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30-Aug-2012 - The EC plan to extend drug GMP guidelines to APIs has met with a mixed response from industry groups, drugmakers and API manufacturers with some - like DSM and CEFIC...
30-Aug-2012 - Hospira has bought Orchid Chemicals and Pharmaceutical’s active pharmaceutical ingredient (API) facility in Aurangabad, India, to support its expanding antibiotic business.
30-Aug-2012 - Brazilian drugmaker Germed Pharmaceuticals has voluntarily recalled batch of the drug cyclosporine.
30-Aug-2012 - Siegfried says lower raw materials costs helped its API business grow in the first half of 2012 and set out plans to expand manufacturing operations in China.
30-Aug-2012 - Drugmakers and importers are not complying with safety reporting requirements according to the Indian Drugs Controller General (DCG), which has given the offending firms three weeks to comply.
29-Aug-2012 - Vitamin B3 may be used to improve the efficacy of antibiotics when treating drug-resistant ‘superbug’ infections such as MRSA, according to new research.
29-Aug-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest new faces and changing places in the world of pharmaceuticals, including news from AstraZeneca, Cresset and Aurobindo.
29-Aug-2012 - The US FDA has revised storage and testing requirement for human blood intended for transfusion or further manufacturing.
29-Aug-2012 - The CDSCO wants to expand its pool of reviewers for drug applications, clinical trials and medical devices and is seeking applications from experts.
28-Aug-2012 - Bosch packaging has launched two new capsule filling machines which it says are capable of handling all current and future applications.
28-Aug-2012 - Bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.
28-Aug-2012 - Mylan will manufacture Pfizer’s generic drugs for the Japanese market under a new collaboration.
28-Aug-2012 - New developments in the delivery space with Depomed signing up another Big Pharma licensee, Silence teaming up to test its tech for MiReven and Micropoint securing development funds for its...
27-Aug-2012 - The US FDA plans to establish a new database for manufacturing facilities required to ‘self-identify’ under new GDUFA laws.
27-Aug-2012 - The EMA has warned Pacira Pharmaceuticals about a number of manufacturing deficiencies following an inspection of the firm’s plant in the US.
27-Aug-2012 - The MHRA wants industry feedback on proposals to make drugs available before they are licensed.
23-Aug-2012 - CSL Group has resolved the manufacturing problems it faced over the last 12 months to finish fiscal 2012 with higher revenue and profits.
23-Aug-2012 - Brazilian regulator Anvisa has extended the deadline for public comment on plans to require excipient manufacturers to be GMP compliant after a month of industrial action by government workers.
23-Aug-2012 - The first universal flu vaccine for all ages is in reach thanks to a DNA vaccine prime, according to the US National Institute of Health (NIH).
23-Aug-2012 - in-PharmaTechnologist.com presents its weekly round-up of the latest chops and changes in the pharmaceutical development and manufacturing industry, including news from Pfizer, Cresset, and Avantor.
22-Aug-2012 - Ranbaxy has asked the US FDA to withdraw 27 ANDAs for products previously made at Indian manufacturing facilities hit with consent decree earlier this year.
22-Aug-2012 - The first effective universal HIV vaccine may soon be on its way thanks to a family of highly potent (HP) antibodies which neutralise the virus, according to new findings.
22-Aug-2012 - Higher revenue from recombinant albumin hyaluronic acid helped Novozymes’ biopharmaceutical business in the first half of 2012, but the firm expects growth to slow in the second half of the...
22-Aug-2012 - Capsugel has launched a non-profit consortium in a bid to establish a lipid formulation classification system.
21-Aug-2012 - From Usain Bolt’s lightspeed sprint double to Russell Brand’s brave but distinctly off-key mauling of the Beatles classic ‘I am the Walrus’ during the closing ceremony, the performances at the...
21-Aug-2012 - Regulatory professionals’ pay packets are going up despite a general industry preference for cost cutting, according to a new report by RAPS.
21-Aug-2012 - Danish regulators say glycerol excipients tested as part of its drug monitoring activities all complied with appropriate quality standards.
21-Aug-2012 - The UN International Narcotics Control Board (INCB) says the diversion of pharmaceuticals at the national level has become one of the major sources of narcotics around the world.
20-Aug-2012 - The US FDA has revised its draft guidance on suicide risk in trials with updated terminology and expanded assessment criteria and has called for drug industry feedback.
20-Aug-2012 - GSK tells in-Pharmatechnologist.com that decision to close Indian API plant was prompted by rising cost of manufacture and availability of third party contractors.
20-Aug-2012 - The SFDA will name and shame companies and individuals responsible for violations of drug and medical device laws in a public blacklist.
16-Aug-2012 - A new hydrogel which can provide a sustained drug release of up to six months could cut diabetes dosage down from 365 injection per year to just two, according to researchers.
16-Aug-2012 - Theorem and Gallus say their new biologics manufacturing partnership is aimed at giving a “leg up” to drugsmakers in emerging markets looking to market products in the US.
16-Aug-2012 - EMD Millipore has announced two new collaborations this week focused on vaccine bioengineering and stem cell media.
14-Aug-2012 - Sanofi has received US FDA approval for an auto-injector that gives audio and visual cues to assist in the injection process.
14-Aug-2012 - US biosecurity experts are calling on industry and the Government to “get a handle” on the supply chain for drugs used in times of pandemic or bio attack.
14-Aug-2012 - New Human Medicines Regulations came into effect this morning, overhauling the UK's regulations on drug manufacturing, importation, distribution, packaging and pharmacovigilance.
14-Aug-2012 - Regulators on both sides of the Atlantic address the shortages that occur when drugmakers fail to comply with GMP in documents published this week.
14-Aug-2012 - A drop in atorvastatin–related orders hurt Codexis in Q2 but the firm's pharma business is unlikely to face cuts.
13-Aug-2012 - in-PharmaTechnologist.com presents its latest low down of the new faces and changing places in the world of pharmaceuticals, including news from Horizon, Conatus and Akorn.
13-Aug-2012 - The US Food and Drug Administration backs pyrogen and endotoxin testing recommendations developed by the USP and AAMI, but has issued a Q&A to set out the regulatory perspective...
13-Aug-2012 - Bosch Packaging Technology says India is becoming one of its key markets, citing the growing pharma sector as a key driver for the development of its new Goa facility
09-Aug-2012 - Tablet technology firm Accu-Break Pharmaceuticals has signed a product development and licensing agreement with Indian generic drugmaker Alembic Pharmaceuticals.
09-Aug-2012 - Inspectors will be able to visit clinical trial sites unannounced and seize records under new draft guidelines issued by the Indian Central Drugs Standard Control Organisation (CDSCO).
09-Aug-2012 - A new formulation of Genetech’s breast cancer drug Herceptin means patients could soon receive treatment via injection, rather than time consuming intravenous drip.
09-Aug-2012 - The International Pharmaceutical Excipients Council (IPEC) Americas has welcomed new SFDA excipient quality and supervision regulations, which it says are largely consistent with its own guidelines.
08-Aug-2012 - The Pharmaceuticals Export Promotion Council of India (Pharmexcil) wants members to suggest changes to tax laws governing pharmaceutical exports ahead of India’s next budget.
08-Aug-2012 - Scientists at UCF (University of Central Florida) believe they have found a simpler and more efficient way to mass produce the structured nanoparticles used for drug delivery and production.
08-Aug-2012 - Merck Millipore – known as EMD Millipore in the US - has launched new sampling bottles and is targeting the biomanufacturing sector.
08-Aug-2012 - Aurobindo has announced long term plans to steer away from its generics making business in a bid to focus on long term API manufacturing partnerships.
07-Aug-2012 - DSM will conduct further cost cutting at its Pharma business as part of a wider ‘profit improvement initiative’ that will see it cut 1,000 jobs over the next 18 months.
07-Aug-2012 - BD is on the lookout for more acquisitions with firms it can easily “plug in” to its business.
07-Aug-2012 - Indian pharma firm Cipla will invest INR5bn ($90.5m) in three new API manufacturing plants.
07-Aug-2012 - Biopharma manufacturers are putting their supply chains at risk by failing to prepare for emergencies, according to a new study by Best Practices, LLC.
06-Aug-2012 - The Chinese Food and Drug Administration (SFDA) has confirmed that drugmakers and suppliers will take on more responsibility for ensuring excipient quality under new provisions.
06-Aug-2012 - West Pharmaceutical Services is sticking with plans to lessen CMO (contract manufacturing organisation) activities and boost proprietary products despite a hefty uptick in contract production in Q2.
06-Aug-2012 - Shasun’s Pharma more than doubled its net profits in Q1 thanks to its thriving API (active pharmaceutical ingredient) contract manufacturing business.
06-Aug-2012 - Results season is well under way and in-PharmaTechnologist.com is here to bring you the latest as companies announce their chops, changes and plans for the coming quarters.
02-Aug-2012 - Dr. Reddy’s may not have as big a hill to climb as some observers suggest to regain customers lost as a result of the closure of its Mexican API plant,...
02-Aug-2012 - Drug industry customers in Western Europe drove the modest gains achieved by GEA pharmaceutical business in Q2 2012.
02-Aug-2012 - Failure to discuss impurities and unacceptable starting materials topped the list of deficiencies in CEP applications in 2011 according to the EDQM.
02-Aug-2012 - The World Anti-doping Authority (WADA) wants pharmaceutical manufacturers to identify drug candidates in their pipelines that could be used to cheat in sport.
01-Aug-2012 - GE Healthcare has started designing a vaccine manufacturing facility for an unnamed drug company, just days after expanding its collaboration with plant-cell production technology firm iBio.
01-Aug-2012 - Unilife has reported a net loss of $52.3m at the end of its fiscal year, up from $40.7m in 2011.
01-Aug-2012 - Lonza has brought in a new exec to oversee cost reduction and efficiency efforts at its largest custom API manufacturing plant in what CEO Richard Ridinger calls the Visp challenge....
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