All News
All news
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News BMS-986036 shows consistent improvement in liver fat, liver injury and fibrosis in patients with NASH in Phase II trial
Primary endpoint of significant reduction in liver fat achieved following 16 weeks of treatment with BMS-986036. -
News Pfizer unveils ATLAS, an Interactive, website that provides global antibiotic resistance surveillance data across 60 countries
Website can help inform global health strategies to mitigate the threat of antimicrobial resistance. -
News CanniMed Therapeutics commences cannabis oils facility expansion
The GMP-compliant ethanol extraction facility will ensure ample supply of cannabinoid-based raw materials for future product development and innovation. -
News World’s largest society for regulatory professionals increases investment in Europe
An investment of more than 2 million euro over 3 years is planned to launch new events and resources. -
News Lilly to present data for galcanezumab for the prevention of migraine at the AAN annual meeting
Treatment could help to reduce the number of days lost to migraine. -
News BioInvent expands manufacturing facility with Mobius bioreactors from Merck
Fully scalable system streamlines drug development and production. -
News Porvair acquires J.G. Finneran Associates
Finneran bringing glass, plastics and assembly manufacturing capabilities and strong US distribution. -
News Merck partners with Drugs for Neglected Diseases initiative
Merck is opening its compound library to DNDi to help find cures for leishmaniasis and Chagas disease. -
News Nivalis Therapeutics and Alpine Immune Sciences agree to merge
Combined company well capitalized with $90 million in funding to advance discovery and development. -
News Fujifilm increases production capacity and establishes new process development facilities
$130M USD investment to support growing market demand. -
News Cardinal Health to acquire leading patient product portfolio from Medtronic for $6.1 billion
Increases Cardinal Health's product breadth in consumable medical products. -
News Cobra Biologics embarks on £15 m gene therapy manufacturing operations expansion
Capacity increase in response to customer demand for DNA and viral vector production. -
News FDA approves Genentech’s Lucentis for diabetic retinopathy
First and only medicine FDA-approved to treat all forms of diabetic retinopathy. -
News Allergan expands leading R&D NASH Program with Novartis Clinical Collaboration
Collaboration focused on Phase 2II clinical trial to evaluate use of Allergan's Cenicriviroc and Novartis' lead FXR agonist to treat NASH. -
News Cobra Biologics Embarks On £15m (165m SEK) Gene Therapy Manufacturing Operations Expansion
Over the next two years Cobra will invest up to £15m (165m SEK) on a phased expansion plan, supporting the company’s R&D expertise in developing rapid and cost effective viral vector and DNA plasmid production platforms. -
News FDA issues complete response letter for baricitinib
Additional clinical data are needed to determine the most appropriate doses. -
News BMS to license anti-eTau and anti-myostatic compounds
Two separate agreements with Biogen and Roche. -
News Scale Up in the pharmaceutical Industry
In the present application from the pharmaceutical process development, the aim is to transfer processes from the 70ml reactor into the 25lt scale, as efficiently and reproducibly as possible. In most cases, such a scale-up step takes place in differen... -
News Arch Biopartners' lead anti-bacterial drug candidate to enter investigator-sponsored Phase I human trial
AB569, which consists of two active ingredients, sodium nitrite and EDTA, has a novel mechanism of action that differs from that of antibiotics. -
News Bosch launches new WFI system at interpack
Efficient alternative to distillation. -
News Regen BioPharma sees success in Its pre-clinical small molecule optimization program for NR2F6
The company's small molecule drug program is aimed at treating cancer and autoimmune diseases . -
News BMS and Apexigen collaborate to evaluate Opdivo in combination with APX005M in advanced solid tumours
Study to evaluate potential of APX005M plus Opdivo to activate antigen-presenting cells in the tumour micro-environment to demonstrate enhanced anti-tumour activity. -
News Recipharm appoints new CFO
Henrik Stenqvist will be based at the company's HQ in Sweden. -
News Takeda enters into strategic collaboration with NuBiyota for microbiome therapeutics
Collaboration to advance oral microbial consortia products developed by using NuBiyota’s microbiome platform for GI indications. -
News Lhasa and Optibrium enter research and product development collaboration
Drug discovery software specialists combine expertise to extend studies into drug metabolism modelling. -
News Amneal Introduces Its First Nasal Spray: Generic Nasonex®
Amneal Pharmaceuticals LLC has launched mometasone furoate nasal spray, the company’s first pharmaceutical product in spray form. Mometasone furoate, available in 50 mcg/spray strength, is an AB-rated therapeutic equivalent to Nasonex®.
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News Colorcon launches Colorcon Academy
Industry leading further education programs unified and expanded. -
News Phase III study shows Genentech’s Alecensa was superior to crizotinib in a specific type of lung cancer
Results showed that people treated with Alecensa lived significantly longer without their disease progressing compared to crizotinib when given as initial (first-line) treatment. -
News BMS earns ENERGY STAR Partner of the Year Award for third consecutive year
Company has achieved an annual energy intensity improvement of more than 3% globally, contributing to an 11.4% reduction in energy consumption since 2010. -
News New technology can detect tiny ovarian tumours
“Synthetic biomarkers” could be used to diagnose ovarian cancer months earlier than now possible. -
News The connected factory - a reality for the process and packaging industry
Bosch showcases i4.0 solutions live at Interpack. -
News Allergan reports topline Phase II data supporting advancement of Botox for the treatment of MDD
Botox is currently being studied as a potential treatment option for adult patients with moderate to severe MDD. -
News FDA approves new indications for Harvoni and Sovaldi
First HCV direct-acting antivirals approved for use in adolescents. -
News Merck receives CRL from the FDA for TECOS study with sitagliptin
CRL relates to Merck's sNDA for Januvia, Janumet and Janumet XR. -
News Hikma enters into settlement agreement with Jazz for sodium oxybate
Agreement terms are "favourable for both parties". -
News Novartis to strengthen R&D pipeline by in-licensing ECF843 for ophthalmic indications
ECF843 is a new therapeutic approach and potential first-in-class Rx treatment in dry-eye. -
News RedHill Biopharma signs exclusive US license from Entera health for commercial GI product EnteraGam
RedHill expects to initiate US promotion of its two commercially-available gastrointestinal specialty products, Donnatal and EnteraGam, in mid-2017. -
News Millipore Express high area filters ideal for processing feed streams with high particulate levels
Greater filtration capacity with a smaller footprint than conventional filters, improving economics for biopharmaceutical manufacturing. -
News Vectura partner launches Breelib nebuliser in Poland
First launch of product using FOX smart nebuliser. -
News Kite presents promising preclinical data from KITE-585, a fully human anti-BCMA CAR T-cell product candidate
Phase I clinical study of KITE-585 in patients with multiple myeloma planned for 2017. -
News Sanofi appoints Bill Sibold Executive Vice President Sanofi Genzyme and Member of the Executive Committee
David Meeker will leave the company at the end of June after a 23-year career with Genzyme and Sanofi. -
News GS1 standards are vital for pharma serialization
Earlier this month, Verify Brand contributed a byline to Pharmaceutical Commerce about the importance of standards. We recently announced that Verify Brand made platform enhancements to the existing functionality of our software’s G... -
News GS1 standards are vital for pharma serialization
Earlier this month, Verify Brand contributed a byline to Pharmaceutical Commerce about the importance of standards. We recently announced that Verify Brand made platform enhancements to the existing functionality of our software’s G... -
News Catalent expands Kansas City clinical storage and secondary packaging capabilities
The five-fold increase in capacity reflects growing demand for cold chain services. -
News Innova Biosciences introduces Biotin Check&Go! Kit
Kit for confirming successful antibody-biotin conjugation. -
News Amgen submits applications in the US and Europe to expand current indication for Xgeva
Applications include data from the largest international trial conducted in multiple myeloma. -
News FDA now happy with Alkem's API facility
Company's CAPA addresses the three Form 483 observations. -
News Sharp announces £9 million investment
Will fund a new manufacturing, packaging and distribution facility. -
News Novartis drug combination Tafinlar + Mekinist receives EU approval for BRAF V600-positive advanced NSCLC
New indication of Tafinlar and Mekinist in advanced NSCLC provides only therapy approved in the EU for BRAF V600-positive NSCLC. -
News Launch of Utibron Neohaler in the US
Represents the latest combination therapy now available for the millions of patients living with COPD in the US. -
News Bruker introduces novel NMR solutions at ENC 2017
New magnetic resonance technologies and applications open new frontiers for biological, chemical and materials research and routine analysis in pharmaceutical and chemical industries. -
News TraceLink announces NEXUS 17 keynote speakers
Speakers to include leaders from Santen, EMVO, Recipharm, MIT. -
News Mylan expands voluntary recall of EpiPen
Recall will extend to additional markets in Europe, Asia, North and South America. -
News BMS and Incyte to advance the combination of Opdivo and Epacadostat into first-line registrational trials
Companies to initiate Phase III registrational trials in first-line NSCLC across the spectrum of PD-L1 expression and first-line head and neck cancer in 2017. -
News PCI Pharma Services Announces Significant expansion in Serialization technology
We are pleased to announce a significant expansion of our market leading Serialization capability. We will increase Serialization capacity across our global supply network to support clients in advance of meeting both US DSCSA and EU FMD implementation... -
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.
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