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Breaking News on Contract Research, Manufacturing & Clinical Trials

Recipharm invests $750k in new GMP suite

27-Apr-2017 - Recipharm has opened a new GMP suite for clinical trial material manufacture at its North Carolina-based facility in Research Triangle Park.

Solubility solutions: Catalent increases spray drying capacity at Pharmatek

27-Apr-2017 - Catalent Pharma Solutions is increasing cGMP spray drying capacity at its Pharmatek facility in response to industry demand for improved solubility.

EAG expanding bioassay lab, adding new staff

26-Apr-2017 - EAG Laboratories is expanding its Columbia, Missouri-based cell bioassay laboratory to support multiple development programs.

DSM Sinochem to up capacity at Delft antibiotic intermediates plant

24-Apr-2017 - DSM Sinochem (DSP) has announced its intention to increase antibiotic production capacity at its facility in Delft, the Netherlands.

IriSys clinical trial material manufacturing contract upped to $6m

24-Apr-2017 - IriSys LLC has been awarded an increase to its five-year prime vendor contract – an agreement now worth up to $6m.

Wearable drug delivery tech firm Unilife files for Chapter 11 bankruptcy

20-Apr-2017 - Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.

Plasticell secures funding for red blood cell substitute development

19-Apr-2017 - Plasticell is advancing multiple projects through which it will develop and manufacture red blood cell substitutes for human clinical transfusion and progress preclinical trials.

News in brief

ABL to fill live virus-based MCMs for BARDA

10-Apr-2017 - ABL, Inc. will provide fill/finish services for live virus-based medical countermeasures (MCM) as part of the five-year contract worth up to $50m.

US FDA hits Indoco with warning due to leaky glaucoma drug

05-Apr-2017 - Leakage problems for of an ophthalmic drug has landed contract manufacturer Indoco Remedies with a US FDA warning letter at its plant in Goa.

Alkem says US FDA has accepted plan to fix Ankaleshwar API plant

04-Apr-2017 - Alkem Laboratories Ltd says the US FDA has accepted its plan to bring its API plant in Ankaleshwar, India up to code.

Shangpharma plans to merge API and research units and list in China

04-Apr-2017 - Shangpharma plans to merge its API unit with its research arm as Shanghai Chempartner, which it will list on the Shanghai or Shenzhen stock exchange.

Sharp investing more than $25m in US, UK operations

03-Apr-2017 - Sharp Packaging Services has purchased Daiichi Sankyo’s packaging facility in the US and is tripling its UK-based clinical packaging business.

China proposes changes to drug trial and API importation laws

03-Apr-2017 - Chinese regulators have proposed changes to rules covering clinical trials, API importation and drug approval in a bid to improve access to medicines.

People on the move

Outsourcing-Pharma’s Hiring and Firing Roundup March ‘17

29-Mar-2017 - Outsourcing-Pharma.com presents this month’s roundup of who is moving where in the contract research and manufacturing industry. 

Pfizer CentreOne: service expansions one step in fulfilling pledge to grow capabilities

28-Mar-2017 - Pfizer CentreOne has recently expanded its fill-finish and highly potent solid oral dose service offerings at two of its contract manufacturing facilities as it aims to fulfill a promise to grow its...

Avista completes $4m facility expansion at former Microtest Labs

27-Mar-2017 - The expanded facility features an additional 4,200 square feet of space to enhance its microbiology, sterility testing, and microbial ID service offerings.

Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT'

24-Mar-2017 - Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

Divi's Labs' Vizag plant banned from shipping to US

23-Mar-2017 - Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

update with comment from FDA

US FDA criticizes Indian drug firm USV for problems at multiple sites

22-Mar-2017 - The US FDA has called on Indian drug firm USV Private Limited to rethink how its tests for microbial contamination at its manufacturing facilities.

DCAT WEEK '17

CDMOs outline new initiatives, investments at DCAT Week

21-Mar-2017 - Manufacturers are investing in capacity and technology to help close the “market gap” for services while expanding to new locations across the globe.

DCAT WEEK '17

DCAT 17: Outsourcing-Pharma goes to New York

21-Mar-2017 - Didn't make it to New York, New York? Outsourcing-Pharma did and we bring you the best of Twitter from this CDMO-heavy event:

Ideal Cures 'building business' with PE investment

15-Mar-2017 - Idea Cures has announced an investment from the global private equity firm, TA Associates, as it aims to grow its manufacturing business.

Nicox resubmits AC-170 NDA after API supplier resolves GMP issues

09-Mar-2017 - Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug...

Mithra CDMO signs up a second Estrogen drug in 20-year Fuji deal

06-Mar-2017 - Mithra CDMO has entered a second agreement for Fuji Pharma to commercialise Donesta in Asia, another of Mithra’s estrogen-based hormone drugs.

Brexit and EU regulations motivate Quotient US buyouts

02-Mar-2017 - UK-based Quotient Clinical’s CEO cites Brexit and upcoming changes in European trial regulations as the motivation for acquiring US CDMO businesses.

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