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Breaking News on Contract Research, Manufacturing & Clinical Trials

GSK back in China via new API manufacturing agreement with Desano

06-Jul-2015 - GSK’s HIV unit ViiV Healthcare and China-based Desano Pharmaceuticals have forged an agreement whereby Desano will manufacture the API of GSK’s HIV drug Tivicay (dolutegravir) in China.

Lonza to set up dedicated manufacturing suite for Alexion

02-Jul-2015 - Lonza will set up a dedicated manufacturing suite for Alexion, producer of the world’s most expensive drug Soliris.

Transgene to shutter French viral vector plant following Novartis snub

01-Jul-2015 - Transgene will close a biomanufacturing facility with the loss of 120 jobs to cut costs after Novartis pulled out of an immunotherapy collaboration last year.

Juniper to make OxSonics' ultrasound particles to aid cancer drug delivery

30-Jun-2015 - Juniper Pharma Services has won a contract to manufacture ‘sono-sensitive particles’ used to aid delivery of cancer drugs into solid tumours for OxSonics.

Novasep expanding conjugation capability to help simplify ADC supply chain

30-Jun-2015 - Novasep is investing €10m ($11m) in a bio-conjugation plant it says will offer drugmakers a more complete antibody-drug conjugation (ADC) service.

US FDA accepts IND for TxCell's Crohn's cell therapy; Firm eyes European CRO for US trial

30-Jun-2015 - TxCell is set to expand a trial of its candidate Crohn’s disease cell therapy to the US after the FDA accepted its IND application.

News in brief

Lonza partners with Octane on personalized cell therapy manufacturing

29-Jun-2015 - Swiss CMO Lonza and Canada’s Octane Biotech have entered an exclusive technology evaluation of the Octane Cocoon cell production platform for personalized cell therapy manufacturing with the goal of a...

TxCell to enhance operator training and sterilisation measures at cell therapy pilot plant

26-Jun-2015 - TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.

UK’s MHRA helps ‘future-proof’ Fujifilm’s mammalian cell culture manufacturing facility

26-Jun-2015 - In a rare move for the UK’s MHRA (Medicines and Healthcare products Regulatory Agency), the regulator has helped to “future-proof” CMO Fujifilm Diosynth Biotechnologies’ mammalian cell culture manufacturing facility in...

IDT Biologika acquires Aeras’ vaccine manufacturing facility

24-Jun-2015 - Vaccine developer Aeras and CMO (contract manufacturing organization) IDT Biologika have formed a strategic partnership that includes the acquisition of Aeras's Biopharmaceutical Development Center (BDC) manufacturing facility by IDT. 

News in brief

apceth expands gene, cell therapy manufacturing business

23-Jun-2015 - German-based contract manufacturer apceth has received regulatory approval to use two new GMP cleanrooms for aseptic processing, which will be used for the handling and genetic manipulation of various types...

New nanotech excipient makes for better delayed-release drugs say researchers

22-Jun-2015 - Swedish scientists who developed the solubility enhancing nanotech excipient Upsalite say it can also be used to improve delayed release formulations.

ScinoPharm to make API for Chinese drugmaker eyeing US celecoxib market

22-Jun-2015 - Raffles PharmaTech has contracted ScinoPharm to make the API for a generic version of the arthritis pain drug celecoxib being developed for the US market.

Novasep signs deals to build in Japanese market

19-Jun-2015 - Novasep has signed two partnership agreements for the Japanese markets.  The agreements were with Allied Laboratories, a life science and chemical consulting company, and with AR Brown, which will represent...

BIO 2015

Wuxi and University of Pennsylvania partner on vector production

18-Jun-2015 - Contract research organisation WuXi has entered a manufacturing collaboration with the University of Pennsylvania to produce gene therapy vectors.

Slovenian regulators slam Polydrug API plant in India

17-Jun-2015 - Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.

Lonza to build viral therapy plant in Texas

17-Jun-2015 - Lonza will build a viral therapy production site in Houston, Texas in a bid to capture a share of the growing gene therapy market.

Biocorp plans IPO to win more Big Pharma device contracts

16-Jun-2015 - Delivery device maker Biocorp has announced plans to go public and list of Paris’ Alternext market as part of an effort to win more Big Pharma deals.

CMO PCI Synthesis lands 12 new biotech, medtech clients amid growth

15-Jun-2015 - Contract manufacturer PCI Synthesis has signed up a dozen new Boston-based biotech and medtech customers as local demand has grown.

US FDA upgrades Jubilant's troubled Washington plant to VAI

12-Jun-2015 - A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.

Sterile CMO round-up: news from Vetter, Dalton and LSNE

11-Jun-2015 - An expansion at Vetter, a contract win for Dalton and a pre-approval inspection at LSNE – welcome to Outsourcing-Pharma’s round-up of sterile manufacturing news.

Exporting to Brazil? ANVISA is tough and hands-on, says Kemwell

10-Jun-2015 - Site audits by Brazilian pharma regulator ANVISA are “exactly the opposite” to the US FDA’s, says CMO Kemwell as it prepares to export to Brazil for Johnson & Johnson.

News in brief

Recipharm’s revenue model praised by Swedish industry group

10-Jun-2015 - Recipharm has been awarded commended for its revenue model and “achievements and success beyond the norm” by industry group, SwedenBio.

Goodwin to manufacture ADC for Aspyrian

10-Jun-2015 - Aspyrian Therapeutics has selected CDMO Goodwin Biotechnology to complete process development, scale-up, and cGMP manufacturing of their novel antibody drug conjugate (ADC).  

Accuratus growing CDMO biz through Array Biopharma's CMC operations

09-Jun-2015 - Accuratus Lab Services has bought the chemistry, manufacturing and controls (CMC) operations of Array BioPharma to boost its CDMO offering.

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