FDA releases draft co-crystal guidance to support NDAs
The US FDA has published draft guidance to help companies submit marketing applications for API-excipient co-crystals.
News from AstraZeneca, Apricus, and BioTime – People on the move
in-PharmaTechnologist presents its round-up of the latest career moves within the world of pharmaceuticals, including news from AstraZeneca, Apricus, and BioTime.
Lonza to supply Elan with API for trials of candidate Alzheimer’s disease drug
Chemicals supplier Lonza will manufacture the API for a candidate Alzheimer’s disease drug being developed by Elan in an agreement announced yesterday.
Drug delivery research round-up
in-PharmaTechnologist presents its round-up of the latest drug delivery research developments in the pharmaceutical world, including tumour targeting peptides and lipid nanoparticle drug-delivery technology.
News from Genesis, Acino and Pharmalink AB – People on the move
in-PharmaTechnologist presents its weekly line-up of the latest appointments in the pharmaceutical industry, including news from Genesis, Acino and Pharmalink AB.
Covance is adding mass spectrometry and other capabilities to meet growing demand for biosimilar comparability services.
FDA nanomaterial draft guidance means pointless extra regulation, say experts
FDA draft guidance defines nanoparticles too broadly and could result in APIs being categorised as nanomaterials, industry said.
ShangPharma opening facility dedicated to major customer
ShangPharma is opening a 100,000 sq ft facility dedicated to serving a big customer as it continues to strengthen ties to top clients.
News from Genzyme, Catalent and Futura – People on the move
Outsourcing-Pharma presents its weekly round-up of the latest happenings in the world of pharmaceutical employment, including news from Genzyme, Catalent and Futura.
Pall sets up Singapore processing COE
Processing technology maker Pall has opened a new centre of excellence in Singapore in a bid to capture a share of the country’s growing biomanufacturing sector.
West inks pre-filled syringe deal with Vetter
Injectable drug delivery systems maker West has struck a new joint venture with Vetter to provide source filled Daikyo Crystal Zenith syringes.
Novozymes rolls out new HA product
Novozymes Biopharma says its new hyaluronic acid has sustainability, safety and production benefits for the pharmaceutical manufacturing sector.
Piramal Healthcare has added commercial-scale antibody-drug-conjugate (ADC) manufacturing capacity at its UK plant predicting increasing demand for this specialist type of contracting.
Using chiral metal surfaces in drug manufacturing could save companies time and money, say researchers at University of Cambridge.
Delivery vehicles can revitalise RNAi sector; AAPS panel
Aptamers and dendrimers can revitalise the faltering siRNA sector by solving delivery problems, AAPS panelists said.
WuXi buys two Chinese CROs in clinical trial expansion
WuXi PharmaTech has expanded into Phase I-IV clinical trial services through the acquisition of two China-based CROs.
News from Novocure, YM BioSciences, and SGVI – People on the move
in-PharmaTechnologist presents its round-up of the latest appointments within the pharmaceutical industry, including news from Novocure, YM BioSciences, and SGVI.
VaxyGen & Georgia State join for protein purification services
VaxyGen is working with Georgia State University (GSU) to offer protein purification, optimisation and production services.
New Hamner - PBM venture says its toxicity testing could save billions in drug discovery
The Hamner Institutes for Health Sciences and private equity firm PBM Capital Group (PBM) have thrashed out a venture for toxicity testing which they say could save the drug discovery industry billions.
Medgenics confirms talks with Baxter on biopump deal
Tissue-based delivery tech developer Medgenics is in talks with Baxter Healthcare about new deal, but says continued focus on Factor VIII is not ‘mission critical’ to biopump platform.
Porcine trypsin guidance may apply retrospectively; EMA
The EMA may apply proposed porcine trypsin guidelines to existing products, such as a GSK vaccine, to cut viral contamination.
Rituximab success paves way for plant produced mAbs
iBio is expanding use of its green plant technology to biosimilar mAbs after producing rituximab using the system.
Dong-A and Meiji Seika to build biosimilars plant
South Korean drugmaker Dong-A and Japan’s Meiji Seika Pharma will build a biosimilars plant in a bid to target the global Ab-based drug market.
CRO sector saw workload, revenues and jobs grow over last decade
The contract research sector has grown markedly over the last decade, with more drugs being examined in more trials by more researchers according to a new Association of Clinical Research Organisations (ACRO) survey.
Aesica plans expansion in US & Asia after investment
CDMO Aesica is to add manufacturing capacity in Asia and the US following a cash injection from private equity firm Silverfleet Capital.
Round-up of SAFC's Glasgow conference
SAFC will extend its focus on high potency production through a number of new investments.
News from Sucampo, Tranzyme, and Next Pharma – People on the move
Outsourcing-Pharma presents its round-up of the latest appointments within the pharmaceutical industry, with news from Sucampo, Tranzyme, and Next Pharma.
Lonza inks stem cell production pact with Mesoblast
Lonza may build a stem cell production facility dedicated to manufacturing Mesoblast products after inking an alliance.
Unigene cuts SDBG to focus gaze on peptides
Peptide-based therapeutics specialists Unigene will focus on high valuation drug development and drug delivery opportunities after cutting loose its Site Directed Bone Growth (SDBG) patent portfolio.
News from Aduro, Catalent, and Eleven – People on the move
in-PharmaTechnologist presents its round-up of the new appointments within the pharma biz, including news from Aduro, Catalent, and Eleven.
ProMetic supplying adsorbent to Chinese biosimilar biz
ProMetic Life Sciences is supplying an affinity adsorbent to a Chinese biopharm for use in scale-up of a biosimilar.
Catalent and Toyobo team up to launch GPEx in Japan
Catalent has struck up a deal with Toyobo Biologics to launch its cell line engineering technology on the Japanese market.
Alkermes moves to Ireland and lands multimillion dollar manufacturing deal
Alkermes has celebrated the launch of its new Irish drug delivery and formulation business by winning a new multimillion dollar manufacturing contract with a ‘top 10 pharma.’
GE Healthcare to invest in biomanufacturing tech
GE Healthcare will expand its range of biomanufacturing technologies under a new oncology-focused investment project.
ShangPharma eyes discovery biology growth with mAb deal
ShangPharma’s emerging discovery biology services unit has inked another antibody development partnership with a Chinese biopharm.
Biocon building Malaysia plant to serve Pfizer insulin deal
Biocon has begun work on the Malaysian biopharm plant that will serve its deal with Pfizer, and is now providing Lipitor ingredients.
CMC adds capacity at Denmark biologics site
Contract manufacturer CMC Biologics has ramped-up bioreactor capacity to meet demand for biologic drugs for Phase III clinical trials and beyond.
SSB and GE sign patent licensing deal for biomanufacturing techs
Sartorius Stedium Biotech (SSB) and GE Healthcare Life Sciences say new cross licensing deal will aid development of their respective biomanufacturing tech offerings.
Cellcura signs HSA-free media deal with IDT for vacc development
CellCura has inked an agreement with IDT Biologika for the testing and adaptation of its protein-free (PF) media for the production of cell lines for vaccine manufacturing.
Roche launches biomanufacturing monitoring tech
Roche has launched a new analysis platform designed to help bio manufacturers monitor and optimise production operations.
Advantar & DavosPharma ally to broaden service offering
Advantar Labs has allied with DavosPharma to accelerate clients’ development programmes with chemistry and analytical services.
Vaccine cell line demand helps Vivalis cut loss in H1
Vivalis cut its operating loss after demand for its vaccine production cell line drove triple-digit revenue growth.
vivoPharm branch out in US with MPI partnership and new Hershey office
vivoPharm has extended its oncology offering after striking up an alliance with MPI Research.
Drug delivery research round up
in-PharmaTechnologist presents a roundup of the latest drug delivery research, including bone marrow targeting nanoparticles and an imaging-treatment combo.
Cyprotex’ H1 income down, but revs soar on US expansion
UK preclinical contractor Cyprotex says H1 profits were hit by the loss of it biggest customer, but is upbeat on revenue growth and potential of in vitro toxicity testing business.
Appointments from AAPS, SurModics, Diamedica, and Sirona Biochem – People on the move
in-PharmaTechnologist presents its latest round-up of the movers and shakers within the pharmaceutical industry, including appointments from AAPS, SurModics, Diamedica, and Sirona Biochem.
New plant moves Irvine into Asia, gives it 2nd media source
Irvine Scientific has begun shipping from the cell culture media plant it built to expand into Asia and give clients the security of a second source.
Unilife creates world's first multi-chamber syringe with in-built safety device
Unilife has developed the world’s first multi-chamber prefilled syringes that have an in-built safety mechanism.
PBS Biotech buys Integrity to add manufacturing capacity
US bioreactor maker PBS Biotech has bought medical device focused CMO Integrity CMI to expand its manufacturing capacity
Takeda gets 24bn yen Govt grant for cell culture vacc plant
Japanese drugmaker Takeda has been awarded JPY24bn ($313m) to develop and a cell culture influenza vaccine and establish a commercial-scale production facility.