All News
All news
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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. -
News Quotient Clinical acquires CDMO from CRL
Acquisition paves the way for Quotient to replicate its Translational Pharmaceutics platform in America. -
News Janssen's two-drug combination demonstrates efficacy in maintaining viral suppression
If approved, this treatment could be the first two-drug regimen for HIV. -
News Aker BioMarine to Build New Krill Vessel
Aker BioMarine has commissioned a new environmentally-friendly krill fishing vessel for NOK 1 billion. The vessel will be constructed in Norway by VARD -
News Scottish CMO opens US office
Symbiosis Pharma now able to offer East and West Coast clients small-scale aseptic manufacturing capabilities to support clinical trials. -
News Hikma's exclusive licensing agreement with Orion for its new Easyhaler product in MENA
Easyhaler is a dry powder inhaler for the treatment of asthma and COPD. -
News Top pharmacovigilance trend in 2017
The Expanding role of pharmacovigilance in rapidly changing regulatory and commercial climates. -
News Ferring backs Foresee's SIF platform for controlled-release formulations
Foresee technology can help to develop stable, formulated peptides in solution for controlled-release therapy for 3- and 6-month durations of action after a single injection. -
News Aquarium-to-bedside drug shows promise in small pediatric trial
NIH-funded research suggests zebrafish models may be efficient resource for identifying drugs for clinical use. -
News Pharma exhibitors at CPHI South East Asia use event to expand sales regionally
Favourable macro trends will be reflected at CPHI South East Asia where domestic manufacturers are increasingly attending the event, with a view to opening up sales in international markets. -
News First patient enrolled in Phase II study evaluating JZP-110 for excessive sleepiness in Parkinson's disease
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor. -
News ChinaSavvy lands $1.3 million engineering contract to supply components for high-tech storage systems
The initial US$1.3 million order is to supply components for ultra low temperature robotic storage systems in the US to major pharmaceutical companies. -
News Pharma Explained: TEST
In the first video in our new series; Pharma Explained, Francess Zipp of Lachman Consultants explains why Good Manufacturing Practices (GMPs) are important and how a strong quality risk management system can ensure adherence to the GMPs. -
News I Holland launches innovative tool coating PharmaCote ECxtra
PharmaCote ECxtra has been developed to stop the issues encountered by hard chrome, but still provide a coating that provides excellent tooling protection. -
News Appeals Court grants stay of permanent injunction for Praluent during appeals process
Praluent continues to be available to patients in the US. -
News Afatinib to be evaluated in combination with pembrolizumab in new trial for patients with SqCC of the lung
Boehringer Ingelheim to conduct trial in collaboration with a subsidiary of Merck (MSD). -
News Designer compound may untangle damage leading to some dementias
NIH-funded preclinical study suggests a possible treatment for Alzheimer’s disease and other neurodegenerative disorders. -
News Austrian Centre of Industrial Biotechnology and GE Healthcare establish a cell line engineering collaboration
Partnership to explore and identify new tools and methods to modify and optimize the CHO cell line performance. -
News Integrated DNA Technologies acquires oligo manufacturing business of GeneWorks
IDT expands its capacity for direct sales of genomic products in Asia-Pacific region. -
News New OTC product with unique technology to help allergy sufferers
GSK launches Flonase Sensimist allergy relief nationwide. -
News Lilly's Trulicity label updated to include use in combination with basal insulin for adults with type 2 diabetes
Trulicity is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine. -
News FDA approves first new treatment in more than a decade for secondary HPT in adults on hemodialysis
Intravenous administration puts delivery in hands of healthcare provider. -
News Dr Reddy's expands commercial operations in Europe
Company to introduce its portfolio of generics in France. -
News Pharmapack Europe Award Winners 2017 – 20 years of innovation
Vial injector, pharma compliance pack, smart packaging and autoinjector for prefilled syringes named best innovations in 2017. -
News TTP Labtech partners with Genedata to provide out-of-the-box data analysis for high throughput screening
The partnership will integrate Genedata Screener software with TTP Labtech’s acumen Cellista and mirrorball to improve screening data management. -
News Smart Pill Bottle receives the Good Design Award 2016
Personal medical device leveraging "Internet of Things" technologies to address medication adherence. -
News STA Pharma expands R&D team at is Changzhou site
By the end of 2017, company plans to increase to 230 process chemists and 70 analytical chemists. -
News Amgen's Repatha significantly reduced the risk of cardiovascular events in FOURIER outcomes study
Landmark Repatha cardiovascular outcomes study meets primary and key secondary endpoint. -
News Frutarom Health increases phytopharmaceutical capacity
Acquisition of Extrakt Chemie and site investments in people, equipment, manufacturing buildings and new offices increases company's position in Germany. -
News Medical marijuana market size to reach USD 55.8 billion by 2025
The growing number of states and countries getting approval for using marijuana in therapeutic applications is a crucial factor driving the demand over the coming few years. -
News FDA accepts two sBLAs for Merck's Keytruda for metastatic urothelial cancer
Keytruda also receives Breakthrough Therapy Designation for second-line treatment. -
News The Safelia autoinjector wins the ‘Exhibitor Innovation’ Award at Pharmapack
A team of industry experts reward Nemera’s autoinjector with a Pharmapack Award as best innovation product. -
News FDA approves BMS's Opdivo for bladder cancer
Opdivo has now been approved in six tumour types in just over 2 years. -
News Meet Pharmaffiliates at CPhI Istanbul 2017 (8-10 March 2017)
It is our pleasure to inform you that We Pharmaffiliates will be present in CPhI Istanbul 2017 which is being held at Istanbul, 8-10 March 2017. We will be open to meet all the Pharmaceutical Technocrats & Commercials and to discuss ... -
News Meet Pharmaffiliates at CPhI North America 2017 (16-18 May 2017)
It is our pleasure to inform you that We Pharmaffiliates will be present in CPhI North America 2017 which is being held at Philadelphia, 16-18 May 2017. We will be open to meet all the Pharmaceutical Technocrats & Commercials and to ... -
News Reach Separations celebrates 5th birthday with record year
The company’s growth has been driven by export, with a three-fold increase in activity outside of the UK during 2016, -
News Leukocare signs up to become Rentschler's specialized tech partner and formulation developer
Rentschler will become the first and only CDMO to have access to Leukocare's patented SPS formulation technologies. -
News KBI Biopharma expands services, including cell therapy manufacturing, through acquisition
Acquisition provides fully equipped facilities for the development and manufacture of clinical stage cellular therapy products, including three ISO7 cGMP manufacturing suites, extensive flow cytometry and analytical infrastructure.
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