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If approved, Rydapt would represent the first targeted treatment for newly diagnosed FLT3-mutated AML in the EU.

The approval marks the first subcutaneous self-injection treatment option for patients with systemic lupus erythematosus.

Expansion will triple capacity, add nearly 300 new jobs.

Collaborations result in development of Corning Valor Glass.

The second smoking intervention study started in 2016 with Biohit Acetium lozenge has been completed confirming the efficacy of Acetium lozenge as an effective way to assist in smoking cessation. This new trial was designed to be adequately powered ...

Given the rising number of guidelines to reduce risks of needlestick injuries, pharmaceutical companies have been searching for systems to ensure safe syringe use. Despite great innovations, adopting new safety systems has always been a trade-off betwe...

GMP Manufacturing line industrialised according to a unique process invented by LIDDS, involving the installation of novel equipment that is new to the pharmaceutical industry.

Goal of the collaboration is to identify therapies and diseases for which there is a high need for pediatric-friendly formulations.

IHAT, a novel synthetic material, is a commercially viable alternative to ferrous salts for iron supplementation.

These data, combined with positive results from two Phase III efficacy studies, support NDA filing planned for fourth quarter of 2017.

This month in Outsource Pharma online, Michael Howe, CEO of Verify Brand, a Minneapolis-based serialization software provider, addresses that even though the DSCSA deadline was extended, many pharma manufacturers, such as Verify Brand’s client Cov...

World first preservative-free eye drops with cross-linked Hyaluronic AcidCross-linked Hyaluronic Acid is a form of Hyaluronic Acid more stable and effective which increases:- Moisturizing properties - Long-term effectiveness- Viscosity and physica...

With support from the CRO, TopiVert has been able to accelerate scale-up and produce GMP batches, which are now being used in clinical trials.

Company announces investments, the sale of several products and a proposal to close a UK manufacturing site.

Overseas buyers at CPHI Korea double in the past 2 years.

TWO MORE VIALS MAKING MACHINERIES, FOR AN INCREASED MANUFACTURING CAPACITY

ordesa corporative brochure

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Investment follows demand for the company's AseptiSafe and PharmaSafe product ranges, which transfer APIs in small- and large-scale pharmaceutical manufacturing environments.

Nerlynx is the first extended adjuvant therapy for patients with HER2-positive breast cancer.

Shire obtains worldwide license to pursue development and commercialization of a novel, potentially differentiated, pre-clinical bi-specific antibody candidate for Hemophilia A.

Array to advance preclinical program for autoimmune disorders; Amgen responsible for clinical development and worldwide commercialization.

Company has experienced double digit growth across its automation, MES and managed services offering.

The service offers quick and efficient path from late-stage discovery to Phase I clinical trials.

Company expects to launch by the end of the year.

Presentations highlight recent discovery of inhibition of formation of toxic beta amyloid oligomers and new insights for Precision Medicine approach for ALZ-801 targeting APOE4 carriers.

KalGene’s Alzheimer’s therapeutics candidate, licensed from the NRC (KAL-ABP-BBB), crosses the blood-brain barrier, and reduces amyloid-beta burden in a transgenic rat model after a 4-week treatment.

Vote marks first proposed biosimilar trastuzumab to be recommended by the committee.

Company expects to supply up to 40 million doses across both vaccines for the US market in the 2017-18 season.

Cosentyx continues to demonstrate it can provide what psoriasis patients want - a life with clear skin.

Ascendis Health recently declared the acquisitions of Sunwave Pharma SRL and NHP Natural Health Pharma Ltd unconditional, together with Cipla Agrimed Proprietary Limited and Cipla Vet Proprietary Limited.

The system's new, variable transport system avoids bottlesnecks or delays in workflow.

A BLA for this indication is under FDA priority review; if approved, CTL019 could become first CAR-T cell therapy available.

Anticipated Prescription Drug User Fee Act (PDUFA) action date for the sNDA is March 2018 .

Company to invest €90 million and cut 200 jobs.

Cialis exclusivity is now expected to end at the earliest on 27 September 2018.

Blincyto is the first and only Bispecific T cell Engager (BiTE) immunotherapy to demonstrate superior overall survival versus standard of care chemotherapy.

Patients in Scotland will now join those in England and Wales and be able to benefit from this potentially life-extending immunotherapy on the NHS.

The collaboration will leverage the expertise of Queen’s University and Erytech’s ERYCAPS platform technology.

CPHI Worldwide 2017 - Messe Frankfurt, Germany (24 - 26 October 2017)

Please see further information on "Serialization and Tamper Evidence" at KLOCKE on the attached pdf-file.

Acquisition adds recombinant-based influenza vaccine to Sanofi Pasteur's portfolio.

Viberzi proven safe and effective in patients who reported inadequate response to prior loperamide use.

Parties to optimize certain novel compounds that target cancer cell transcription and proliferation.

Cobalt's portfolio of solutions accelerates entry into high-growth Raman spectroscopy market and expands Agilent’s value proposition for pharmaceutical and biopharma customers.

Owlstone Medical and Cancer Research UK initiate pan cancer clinical trial.

Orencia now approved in three autoimmune diseases.

The 2017 awards include eight new categories - celebrating outstanding achievements in the pharma industry.

Selexipag is an innovative, oral treatment that specifically targets the prostacyclin pathway.

NEXUS 17 attendees claim the greatest serialization challenge thus far has been line vendors’ inability to deliver a solution on time and within scope.

Actavis's products directly infringe Lilly's vitamin regimen patents in the UK, France, Italy and Spain.

SHP654 aims to deliver sustained protection against bleeds for patients with hemophilia A.

ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL.

To know in brief about the concept development of tablet coating system, transformation in tablet coating system, its uses, various opportunities with acrylate polymer advantage.

The new 5-axis machine will speed up the production and delivery of larger diameter valves up to 350 mm.

IH-TMS Tool Management System and the company's latest tool coating solutions interest exhibition visitors.

Acquisition create leading integrated solutions provider to the global pharma and consumer healthcare industries.

Company has immediately initiated commercialization activities.

Label update includes 52 week data from CLEAR study demonstrating long-term superiority of Cosentyx versus Stelara in psoriasis.

Pharma clients now have direct and immediate access to a fully compliant safety database without needing to invest in their own system or use an interim solution to ensure compliance.

Opdivo demonstrates superior recurrence-free survival versus Yervoy in adjuvant setting in CheckMate -238.

Brilliance tubes provide a user-friendly and attractive all-in-one solution.

ChargePoint Technology has invested in new manufacturing machinery at its UK facility to meet increased demand for larger diameter valves for use in large scale drug manufacturing that requires containment.

PCI Pharma Services (PCI) are pleased to announce a significant expansion of our market-leading Serialization capability at our Hay-on-Wye site in the UK.

First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

NOX-A12 has the potential to transform cancer types that are resistant to checkpoint inhibitor therapy into checkpoint inhibitor sensitive tumours

Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate to severe plaque psoriasis.

Idifarma, a Spanish CDMO, has expanded its GMP manufacturing offering with the installation of new automatic capsule filling capabilities at its EU-GMP approved plant in Pamplona, Spain.

NIAID-funded trial counters current thinking about treatment effectiveness.

In clinical studies, baricitinib has demonstrated significant improvement in the signs and symptoms of RA compared to standard-of-care therapies.

Three new TurboVap evaporation systems increase laboratory reliability.

First-and-only fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population.

Developed to support assay development and validation for detection of anti-drug antibodies.

Pre-clinical collaboration focused on up to 10 targets nominated by GSK.

Investments in commercial and development spray drying, and flexible manufacturing solutions.

Danapak Flexibles A/S, a subsidiary of Schur Flexibles Group, has been a supplier of flexible packaging materials for almost 40 years.

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Senn Chemicals - Solutions Synthesized PPT

Strengthens leadership in rare blood disorders with first-in-class candidate to treat cold agglutinin disease, a chronic autoimmune hemolytic anemia with no approved therapies.

The Global Phenacetin Market 2017 examines the performance of the Phenacetin market. It encloses an in-depth judgment of the Phenacetin market state and the competitive landscape globally. This report analyzes the potential of Phenacetin mark...

The Chaim Sheba Medical Center now offers the hydrogel spacer to reduce side-effects during prostate cancer radiation therapy.

Company's modification makes the SPU 2000 a more cost effective laboratory tool.

In ALK-positive advanced NSCLC patients, Zykadia demonstrated superior median progression-free survival compared with SOC chemotherapy with maintenance.

The patch can dramatically reduce the cost of vaccination, as self-administration can eliminate the need to have health workers oversee the process.

New world-scale ibuprofen production plant in Ludwigshafen; additional capacity expansion of ibuprofen plant in Bishop, Texas.

Two new biosimilar medicines available to treat patients with specific blood cancers and a range of inflammatory condition.

Company to consider whether to file new drug applications with the FDA and other regulatory agencies.

Agreement concerns an existing inhaled combination therapy for asthma and COPD delivered using a pMDI.

In this interview, Mr Guillet discusses Biocorp’s existing connected device offering, how it delivers value for the company’s pharmaceutical partners, the development of the accompanying software and data architecture, and how Biocorp has very signific...

Amino Acid Building Blocks Flyer

Novel approach capitalises on commonality across pathogens.

New offering restores lipid layer and brings hydration to all three layers of tear film damaged by Dry Eye.

Innova’s range of antibody and protein labeling products and services ideally complements SYGNIS’ customer base and existing genomics and proteomics portfolio.

The CDMO is now approved to manufacture medicinal products for the US, Europe and Japan.

B&W Tek, a mobile spectroscopy solutions company that delivers lab quality Raman, LIBS, UV-Vis and NIR solutions through user-friendly mobile platforms, is proud to announce updates to their BWSpec software, expanding the software supporting B&...

Resourcing the deployment of serialization systems and processes also cited as a significant barrier to compliance with European FMD,

Advanced software solution ensures superior manufacturing quality and enables effective decision-making.

US business will be organized into two entities - a US Generics Division and a US Injectables Division.

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multi-national company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular ...

Cladribine Tablets is the first and only investigational medicinal product to have shown a sustained 4 years of disease control with a maximum of 20 days of oral treatment over 2 years in clinical trials.

New indication supported by results of Phase III PALOMA-3 Trial of Ibrance in combination with fulvestrant.

New modular membrane chromatography solution for large-scale applications .

If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe.

The addition enables the CDMO to scale-up early-phase bench top processes to support later stage clinical development and niche, low volume manufacturing requirements.

Attendees learnt how Aptar's solutions could be applied to the Chinese market in a changing regulatory environment.

Mydayis demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-administration, compared with placebo, in total score on a skill-adjusted math test that measures attention in ADHD.

Arcinova has invested in a Uniqsis FlowSyn continuous flow reactor enabling them to develop and simplify the scale-up of a challenging API batch process.

AMG 334 (erenumab) is the first anti-CGRP monoclonal antibody developed for migraine prevention to receive EMA regulatory filing acceptance.

Compared with other small-scale R&D freeze dryers, the LyoCapsule lyophilizer is the only system that can monitor and independently control the wall temperature via use of the center vial product temperature.

Recently, Unither Pharmaceuticals partnered with Biolane to developed a single-unit dose featuring a more rounded tip that fits perfectly with babys’ nostrils. The “BB dose” guarantees a greater safety of the gesture of the mother with the infant. ...

The manufacture of solid dosage form pharmaceutical products would be transferred from the Osaka Plant to the new plant.

Compounded Sodium Bicarbonate PF 8.4% 50mEq per syringe is expected to help alleviate chronic drug shortage impacting the nation's hospitals.

The compound has the potential to be used as a monotherapy or in combination with approved therapies to address unmet needs in cancer treatment.

iOnctura is set up to develop a pipeline of assets targeting immunosuppression in the tumour microenvironment.

Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumours and is the number one prescribed agent by oncologists for this indication in the US.

Actelion will now become part of the Janssen Pharmaceutical Companies of J&J.

Sandoz now has four biosimilars approved in Europe - more than any other company.

Pfizer says shortages caused by manufacturing, distribution and third party delays.

Company shifts manufacturing focus in Ireland to reflect growing biologics portfolio with ongoing investment in Cruiserath biologics facility.

The pause is to allow for additional information to be collected to better understand more reports of death in the Keytruda groups.