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Headlines > October 2010

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B. Braun recalls heparin after OSCS detected

28-Oct-2010 - B. Braun is recalling lots of its injectable anticoagulant, Heparin, manufactured in 2008, after finding a sample used to manufacture Heparin Sodium USP active pharmaceutical ingredients (APIs) was contaminated.

Endeavour sees recovery in intermediates sector

28-Oct-2010 - Drug industry demand for chemical intermediates and development projects has rebounded significantly in the last 12 months according to UK group Endeavour Specialty Chemicals.

News in brief

Novartis plans $600m investment in US R&D site

28-Oct-2010 - Novartis will invest $600m to expand its US R&D campus over the next five years to strengthen its position in US development hotspot.

Aoxing Pharma and Johnson Matthey form narcotics and neurological drug firm in China

28-Oct-2010 - Aoxing Pharma and Johnson Matthey team up to research, develop, manufacture and market active pharmaceutical ingredients (APIs) for narcotics and neurological drugs in China.

Overseas FDA offices bring benefits but planning needed

28-Oct-2010 - 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...

FDA may never have inspected 88 per cent of Chinese sites

27-Oct-2010 - The FDA may never have inspected 88 per cent of the 920 Chinese facilities in its inventory, according to the GAO.

GSK fined $750m for old Puerto Rico plant violations

27-Oct-2010 - UK-drugmaker GlaxoSmithKline (GSK) must pay $750m to settle a law suit criticising manufacturing practices at plant in Cidra, Puerto Rico that was shut down in 2009.

Puerto Rico’s tax cuts to “hinder” offshore biopharma firms

27-Oct-2010 - PhRMA says a new Puerto Rico law to tax offshore manufacturers will “dramatically hinder” biopharma companies.

Biocon investing $161m in Malaysian biomanufacturing site

27-Oct-2010 - India-based Biocon is investing RM500m ($161m) in Malaysia to establish a cGMP biomanufacturing and R&D facility.

ATMI and Austar open packaging materials plant in China

26-Oct-2010 - ATMI opens new packaging plant in China; positions for growth of bioprocess business in Asia and sees modest growth of life sciences business in Q3.

News in brief

West adds 1ml Daikyo Crystal Zenith syringe

26-Oct-2010 - West has launched the Daikyo Crystal Zenith 1ml long insert needle syringe system to meet demand for break-resistant delivery options.

Exclusive interview

Rx-360 membership to “snowball” as it prioritises growth

26-Oct-2010 - Rx-360 expects membership numbers to “snowball” in the coming year as it looks to build on progress made in establishing the consortium.

Appointments at Jennerex, a new KV subsidiary and Takeda – People on the move

26-Oct-2010 - in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Jennerex, a new KV subsidiary and Takeda.

USDA backs Unilife’s US HQ construction

25-Oct-2010 - Unilife wins US Department of Agriculture (USDA) as guarantor for new manufacturing facility and global headquarters in York, Pennsylvania, US.

FDA finds excessive peroxide levels in Crospovidone batch

25-Oct-2010 - US FDA finds high levels of peroxide in batch of the excipient Crospovidone made by China’s Tianjin Boai NKY International (TBNI).

USP and MENA government labs form Network to better drug quality

25-Oct-2010 - The United States Pharmacopeial Convention (USP) and six government drug control laboratories in the Middle East and Northern Africa (MENA) join to launch a drug quality improvement Network.

News in brief

Genzyme values itself at $22.7bn, $20 per share higher than Sanofi bid

25-Oct-2010 - US Biotechnology firm Genzyme predicts 2011 earnings in $4.30 to $4.60 range, which would make it worth $89 per share or $22.7bn.

Sanyo adds cost-effective GMP cell processing unit

25-Oct-2010 - Sanyo Biomedical is launching a cost-effective, space-saving stand-alone cell processing work station (CPWS) for GMP production.

Reaxa spin-off ADC Biotechnology talks new processing tech

21-Oct-2010 - A developmental purification system for Antibody-Drug-Conjugates will be launched by ADC Biotechnology (ADBC), a spin off from Reaxa, which promises reduced manufacturing costs for “magic bullet” cancer drugs.

iGPS launches ‘fungicide-free’ plastic pallet rental service

21-Oct-2010 - iGPS is offering what it claims is the world’s first pallet rental service to supply plastic pallets with embedded radio frequency identification (RFID) tags to the pharmaceutical and life sciences...

WHO begins prequalification programme for selected APIs

21-Oct-2010 - The WHO is today initiating a pilot prequalification programme for selected APIs used in drugs for HIV and related diseases, antimalarials and anti-tuberculosis medications.

Access & Lotus move to protect oral delivery tech IP

21-Oct-2010 - Access Pharmaceuticals and Lotus Pharmaceuticals have both moved to protect their oral delivery technologies with patents.

News in brief

New industrial CPO grade launched to meet drug sector demand

21-Oct-2010 - Bio-Research Products (BRP) launches lower cost, industrial chloroperoxidase (CPO) for organic syntheses in pharmaceutical manufacturing.

FDA cGMP warning letters round up

20-Oct-2010 - in-PharmaTechnologist presents a round up of cGMP related warning letters issued by the FDA this week.

J&J’s musty-smelling Tylenol is recalled again

20-Oct-2010 - Johnson & Johnson (J&J) recalls another 128,000 bottles of its over-the-counter painkiller, Tylenol, after new complaints of a “mouldy odour.”

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