14-May-2012 By Nick Taylor
The ICH has sent its Q11 guidelines on APIs to regulatory bodies in the US, European Union and Japan for adoption.
09-May-2012 By Gareth Macdonald
Continuous processing is still hamstrung by a lack of control systems and is not ready for specific FDA guidance according to an industry expert panel which met at Interphex last week.
09-May-2012 By Nick Taylor
The Indian government says multinational companies are running “a concerted campaign” against its generics industry.
07-May-2012
The EMA has published final guidelines on manufacturing quality documents needed for biologics entering clinical trials.
07-May-2012 By Nick Taylor
The need for novel delivery technologies is greater than ever as firms scramble to extract maximum value from drugs, an Interphex speaker said.
03-May-2012 By Nick Taylor
Hospira thinks steps it took last week have fixed problems that disrupted contract manufacturing at a NC plant.
02-May-2012 By Nick Taylor
The Indian government is to invest more than $37m to bring vaccine manufacturing plants in line with cGMPs.
30-Apr-2012 By Nick Taylor
PhRMA has spoken out against FDA plans to allow biosimilar manufacturers flexibility in delivery device and formulation choice.
26-Apr-2012 By Natalie Morrison
Sub-Saharan Africa is a “very attractive market” because of local leaders’ new focus on supporting generics makers, according to Sandoz.
26-Apr-2012 By Nick Taylor
In-PharmaTechnologist presents an interactive map showing the global distribution of US FDA cGMP warning letters in fiscal 2011.
25-Apr-2012 By Nick TAYLOR
Amgen has told the FDA that draft biosimilar guidance risks inhibiting manufacturing improvements and burdening industry.
25-Apr-2012 By Nick Taylor
Half the pharma firms sent FDA GMP warning letters sent fiscal 2011 were criticised for failing to thoroughly investigate the failure of a batch.
18-Apr-2012 By Nick Taylor
The US FDA IT system for improving oversight of regulatory compliance needs “considerable work”, a GAO report found.
05-Apr-2012 By Nick Taylor
The G20 should add investment in developing countries’ regulatory systems to its agenda to secure the drug supply chain, an IOM report said.
20-Mar-2012 By Nick Taylor
The US FDA will today publish a final rule to change cGMP labelling controls, 15 years after proposing the revision.
27-Feb-2012 By Nick Taylor
Sole suppliers that outsource manufacture must alert the FDA of interruptions at their CMOs, the Agency wrote in draft drug shortages guidance.
16-Jan-2012 By Nick Taylor
The US FDA has sent its generic user fee recommendations to Congress ahead of a meeting to discuss the plan next month.
04-Jan-2012 By Nick Taylor
The FDA should encourage industry to submit draft guidance to speed regulatory development, an agency working group found.
14-Dec-2011 By Nick Taylor
The EMA has recommended recalling a batch of Gilead’s Vistide manufactured by Ben Venue over particle contamination concerns.
FDA anti-adulteration efforts hindered by industry; GAO
28-Nov-2011 By Nick Taylor
Industry reluctance to share information on economic adulteration is hindering FDA efforts to tackle tainted ingredients, a GAO report found.
EC seeks industry feedback to shape serialisation policy
24-Nov-2011 By Nick Taylor
The EC is seeking industry comments before implementing the serialisation aspect of the falsified medicines directive.
FDA nanomaterial draft guidance means pointless extra regulation, say experts
22-Nov-2011 By Natalie Morrison
FDA draft guidance defines nanoparticles too broadly and could result in APIs being categorised as nanomaterials, industry said.
Globalised supply chain drives EMA to rethink batch release
09-Nov-2011 By Nick Taylor
The EMA plans to update guidance on certification and batch release in response to globalisation of the pharma supply chain.
Canadian drug shortage plan fails to tackle problems; analyst
19-Oct-2011 By Nick Taylor
Canadian pharma manufacturers’ plan to stop drug shortages by sharing information fails to tackle underlying concerns, an analyst said.
EU Commission may revise guidance on pharma literature
13-Oct-2011 By Natalie Morrison
The EU Commission could soon revise its guidance for information allowed on packaging of prescription-only medicines, after European Parliament urged it to update its original policy.
ScinoPharm goes public in preparation for expansion opportunities
05-Oct-2011 By Natalie Morrison
Active pharmaceutical ingredient (API) manufacturer ScinoPharm has gone public in a bid to raise funds for its upcoming expansions.
FDA awards $35m to improve US drug production
05-Oct-2011 By Nick Taylor
The FDA has awarded a $35m (€26m) grant to make US drug production less expensive and reverse the offshoring trend.
FDA asks for powers to stop another heparin-like crisis
15-Sep-2011 By Nick Taylor
The FDA needs additional powers to update its “antiquated, domestically-focused statute” and end the “competitive advantage of non-compliance”, an agency official said.
Blue Chip gives social networking in patient recruitment the thumbs up
26-Jul-2011 By Natalie Morrison
Blue Chip Patient Recruitment says the future of patient sourcing for clinical trials lies in social media.
FDA must be empowered to oversee supply chain; report
13-Jul-2011 By Nick Taylor
Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report.
Pfizer begins ‘virtual’ trial and calls for innovation in research
09-Jun-2011 By Gareth Macdonald
Pfizer has begun what it claims is the world’s first ‘virtual’ trial and says that such innovation is needed to make sure clinical research is sustainable.
Pfizer teams with Parexel and Icon in CRO sector's latest strategic deals
Update
26-May-2011 By Gareth Macdonald
US drugmaker Pfizer has teamed up with Parexel and Icon in the latest Big Pharma CRO strategic partnerships.
Direct San Diego to London flight boon for drug sector says Biotec
11-May-2011 By Pooja Kondhia
A new direct flight between London Heathrow and San Diego from 1st June 2011 will benefit the international biotech sector according to UK-based Biotec Services International.
Adherence packaging also boosts patient Rx persistence
03-May-2011 By Staff Reporter
Pharmaceutical packaging designed to improve adherence is also effective at boosting “patient persistency” according to new research.
Hamburg calls for more FDA powers to ensure drug quality
14-Apr-2011 By Nick Taylor
FDA Commissioner Hamburg has asked for more supply chain security and quality control regulatory powers.
Kerry adds two Chinese sites to logistics network
24-Mar-2011 By Nick Taylor
Kerry Logistics has opened two distribution centres in China to serve pharmaceuticals, fine chemicals and other industries.
UK budget aims to attract & keep pharma manufacturers
24-Mar-2011 By Nick Taylor
The UK has drafted a budget to attract and keep business but there are still significant barriers to investment, warns the CIA.
Gerresheimer buys Bazilian plastic pack firm Vedat
23-Mar-2011 By Gareth Macdonald
Gerresheimer has bought Brazilian pharmaceutical plastic packaging maker Vedat, citing rapid growth of the country’s drug market, particularly the generics segment, as the main driver for the acquisition.
Canada lost more than 3,600 pharma jobs in H2 2010
16-Feb-2011 By Nick Taylor
Canada lost more than 3,600 pharmaceutical jobs in the second half of 2010 as domestic and export sales slowed.
Bill to tackle prescription drug shortages enters US Senate
09-Feb-2011 By Nick Taylor
A bill requiring biopharm manufacturers to give the FDA early notification of potential drug shortages has been introduced to the US Senate.
26-Jan-2011 By Alexandria Pešić
GSK and Teva will invest in Russian drug manufacturing in response to PM Vladimir Putin’s warning that Pharmas will face restrictions if they fail to boost local production and transfer technology.
NHS offering prize to innovations tackling patient compliance
18-Jan-2011 By Nick Taylor
The UK NHS will award a prize to innovations that increase patient compliance and, as a result, help it make better use of resources.
10-Jan-2011
Cultural diversity within India underpins differing attitudes to oral dose pharmaceutical packaging and this could impact on prescribing habits.
Top regulation & enforcement articles of 2010
23-Dec-2010 By Nick Taylor
Regulations and enforcement were big topics yet again in 2010. in-PharmaTechnologist presents five of our most read on the topics, covering starting material quality and overseas inspections.
Top 5 biopharm cutback and closure articles of 2010
21-Dec-2010 By Nick Taylor
Big pharma continued to cut in 2010, closing plants and laying off staff in an attempt to cut costs and adjust post-merger. in-PharmaTechnologist presents a round up of five of the most read in 2010.
Guidelines needed for inconsistent OTC medication dosing warnings, urge researchers
02-Dec-2010 By Alexandria Pešić
Mandatory guidelines for labelling of OTC liquid medication for children should be issued, said researchers who found major inconsistencies in labels and dosage measuring devices.
China to claim second place in drug market by 2015, says IMS Health
17-Nov-2010 By Alexandria Pešić
IMS Health predicts China will become the world’s second largest pharmaceutical market by 2015 due to robust economic growth and healthcare reforms that allow for increased spending on drugs.
Overseas FDA offices bring benefits but planning needed
28-Oct-2010 By Nick Taylor
Overseas FDA offices have realised immediate benefits but strategic planning is needed to ensure the ventures, critical aspects of the agency’s ability to ensure drug quality, are long-term successes according to the GAO.
FDA may never have inspected 88 per cent of Chinese sites
27-Oct-2010 By Nick Taylor
The FDA may never have inspected 88 per cent of the 920 Chinese facilities in its inventory, according to the GAO.
Pandemic vaccine production time could be halved in 3 years
25-Aug-2010
A review of US capabilities has concluded that the time to produce a pandemic vaccine could be halved through adoption of short-term policies.