Regulatory professionals working for contract research organisations (CROs) in emerging markets could benefit from taking a test to bring them up to par with those in developed countries, according to RAPS.
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.
Outsourcing-Pharma.com presents its weekly round-up of the latest chops and changes in the world of pharmaceuticals, including news from INC Research, Y-Prime and Ariana.
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 – asking for clarification on the future of EudraLex Volume 4 Part II.
Hospira has bought Orchid Chemicals and Pharmaceutical’s active pharmaceutical ingredient (API) facility in Aurangabad, India, to support its expanding antibiotic business.
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.
Vitamin B3 may be used to improve the efficacy of antibiotics when treating drug-resistant ‘superbug’ infections such as MRSA, according to new research.
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.
GlaxoSmithKline (GSK) and AstraZeneca have been attracted by NHS efforts to work with sponsors and CROs outside the UK according to Government investment group, UK Trade and Investment.
United Drug (UD) has bought firms in the pharmacovigilance and market access sectors, following up on its acquisition in the contract packaging industry last week.
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 microneedle system.
Health economics and outcomes research teams must have a greater influence over clinical trial design if pharma firms are to achieve reimbursement goals, according to Cutting Edge Information.
CROs conducting 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.
Cobra Biologics claims a new micro bioreactor technology it has adopted can cut three months off cell line development timelines and facilitate faster production scale-up.
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.
Comprehend Systems recently made its data analytics, visualisations and reports software available from the cloud. CEO Rick Morrison spoke with Outsourcing-Pharma.com about the firm’s reasoning, and why no rockets were needed in the launch.
United Drug wants the US courts to throw out accusations it disclosed confidential data about Catalent’s packaging business after secret acquisition talks collapsed last year.
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 year.
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.
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.
Genomic analysis seems to be an area of interest for the contract services sector at the moment with Northern Ireland-based Almac and US CRO Quintiles only the latest firms to make investments in the field.
The proposed changes to European clinical trial regulations accepted by the European Commission (EC) in July will put Europe on an equal playing field, according to Clinipace’s Andrea Schiefer.
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.
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 London 2012 Olympics were never less than spectacular.
Outsourcing-Pharma.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceuticals, including news from INC Research, Elsevier and Invetech.
Preclinical CRO Bioanalytical Systems (BASi) saw revenue, margins and gross profits fall during its fiscal third quarter but the firm is positive about the impact of recent restructuring efforts.
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.
