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Top regulation & enforcement articles of 2010

23-Dec-2010 - 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.

Catalent fined after contact with olanzapine leads to dermatitis

22-Dec-2010 - Catalent has been fined after contact with olanzapine led to employees developing dermatitis, an incident the company “deeply regrets”.

Big pharma is biggest defrauder

21-Dec-2010 - Big pharma has eclipsed the defence industry as the biggest defrauder of the US federal government under the False Claims Act (FCA), say researchers.

Top 5 biopharm cutback and closure articles of 2010

21-Dec-2010 - 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.

Aesica buys UCB plants and signs long-term supply deal

20-Dec-2010 - Aesica has bought three manufacturing sites from UCB, making its first foray into continental Europe and more than doubling its production capacity.

DSM expands process R&D offering in deal with c-LEcta

16-Dec-2010 - DSM Pharmaceutical Products has expanded its portfolio of alcohol dehydrogenases in a licensing deal with German custom enzyme developer c-LEcta.

Bayer injects €35m in biologics project expansion

16-Dec-2010 - Bayer HealthCare is investing €35m ($47m) in a new centre for the biotechnological production of ‘innovative’ pharmaceuticals to be used in clinical trials.

Aptuit threatens to chop hundreds of jobs in Scottish plant closures

15-Dec-2010 - Aptuit said it may close two manufacturing facilities in Scotland with the loss of 340 jobs as a result of falling drug industry demand.

Novel drug delivery critical to pharma’s future, says report

14-Dec-2010 - Pharma should forget about ‘the next blockbuster drug’ and invest more money creating novel drug delivery systems with emerging developers to enhance product value and efficacy, say researchers.

Vical hails universal vaccine adjuvant in research review

14-Dec-2010 - Vical has published a review of Vaxfectin data showing the adjuvant boosts the immune response of DNA-based vaccines against cancer and a range of pathogens.

News in brief

J&J bids EUR1.75bn for Crucell

09-Dec-2010 - US healthcare major J&J has launched a bid for Nertherlands-based Crucell, manufacturer of the PER.C6 biomanufacturing cell line.

IDRI wins BARDA adjuvant development contract

09-Dec-2010 - IDRI is developing adjuvant formulations to support sustainable production of pandemic influenza vaccines after being awarded a BARDA contract.

Takeda & Baxter aim to set up cell culture site in Japan

08-Dec-2010 - Takeda is collaborating with Baxter to establish a Vero cell-based influenza manufacturing facility in Japan and launch vaccines in the country.

Commitment to ICH M7 can fix genotoxic impurity issues

07-Dec-2010 - Drafting ICH M7 guidance on genotoxic impurities will require a lot of work from industry and regulators but has the potential to resolve a number of issues.

List of pharma sites vital to US security released by WikiLeaks

06-Dec-2010 - WikiLeaks has published a list of overseas biopharmaceutical facilities considered vital to US national security as part of its release of leaked diplomatic cables.

DSM’s benzoic acid, sodium benzoate business cleared for sale

06-Dec-2010 - DSM Special Products and DSM IP Assets look set to be sold to equity investor Sun Capital as the European Commission has given competition approval with no strings attached.

Lubrizol opens Indian coating applications lab and plans recruitment

30-Nov-2010 - Lubrizol has opened a new applications centre in India to capture a share of the country’s growing coatings and drug ingredients market.

Anti-counterfeiting held back by self-interest & politics

29-Nov-2010 - Narrowly defined pharma self-interest and lack of coordinated political effort means, despite the best effort of some, the problem of counterfeiting may be worsening.

Pfizer and IPHA welcome Irish commitment to 12.5 corporation tax rate

29-Nov-2010 - Pfizer has welcomed Government commitments to keep Ireland’s 12.5 per cent corporation tax rate in face of recent EU pressure to increase it as a condition of the €85bn 7-year IMF bailout.

Control excipient reactivity with packaging & aluminium lakes

25-Nov-2010 - Aluminium lakes and in-liner packaging can, in some cases, be used to control reactive components in excipients and therefore overcome drug product instability.

Drugmakers are blind to colours, say researchers

24-Nov-2010 - Drug manufacturers do not pay enough attention to the colour of their drugs, according to researchers examining the importance of aesthetics in pharmaceutical over-the-counter (OTC) products.

News in brief

Camlin Fine Chemicals’ board of directors OK Italian acquisition

24-Nov-2010 - Camlin Fine Chemicals has been given the green light from its board of directors to acquire an unnamed Italian fine chemicals manufacturer and form a subsidiary company to help boost its presence in the Middle East.

Industry, innovation & Viagra-stuffed teddies at AAPS

22-Nov-2010 - Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.

Dissolution devise makes ‘dosage dumping’ a thing of the past, says Agilent

18-Nov-2010 - Agilent Technologies has launched its 708-DS Dissolution Apparatus, a quality control instrument that can be set up for manual or automated applications to measure the release rate of an API over time.

GEA ups Asian freeze-drying activity with BSGT purchase

17-Nov-2010 - GEA Pharma Systems stamps its authority in the Asian Pacific’s emerging freeze drying industry acquiring Beijing Sino-German Tianhe Technology (BGST).

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