guidance to help PET drug manufacturers comply with media fill rules ahead of a clampdown in June.
10-Apr-2012 - A new filtration cartridge supply deal between GE Healthcare and Refine Technologies is a further indication of Biopharma’s desire for greater connectivity between processing techs.
10-Apr-2012 - USP plans to open a laboratory and training centre in Ghana to strengthen quality control and offer services in sub-Saharan Africa.
10-Apr-2012 - The US FDA has debarred four former quality control officials who worked at Able Laboratories when it recalled all its products.
05-Apr-2012 - Catalent and BASF have joined forces to tackle bioavailability challenges from feasibility studies to commercial supply.
05-Apr-2012 - The G20 should add investment in developing countries’ regulatory systems to its agenda to secure the drug supply chain, an IOM report said.
04-Apr-2012 - American Regent is recalling three lots of cyanocobalamin injection, USP after finding cracks in the bottom and sides of vials.
04-Apr-2012 - Drugmakers should not ask excipient suppliers for metal impurity data until exposure limits are agreed according to industry group IPEC Federation.
04-Apr-2012 - The FDA has found counterfeits of a Roche oncology drug in US medical practices six weeks after the discovery of fake Avastin.
04-Apr-2012 - The FDA says it expects more boards to join an inter-regulatory API (active pharmaceutical ingredient) inspection programme after simplifying the sign-up process.
03-Apr-2012 - Novartis has established a new headquarters in Turkey, and and says its hopes to build a manufacturing plant in the area.
03-Apr-2012 - The PIC/S has published a document to harmonise how inspectors assess quality risk management as detailed in ICH Q9.
03-Apr-2012 - EMA inspections will cost manufacturers more than €20,000 after the regulator raised its fees for the new financial year.
03-Apr-2012 - IHolland has set out to solve a major tableting industry sticking point, namely sticking during tablet production.
02-Apr-2012 - Thermo Fisher Scientific has introduced single-use bioreactors that use a control system to cut setup times.
02-Apr-2012 - in-PharmaTechnologist presents its weekly round-up of the latest appointments within the pharmaceutical industry including news from Raptor, Cangene and Merck & Co.
02-Apr-2012 - The FDA will assess industry responses to drug cargo thefts as part of its fight back against crimes in the pharmaceutical supply chain.
02-Apr-2012 - The number of fake or adulterated drugs found in India fell 40 per cent from 2008 to 2010 despite an uptick in testing, government data claims.
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