All News
All news
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News Additional Cryogenic Storage Capacity at Rockford, IL Facility
PCI Clinical Services (PCI) are pleased to announce a second phase 400 percent increase in Cyrogenic storage capabilities at our Rockford, Illinois site. The announcement follows our initial capital investment in specialist cryogenic storage in Rockfor... -
News Capsugel expands late-stage inhalation product development capabilities
Installation of state-of-the-art Harro Hӧfliger encapsulation unit expands clinical- and commercial-scale capacity for dry powder inhalation applications. -
News Cherwell makes an impact with new continuous monitoring microbial air samplers
ImpactAir high performance air sampler range joins Cherwell’s portfolio of cleanroom microbiology products. -
News Bosch launches new KLV series for container closure integrity testing
Inspection of up to 600 glass containers per minute using unique group testing. -
News Mylan completes acquisition of Cold-EEZE brand
Cold-EEZE is now Mylan's largest US consumer healthcare brand. -
News FDA approves Genentech’s Ocrevus for relapsing and primary progressive forms of MS
An important new treatment option for people with relapsing forms of multiple sclerosis demonstrating superior efficacy on the three major markers of disease activity compared with Rebif. -
News Tesaro announces FDA approval of Zejula for women with recurrent ovarian cancer
US commercial launch planned for late April. -
News Butterworth Labs to expand operations by 15%
Part of a longer term plan to increase capacity. -
News Merck introduces Mobius MyWay portfolio for customized single-use assemblies
Offers more flexibility, better supply predictability and shorter lead times for more efficient and safer drug manufacture. -
News Analytical protein aggregate separation without a column
System can achieve separations with higher resolution, reproducibility and recovery then has previously been possible. -
News Chemotherapy as a tablet instead of an intravenous infusion
New production method for solid dispersions of docetaxel and paclitaxel. -
News Fiasp - a new, ultra-fast acting mealtime insulin
Canada first country to launch Fiasp. -
News Regeneron and Sanofi announce FDA approval of Dupixent
First targeted biologic therapy for adults with moderate-to-severe atopic dermatitis. -
News Encouraging results of Phase IIa study with Evenamide in patients with schizophrenia
Unique mechanism: glutamate modulation and voltage-gated sodium channel blockade. -
News Eprex marketing authorisation extended to include treatment of symptomatic anaemia
French Health Authority ANSM grants approval in the Mutual Recognition Procedure; the relevant health authorities are required to implement the new indication within 30 days. -
News Pfizer receives positive CHMP opinion for Trumenba for prevention of meningococcal group B disease
Trumenba has been studied in a global clinical development program evaluating the vaccine in adolescents and adults. -
News Invivotek completes solar farm and facility expansion
Provides a cleaner, renewable energy source to reduce costs and lessen the CRO facility's impact on the environment. -
News BMS receives positive CHMP opinion recommending Opdivo for head and neck cancer
Opdivo already approved by the EC for six indications in four distinct tumour types. -
News FDA approves Parkinson's disease drug
First NCE approved for PD patients with motor fluctuations in the US in more than a decade . -
News Lilly to invest $850 million in US capital projects in 2017
Significant investment in manufacturing diabetes medicines continues with new $85 million commitment in Indianapolis. -
News Cobra Biologics wins ‘CMO Leadership Award’ in five categories
More than 80 contract manufactures were assessed by 26 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. -
News Aptar Pharma’s Preservative-Free Multidose Dispenser chosen for Restasis Multidose launch
Aptar Pharma’s Ophthalmic Squeeze Dispenser system is the result of more than 10 years of development and experience in the delivery of preservative-free ophthalmic solutions. -
News Reig Jofre starts marketing of three new injectble products for hospitals
Developments correspond to generic products based on specialized pharmaceutical technologies. -
News TraceLink and Advanco partner to simplify serialization line management integration
Partnership to collaborate with industry to reduce risk and ensure optimal compliance for all members of the pharmaceutical supply chain. -
News Aptar Pharma inaugurates Congers site expansion
New site will be used to complete premium injectable elastomeric component manufacturing. -
News SGS expands quantitative bioanalytical services for protein therapy development at Poitiers, France laboratory
The two new systems offer faster method development and the ability to quantify multiple proteins simultaneously. -
News I Holland showcases new tool coating for the first time at Interphex Japan
PharmaCote ECxtra eliminates problems encountered during the hard chromium coating process. -
News Eurofins to invest millions in new UK facility
5800-m2 facility will provide a range of GMP pharmaceutical testing services. -
News Recipharm partners with Sato to manufacture product for Japanese market
CDMO will manufacture and deliver Emla Patch - a local anaesthetic product. -
News Mylan receives tentative approval for "TLE400" under PEPFAR
TLE400 is a fixed-combination containing Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg. -
News Uninterrupted Pradaxa showed less major bleeding than warfarin in atrial fibrillation patients
Patients studied in the trial were reflective of those undergoing catheter ablation in routine clinical practice, providing highly relevant data to treating physicians. -
News AstraZeneca study shows SGLT-2 inhibitors significantly reduced hospitalizations for heart failure and death
Landmark real-world evidence from an international study of more than 300,000 patients with type-2 diabetes showed treatment with SGLT-2 inhibitors reduced risk of hospitalization for heart failure by 39% and all-cause mortality by 51%. -
News Apogenix presents data on novel Hexavalent TNF receptor agonists
Agonists for GIT, CD27 and CD40 receptors in development for cancer immunotherapy exhibit significant in vitro- and in vivo activities. -
News New analysis shows Novartis Entresto improves glycemic control among heart failure patients with diabetes
New use of insulin was also reduced by 29% among patients taking Entresto compared to enalapril-treated patients. -
News Dementia Consortium funds Manchester-based team targeting immune system in search for new dementia treatments
Team led by Dr David Brough awarded £191,757 by public-private initiative driving early-stage drug discovery programmes. -
News Merck introduces Millipore Express high area filters for more effective processing and optimum yield
Greater filtration capacity with a smaller footprint than conventional filters, improving economics for biopharmaceutical manufacturing. -
News Landmark outcomes study shows that Repatha decreases LDL-C to unprecedented low levels
Amgen has announced that the 27,564-patient Repatha (evolocumab) cardiovascular outcomes study, FOURIER, established for the first time that maximally reducing low-density lipoprotein cholesterol (LDL-C) levels with Repatha, beyond what is possible wit... -
News Growing market for generics and liberalization of OTC medicines driving demand at CPHI Japan 2017
PIC/S membership accelerating international interest with market forecast to reach US$115bn by 2024. -
News FDA approves Novartis' Kisqali as first-line treatment for HR+/HER2- metastatic breast cancer
Kisqali plus letrozole showed treatment benefit across all patient subgroups regardless of disease burden or tumour location. -
News Bosch showcases new development for continuous manufacturing
The Xelum platform combines dosing, mixing, granulating and pressing, paving the way for more efficient tablet manufacturing. -
News Shire receives European approval for label extension of Cinryze
Cinryze is the first and only Hereditary angioedema treatment approved for routine prevention in paediatrics. -
News Optimizing development resources for efficient product development
Nowadays, efficient process research and development are, more than ever, an absolute must for contract manufacturers and API manufacturers. New products/processes need to be pushed through to market readiness faster and faster. However, development de... -
News Welcome to visit us during CPhi Russia 2017
Welcome to visit us at booth 802 during CPhi Russia 2017 on Mar.28-30. -
News Merck's Keytruda receives FDA approval to treat patients with refractory classical Hodgkin lymphoma
Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat cHL regardless of prior stem cell transplantation or use of brentuximab vedotin -
News Metrion and Concept introduce integrated ion channel drug discovery service
Supports small molecule ion channel drug discovery, from initial screening to development candidate. -
News $100 billion of revenues up for grabs for drug manufacturers as patents for key biologics expire
For success in the biosimilars sector, manufacturers must adopt QbD, DoE and PAT initiatives. -
News Allergan and Editas Medicine all set to discover and develop CRISPR genome editing medicines for eye diseases
Alliance brings together eye care and CRISPR innovators to develop transformative medicines for patients. -
News Pfizer launches new antibiotic in the UK and Germany
Zavicefta treat complicated infections caused By Gram-negative bacteria. -
News Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations
Dietary supplement products "misbranded" and unapproved new drugs being marketed with drug claims despite not being approved for any use. -
News BASF inorganic specialties divestiture creates new business named Callery
Current product portfolio includes a range of specialty alkoxide bases and borane derivatives. -
News FLUOROURACIL (5-FU): MAKE THE MOST OF OUR OWN DOCUMENTS (CEP, DMF)
Together with Oxaliplatin and Folinic Acid, 5-FU is used in the most successful first line treatment of colon cancer (FOLFOX). As a second line treatment, it is successfully applied with Folinic Acid and Irinotecan (FOLFIRI). We can provide all these o... -
News NEOSTIGMINE METHYLSULFATE WITH SUPPORT AS STRONG AS AN ELEPHANT
With DCS Pharma your registration will be smooth because we have the most reliable source available, with complete documentation for regulated markets and full regulatory support. -
News Mylan announces global settlement and license Agreements with Genentech and Roche on Herceptin
Settlement provides Mylan with global licenses for its trastuzumab product. -
News Repatha demonstrates reduced need for apheresis in patients with high LDL-C in study
Data suggest an alternative option for patients. -
News GSK Consumer Healthcare launches new toothpaste in the US specifically formulated for gum health
parodontax - first toothpaste proven to help consumers leave bleeding gums behind. -
News Boehringer's investigational anti-CD33 monoclonal antibody gains orphan drug designation for treatment of myelodysplastic syndromes
BI 836858 was previously granted orphan drug designation for the treatment of patients with AML. -
News Proclara Biosciences Australia awarded grant to help develop new biotherapy with blockbuster potential
Work on a second-generation fusion protein due to start in 2017 at Patheon's manufacturing facility in Brisbane. -
News Hikma launches desvenlafaxine succinate extended-release tablets in the US market
The tablets are indicated for the treatment of major depressive disorder. -
News Bavarian Nordic announces collaboration to evaluate CV301 and Tecentriq in bladder cancer
Collaboration is the second to evaluate a combination of CV301 with a checkpoint inhibitor. -
News Q Laboratories, Inc. expands Microbial Identification Capabilities
Q Laboratories, Inc. (Cincinnati, Ohio) has added another tool to their microbial identification capabilities by acquiring the Bruker MALDI Biotyper®. This technology allows for rapid, cost-effective, accurate identification of thousands of microorgani... -
News I Holland to showcase its most innovative tooling solutions at PHARMACONEX
Tooling products focused on increasing productivity for the tablet manufacturer. -
News Horizon Discovery enters into R&D and licensing partnership for bioproduction cell line optimisation
Partnership formed to evaluate the impact of Amplycell’s novel cell fitness technology on expression capacity of Horizon’s bioproduction cell line. -
News Apotex to invest $184 million to grow US manufacturing presence
Expansion plan comprises company's largest investment in the US. -
News PCI Pharma expands its serialization capability
The multi-site installations support a variety of drug delivery forms, including bottles, unit cartons and parenteral kits, as well as unit dose wallets and child resistant/compliance prompting packaging. -
News BMS appoints Dr Thomas J. Lynch, Jr., Executive Vice President and Chief Scientific Officer
He succeeds Dr Francis Cuss, 62, who will retire from the company. -
News FDA accepts sNDA for Vraylar
Application seeks to expand Vraylar label to include Phase III clinical data for the maintenance treatment of schizophrenia. -
News CPHI China to launch China Pharma Week
Expanded week of dedicated sessions and trends on the world’s second largest pharma market. -
News Bosch underlines line competence for liquid pharmaceuticals
Easy scale-up with Pharmatec pilot fermenter. -
News Novartis' Cosentyx shows almost all psoriasis patients rapidly regain skin clearance following a treatment pause
Cosentyx has shown superior and sustained results versus both Stelara and Enbrel, delivering long-lasting clear or almost clear skin. -
News Vertex to acquire CTP-656 from Concert Pharmaceuticals for the treatment of cystic fibrosis
Vertex to develop CTP-656 for potential use in future combination regimens aimed at treating the underlying cause of CF. -
News GSK study shows Nucala significantly improves quality of life and lung function in severe asthma patients
Provides hope for patients with severe asthma, who currently have very limited treatment options. -
News Sandoz proposed biosimilar adalimumab demonstrates equivalent efficacy as Humira
Comprehensive development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. -
News First ever biosimilar of interferon beta-1a approved in Russia
Represents Biocad's third authorized medicine for the treatment of relapsing-remitting multiple sclerosis. -
News CDMO invests in system to boost pharmaceutical formulation development
Alcami will use the D8 DISCOVER HTS to add XRD capabilities to their laboratory service portfolio. -
News Allergopharma opens new biopharmaceutical production in Reinbek
Merck's €42 million investment expands the allergies business on a global scale. -
News Sanofi Pasteur and MedImmune collaborate on monoclonal antibody to prevent illnesses associated with RSV
MEDI8897 has been engineered to have a long half-life so that only one dose would be needed for the entire RSV season. -
News NICE expands positive recommendation for Erbitux as first-line treatment for RAS wild-type mCRC
More patients now able to receive a standard-of-care treatment with Erbitux plus Folfiri or Folfox. -
News Roquette commits to bioharma market with new products
Reinforces position as a supplier of excipients and raw materials for the pharmaceutical and biopharmaceutical industries. -
News Arquer Diagnostics awarded funding under Innovate UK’s Biocatalyst programme
Funding will be used to prepare for international clinical study to evaluate the Company’s ELISA-based urine test for prostate cancer. -
News Astellas and Affinivax announce worldwide partnership for MAPS vaccine targeting pneumococcal disease
Affinivax’s MAPS vaccine technology overcomes the limitations of current conjugate vaccine technology, creating a MAPS pneumococcal vaccine that enables broader protection. -
News Russia’s pharmaceutical market to double to $39 billion by 2021
Government plans to construct 10 factories for the manufacturing of biosimilars by 2020, with an additional investment of $265.3 million. -
News CPHI expands in Middle East & Africa with Abu Dhabi event in 2018
CPHI Middle East & Africa is a natural progression and rebrand of the rapid growth seen at CPHI Istanbul. -
News Lilly completes acquisition of CoLucid Pharmaceuticals
Acquisition enhances Lilly's existing pain management. -
News FDA accepts BLA for avelumab for the treatment of metastatic urothelial carcinoma for Priority Review
Second Biologics License Application accepted by the FDA for avelumab. -
News Pharma's most innovative companies; the 2017 ranking
Innovation is being driven increasingly by smaller, possibly more agile, companies. -
News Malvern launches MicroCal PEAQ-DSC for faster, more accurate characterization of protein and biomolecule stability
Supports a wide range of needs across the biopharma development cycle. -
News Merck launches integrity test system for verification of filters and processing equipment
New model incorporates an improved algorithm to simplify test creation and accelerate test completion. -
News Sanofi and Lonza join hands to establish large-scale biologics production facility
Partnership leverages Lonza's expertise in large-scale mammalian cell culture facilities alongside Sanofi's strength in developing and launching biologics based treatments. -
News CHMP recommends EU Conditional Marketing Authorisation for Natpar for patients with chronic hypoparathyroidism
If approved, Natpar would be the first licensed recombinant parathyroid hormone in Europe for the management of chronic hypoparathyroidism, the only endocrine-deficiency disorder with no hormone treatment. -
News Novartis receives positive CHMP opinion for Tafinlar + Mekinist in BRAF-positive NSCLC patients
If approved, Tafinlar + Mekinist will be the first targeted therapy specifically for NSCLC patients with a BRAF V600 mutation. -
News Endo Pharmaceuticals recalls one lot of Edex
Recall due to potential lack of sterility assurance. -
News Real-world data show lower risk of stroke and major bleeding for Pradaxa compared with warfarin
Compared with warfarin, Pradaxa was associated with a 26% reduced risk of stroke and a 20% reduced risk of major bleeding. -
News SGS platform provides modeling and simulation solutions for clinical trials
Tool explores the time course of drug exposure, biomarker response and outcome. -
News Updated Phase I Data show Bavarian Nordic's vaccine candidate induces broad and durable immune response against RSV
Antibody levels maintained against multiple targets 6 months post vaccination. -
News Tillotts Pharma in Germany dedicated to gastrointestinal health
Portfolio includes treatments for Crohn's disease, ulcerative colitis, and bowel preparation before endoscopy. -
News Repatha receives EC approval for new 420 mg single-dose delivery option
Approval of the automated mini-doser marks first hands-free administration option for a PCSK9 inhibitor in Europe. -
News NIH begins study of vaccine to protect against mosquito-borne diseases
Experimental vaccine targets mosquito saliva. -
News Cell lines and media for difficult to culture tumour types
Aids R&D initiatives to advance precision medicine. -
News Can yeast rise to the challenge of curing cancer?
Modified baker’s yeasts cause an immune response and the production of lymphocyte killers, which detect and eliminate cancerous cells. -
News 2016 leaves pharma facing stormy waters
EP Vantage Releases its Annual Pharma and Medtech Sector Review Reports for 2016. -
News Innova Biosciences introduces Magnetic Conjugation Kit
New kit enables covalent conjugation of antibodies and proteins to magnetic particles. -
News Recipharm completes strategic acquisition in India
The acquired business is now known as Recipharm Pharmaservices Private Ltd. -
News Russian Government drive to increase domestic manufacturing fuelling growth at CPHI Russia
Distributors, API manufacturers, and machinery providers seeing high demand across Russia and CIS. -
News New data in Crohn’s disease patients shows similar efficacy and safety profiles for Inflectra and Remicade
Trial data further supports the existing clinical profile of CT-P13 in inflammatory bowel disease. -
News Companies harness AI power to improve medication adherence
Unique sensor technology tracks inhalation profiles and technique. -
News Sartorius and EMBL join forces to offer advanced training and science education
Sartorius is offering its expertise to enhance scientific education and practice. -
News Phase II study supports potential for Genentech’s Tecentriq plus Avastin for people with mRCC
Study showed that people whose disease expressed PD-L1 and were treated with Tecentriq plus Avastin had a 36% reduction in the risk of their disease worsening -
News Vectura achieves £9 million royalty cap from GSK Ellipta products
Company achieves the £9 million calendar year royalty cap on net sales of Ellipta products a year earlier than previously guided. -
News FDA expands approval of Spiriva Respimat inhalation spray
Steroid-free Spiriva Respimat now approved as asthma treatment for age 6 and older. -
News Catalent completes Accucaps acquisition
Expands softgel development and manufacturing capabilities and capacity. -
News FDA accepts BLA for Mylan and Biocon's proposed biosimilar pegfilgrastim for review
The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer. -
News Valeant's treatment for plaque psoriasis gets FDA thumbs up for Siliq
More than 50% of patients in three clinical studies who used Siliq achieved total skin clearance within a year. -
News SGS expands elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France
Investment in a inductively coupled plasma mass spectrometry system is a move to address the updated ICH Q3D regulatory guidelines on elemental impurities. -
News Pharmapack Europe 2017 highlights new developments in pharma packaging and drug delivery
Trends include ‘human factor’ principles, with ‘individualised packaging and serialisation’ as the integral solutions of the future. -
News Generic and Biosimilar Manufacturers launch new brand and campaign
Generic Pharmaceutical Association becomes Association for Accessible Medicines. -
News Reig Jofre launches first dietary supplement for female androgenetic alopecia
Complidermol 5α PLUS tackles not only the known hormonal factor, but also the oxidative and inflammatory factors, new pathophysiological factors identified as causes of this condition. -
News EC approves once-daily Olumiant tablets for treatment of adults with active RA
Baricitinib, marketed as Olumiant, is the first JAK inhibitor approved to treat RA in the EU. -
News Alzheon to present new clinical data and analyses for ALZ-801
The presentations highlight Alzheon’s ‘precision medicine’ approach to drug development for Alzheimer’s disease.
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