Analytical (technologies & services)

update

EIB loans Poland's biggest drugmaker €45m to develop biosimilars

10-Jun-2015 By Gareth Macdonald

The European Investment Bank (EIB) has loaned Polpharma €45m to fund development of biosimilars and improve access to medicines in Europe.

NIH’s PDS suspends manufacturing operations

05-Jun-2015 By Zachary Brennan

The National Institutes of Health’s (NIH) Pharmaceutical Development Section (PDS), which manufactures products for clinical trials, has suspended operations due to the discovery of serious manufacturing problems and contamination by US FDA inspectors.

update

The age of phage? World first cGMP certification for phage therapy plant

03-Jun-2015 By Gareth Macdonald

AmpliPhi Biosciences’ phage-based antibacterial therapies plant in Ljubljana has been deemed to meet manufacturing standards by Slovenian regulators.

Mexican scorpion research could yield cancer and Parkinson's disease drugs

03-Jun-2015 By Gareth Macdonald

Proteins found in scorpion venom could yield cancer and Parkinson’s disease drugs say Mexican researchers.

Finnish Medicines Agency: No evidence of adverse events from biosimilar switches

27-May-2015 By Zachary Brennan

There is no evidence for adverse effects due to a switch from a reference product to an approved biosimilar and the “theoretical basis of such adverse effects is weak,” according to the latest statement on biosimilars from the Finnish Medicines Agency...

Mammoth undertaking: CRISPR/Cas9 gene editing goes beyond medicine

22-May-2015 By Gareth Macdonald

Big Pharma is not the only slow moving behemoth involved in the CRISPR/Cas9 revolution with a US team citing the gene editing tech as key to its efforts to resurrect the woolly mammoth.

Bioquell mulls sale citing investor interest in pharma and worries resistance worries as growth opportunities

19-May-2015 By Gareth Macdonald

Bioquell has launched a strategic review of its contamination control technology business which could result in a sale of the company.

My DNA, my data: British people would want to know if they have genes linked to diseases

29-Apr-2015 By Gareth Macdonald

Most Brits would want to know if they carry genes linked to life-threatening diseases according to UK researchers who say this could have implications for drug development.

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

28-Apr-2015 By Dan Stanton

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

News from CPhI Japan

Sakigake: New Japanese drug laws will foster global innovation says MHLW

28-Apr-2015 By Gareth Macdonald

‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.

Measuring mAbs with magnetic resonance can help regulatory testing

24-Apr-2015 By Anthony King

US researchers have discovered the most precise method yet for measuring the structure of monoclonal antibodies.   The technique gives manufacturers and regulators a way of assessing and comparing the performance and quality of mAbs using nuclear magnetic...

Sigma-Aldrich opens doors to latest Singapore biopharma investment

22-Apr-2015 By Dan Stanton

Sigma-Aldrich has opened a cell culture Technical Center in Singapore and plans to expand further in the city-state with a cGMP distribution site.

Sartorius adds biologics testing through acquisition of CRO BioOutsource

17-Apr-2015 By Dan Stanton

Sartorius has expanded its biopharma services to include contract testing by buying CRO BioOutsource.

StemBioSys closes $8m in funding to help launch its stem cell culture system

17-Apr-2015 By Zachary Brennan

San Antonio, Texas-based StemBioSys has closed an $8m round of Series A preferred stock financing that it will use to help launch its bone marrow-High Performance MicroEnvironment (BM-HPME) stem cell culture system.

Bayer spends $100m on haemophilia development in Berkeley

16-Apr-2015 By Fiona BARRY

Bayer has announced it will create a $100m (€94m) product testing site in California for its haemophilia A pipeline.

Super-sensitive protein measurement assay for CRO Eurofins

07-Apr-2015 By Fiona BARRY

Eurofins Bioanalytical Services has announced it will offer an extra-sensitive immunoassay service for biopharma developers.

Novartis settles CAR-T patent dispute with Juno for $12m, future payments

07-Apr-2015 By Zachary Brennan

Juno Therapeutics has agreed to settle litigation with Novartis and the Trustees of the University of Pennsylvania after Juno entered into a December 2013 license agreement with St. Jude Children’s Research Hospital, which owned the patent rights. 

Thermo licenses CRISPR tech from ToolGen

18-Mar-2015 By Anthony King

Thermo Fisher Scientific has licensed CRISPR/Cas9 intellectual property from ToolGen, a Korean biotech focused on genome editing.

NC introduces biosimilar substitution bill as MA looks to amend its law

12-Mar-2015 By Zachary Brennan

North Carolina is jumping on the biosimilar substitution legislation bandwagon with a new bill unveiled this week, while Massachusetts is looking to slightly tweak its law.

Path of Khan: DNA tests show millions of Asian men descended from 11 nomadic kings

12-Mar-2015 By Gareth Macdonald

Ancient nomadic kings’ love of life in the saddle did not hamper another of their favourite pastimes according to a study suggesting millions of Asian men are descended from just 11 fathers.

VWR expands deal with enzymes firm NEB in latest biopharma-focused expansion

03-Mar-2015 By Gareth Macdonald

VWR has expanded its distribution deal with industrial enzymes firm New England Biolabs (NEB) in its latest biopharma-focused move.

Mundipharma associate launches Remsima in UK and preps for wider roll out

25-Feb-2015 By Gareth Macdonald

Mundipharma’s associate Napp Pharmaceuticals launched Celltrion’s Remicade biosimilar Remisma in the UK today, just 24 hours after the originator lost patent protection.

UK gives $31m to industry-academic biodevelopment collabs

25-Feb-2015 By Fiona BARRY

The UK has granted £20m ($31m) to the biotech industry – including Horizon, FujiFilm, and Cobra Biologics, to bring mAb, cell expression, and antibiotic projects to market.

Novasep signs €4.7m biomanufacturing deal with biotech

18-Feb-2015 By Zachary Brennan

Novasep has signed a €4.7m ($5.4m) agreement with Celladon, a clinical-stage biotechnology company, to prepare to supply the drug substance for the heart failure treatment Mydicar.

Repligen finishes plant expansion and forecasts higher tech revenues in 2015

13-Feb-2015 By Gareth Macdonald

Repligen has finished an expansion at its US filtration system facility eight months after bolstering its offering in this area by buying a platform from Refine Technology.

GSK invests further in vaccines with $190m buy of GlycoVaxyn

13-Feb-2015 By Zachary Brennan

Fresh of its acquisition of Novartis’ vaccine business, GlaxoSmithKline is doubling down with the purchase of GlycoVaxyn AG, a Swiss-based specialist vaccine maker, for $190m (£124m). 

update: WHO says tech like Nanopatch can help get vaccines to the people that need them

Vaxxas raises $20m for nanopatch vaccine trials

10-Feb-2015 By Gareth Macdonald

Vaccine patch firm Vaxxas has raised $20m (€17.7m) to fund clinical development of its pipeline of influenza, polio and bacterial infection vaccines.

US dollar prompts ThermoFisher to predict flat revs in 2015 and move reagents to Lithuania

30-Jan-2015 By Gareth Macdonald

ThermoFisher has forecast flat sales and earnings in 2015, warning that weaker currencies in key markets will offset higher biopharma spending.

Tech that can untangle hard boiled eggs could save biopharma time and money, say researchers

28-Jan-2015 By Gareth Macdonald

Researchers have used shear stress to repair misfolded proteins in an approach that could help biopharmaceutical firms bypass expensive refolding techniques and time-consuming cell line optimization.

Australia doubles back on biosimilar naming conventions to follow WHO move

23-Jan-2015 By Zachary Brennan

Australia’s TGA (Therapeutic Goods Administration) is shifting its stance on the way it plans to name biosimilars to keep the country more in line with the WHO’s (World Health Organization) proposed policies.

Biosimilar mAbs may have tougher time winning US FDA approval says expert

21-Jan-2015 By Gareth Macdonald

So far most biosimilars filed in the US have been ‘low risk’ according to contractor BioOutsource, which warned that developers seeking approval for copycat mAbs face higher legal and regulatory hurdles than in Europe.

ABEC buys Ireland plant to make bioprocessing equipment in Europe

16-Jan-2015 By Dan Stanton

Bioprocess equipment maker ABEC has bought an ex-electronic component facility in Ireland in order to gain greater access to the European market.

CAR-T race heats up with flurry of new deals

09-Jan-2015 By Zachary Brennan

The hype around developing new CAR-T (Chimeric Antigen Receptor transduced T) cell therapies, which can fight cancers by modifying patients’ immune cells, seemed to hit a new high this week, with two partnerships and an acquisition.

Harvard, Korean scientists develop new material to help deliver 3D vaccines

19-Dec-2014 By Zachary Brennan

Korean and Harvard University scientists have developed a way to non–surgically inject programmable biomaterial to deliver a 3D vaccine that can more effectively treat diseases like cancer or HIV.

Bruker to pay $2.4m to settle SEC charge of improper payments in China

16-Dec-2014 By Gareth Macdonald

Bruker Corp will pay $2.4m to settle US SEC charges that employees improperly funded Chinese officials' sightseeing trips to win analytical tech contracts at state labs.

Amgen, Pfizer weigh in on EMA draft guideline on biosimilars

04-Dec-2014 By Zachary Brennan

Biopharma heavyweights Amgen, Pfizer and a number of other companies offered their unique takes on the biosimilar draft guidance from the EMA, calling for more clarity and some new additions before the final draft takes effect.

Scientists content this winter: Genes show car park skeleton is Richard the third

02-Dec-2014 By Gareth Macdonald

Richard the III was blond, blue-eyed and may owe a substantial parking fine based on new genetic research that solves a 529-year old missing persons case.

J&J gets piggyBac from Transposagen to develop T-Cell therapies

26-Nov-2014 By Dan Stanton

There is an upsurge in biopharma demand for cell and gene therapy applications, says Transposagen as it inks a deal with Janssen to develop allogeneic Chimeric Antigen Receptor (CAR) T-cells.

Agilent: Biologics growth presents biggest consumables opportunity

21-Nov-2014 By Dan Stanton

The growth in biologics has given Agilent Technologies a “huge opportunity for services and consumables,” according to the firm’s CEO-Elect.

Mind the gap: GSK and UK scientists say smaller is better for some biopharmaceuticals

19-Nov-2014 By Gareth Macdonald

UK researchers working with GSK say a newly identified immune cell communication mechanism could explain why some drugs don’t work and drive development of smaller, large molecule meds.

GE sets up in Istanbul in bid to capture a share of Turkish tech market

14-Nov-2014 By Gareth Macdonald

Turkey’s efforts to increase local biopharmaceutical production have prompted GE Healthcare Life Sciences to set up a biopharmaceutical technology training centre in Istanbul.

AZ, ISIS expand partnership to develop novel delivery methods for antisense oligonucleotides

14-Nov-2014 By Zachary Brennan

Isis Pharmaceuticals and AstraZeneca have expanded their partnership to develop novel delivery methods for antisense oligonucleotides in order to target the desired tissue more effectively. 

VWR steps into world of single-use with two acquisitions

11-Nov-2014 By Zachary Brennan

Lab service provider VWR is moving into the industry of single-use bioprocessing with the acquisitions of Integra Companies and STI Components.

Amgen files FDA petition, lawsuit seeking info on Sandoz biosimilar manufacturing

07-Nov-2014 By Zachary Brennan

The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.

Thermo Scientific issues software update after confirming bug in its bioequivalence data platform

04-Nov-2014 By Dan Stanton

Thermo Fisher Scientific has issued a letter to users of its Kinetica technology software confirming discrepancies in its bioequivalence data.

dispatches from AAPS

Breaking Ad: Can virus-delivered gene therapy help meth addicts quit?

04-Nov-2014 By Gareth Macdonald

Addicts struggling to kick a meth habit could be helped by gene therapy according to the team behind a US National Institutes of Health funded project.

Brand new invention to help biopharmas avoid cryoconcentration

24-Oct-2014 By Gareth Macdonald

Encountering vanilla ice is a dreadful experience, as anyone who has found patches of frozen water and ingredients in ice cream can testify.

Consultant: Commercial bioequivalence software in need of validation in wake of Thermo Scientific's review

22-Oct-2014 By Dan Stanton

A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.

GMP challenges holding back Big Pharma's personalised vaccine uptake, says immatics

21-Oct-2014 By Dan Stanton

Biopharmas struggle to comply with GMP requirements for personalised meds and the outstanding questions mean some are reluctant to invest according to German firm immatics.

Sigma-Aldrich signs microbial growth system distribution deal with BioSilta

15-Oct-2014 By Dan Stanton

Despite a $17bn bid from Merck KGaA, it’s “business as usual” at Sigma-Aldrich which has signed a distribution agreement with reagent-based microbial growth systems firm BioSilta.