Drug delivery, formulation

Smart injector allows for in-home injections

10-Oct-2016 By Melissa Fassbender

QuiO has raised $1.05m to develop its real-time adherence monitoring solution for injectable therapies – a device which could allow CROs to monitor injection events remotely. 

CDMO MabPlex expands cGMP manufacturing facilities in China

05-Oct-2016 By Melissa Fassbender

MabPlex International is expanding its biomanufacturing facilities in China to meet biologic demand for “the foreseeable future.”

Alcami enhances analytical services in Edison, NJ

27-Sep-2016 By Melissa Fassbender

The latest in a series of investments, Alcami has strengthened its analytical services capabilities at its Edison, New Jersey-based site.

Colorcon and Dow extend controlled release alliance

22-Sep-2016 By Staff Reporter

Colorcon and Dow have expanded a nine year controlled release alliance to include further solubility, coating and ion exchange platforms.

Lonza licenses rights to sell synthetic AAVs to gene therapy developers

14-Sep-2016 By Gareth Macdonald

Lonza has licensed rights to synthetic adeno-associated viral (AAV) vectors developed by scientists at US hearing research centre, Massachusetts Eye and Ear.

Catalent to plug bioavailability tech gap with Pharmatek Laboratories buy

13-Sep-2016 By Gareth Macdonald

Catalent has announced its intention to buy Pharmatek Laboratories to boost its drug bioavailability offering.

Needle-free tech company partners with WHO as part of polio eradication effort

01-Sep-2016 By Melissa Fassbender

PharmaJet has inked a multi-year deal with the World Health Organization for its needle-free technology, which uses 80% less vaccine than traditional methods.  

Public Patheon's $2bn warchest may bolster biologics offering, analyst

17-Aug-2016 By Dan Stanton

Biomanufacturing demand will drive revenues for Patheon according to an Evercore ISI analyst, who has predicted the newly-listed CDMO will strengthen its capabilities through M&A.

update

US FDA changes policy on switching hard gel capsule suppliers

16-Aug-2016 By Gareth Macdonald

Drug manufacturers that change hard gelatin capsule suppliers do not need to seek approval beforehand under a policy introduced by the US FDA this week.

Catalent wins early-phase contract for Arch's inhaled orphan drug

11-Aug-2016 By Dan Stanton

Arch Biopartners has selected Catalent to carry out studies and make batches of its orphan drug candidate AB569 for upcoming clinical trials.

CRO Velesco Pharma adds compound management services

03-Aug-2016 By Melissa Fassbender

The contract research organization (CRO) Velesco Pharma has opened a new laboratory in its Plymouth, MI-based facility to support an increased demand for materials management.

West: Amgen mAb approval helps validate drug delivery tech

01-Aug-2016 By Dan Stanton

Regulatory approvals are driving interest in West's Smartdose and Crystal Zenith delivery technologies, the firm says ahead of the launch of a monthly-dose version of Amgen's Repatha.

CRO Profil Institute forms strategic partnership with HighTide

29-Jul-2016 By Melissa Fassbender

Profil Institute and HighTide Biopharmaceutical have formed a strategic partnership focused on developing new therapies for diabetes and NAFLD/NASH.

Open-source drug discovery project advances drug development

29-Jul-2016 By Melissa Fassbender

The first of its kind trial has successfully identified several compounds to pursue and has given rise to more than a dozen drug development projects.

Patheon will list on NYSE today

21-Jul-2016 By Gareth Macdonald

API and drug maker Patheon will begin trading on the New York Stock Exchange under the symbol PTHN later today.

ABC Labs unified under newly formed EAG Laboratories

13-Jul-2016 By Melissa Fassbender

The independent lab network has combined 11 of its brands, including ABC Laboratories, to reside under a single company in order to “leverage cross functional capabilities,” says CEO.

NIH: million-person precision medicine study 'a constant learning process'

12-Jul-2016 By Melissa Fassbender

The Precision Medicine Initiative (PMI) Cohort Program is expected to launch later this year with the goal of enrolling more than one million US participants by 2020.

Juno submits 'Complete Response' to FDA following 3 deaths in ph II trial

12-Jul-2016 By Melissa Fassbender

The FDA has placed on clinical hold on Juno’s Ph II clinical trial of JCAR015 following the death of two patients last week and will “continue to work” to ensure patient safety, says representative.

French plant transfers to Vectura Group as Aenova's lease ends

05-Jul-2016 By Dan Stanton

Aenova’s lease of a manufacturing plant in France has ended and the facility has been transferred back to SkyePharma, now part of the Vectura Group.

Charles River acquires analytical CRO

28-Jun-2016 By Melissa Fassbender

Charles River Laboratories has acquired Blue Stream Laboratories, expanding the company’s biologic and biosimilar development capabilities.

DIA 2016

'Now is the time to include Japan' says Parexel

24-Jun-2016 By Melissa Fassbender

Japan “welcomes innovation” as it makes significant investments in infrastructure and regulatory changes.

Alcami enhances laboratory services at Wilmington, NC headquarters

21-Jun-2016 By Melissa Fassbender

Alcami has announced an upgrade to its laboratory service capabilities at the company’s Wilmington, NC-based headquarters.

Collegium's OxyContin rival is first drug using Deterx anti-abuse tech launched in US

21-Jun-2016 By Gareth Macdonald

Collegium Pharmaceutical has launched the first product formulated using its Deterx anti-abuse technology in the US.

CrownBio expands immuno-oncology offerings

16-Jun-2016 By Melissa Fassbender

Crown Bioscience has expanded its immuno-oncology platform at its facilities in Europe, the US, and Asia to include immunophenotyping analysis.

Dispatches from BIO 2016

Drug development in space: how microgravity enables pharma

15-Jun-2016 By Melissa Fassbender

Eli Lilly is conducting several experiments on the International Space Station (ISS) US National Laboratory over the next year – with several implications for pharma back on Earth.

AMRI to provide services for drug development consortium

15-Jun-2016 By Melissa Fassbender

As a dedicated Chemical Biology Consortium center, AMRI will provide a variety of drug discovery services to help advance early stage drug discovery projects.

Oasmia reviewing proposals from firms interested in API solubility enchancement tech

31-May-2016 By Gareth Macdonald

Oasmia Pharmaceutical AB has started reviewing ‘term sheets’ from firms interested in its vitamin A-derived drug delivery tech.

Colorcon to buy BASF's Kollicoat coating system product

25-May-2016 By Gareth Macdonald

Colorcon will buy BASF’s Kollicoat excipient coating system product line in a deal announced today.

Albumedix tech key to Chinese efforts to develop once-a-week diabetes drug

23-May-2016 By Gareth Macdonald

Recombinant albumin supplier Albumedix will help Hebei Changshan Biochem Pharma develop a once-a-week diabetes treatment.

Finished dosage formulations demand driving changes for CMOs

18-May-2016 By Melissa Fassbender

As “one of the fastest growing areas in pharma,” the demand for finished dosage formulations is having an impact on several aspects of the CMO industries.

Biogen eyes Regenxbio delivery tech for candidate occular gene therapies

17-May-2016 By Gareth Macdonald

Biogen has licensed rights use a gene therapy delivery technology from developer Regenxbio.

Microbiome research tool developed for drug development

16-May-2016 By Melissa Fassbender

Researchers have developed an organ-on-a-chip model that will allow for preclinical testing in an environment analogous to the human gastrointestinal tract.

CRO Evotec sees spin-out firm as strategic opportunity

12-May-2016 By Dan Stanton

Evotec’s auto-immune spin-out Topas represents “a strategic opportunity” for the CRO, which reported strong first quarter sales this week.

Aptuit acquires Kuecept, expands formulation services

10-May-2016 By Melissa Fassbender

Aptuit has acquired Kuecept to help meet demand for specialist drug pre-formulation, formulation prototyping, and formulation development services.

AMRI acquires API business, expands into Europe

05-May-2016 By Melissa Fassbender

AMRI has acquired the Italy-based chemical company, Euticals, in a move that expands its API development and manufacturing business.

French regulators lift manufacturing ban at Catalent softgel plant

02-May-2016 By Dan Stanton

Full production at Catalent’s Beinheim softgel plant has begun five months after the discovery of out-of-place capsules led to French regulators suspending operations.

Aptar launches sensor counter tech for MDIs

28-Apr-2016 By Staff Reporter

Aptar Pharma has launched a new counter technology for metered dose inhalers (MDIs) it says can help enhance patient adherence.

GSK's Ware Ellipta plant to supply US after Zebulon line operational

25-Apr-2016 By Gareth Macdonald

GSK has confirmed its new UK plant will continue to supply the US with Ellipta inhalers after capacity at its facility in North Carolina comes online this year.

WHO removes TB and malaria drug APIs made by Anuh Pharma from approved list

21-Apr-2016 By Gareth Macdonald

The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.

'It was time' for dedicated polymer group, says PCI CEO

21-Apr-2016 By Melissa Fassbender

PCI Synthesis has formed a cGMP Advanced Polymer Development and Manufacturing Group after experiencing a growing demand from the industry.

PCI Synthesis sets up polymers development lab

20-Apr-2016 By Gareth Macdonald

API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.

Famar set to step into North America by buying Quebec plant from Bayer

18-Apr-2016 By Dan Stanton

European CDMO Famar says it will continue making products on behalf of Bayer after acquiring a Canadian manufacturing facility from the firm.

Colorcon launches new coating for multiparticulate pills

13-Apr-2016 By Staff Reporter

Colorcon has launched a tablet coating system for multiparticulate dosage forms citing growing demand for such pills, particularly among the elderly.

Quotient invests in spray drying tech in response to demand

12-Apr-2016 By Gareth Macdonald

Quotient Clinical has expanded spray drying capacity at its facility in Nottingham, UK citing growing industry interest in solubility enhancement.

Catalent softgel plant hit with US FDA 483 while client Opko receives CRL

31-Mar-2016 By Dan Stanton

The US FDA says it will not approve Opko's kidney disease drug Rayaldee until contract manufacturer Catalent fixes problems at its softgel plant in Florida.

Hikma: Ben Venue tech transfer and network investments to boost injectables biz

17-Mar-2016 By Dan Stanton

Hikma says the $82m pumped into its injectables network last year will be a factor in returning the sector to growth in 2016.

MannKind's troubles trickle-down to hit insulin API supplier Amphastar

15-Mar-2016 By Dan Stanton

Amphastar has predicted last year’s insulin API sales growth will not be repeated in 2016 due to uncertain demand from Afrezza maker MannKind.

Plant-based vaccines poised to challenge $4bn seasonal flu shot market

14-Mar-2016 By Phil Taylor

An influenza vaccine produced in tobacco plants could make a big impact in the market if it reaches the market in the US in time for the 2018-19 flu season, says a market analyst.

AAI/CML claims clinical material production time reductions of 65%

14-Mar-2016 By .

AAIPharma and Cambridge Major Labs (CML) under a merged entity have driven efficiencies in end-to-end drug manufacturing, the firm says, dramatically reducing material delivery time.

'One-pot' formula creates bio-adhesive gel for drug delivery

14-Mar-2016 By Melissa Fassbender

Researchers studying chemical reactions in urine have created an adhesive gel for drug delivery applications that they say is cheaper and easier to make than hydrogel-based carriers.