Market News

China and India tipped to become the highest revenue-generating emerging market for generic drug manufacturers in the next 5 years.

Gavi allows freezing of oocytes and embryos at key stages, whereas Geri medium supports undisturbed embryo growth.

Opadry QX is a new tablet film coating, designed to meet the manufacturing flexibility, batch consistency and efficiencies.

HPAPI growth driven by virtual and mid-sized pharma, with biosimilars expanding rapidly in Europe.

The CDMO will specialise in delivering API development and manufacturing solutions.

As part of the serialisation roll-out, the CDMO has developed a unique pricing model which spreads the cost of the process across each customer’s ongoing supply agreement, removing the need to make any upfront investment.

Company to expand its activities in R&D/QC testing, and to offer new analytical services to clients.

Adds speed and flexibility for small-scale API production.

MEDI2070 is in development as a next-generation IL-23-only targeted therapy for Crohn's disease and ulcerative colitis.

Assemblies save up to 60% on processing time and offer a safe approach to ultrafiltration of biologics and vaccines.

James O’Brien will lead the company's manufacturing execution system business to its next phase of growth.

Will enable manufacturers to reduce costs by eliminating cleaning and validation requirements, as well as hardware infrastructure.

The reductions are expected to affect R&D units and headquarter staff functions.

New site expands the company's global operations for small molecule and biologics manufacturing, and marks the company's first manufacturing presence in Asia.

New long-term collaboration to develop next generation oncolytic virus platform and lead candidate VSV-GP.

The company will exhibit and demonstrate a range of instruments and consumables from the liquid handling portfolio, including: pipettes & tips, manual and electronic dispensers and automated pipetting systems.

Providing value added development services will allow participants to edge out competition, finds Frost & Sullivan's Transformational Health team.

Main drivers of this substantial growth include medical tourism, a lack of strict price regulation, a rising disease burden, and a lack of dependence on imported branded products.

The HMI 4.0 is suited for both stand-alone machines and entire lines and provides an interface for data collection, data sharing and visualization

The technology controls the freezing stage of the freeze drying process for more consistent and repeatable outcomes that aid drug development, scale-up and production efforts.

The new laboratories will enable pharmaceutical companies to test various topical and transdermal formulations for both new and existing drugs.

Removes protein aggregates and other impurities in high pH and high conductivity mAb feed streams.

Continuous processing at a ‘tipping point’, with CDMO implementation over next 3 years, but the industry needs a better definition of what ‘continuous’ means.

Acquisition of PharmaCore’s portfolio also complements Cambrex's existing large-scale, multi-purpose manufacturing facilities in the US and Europe.

Company to continue to operate as one company with two distinct and complementary businesses to retain operating strength and financial flexibility.

Funds will be used for Phase II development and manufacturing.

Innovative excipients for controlled release including, new biodegradable, biocompatible polymers for sustained release injectables and Parteck SRP 80 for oral solid formulation.

Comprehensive roadmap lays out key commitments the pharmaceutical companies pledge to deliver by 2020 to reduce antimicrobial resistance.

Jeremy Drummond will focus on growing the CDMO’s API and finished dosage form development and manufacturing business in Europe and North America.

Alliance will be extended to include Dow’s advanced technology-based pharmaceutical excipients.

Fully integrated site from raw material to API, formulation, filling and finish.

Viventia’s Lead Product Candidate, ViciniumTM, being developed for high-grade non-muscle invasive bladder cancer, with topline Phase 3 data expected in 1H 2018.

Company also in the process of setting up a training collaboration with National Institute for Bioprocessing Research and Training (NIBRT) to develop skills for Ireland’s biologics sector, training 1,500 professionals per year.

Innovative Twin system with two 3,000-L bioreactors and associated downstream processing equipment put into operation. Second significant expansion in one year.

Focus on Merck’s brands Glucophage, Concor and Euthyrox to meet increasing patient needs in the areas of diabetes, cardiovascular diseases and thyroid disorders.

Acquisition expands global GI R&D pipeline and takes a leading R&D position in NASH

Combination provides an enterprise platform for comprehensive data management, analysis and compound design in drug discovery.

New 24-page guide that brings together applications, protocols, results and citations for researchers.

Current R&D strategies in osteoarthritis are characterized by a trend towards developing new analgesics with novel MOAs, and drugs with disease-modifying effects.

Unique antibody purification system compatible with any conjugation technology.

Creates 40 R&D jobs and grows total to 120 new roles at new site.

Adds first-in-class technology to company's innovative eye care pipeline.

Shire to consider appeal.

Alessandro Maselli is to become its new Senior Vice President of Global Operations, and Christine Dolan will assume the role of Senior Vice President of Global Product Development.

Focus on issues in modern tablet production and how elements including punch and die design, tooling specification and aftercare can affect the end product.

782 products currently in the ophthalmology therapy pipeline.

Vitae Pharmaceuticals acquired for a total transaction value of approximately $639 million.

Five year project will create more cost-effective purification program.

Mugard is a medical device for the prevention and management of the signs and symptoms of oral mucositis caused by chemotherapy and radiation therapy.

Acquisition adds expanded drug development services and spray drying technology.

The Korean biosimilar market was another area that gathered much international interest at CPHI Korea.

This agreement allows any organisation, through CPI or NIBRT, to access Horizon’s biomanufacturing cell lines for research purposes.

The combination of the two businesses allows Lonza to offer InterHealth’s more than 15 branded ingredients, including its cornerstone ingredient, UC-II, which is revolutionizing the joint-health segment.

Suanfarma - a specialised supplier of raw materials to the pharmaceutical industry - acquires a stake in the CDMO.

Will provide cGMP storage, local labelling, secondary packaging, comparator sourcing, handling and distribution of ambient and cold chain supplies to clinical site returns management.

Patent covers East Indian sandalwood oil-containing compositions that can be used to treat a variety of cancers.

The CDMO' investment will reinforce its expertise in opiate and synthetic drug development and production.

Is the first registration Dechra has achieved through Putney's development pipeline since it acquired the US-based business

Company has invested in semi-automated vacuum stopper equipment to generate prefilled syringe samples that can be used to screen and select components, complete compatibility studies, and conduct developmental stability studies.

“The Clear Your Head Medicine” is poised to lead the sinus category, offering clarity in a confusing allergy and cold aisle.

Chrono Therapeutics is developing a wearable transdermal drug delivery device offering a personalised behavioural support system that times nicotine delivery to when smokers have their strongest cravings.

Enhances viral safety while maintaining cell line productivity, protein quality.

Patent claims are directed to a novel formulation of Locilex, a topical antimicrobial peptide formulated as a topical cream, and the use of Locilex as a method of treating skin or wound infections.

The acquisition will generate a new and strong international microbial CMO, offering the complete services from process development to large-scale market supply.

Company's immuno-oncology and histology services have allowed clients' go/no-go decisions to be made earlier in the drug development process and ultimately reduce clinical attrition.

Patent and market authorization for human hyperacute serum product.

The BlueWind VIVENDI System is a wireless, battery-less neurostimulator which is 90% smaller than typical neurostimulators in the market.

The Aerobika device demonstrated a clinically-significant reduction in exacerbations in as little as 30 days of treatment, when used as an add-on to usual COPD medications.

To be Commercialized in Portugal and Ireland as Vitaros and in Poland as Vytaros.

2016 report topics include 3D printing, FDA quality metrics, contract services, pharma growth in China and India, and generic licensing.

The plant will continue to manufacture critical AstraZeneca pharmaceutical products on a contract basis.

Webinar will focus on the nasal drug delivery route in the treatment of central nervous system diseases.

The investment includes the installation of new multi-purpose reactors and upgrading of the control room within an existing plant on site.

Acquisition of RetroSense Therapeutics adds global rights to RST-001, a novel gene therapy approach for the potential treatment of Retinitis Pigmentosa.

A range of best-in-class solutions that drive productivity in the laboratory.

First Generic and clinically validated product for Multiple Sclerosis in Europe.

Generic equivalents to Razadyne.

Compact device capable of delivering high viscosity drugs including some of the newest biologics.

Therapeutic equivalent generic version of GSK's Wellbutrin SR.

US Patent and Trademark Office has ruled in favour of Mylan in its inter partes review proceeding.

Unique product and service portfolio extensively covers all steps from cell line development to commercial manufacturing processes.

The CDMO has expanded its capabilities with a new automatic vial filling line to meet increased demand.

The artificial nose can sniff out Pulmonary Arterial Hypertension on a person’s breath as the disease alters its signature.

The new facility will be the global Center of Excellence for Extractable Studies and Impurities Profiling, as a hub across the global network of laboratories.

Company will discuss common tabletting problems such as increasing output without capital expenditure, eliminating sticking and abrasion, minimising headwear and corrosion, all of which can be done through innovative means.

The agreement comprises technology transfer and commercial manufacturing of the products Entocort and Asacol.

With the addition of Agrippal and Fluad, PaxVax is building a robust portfolio of vaccines for the Swiss market.

Merger creates global leader in life science and advanced technology materials.

World’s first wireless, miniature implantable device hailed by doctors and patients as a long-term therapy breakthrough.

Informing the pharmaceutical drug development, manufacturing and commercialization industry.

List price of $300 per generic EpiPen two-pack carton, which represents a discount of more than 50% to the Mylan list price.

Xiidra is the only prescription eye drop approved by the FDA for the treatment of both signs and symptoms of dry eye disease.

Companies will collaborate to develop and commercialize four generic products - two CNS stimulants and two beta blockers.

Patent expected to be valid until 2032, once granted.

Potential for 100 mg blister cards being packaged in 200 mg containers.

Approximately 40,000 women in England seek hospital treatment for uterine fibroids every year.

New Webinar Hosted by Xtalks.

USPTO has ruled in favour of Mylan in its inter partes review proceeding and found all claims of two related Copaxone 40 mg/mL patents to be unpatentable.

The investment will see the introduction of a new lyophiliser for vials, increasing the facility’s capacity by approximately 20%.

Mylan doubling the eligibility for patient assistance, effectively eliminating out-of-pocket expense for uninsured and under-insured patients.

A number of pipeline T2DM therapeutics are anticipated to be significant contributors to market growth over the forecast period, with some even expected to reach blockbuster status.

Patient centricity, combination products, packaging innovation and biotherapeutics showing promise at the forefront of the industry’s development.

Will invest more than $80 million.

Recall due to presence of iron oxide particulate matter.

Under this partnership, BioTechnique will manufacture a commercially available vaccine product in a new, shelf-stable dosage form.

Used by eight out of the top 10 global pharmaceutical companies, ERM’s newest version includes the industry’s first triple federated search engine.

Recognized for innovation and advancements in cell therapy.

Topics covered include why, how and when instruments should be calibrated to ensure they are delivering accurate measurement.

Despite the restoration and maintenance of sinus rhythm being a common practice in the management of atrial fibrillation, the available antiarrhythmic drugs are of modest efficacy and have unfavorable safety profiles.

A component of Regeneron's Rapid Response program, which is also targeting Zika and Ebola.

Medivation agrees to transaction valued at $81.50 per Medivation share in cash, for a total enterprise value of approximately $14 billion.

GBI Research’s analyses identifies 129 first-in-class programs in active development.

Expansion is the result of the demand for the company's automation, process control and serialization technology services.

Products now approved in seven countries.

Cut in staff due to failed clinical study of CRLX101.

Partner to fully fund development of new production routes for a family of APIs.

Patent broadly covers pharmaceutical compositions for microbiome therapeutics based on bacterial consortia.

Product is therapeutically equivalent to Spectrus Pharmaceuticals' reference listed drug Fusilev Injection.