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J&J buying Actelion for $30bn, but should CMOs be concerned?

26-Jan-2017 - With no production sites of its own, we question whether Johnson & Johnson’s manufacturing network is likely to incorporate Actelion’s substantial product portfolio.

Unregistered vs fake - How terminology sparked a media war in Ghana

21-Oct-2013 - In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers...

What Obama means for Pharma this time

07-Nov-2012 - Barack Obama’s re-election will mean millions more US citizens have health insurance, which has significant implications for the pharmaceutical industry.

Roche faces obstacles in acquiring Genentech

28-Jul-2008 - Roche’s proposed $44bn acquisition of Genentech is facing some opposition with Wall Street saying the offer undervalues the company, disquiet among the biotech’s employees and shareholders suing the Swiss giant....

FDA evolves application process

15-Jul-2008 - The US Food and Drug Administration (FDA) is continuing to evolve in the face of current challenges through the launch of two new initiatives.

US Senator seeks probe into pharma outsourcing

16-Jun-2008 - A US senator has asked the Food and Drug Administration (FDA) for a probe into outsourcing of production for pharmaceuticals, as well as ways to make drugmakers accountable for products...

Big pharma responds to EU anti-counterfeiting

09-Jun-2008 - Big pharma's responses to the European Commission's proposals for tackling counterfeiting have thrown up a diverse range of viewpoints.

Pharma must adapt to emerging markets

19-May-2008 - Pharmaceutical companies are having to radically change their practices when it comes to tackling emerging markets such as China, India, Russia and Brazil, according to IMS.

Japan's contract manufacturing awakening

13-May-2008 - 2005 marked the real beginning of contract manufacturing in Japan, which had been held back by an overly-cautious regulatory environment and significant and unique quality and specification demands in the marketplace.

EC 'unlikely to support ban on primate testing'

13-Feb-2008 - The European Commission is unlikely to support an outright ban on the use of non-human primates in research, but has just published a new document which indicates that significant changes...

UK Government plans will stifle innovation, say biotechs

16-Jan-2008 - New UK Government proposals to scrap Capital Gains Tax (CGT) relief will stifle life science innovation, according to a group of biotech small and medium enterprises (SMEs).

Warding off the generic attack

07-Jan-2008 - A recent report has detailed the challenges facing the pharma industry as the generic flood gates open, with the constant advice to start planning early still apparently not heeded by...

Paediatric drugs and testing highlighted

26-Nov-2007 - The importance of paediatric drug formulations and clinical trials in children was highlighted at this month's American Association of Pharmaceutical Scientists (AAPS) conference in San Diego.

South Africa 'underutilised' for clinical trials

20-Nov-2007 - While India, the Asia-Pacific, Eastern Europe and Latin America are all gaining recognition as potential new hot spots, South Africa remains 'underutilised as a clinical trial destination,' according to a...

FDA failure on foreign inspections frightening

05-Nov-2007 - A US government audit has confirmed the Food and Drug Administration's (FDA's) continual lack of inspection of foreign drug manufacturing plants.

Pharma must 'reinvent' itself to survive

02-Nov-2007 - With IMS Health's annual forecast for the pharma industry predicting slower approvals, more black box warnings and the continuation of the 'wave of genericization,' the shift by pharma firms to...

Pfizer partners in shock after surprise Exubera exit

22-Oct-2007 - We've all cringed at stories of people dumping their partners via text message but in the world of business, Pfizer seems to have taken things to a new level when...

'We are not anti-Asia' says EU chemicals body

09-Oct-2007 - There have been more calls this month to tighten regulations on pharmaceutical ingredient suppliers in the wake of the recent safety concerns emanating from low-cost regions such as China and...

Pharmaceuticals is top R&D spender

08-Oct-2007 - As an increasingly desperate pharma industry strives to fill drug pipelines, the sector has, for the first time, topped a poll of which industries spend the most on research and...

FDA told its safety monitoring of clinical trials not good enough

02-Oct-2007 - The US Food and Drug Administration (FDA) has been called into question again after the release of a damning report, this time suggesting the agency is inadequate in its safety...

UK tightens Phase I guidelines

21-Aug-2007 - The Association of the British Pharmaceutical Industry (ABPI) has now published revised guidelines for Phase I trials in the UK.

No lack of innovation in pharma, says Wyeth

14-Aug-2007 - The often cited decline in R&D productivity and dwindling innovation within the pharma industry is actually a thing of the past, according to Wyeth's head of business development.

Speculation on gene therapy trial death 'premature'

08-Aug-2007 - Targeted Genetics said it was 'premature as well as irresponsible' to draw any conclusions on what caused the death of a patient who participated in a clinical trial testing the...

Informed consent 'not up to scratch'

18-Jul-2007 - A recent survey of clinical trial participants in the US has revealed worrying signs that the informed consent process is 'not up to scratch'.

China carries out execution on corrupt drug official

10-Jul-2007 - China has wasted no time in executing the first of its convicted corrupt former drug officials after his desperate appeal for life failed.

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