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Breaking News on Contract Research, Manufacturing & Clinical Trials

WuXi adding ADC tech to services in Ambrx acquisition

22-May-2015 - A consortium including WuXi PharmaTech has agreed to acquire biotech client Ambrx for its antibody-drug conjugate (ADC) conjugation technology.

Gilead's reliance on CMOs gives firm 'flexibility' says CFO

21-May-2015 - Reliance on CMOs and CROs has allowed the flexibility to make Gilead a top 10 pharma firm, and the use of third-parties will remain part of its strategy according to...

Biologics and R&D investment driving freeze-drying demand says Symbiosis

21-May-2015 - Biologics and focused R&D spending are driving the market for lyophilisation according to Symbiosis Pharmaceutical Services, which says its freeze-drying tech investment reflects this surge in demand.

Pharmatek bulks out spray dried dispersion services

20-May-2015 - CDMO Pharmatek has expanded its bioavailability services on the back of client demands, installing new spray dried dispersion equipment.

Two sterile compounders hit by FDA warning letters for violating cGMP

20-May-2015 - The US FDA has lambasted two sterile compounders for violating cGMP in letters citing recent legislation brought in to ensure such companies are fully regulated.

Cancer-hunting shark proteins are the future of drug conjugation, says Almac

19-May-2015 - Almac is coupling tiny shark proteins to a cancer-killing warhead to develop an oncology drug, saying their small size makes for easy conjugation. 

European freeze-drying market heats up: Symbiosis invests citing high demand

19-May-2015 - Symbiosis Pharmaceutical Services has launched a bulk freeze drying offering for APIs and intermediates, citing new contracts as a driver for the investment.

Catalent to use GPEx cell line tech to make Amarantus' protein candidate

18-May-2015 - Amarantus BioScience has selected Catalent to make the protein mesencephalic-astrocyte-derived neurotrophic factor (MANF) for its Phase I candidate.

Tigermed Envy? WuXi may be eyeing a launch on Shenzhen exchange

14-May-2015 - With WuXi pushing full steam ahead in its bid to go private, one expert says that the company may be envious of a competing CRO -- Hangzhou Tigermed, which is...

SAFC expands ADC and bulk drug manufacturing in CA, MO

13-May-2015 - SAFC has announced investments in gene therapy manufacturing sites in Missouri and California.

Perrigo enters softgel space buying ex-Banner operations for $34m from Patheon

13-May-2015 - Patheon has sold its Mexican operations to Perrigo for $34m as it looks to transform the Banner business it acquired back in 2012.

Lonza to help Nikon set up a contract cell and gene therapy manufacturing business in Japan

08-May-2015 - Under the partnership, Nikon will have access to Lonza’s quality and operating systems, facility design and ongoing consulting services for the establishment of a wholly-owned Nikon cell and gene therapy...

Registering as an outsourcing facility helps rid compounding safety stigma, Fagron

07-May-2015 - Compounding pharmacies must show they can produce high-quality medicines in order to overcome their safety stigma, according to Fagron which is opening a sterile facility in Kansas.

Update

Hospira to lay off 100 following closure of Clayton, NC plant

07-May-2015 - Hospira’s closure of its manufacturing facility in Clayton, North Carolina, which it says is a cost rather than a quality issue , will result in the laying off of 100 employees, according...

AMRI riding high on API acquisitions, expects more M&A to come

06-May-2015 - AMRI attributed a robust first quarter to its growing API business and recent acquisitions, and says to expect more M&A activity this year.

API firms stand to gain by seeking prequalification says the WHO

05-May-2015 - Persuading API manufacturers to seek prequalification is a challenge according to the WHO, which wants to raise awarness about the process and the positive impact it has on a suppliers' reputation....

Indian API and generics firms want a bigger share of the Japanese market

04-May-2015 - Indian generics firms see opportunities in the Japanese drug market according to a trade delegation that visited Tokyo last week seeking supply contracts.

News in brief

WuXi begins construction on $150m disposable biomanufacturing site in China

04-May-2015 - WuXi PharmaTech subsidiary WuXi Biologics has begun construction on a new $150m biologics manufacturing facility in Wuxi, China, which is expected to be the largest mammalian cell culture manufacturing sire using disposable...

Alkermes: Sale of 'non-core' CMO unit supports blossoming portfolio

04-May-2015 - Alkermes will continue to streamline its manufacturing and infrastructure to support a growing portfolio following the sale of its legacy CMO site.

FDA calls on manufacturers to begin switch from batch to continuous production

01-May-2015 - Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma manufacturers and CMOs should begin to consider the switch as in the long-run...

Catalent and 3M stress the importance of being bioavailable

30-Apr-2015 - [View the story "Bracknell hosts earnest drug delivery tech discussion" on Storify]

Lonza predicts growth despite strong Swiss franc in 2015

29-Apr-2015 - Lonza has predicted that revenues and profits will grow in 2015 despite the strong franc, citing pharma portfolio optimization and demand for outsourced manufacturing services.

Celgene in $450m deal to commercialise MedImmune's anti-PD-L1 candidate

28-Apr-2015 - AstraZeneca has inked a development and commercialisation deal with Celgene for its haematology programmed cell death ligand 1 (PD-L1) candidate, MEDI4736.

Bio-CMO sector to grow over 40% on Big Biopharma's burgeoning pipelines

24-Apr-2015 - Cheaper disposable manufacturing techs and increased demand for outsourced production will see more CMOs enter the contracting sector according to HighTech Business Decisions

MHRA licence to allow CDMO Juniper to manufacture 'Specials'

23-Apr-2015 - Juniper has received a licence to make unlicensed medicinal products – or ‘Specials’ – but will only produce batches with relatively high volumes to keep clients’ costs down.

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