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31-Jan-2013 - Diabetes sufferers could be injecting insulin just once a week if a new drug delivery technique is picked up by a big pharma company.
31-Jan-2013 - Lonza says it will “move from a product-oriented to a market-oriented organisation” suggesting a restructuring of its manufacturing division is on the cards.
31-Jan-2013 - Clinical trial inspectors are being called on by the European Medicines Agency (EMA) to focus their efforts more on findings that are likely to impact the benefit-risk evaluation of a...
31-Jan-2013 - Protein Sciences says it will license the novel manufacturing technology behind recently approved influenza vaccine, Flublok, to other producers.
30-Jan-2013 - Pfizer's CEO has raised the possibility of more cost cutting in manufacturing operations in 2013 to offset the impact of patent loss for key products.
30-Jan-2013 - Taiwanese API maker Scinopharm has taken a first step towards developing its own drug portfolio in partnership with delivery tech firm Foresee Pharmaceuticals.
30-Jan-2013 - The Association of Clinical Research Organizations (ACRO) and others are cautioning the FDA against issuing guidance that could muddle or duplicate the responsibilities of institutional review boards (IRBs) and trial...
30-Jan-2013 - As the Food and Drug Administration (FDA) ramps up its inspections of foreign pharma manufacturers in an attempt to root out GMP inconsistencies and faulty processes, a recent warning letter ...
29-Jan-2013 - Danish companies that make, use, distribute or import APIs will need to register by March 1 or cease operations according to the Danish Health and Medicines Authority (DKMA).
29-Jan-2013 - Granules India says it expects to be back on track by 2014 following slow sales growth and depressed profitability margins.
29-Jan-2013 - The US Food and Drug Administration (FDA) has finalized a rule clarifying current good manufacturing practice (cGMP) requirements for single-entity and co-packaged drug-device combination products with few changes to its...
28-Jan-2013 - The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.
28-Jan-2013 - The European Medicines Agency (EMA) is looking to integrate guidance from the International Conference on Harmonization (ICH) and US Food and Drug Administration (FDA) into the revisions of two annexes...
28-Jan-2013 - European drugmakers are seeking between six months and a year to prepare and print updated product information, including the black symbol for drugs that require additional monitoring as part of...
28-Jan-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Novartis, Bayer and Tranzyme.
28-Jan-2013 - Freeman Technologies has signed a Canadian distribution deal for its powder flow analysis tech in a bid to win more QbD and PAT-focused Pharma customers.
24-Jan-2013 - Despite conflicting media reports and confusion over where India stands in its regulation of clinical trials, Indian drug officials have until the end of January to respond to a Supreme...
24-Jan-2013 - Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.
24-Jan-2013 - Following a wave of recent investment in ADC production, Synthon has opened an ADC manufacturing facility in Nijmegen, Netherlands, to help bring its first preclinical ADC program to clinical trials...
24-Jan-2013 - Fuisz Pharma says a new tablet design will be of interest to pharma formulators who find esophageal transit failures hard to swallow.
23-Jan-2013 - ‘Unfair competition’ from Asian drugmakers and the prevalence of counterfeits are among the challenges facing African manufacturers according to a new pan-African industry group set on fostering local production.
23-Jan-2013 - The cost of proposed new tests designed to ensure levothyroxine tablet quality is a small price to pay for manufacturers to ensure patient safety says the UK MHRA.
23-Jan-2013 - Impax Pharmaceuticals says it remains confident of resolving issues at its manufacturing facilities following the rejection of its Parkinson’s drug Rytary.
23-Jan-2013 - The UK's cell therapy industry now has a database of all ongoing clinical trials in the country with the aim of expanding research partnerships and pushing more early-stage trials to...
22-Jan-2013 - Regional manufacturers’ associations have set up a pan-African organisation designed to promote local drug production.
22-Jan-2013 - Chinese regulators have just 11 days left to define which excipients must be licensed or require DMFs under new quality regulations due to be introduced next month.
22-Jan-2013 - The Singapore Economic Development Board (SEDB) says it wants to nurture industry, academic and institutional alliances to attract further global investment in ‘Asia’s fastest growing bio-cluster.’
22-Jan-2013 - The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.
22-Jan-2013 - The European Union is now recognizing GMP inspections in both Israel and New Zealand, which should lead to less delay in bringing drugs to market and fewer inspections in all...
21-Jan-2013 - Reagent Proteins says its ability to produce scalable amounts of protein CRM197 supports the current demand in production of conjugate vaccines.
21-Jan-2013 - Lonza has agreed to evaluate BaroFold’s high-pressure refolding technology for difficult to express microbial products expressed as inclusion bodies.
21-Jan-2013 - Indian drug manufacturers have 18 months to test drugs not approved by India’s Central Drugs Standard Control Organization (CDSCO) for efficacy and safety or they will be pulled from the...
21-Jan-2013 - BASF has had its offer for omega-3 API maker Pronova Biopharma accepted by 97.7 per cent of the Norwiegan firm’s shareholders.
18-Jan-2013 - German chemicals giant BASF expects its revised takeover bid for Norwegian omega-3 API manufacturer Pronova Biopharma ASA to be accepted by resistant shareholders.
17-Jan-2013 - Mitsui & Co has upped its stake in Indian API maker Arch Pharmalabs in an effort to expand its CMO business.
17-Jan-2013 - DSM hints at high yield and cost-cutting benefits in licensing its cell growth technology to Amgen.
17-Jan-2013 - People who report illegal drug production could now earn up to 300,000 Yuan ($48,250) under a revised reward scheme launched by the SFDA.
17-Jan-2013 - Indian pharmaceutical exporters now need to apply barcodes on their secondary packages as part of an effort to increase safety and traceability, but some have avoided the requirements, experts say.
17-Jan-2013 - Foreign generic drug and API manufacturers will have to pay $15,000 more than their US counterparts because of additional costs required for the US Food and Drug Administration (FDA) to inspect the...
16-Jan-2013 - EU pharmaceutical and active substance manufacturers should determine the threshold for cross-contamination when multiple drugs are produced in shared facilities.
16-Jan-2013 - In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from AstraZeneca and Roche.
16-Jan-2013 - The drug industry is seeking more clarity on the descriptions of variations made to marketed drugs under the European Commission’s regulation governing the ways marketing authorizations can be re-classified.
15-Jan-2013 - BASF has increased its cash offer for omega-3 API maker Pronova Biopharma to €684m.
15-Jan-2013 - BASF says revised offer for omega-3 API maker Pronova Biopharma is fair value given recent Greek Government decision to stop reimbursing two key drugs.
15-Jan-2013 - Aptuit says that collaboration amongst its global facilities was a key factor in bringing Lomitapide to market.
15-Jan-2013 - The US Food and Drug Administration (FDA) can require opioid generics to have abuse-deterrent properties if the same requirements are applicable to their brand name counterparts, FDA Commissioner Margaret Hamburg...
15-Jan-2013 - Demand for improved bioavailability solutions will drive drug delivery dealmaking in 2013 according to a pharmaceutical industry expert.
14-Jan-2013 - The UK MHRA says regulators Europe-wide are asking drugmakers for additional data to identify plants that need to be inspected under new EU API import rules.
14-Jan-2013 - Solstice Biologics says its new “limitless” RNAi technology will win back Big Pharmas previously put off by delivery difficulties.
14-Jan-2013 - Catalent will invest $20m to upgrade its US pressurized Metered Dose Inhaler (pMDI) capabilities as part of a wider expansion of its inhaler business.
10-Jan-2013 - Winning US FDA approval for omega-3 API suppliers like BASF and Chemport is a key milestone for Amarin in 2013 according to CEO Joe Zakrzewski.
10-Jan-2013 - A US advocacy group says poor HHS oversight of an ongoing type-1 diabetes study could undermine rules designed to protect children in trials.
10-Jan-2013 - Novartis says the acquisition of Dendreon’s Provengen plant was an investment in its activated cellular immunotherapy programme.
09-Jan-2013 - The European Medicines Agency (EMA) plans to ask drugmakers to foot the bill for increased spending in 2013.
09-Jan-2013 - Bosch has completed the integration of Japanese acquisition Eisai Machinery, renaming the unit as Bosch Inspection Technology.
08-Jan-2013 - Lonza plans to double ADC capacity at its facility in Visp, Switzerland by 2014 in a move that it says could create new jobs.
08-Jan-2013 - The World Health Organisation (WHO) should buy more drugs made in China according to the SFDA.
07-Jan-2013 - An oral solid dose manufacturing plant operated by Kemwell has passed an inspection by the US Food and Drug Administration (FDA).
07-Jan-2013 - API maker BioVectra has been acquired by autoimmune disease focused drugmaker Questcor Pharmaceuticals for C$50m.
07-Jan-2013 - Saltigo says climbing raw materials, energy and shipping costs prompted it to increase the price of key chemical intermediates, 1,2,4-triazole and chloroformate.
03-Jan-2013 - Scientists from targeted therapeutics firm Arrowhead Research claim a vesicle bursting polymer can overcome siRNA delivery difficulties.
03-Jan-2013 - 3M Drug Delivery will help commercialize a transdermal osteoporosis treatment under an extension to its deal with Radius Health.
03-Jan-2013 - The Indian Pharmacopoeia Commission (IPC) says a first of its kind guidance manual will help drugmakers comply with quality requirements and testing procedures.
03-Jan-2013 - An advocacy group says actor Jack Klugman's support was key for US law that encouraged pharmaceutical firms to make drugs for rare diseases over the past 30 years.
03-Jan-2013 - Mitsubishi Chemical Holdings (MCHC) has announced plans to buy the ‘dominant’ pharma-grade HPMC capsule maker Qualicaps as the global gelatin shortage continues.
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