All News

Agreement is the first step in TPI Enterprises’ plan to expand its presence in the UK market.

AB-SA01 meets primary endpoints of safety and tolerability and reduces S. aureus bacterial load in all patients.

Labeling revisions also include updates to corresponding warning and addition of clinical data on superior efficacy of Chantix compared with bupropion or nicotine patch.

Pharmapack 2017: focus on tailor-made packaging. solutions

Guidelines include new recommendation to consider the use of Jardiance in people with type 2 diabetes and established cardiovascular disease to reduce the risk of cardiovascular death.

The new automated mini doser with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration.

Authorized generic offered at more than 50% below wholesale acquisition cost of EpiPen auto-injector.

In its decision, the jury also concluded that Gilead “willfully” infringed upon the patent.

The project aims to create a step-change in the capabilities of current bioproduction methods, meeting unmet needs in the field of viral vector production.

apceth Biopharma will perform clinical manufacturing, process validation activities and commercial manufacturing for LentiGlobin and Lenti-D drug product.

Acquisition will make Lonza a fully integrated solutions provider in oral delivery technologies and active ingredients to the consumer healthcare and nutrition markets.

Catalent Biologics will employ its proprietary GPEx cell line technology and ambr workstation to develop, optimize the process for expression, and manufacture antibodies for further investigation by MVI and its partners.

Phase IV study demonstrates a lack of improvement in progression-free survival in patients with chemotherapy-naïve metastatic CRPC whose prostate-specific antigen has previously progressed on Xtandi.

Laboratory and office facility to be constructed on the site by 2019.

Several late-stage pipeline drugs are expected to achieve blockbuster status by the end of 2022,

CDMO appoints Anders Högdin and Aaron Small to lead the growth of its pharmaceutical development services business in the US and Europe.

New shareholder, Axxamof Milan, Italy, will transfer certain therapeutic assets to the R&D programs of Acousia.

Additional storage expansion strengthens the facilities’ ability to meet increased customer demand in prefilled syringes.

Company will also close its Hopewell, New Jersey site and will not renew its lease at the Lake Union Steam Plant site in Seattle, Washington.

New once-a-day formulation indicated to improve blood sugar when used along with diet and exercise.

Actions will help to improve the company's financial profile.

Company expects the generic capsules will save up to $500 million during this upcoming season.

Users of LyoSpeed on Series 3 HT Evaporators report a greater percentage of samples yield dry powders than they have previously been able to achieve.

Acquisition would "fit perfectly with Lonza's Healthcare Continuum strategy".

Pharma manufacturers are feeling encouraged to explore new possibilities.

Lucentis the only treatment available for a wide range of CNV conditions.

"MEDI1814 has a unique mechanism among antibodies in clinical development and could provide a distinct approach to treating Alzheimer's disease."

New company will develop, to proof-of-concept, AP-101, a human monoclonal antibody targeting misfolded SOD1 for the treatment of amyotrophic lateral sclerosis.

Clinically proven and cost-effective solution for gastroesophageal reflux disease recently launched in China.

MJR technology offers reformulation options that can lead to a superior profile for an API.

Pharma giant says it complied with established competition law.

Helps shape better supply chain to pharmaceutical and healthcare Industries.

Move will allow the company to focus efforts and resources more fully on its core US Branded assets.

Investment enables the CDMO to provide a one-stop-shop service from lab-scale development to manufacturing of clinical batches and dossier compilation to specialised commercial manufacturing.

Combining nivolumab and ipilimumab could provide significant tumour reduction.

The deal allows Lonza to fully focus on developing its other technologies.

Collaboration will explore the potential of novel applications of Albumedix’s albumin-based drug delivery platform, Veltis.

SP Scientific's whitepaper emphasis the importance of using external washers to remove particles from the outside of vials.

Brings specialist knowledge of modified release technologies, polymer engineering and science, solids, liquids, semi-solids, nasal delivery, and the switch from prescription to OTC medications

Site will use the latest bioprocessing techniques and will employ flexible production strategies to enable it to supply both clinical- and commercial-scale products.

The CDMO’s initiatives include laboratory research for the preparation of APIs, with a particular focus on chiral molecules and emphasis on the principles of sustainable development and ‘green chemistry’.

If approved, the product could provide blood cancer patients with access to potentially life-saving medicine.

UCL pioneers the engineering of novel nanoscale drug delivery vehicles, which can be tuned to release a range of cargos.

The only oral T2D medicine to provide a life-saving cardiovascular benefit.

Represents a potentially novel disease-modifying therapeutic option.

Haemopharm, a pioneer in the manufacture of flexible bags for sterile solutions and dialysis, will demonstrate a novel system for formulating and administering medication at the bed-side. Fillchoice® room is a medical device that provides a compounding...

The new product, Laccure Pessary, will be manufactured, packaged and distributed globally from Recipharm’s facility in Karlskoga that specialises in the production of semi-solid products.

The Dolphin brand is currently the third largest on the Russian market for nasal rinsing.

As regulatory pressure increases companies are saving time and money with effective extractables and leachables programmes.

The added space will house state-of-the-art clean rooms and integrated best-in-class vision equipment.

T2DM therapies are capable of modifying the activity of insulin in the brain.

New entrants, as well as smaller companies, will expand the use of cell culture-based manufacturing methods to increase their presence.

Company to invest more than 100 million euro in dengue vaccine manufacturing plant in Germany

Partnership combines MolPort’s 6.3 Million HTS Compounds with StarDrop’s data analysis and compound design capabilities.

Enables detailed control in thawing of cell and gene therapies.

If approved by the FDA, avelumab could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

The silicone capmats reseal after each piercing and may be re-pierced many times without loss of function.

Mechanical thrombectomy is a more effective treatment than clot-busting drugs alone for acute stroke caused by blockage of a large blood vessel by a clot.

Company gains additional API capacity and major supply agreement with Roche

Jean Vuillecard, Innovation & Product Manager, and Eric Dessertenne, Head of Business Development, define the limitations of traditional strategies to train, educate and track patient adherence with inhaled therapeutics and show how connectivity and ot...

Company acquires two state-of-the-art facilities offering integrated softgel development, manufacturing and packaging.

Enables standardization and audit of remote freezing and thawing.

The license allows Mylan to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of hepatitis C virus.

No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks.

Collaboration already demonstrating successful path towards discovery and development of novel anti-infective drug candidates.

The increase in diagnosed prevalent cases and the launches of interleukin (IL)-17 inhibitors, such as Eli Lilly’s Taltz and AstraZeneca’s Lumicef, will drive the market.

Domestic sales identified as chief driver behind unexpected rise in revenues.

It's anticipated that 65% of the total NSCLC market will go to immuno-oncology therapies.

Opdivo is now the first and only PD-1 inhibitor approved for a hematologic malignancy in the European Union.

Rephine awarded “Industry Partner of the Year”

Lilly's solanezumab fails to meet primary endpoint of Phase III study.

Chase acquisition adds a new Phase III ready program for Alzheimer's disease to Allergan portfolio.

Pomalidomide available to people in England immediately via the Cancer Drugs Fund.

Many companies embracing alternative funding sources, such as angel investors, as investments from VC firms continue to decrease.

Studies suggest calcilytics may represent effective future asthma therapeutics.

The asthma and COPD treatment will be delivered using Vectura’s proprietary dry powder inhalation technology and device.

The company will create a cross-disciplinary Kendall Square campus, with teams spanning research, clinical development, medical affairs, business development and other related functions.

The type 2 diabetes treatment for adults will be delivered using SoloStar technology.

The XEN Glaucoma Treatment System reduces intraocular pressure in patients with refractory glaucoma.

The event was a great success with an overwhelming response.

Indication now includes use in children 6 months and older.

Grant will be used to tackle one of the biggest bioproduction problems currently facing the industry

Deal followed results of Phase II SUSTAIN study of SelG1 in reduction of vaso-occlusive pain crises, a major complication of SCD with limited treatment options.

ITCA 650 is the first investigational drug to use Intarcia's disruptive Medici Drug Delivery System to deliver chronic medicines just once or twice yearly.

Second Phase III study confirms results from previous studies.

BI 695502 met all the pre-defined primary and secondary endpoints in the INVICTAN-1 study.

The OPTICORE coating technology allows targeted drug release in the large intestine to improve local and/or systemic drug bioavailability.

For patients this could mean more are able to achieve a normal life expectancy, without compromising on their quality of life.

INTERSCIENCE catalog

Will coordinate and organize the company’s existing initiatives in sustainability and maximizing social impact, and its employee-driven community programs.

Therapeutic vaccines will increase the overall survival of poor-performance-status patients, and enable more rounds of treatments to be given, thus driving market growth.

Trial results also provide a cost-saving argument for introducing Smartinhaler into routine practice.

Coating acts as an effective barrier to many of the extractables and leachables that can be released from the elastomer.

Treatment provides the opportunity for fewer infusion sites and shorter infusion durations.

Novo Nordisk’s N9-GP and CSL-Behring’s CSL-689 are expected to be launched in the forecast period and capture significant market share.

The acquisition reflects growing demand for the specialist packaging solutions for powders, minitabs or granules into stickpack sachets.

CSL112 is being developed to reduce the high incidence of early recurrent cardiovascular events.

The spin-off of Bioverativ is on track to be completed in early 2017.

Titan Enterprises offers online informative and unbiased guidance document.

Nearly two-thirds of patients experienced plaque regression with Repatha on top of optimized statin therapy.

Two-thirds of pharmaceutical manufacturing is outsourced; preferred providers pick up largest share.

There are 90 pipeline cannabinoid products, including two in Phase III development.

Data in Japan, China and South Korea will form basis of new regulatory submissions for Benlysta.

The company’s insurance carrier will make a cash payment of $2.0 million to NRM.

Company prepares to start the production of sterile anti-infective injectable products at this site during 2018.

Avecia's Milford site is expected to be the largest cGMP oligonucleotide facility in the world.

First treatment advance for secondary hyperparathyroidism in more than a decade.

Is the only oral type 2 diabetes medicine shown to reduce the risk of cardiovascular death.

Treatment combines two widely used and complementary medicines into a single daily injection for people with type 2 diabetes who are struggling to keep their blood sugar levels under control.

Treatment proven in a Phase III trial to significantly extend overall survival for patients with recurrent or metastatic squamous cell head and neck cancer.

New services to enable US biopharmaceutical companies to accelerate development of biosimilars.

The first study initiated as part of this agreement is a Phase III registrational trial evaluating Kyprolis in combination with Darzalex and dexamethasone compared to Kyprolis and dexamethasone alone.

Taytulla 1 mg/20 mcg will provide women with a new and effective option.

CDMO to invest in its facility in Hlohovec, Slovakia, to increase the scale at which it can perform wurster coating of the pellets.

Screening method provides a potential new approach to repurpose known drugs and compounds.

Research has shown that boosting immunity in the nose and lungs may be the best way of increasing defence against RSV.

Currently, there is no available drug that can treat the negative symptoms of schizophrenia, according to GlobalData.

Biologics and monoclonal antibodies to become a bigger presence within the small-molecule-dominated landscape.