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Manufacturing facility news in brief

18-Aug-2008 - in-PharmaTechnologist.com's round-up of developments in pharmaceutical manufacturing features news of SAFC’s new highly potent API plant, ISPE’s Facility of the Year Awards and Israel’s proposed entry into PIC/S.

Genentech rejects Roche but leaves door ajar

14-Aug-2008 - Genentech’s special advisory committee has rejected Roche’s $44bn offer for the biotech believing that it “substantially undervalues” the company.

Ranbaxy expects probe to be dropped soon

30-Jul-2008 - Ranbaxy’s CEO has confidently asserted that the US Food and Drug Administration’s (FDA) court action will be dropped in the near future and fired another warning shot at the “negative elements” he believes were behind the controversy.

EMEA clears Viracept contamination of health risk

29-Jul-2008 - Patients who took Roche’s antiviral Viracept (nelfinavir) from batches contaminated with ethyl mesilate do not have an increased risk of developing cancer, according to the EMEA.

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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.

Manufacturing facility news in brief

28-Jul-2008 - in-PharmaTechnologist.com's round-up of developments in the pharmaceutical manufacturing space features news of a fire at MY Healthcare, Helsinn's FDA approval and a safety award for Wyeth.

West African conference to eradicate counterfeits

24-Jul-2008 - West African states are meeting to devise a plan for cleaning up their tarnished reputations with regards to the flow of counterfeit pharmaceuticals in the region.

FDA relaxes GMP rules for Ph I candidates

24-Jul-2008 - The US Food and Drug Administration (FDA) has relaxed the regulatory good manufacturing practice (GMP) rules for drugs in early-stage clinical trials in recognition of the different requirements of trial scale and industrial scale manufacture.

GSK continues shift in strategic direction

24-Jul-2008 - The pace of change at GlaxoSmithKline (GSK) is showing no sign of slowing, with new CEO Andrew Witty unveiling the company’s new strategic direction with the release of second quarter results.

Pharma manufacturing products: news in brief

23-Jul-2008 - Millipore, Purfresh and ESS Technologies have all recently launched products used in the pharmaceutical manufacturing industry.

Digitek, heparin and the likelihood of lawsuit success

22-Jul-2008 - The heat is being turned up on Actavis Totowa as Federal lawsuits begin to pile up following the Digitek (digoxin) recall.

FDA reviewers and inspectors to forge closer links

21-Jul-2008 - The US Food and Administration says that a new project examining the interaction between its review and facilities inspection arms will help improve inter-departmental communication, particularly during pre-approval inspections (PAI)

Conformia helps ICH QbD implementation

21-Jul-2008 - US software company Conformia hopes that its new web-based drug development suite will help pharmaceutical firms meet with new quality by design (QbD) and risk management guidelines.

Four years in prison for counterfeiter

21-Jul-2008 - A man has been sentenced in the US to four years imprisonment for trafficking 38,000 counterfeit Viagra (sildenafil citrate) tablets with a wholesale value of $400,000.

Ranbaxy claims big pharma company behind falsification accusations

17-Jul-2008 - Ranbaxy has claimed that a pharmaceutical company is making a concerted effort to depress the company's share price by initiating the accusations that the generics manufacturer falsified data to achieve compliance.

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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.

FDA launches QbD pilot programme

15-Jul-2008 - The US Food and Drug Administration (FDA) is launching a quality-by-design (QbD) pilot programme for biotechnology submissions.

Start-ups shot down as credit crunches

09-Jul-2008 - The credit crunch is putting the squeeze on start-ups and established companies alike, with numerous firms struggling to obtain the financing that is their lifeblood.

Polish bureaucracy holding back clinical growth

08-Jul-2008 - Poland urgently needs to take some of the red tape out of clinical trial applications if it is to fulfil its potential as a hub for clinical research, according to new market research.

Ph. Eur. to revise monographs for genotoxic impurities

08-Jul-2008 - The new guidelines for how monographs will be revised and elaborated to tackle potentially genotoxic impurities (PGIs) have been published by the European Pharmacopeia Commission.

GMP reprieve for Vietnamese facilities

07-Jul-2008 - Pharmaceutical manufacturers in Vietnam have gained a reprieve after the Ministry of Health (MoH) informed them that those without good manufacturing practice (GMP) certificates can continue production for now.

Pharmaceutical facility news in brief

03-Jul-2008 - in-PharmaTechnologist.com's periodic round-up of developments in the field of pharmaceutical facilities includes news of two environmental fines, MHRA plant approval and a strike at Teva.

Manufacturing technology news in brief

02-Jul-2008 - in-PharmaTechnologist.com's periodic round-up of developments in pharmaceutical manufacturing equipment includes Mesa's real time monitoring, cleaning products and Beijer's new operating panel.

Pharmaceutical manufacturing: people on the move

01-Jul-2008 - in-PharmaTechnologist.com presents its periodic round-up of personnel changes in the pharmaceutical manufacturing sector.

Parallel traders EU counterfeiting response

30-Jun-2008 - Parallel traders have hit back at some of the EU Commission's anti-counterfeiting measures and big pharma's support for them.

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