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.

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.

People on the move: pharma jobs

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.

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.”

News in brief

US OKs Sanofi’s Genzyme bid; French strike hits Romainville plant

20-Oct-2010 - Sanofi Aventis has been given the go ahead to pursue US biotech Genzyme by the country’s antitrust authorities.

Particle Sciences boost delivery tech offering with Solumer

20-Oct-2010 - Particle Sciences (PSI) becomes provider of Solumer drug delivery tech in deal with Israeli developer SoluBest.

Lilly to close Singapore R&D unit; double sales force in emerging markets

20-Oct-2010 - Eli Lilly has unveiled plans to close its Singapore R&D centre by the end of the year and relocate discovery operations to its global headquarters in the US.

News in brief

WR Grace’s acquisition of Synthetech approved by US Bankruptcy Court

19-Oct-2010 - Industrial catalysis firm WR Grace has been OKed to acquire fine chemicals group Synthetech by the US Bankruptcy Court.

Microscan adds track and trace label verification system

19-Oct-2010 - Microscan has introduced a system for inspecting and verifying package label content that can be implemented with the minimum of cost and effort.

Week-long anti-counterfeiting effort confiscates 1m pills

19-Oct-2010 - A week of global anti-counterfeiting law enforcement coordinated by Interpol led to the shutdown of 290 websites, seizure of 11,000 packages and confiscation of 1m pills.

SurModics cuts workforce and restructures to combat falling revs

18-Oct-2010 - Drug delivery and pharmaceutical coating technologies firm SurModics will cut jobs and reorganise operations in a bid to reverse falling revenues and tumbling profits.

News in brief

FDA, PAHO cooperate on info hub for the Americas

18-Oct-2010 - The FDA and PAHO are collaborating to develop an information hub for medical products and regulatory processes in the Americas.

NovaDel pilot PK study compares oral spray to Viagra

18-Oct-2010 - Data from a study comparing an oral spray formulation of sildenafil citrate to Viagra has been presented by NovaDel Pharma.

People on the move: pharma jobs

18-Oct-2010 - in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including board elections at ISPE and appointments at Advaxis and Asubio.

Pfizer opens £26.3m UK biotech packaging expansion

18-Oct-2010 - Pfizer has invested £26.3m ($41.7m) into a new facility at its biotech packaging and distribution site in Havant, UK.

News in brief

Baxter merges delivery tech and renal units

14-Oct-2010 - Baxter International will combine its delivery business, which supplies IV infusion systems and intravenous solutions, with its renal products unit in new Medical products division.

FDA & WHO collaborate on surveillance of counterfeit drugs

14-Oct-2010 - The FDA is to collaborate with the WHO to build a global surveillance and monitoring system for combating falsified medicines and breaches of the supply chain.

Stemedica & AnC form stem cell production joint venture

14-Oct-2010 - Stemedica and AnC Bio have formed a joint venture to manufacture stem cells for the treatment of ischemic stroke and other degenerative disorders.

Pharmatek ‘roll’ out new equipment to expand GMP manufacturing capabilities

13-Oct-2010 - Pharmatek Laboratories has once again expanded service offerings at its San Diego, California facility by adding two roller compactors to its solid oral dosage form manufacturing capabilities.

European Centre for Chirality to open in December

13-Oct-2010 - New ‘chiral center’ in Belgium promises to help drug firms comply with regulatory demands for quality and accelerate registration of new compounds.

News in brief

Shipping pallets are likely source of Pfizer’s malodorous Lipitor, says Rexam

13-Oct-2010 - “Musty smells” associated with three Lipitor bottles indicate a problem within the supply chain, says Rexam of Las Piedras, Puerto Rico, who were confirmed by Pfizer as the “third-party recalling...

Anti-addiction drug delivery implant outperforms placebo

13-Oct-2010 - In Phase III trials an implanted drug delivery device administering a steady low-dose of buprenorphine reduced illicit opioid use compared to placebo.

IMS prediction: Emerging markets front 5-7 % rise in drug sales for 2011

13-Oct-2010 - IMS Health predicts that global drug sales will increase 5 to 7 per cent next year, driven by development of innovative pharmaceuticals and growth of emerging markets.

Halozyme to cut workforce 25% and focus on drug delivery partnerships

12-Oct-2010 - Halozyme Therapeutics will cut its workforce 25 per cent to focus on strategic alliances and development of most advanced in-house candidates.

News in brief

Merck launches binder eliminating tablet excipient

12-Oct-2010 - Merck KGaA has expanded its Parteck range with a directly compressible magnesium salt excipient that eliminates need for binders in tablet production.

SoluBest and Dr Reddy’s ink formulation development deal

12-Oct-2010 - SoluBest and Dr Reddy’s Laboratories are joining forces to develop a proprietary formulation of one of SoluBest’s pipeline compounds using its Solumer platform.

People on the move: pharma jobs

12-Oct-2010 - in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at NormOxys, Caraco, Shire and ChemWorth.

“Musty odour” caused Pfizer to recall 191,000 bottles of Lipitor

11-Oct-2010 - Pfizer says low levels of 2,4,6 tribromoanisole were detected in seven lots of the cholesterol buster, Lipitor, that it recalled in August.

Novartis and Synthetics Genomics Vaccines to co-develop synthetic flu vaccines

11-Oct-2010 - Novartis will use technology from Synthetics Genomics Vaccines to speed up the development of influenza vaccines for seasonal and pandemic flu outbreaks.

NIAID awards $15.5m to needle-free dengue vaccine

11-Oct-2010 - Inviragen and PharmaJet have been awarded a $15.5m (€11.1m) contract by the US NIAID to develop a needle-free dengue vaccine.

News in brief

Sanofi to cut 1,700 US jobs

11-Oct-2010 - Sanofi Aventis says eliminating 1,700 jobs in US will help it concentrate resources on business development, investment in late-stage development projects and will position it for growth after patent expiry.

Novo inject $73m into US manufacturing facility expansion

07-Oct-2010 - Novo Nordisk is investing $73m in the expansion of its manufacturing facility in Clayton, North Carolina, to make room for increased production capacity for the biopharma giant’s insulin delivery services....

Capsugel up for sale as Pfizer reviews strategy?

07-Oct-2010 - Pfizer has hired Morgan Stanley to review its Capsugel business unit with the possibility of selling the maker of capsules for dietary supplements and oral medicines.

News in brief

Accucaps adds high potency soft gel capabilities

07-Oct-2010 - Accucaps has added a Speciality Products Centre to support clients' high potency liquid filled soft gel formulation needs.

China's API players have bright 'potential future'

07-Oct-2010 - China leads the field in 'potential future' API suppliers, positioning it to become a dominant force as these companies develop, Thomson Reuters said at CPhI 2010.

Cargill adds excipient for ODT formulations at CPhI

07-Oct-2010 - Cargill is using CPhI 2010 to launch a formulation of its Zerose erythritol excipient for use in orally disintegrating tablets (ODT).

News in brief

GSK to cut 121 jobs at key Irish plant

07-Oct-2010 - GlaxoSmithKline has told its workforce that 55 jobs will be axed at its manufacturing base in Currabinny, Co Cork, and 66 jobs will be lost as a result of revised shift-working plans.

Univar inks EU supply deal with Dow

06-Oct-2010 - Univar is now exclusively distributing Dow's Carbowax Sentry PEGs in Europe and the range is proving popular at CPhI 2010 with manufacturers facing restricted supply from other sources.

Galapagos’ unit, Argenta signs $46m drug discovery deal with Janssen

06-Oct-2010 - Galapagos’ acquisition, Argenta, has signed up to a $46m cancer drug discovery service deal with Janssen Pharmaceutica, aimed at delivering novel cancer drug candidates.

Pack-Smart, ISRA launch folded carton inspection tech

06-Oct-2010 - Pack-Smart and ISRA Surface Vision have developed a system to compare folded cartons against print quality requirements at speeds of up to 300 metres per minute.

People on the move: pharma jobs

05-Oct-2010 - in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Oso BioPharmaceuticals, Creabilis SA and Clondalkin.

News in brief

Gilead warned by FDA on US manufacturing plant

05-Oct-2010 - Gilead Sciences has received a warning letter from the US Food and Drug Administration (FDA) concerning manufacturing problems at the San Dimas, California, plant, where HIV medicines are made.

RXi and EyeGate’s needle-free ocular RNAi delivery: Part 2

05-Oct-2010 - RXi and EyeGate lift the lid on ocular delivery of RNAi therapeutics for retinal disorders as the two firm’s team up to provide a unique needle-free solution.

Sanofi launches hostile Genzyme bid; Pfizer close on Uplyso Brazil deal

04-Oct-2010 - French drugmaker Sanofi Aventis has tabled an $18.5m, $69 per share, hostile takeover bid for Genzyme after failing to secure an amicable acquisition.

Taxol precursors produced in engineered E coli

04-Oct-2010 - Cost-effective, large-scale production of oncology drug Taxol (paclitaxel) intermediates could eventually be achieved using engineered Escherichia coli.