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Headlines > May 2013

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GSK's €250m Acquisition Brings T-Cell Vaccine Tech In-House

30-May-2013 - GlaxoSmithKline has brought its vaccine development in-house with the purchase of Okairos and its supplementary technology platform.

3M Prepared as Final Two CFC-Based Inhalers to be Phased Out

30-May-2013 - 3M says it has cooperated with the FDA and invested in its facilities in preparation of the phase-out of CFC containing metered dose inhalers (MDIs).

Fresenius to Import TPN Drug Components from Norway to Cut US Shortage

30-May-2013 - The US FDA is allowing Fresenius Kabi USA to import trace elements and phosphate injections from its Norway plant to help improve a critical shortage of components of total parenteral...

DISPATCHES FROM INTERPHEX

Thermo Fisher: Single-Use Tech's Evolution and Increased Industry Use

29-May-2013 - Over the last decade single-use technologies have moved into manufacturing scales and are increasingly being deployed worldwide, according to Thermo Fisher Scientific.

Cobra's Cell Line Development Tech Bags Recopharma Contract

29-May-2013 - As Cobra wins a cell line development contract with Recopharma, the firm says its cost-effective gene expression technology has been its biggest growth area.

US FDA Recommends CMO Quality Agreements in Long-Awaited Draft Guidance

29-May-2013 - Although written quality agreements are not required under cGMP regulations, the US FDA is recommending that pharma companies and CMOs adopt the agreements to delineate responsibilities.

Clinical Investigator Hit with US FDA Warning Letter for Falsified Data

29-May-2013 - The US FDA has sent a warning letter to a clinical investigator after he failed to take adequate action on falsified data in a study he oversaw.

Newcastle Uni Develops Skin Test That Predicts Reaction to New Drugs

29-May-2013 - Scientists at the UK University have developed what they refer to as 'a simple lab-based skin test' which eliminates the risk of adverse reactions to new drugs, cosmetics, and household chemicals....

Voluntary Drug Recalls from Fresenius, J&J and Glenmark

28-May-2013 - Fresenius Kabi says drug shortages won’t be affected as it recalls a lot of magnesium sulphate, and there’s news from Glenmark and J&J – welcome to in-Pharmatechnologist.com's recall round-up....

Sinovac Receives Updated cGMP Accreditation from CFDA

28-May-2013 - Vaccine manufacturer Sinovac has updated its GMP accreditation to international standards, short of the deadline set by the CFDA.

EMA Updates Inspector Expectations for API Audits

27-May-2013 - As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or...

Malaysia's Pharmaniaga Targets MENA Region with Saudi J-V

27-May-2013 - Pharmaniaga Berhad has set up a joint venture to manufacture pharmaceuticals in Saudi Arabia citing opportunity growth in the region as a major catalyst.

Wockhardt to Suffer Revenue Loss After FDA Import Alert

27-May-2013 - Generic firm Wockhardt has received a US import alert from for all drugs from its Indian plant.

Ranbaxy Looks to Rebuild Quality Reputation as Daiichi Vows Legal Action

27-May-2013 - Ranbaxy Laboratories is putting all of its weight behind a quality push following its admission of manufacturing adulterated drugs, and just as its parent company Daiichi Sankyo is pursuing legal...

News from Sanofi and Boehringer Ingelheim – People on the move

27-May-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Sanofi and Boehringer Ingelheim.

News focus

Oral Insulin: All Mouth, or an Injection of Hope for Type 1 Diabetes?

23-May-2013 - Can oral insulin succeed where other alternative delivery methods have failed? Dan Stanton, from in-Pharmatechnologist.com assesses its chances. 

Sandoz Recalls Injectable Following Contamination at Austrian Plant

23-May-2013 - Sandoz has recalled two lots of an injectable drug after vials were discovered to contain foreign matter, though is unsure of the cause for now.

Pfizer Takes Issue with European Commission’s Plans to Regulate ATMPs

23-May-2013 - Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).

Impax Hires Specialists to Help Sort Manufacturing Issues

22-May-2013 - Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its...

Possible API Contamination at Chinese CMO Leads to Canadian Recalls

22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.

DISPATCHES FROM INTERPHEX

New DFS Unit Built on Technology, R&D and Manufacturing, says Capsugel

22-May-2013 - Following a busy few months, Capsugel spoke about the formation of its Dosage Form Solutions Unit, its technology and the integration of Encap at this year's Interphex in New York.

FDA Hits Boehringer-Ingelheim with Warning Letter for Particles, cGMP Violations

22-May-2013 - Boehringer-Ingelheim’s German API and pharmaceutical manufacturing facility was cited by the FDA for two API and two drug cGMP violations, as well as failing to respond with sufficient corrective actions...

Bioartificial Liver Project Looks to Disposable Bioreactors for Large Scale Cultures

22-May-2013 - Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver...

EMA Biosimilars Draft: Non-EU Reference Avoids Clinical Trial Repeats

21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.

Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing

21-May-2013 - Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.

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