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Site is also expected to house production of a new subcutaneous form of belimumab, which is currently under review with the FDA.

P-321 is a Phase II investigational topical treatment for dry eye disease.

One of the first companies to offer a generic version of Vytorin.

Alunbrig approved for ALK+ metastatic non-small Cell lung cancer patients who have progressed on or are intolerant to crizotinib.

Daklinza and Sunvepra combination approved for genotype 1b, the most common chronic hepatitis C (HCV) genotype in China; combination has a 91-99% cure rate.

New generation of bioreactors combined with new Flexsafe STR bags offer a fully scalable, single-use system.

Acquisition adds best-in-class body contouring business to Allergan's facial aesthetics, plastic surgery and regenerative medicine businesses.

Zenith Technologies surpasses the €20 million milestone for sales of its manufacturing execution system (MES) services.

CPHI North America will feature the first-ever Connect Conference.

NIH rat study suggests amitriptyline temporarily inhibits the blood-brain barrier, allowing drugs to enter the brain.

System allows tablet manufacturers to keep a record of tablet quantities by number of tablets, work order or batch information to ensure production is run efficiently.

Thiotepa is now available through Amneal Biosciences in both 100 mg/vial and 15 mg/vial as branded TEPADINA® (thiotepa) for injection. The product is supplied as a powder for solution in single-dose vials for intravenous, intracavitary, or intravesical...

Company has also installed a high pressure, precision roller compactor to further support the development of spray-dried dispersions.

Natpar is the first and only licensed recombinant human parathyroid hormone therapy for chronic hypoparathyroidism.

Transactions provide access to attractive pharmaceutical growth markets.

Monthly dosing schedule now approved in both US and EU.

Formulations can be delivered as spray, drop, solution, medical wipe or dermal patch.and offer non-touch applications.

Novartis and Amgen to co-commercialize AMG 334 (erenumab) in the US; Novartis to gain exclusive rights in Canada,

Is the largest single investment Sartorius Group has made outside Goettingen in the current year.

The first intranasal neurostimulating device proven to temporarily increase tear production.

Marken has launched a 24 hour, 7 day a week call center for patients enrolled in clinical trials. The call center, known as Marken’s Patient Communication Center, is based in Philadelphia (USA) and is dedicated to the logistics needs of patients who pa...

First live demo of PLG’s powerful new AI-based social media listening solution, PLG inVolv, designed to help life sciences firms meet their pharmacovigilance obligations.

Significant investments in Bensheim headquarters; consistent portfolio additions; cleanroom expansion in China.

The $750k investment is intended to produce CTM for clinical studies up to Phase II for non-sterile dosage forms, including metered dose inhalers and semi-solid topical products.

The Phase III study compared abemaciclib in combination with an aromatase inhibitor versus an aromatase inhibitor alone in patients with HR+, HER2- advanced breast cancer.

Company has invested €300,000 into the project, which is part of a wider €40 million investment into new serialisation technology and processes to comply with the European Falsified Medicines Directive.

Company receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers.

Primary endpoint of significant reduction in liver fat achieved following 16 weeks of treatment with BMS-986036.

Website can help inform global health strategies to mitigate the threat of antimicrobial resistance.

The GMP-compliant ethanol extraction facility will ensure ample supply of cannabinoid-based raw materials for future product development and innovation.

An investment of more than 2 million euro over 3 years is planned to launch new events and resources.

Treatment could help to reduce the number of days lost to migraine.

Fully scalable system streamlines drug development and production.

Finneran bringing glass, plastics and assembly manufacturing capabilities and strong US distribution.

Merck is opening its compound library to DNDi to help find cures for leishmaniasis and Chagas disease.

Combined company well capitalized with $90 million in funding to advance discovery and development.

$130M USD investment to support growing market demand.

Increases Cardinal Health's product breadth in consumable medical products.

Capacity increase in response to customer demand for DNA and viral vector production.

First and only medicine FDA-approved to treat all forms of diabetic retinopathy.

Collaboration focused on Phase 2II clinical trial to evaluate use of Allergan's Cenicriviroc and Novartis' lead FXR agonist to treat NASH.

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.

Additional clinical data are needed to determine the most appropriate doses.

Two separate agreements with Biogen and Roche.

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...

AB569, which consists of two active ingredients, sodium nitrite and EDTA, has a novel mechanism of action that differs from that of antibiotics.

Efficient alternative to distillation.

The company's small molecule drug program is aimed at treating cancer and autoimmune diseases .

Study to evaluate potential of APX005M plus Opdivo to activate antigen-presenting cells in the tumour micro-environment to demonstrate enhanced anti-tumour activity.

Henrik Stenqvist will be based at the company's HQ in Sweden.

Collaboration to advance oral microbial consortia products developed by using NuBiyota’s microbiome platform for GI indications.

Drug discovery software specialists combine expertise to extend studies into drug metabolism modelling.

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®.

Industry leading further education programs unified and expanded.

Results showed that people treated with Alecensa lived significantly longer without their disease progressing compared to crizotinib when given as initial (first-line) treatment.

Company has achieved an annual energy intensity improvement of more than 3% globally, contributing to an 11.4% reduction in energy consumption since 2010.

 “Synthetic biomarkers” could be used to diagnose ovarian cancer months earlier than now possible.

Bosch showcases i4.0 solutions live at Interpack.

Botox is currently being studied as a potential treatment option for adult patients with moderate to severe MDD.

First HCV direct-acting antivirals approved for use in adolescents.

CRL relates to Merck's sNDA for Januvia, Janumet and Janumet XR.

Agreement terms are "favourable for both parties".

ECF843 is a new therapeutic approach and potential first-in-class Rx treatment in dry-eye.

RedHill expects to initiate US promotion of its two commercially-available gastrointestinal specialty products, Donnatal and EnteraGam, in mid-2017.

Greater filtration capacity with a smaller footprint than conventional filters, improving economics for biopharmaceutical manufacturing.

First launch of product using FOX smart nebuliser.

Phase I clinical study of KITE-585 in patients with multiple myeloma planned for 2017.

David Meeker will leave the company at the end of June after a 23-year career with Genzyme and Sanofi.

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...

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...

The five-fold increase in capacity reflects growing demand for cold chain services.

Kit for confirming successful antibody-biotin conjugation.

Applications include data from the largest international trial conducted in multiple myeloma.

Company's CAPA addresses the three Form 483 observations.

Will fund a new manufacturing, packaging and distribution facility.

New indication of Tafinlar and Mekinist in advanced NSCLC provides only therapy approved in the EU for BRAF V600-positive NSCLC.

Represents the latest combination therapy now available for the millions of patients living with COPD in the US.

New magnetic resonance technologies and applications open new frontiers for biological, chemical and materials research and routine analysis in pharmaceutical and chemical industries.

Speakers to include leaders from Santen, EMVO, Recipharm, MIT.

Recall will extend to additional markets in Europe, Asia, North and South America.

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.

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...

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...

Installation of state-of-the-art Harro Hӧfliger encapsulation unit expands clinical- and commercial-scale capacity for dry powder inhalation applications.

ImpactAir high performance air sampler range joins Cherwell’s portfolio of cleanroom microbiology products.

Inspection of up to 600 glass containers per minute using unique group testing.

Cold-EEZE is now Mylan's largest US consumer healthcare brand.

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.

US commercial launch planned for late April.

Part of a longer term plan to increase capacity.

Offers more flexibility, better supply predictability and shorter lead times for more efficient and safer drug manufacture.

System can achieve separations with higher resolution, reproducibility and recovery then has previously been possible.

New production method for solid dispersions of docetaxel and paclitaxel.

Canada first country to launch Fiasp.

First targeted biologic therapy for adults with moderate-to-severe atopic dermatitis.

Unique mechanism: glutamate modulation and voltage-gated sodium channel blockade.

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.

Trumenba has been studied in a global clinical development program evaluating the vaccine in adolescents and adults.

Provides a cleaner, renewable energy source to reduce costs and lessen the CRO facility's impact on the environment.

Opdivo already approved by the EC for six indications in four distinct tumour types.

First NCE approved for PD patients with motor fluctuations in the US in more than a decade .

Significant investment in manufacturing diabetes medicines continues with new $85 million commitment in Indianapolis.

More than 80 contract manufactures were assessed by 26 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey.

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.

Developments correspond to generic products based on specialized pharmaceutical technologies.

Partnership to collaborate with industry to reduce risk and ensure optimal compliance for all members of the pharmaceutical supply chain.

New site will be used to complete premium injectable elastomeric component manufacturing.

The two new systems offer faster method development and the ability to quantify multiple proteins simultaneously.

PharmaCote ECxtra eliminates problems encountered during the hard chromium coating process.

5800-m2 facility will provide a range of GMP pharmaceutical testing services.

CDMO will manufacture and deliver Emla Patch - a local anaesthetic product.

TLE400 is a fixed-combination containing Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg.

Patients studied in the trial were reflective of those undergoing catheter ablation in routine clinical practice, providing highly relevant data to treating physicians.

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%.

Agonists for GIT, CD27 and CD40 receptors in development for cancer immunotherapy exhibit significant in vitro- and in vivo activities.

New use of insulin was also reduced by 29% among patients taking Entresto compared to enalapril-treated patients.

Team led by Dr David Brough awarded £191,757 by public-private initiative driving early-stage drug discovery programmes.

Greater filtration capacity with a smaller footprint than conventional filters, improving economics for biopharmaceutical manufacturing.

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...