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Breaking News on Contract Research, Manufacturing & Clinical Trials

CMC Biologics, Trellis sign long-term agreement to advance mAbs

02-Aug-2017 - CMC Biologics and Trellis Bioscience have entered into a manufacturing agreement for the process development and production of two of Trellis’ monoclonal antibodies (mAbs).

STA: merger with WuXi division follows single source contract provider trend

01-Aug-2017 - STA Pharmaceutical has merged with WuXi AppTec’s Pharmaceutical Development Services (PDS) to create a “more complete and integrated platform.”

Avantor site launches with biopharma lean

27-Jul-2017 - Avantor has opened a research centre in New Jersey, US offering gene to protein expression and drug delivery contract services.

STA: Pilot program to enable CMO use in China is a 'huge opportunity'

27-Jul-2017 - The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.

Recipharm installs dedicated production line for prostate cancer depot

26-Jul-2017 - Recipharm has installed a dedicated production line to make prostate cancer drug Liproca Depot for Swedish pharma firm LIDDS AB.

BASF selects Icertis ICM to modernize its global contracting process

26-Jul-2017 - BASF SE has selected the Icertis Contract Management (ICM) platform to automate its contracting processes and improve visibility into contractual obligations and deviations.

Feature

Compounding quality concerns: Legislation could 'fundamentally undermine' patient protections

25-Jul-2017 - Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).

Eurofins acquires India-based preclinical CRO

24-Jul-2017 - Eurofins Scientific has acquired the India-based preclinical CRO Advinus Therapeutics after raising €650m.

ABL advancing HIV vaccine as part of 7 year, $318m contract

19-Jul-2017 - ABL, Inc. has been awarded a preclinical development support contract to help advance an HIV vaccine and other biologics candidates.

Glenmark selects Cyndea to make gel capsule drugs

19-Jul-2017 - Cyndea Pharma and Glenmark Pharmaceuticals have partnered to make generic soft-gelatin capsule products for multiple markets.

Alcami relocating headquarters to RTP, new jobs expected

17-Jul-2017 - Alcami is moving its global headquarters to Research Triangle Park (RTP) in Durham, North Carolina.

Nitto Denko Avecia’s expanded API site to open in Massachusetts, US

17-Jul-2017 - Nitto Denko Avecia has announced it will launch its expanded Milton, Massachusetts-based oligonucleotide API facility next month.

DIA 2017

When, where, and how? Experts examine the current state of Brexit

13-Jul-2017 - The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.

PCI 'ahead of the curve,' expands serialization capabilities at UK-based facility

13-Jul-2017 - PCI Pharma Services continues to expand its serialization capabilities following an extended regulatory deadline that will provide much-needed “breathing room” for the industry.

News in brief

Catalent re-ups manufacturing deal for Pfizer Liqui-Gels

12-Jul-2017 - Catalent Pharma Solutions has signed an exclusive long-term supply agreement with Pfizer.

Thermo Fisher takes rain check: storm closes clinical packaging site

05-Jul-2017 - A storm in Lehigh Valley, Pennsylvania, US has forced Thermo Fisher Scientific’s clinical package and storage facility to close temporarily.

CordenPharma and GE to cover 'any Oligo customer needs,' say companies

03-Jul-2017 - CordenPharma and GE Healthcare have teamed up to serve the fast growing Oligonucleotide market with complementary offerings.

People on the move

Outsourcing-Pharma's Hiring and Firing Roundup June '17

29-Jun-2017 - This month’s round up includes a new chief manufacturing officer at Brammer Bio and an executive hire at PPD who will help guide the CRO’s laboratory services.

News in brief

QS Pharma gets nod from EMA for commercial manufacture

27-Jun-2017 - The European Medicines Agency (EMA) has approved QS Pharma to manufacture medicinal products for commercial use in Europe.

Avista supporting cGMP manufacture of hapten for opioid vaccine development

26-Jun-2017 - Avista Pharma Solutions, Inc. has been contracted to manufacture an opioid-derived small molecule, which is a component of a conjugate vaccine being developed to treat opioid addiction.

Baxter hires Indian contractor to expand injectables pipeline

22-Jun-2017 - Baxter International has announced an agreement with India-based Dorizoe Lifesciences to develop over 20 generic injectables, a sector it says is growing annually.

Label concept combines first-opening indication, blinding for clinical trials

19-Jun-2017 - Schreiner MediPharm’s new Flexi-Cap for Clinical Trial Supplies provides anti-counterfeit protection with blinding for transparent containers.

update

Continuous manufacturing process 'well-placed and capable,' says CEO

07-Jun-2017 - Teams of engineers at CordenPharma and Acasti Pharma came together to develop a proprietary continuous manufacturing process – which simplifies scale up and process re-validation.

AMRI set to be acquired by private equity

06-Jun-2017 - Private equity continues to make inroads in the contract research industry with two firms set to purchase AMRI in a deal worth $21.75 per share.

Acasti and CordenPharma look to continuous production for omega-3 drug

06-Jun-2017 - Continuous manufacturing equipment installed at a CordenPharma French facility has reduced cycle time and cost of making a hypertriglyceridemia drug, says Acasti Pharma.

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