Market News

Two new biosimilar medicines available to treat patients with specific blood cancers and a range of inflammatory condition.

Agreement concerns an existing inhaled combination therapy for asthma and COPD delivered using a pMDI.

Novel approach capitalises on commonality across pathogens.

New offering restores lipid layer and brings hydration to all three layers of tear film damaged by Dry Eye.

Innova’s range of antibody and protein labeling products and services ideally complements SYGNIS’ customer base and existing genomics and proteomics portfolio.

The CDMO is now approved to manufacture medicinal products for the US, Europe and Japan.

Resourcing the deployment of serialization systems and processes also cited as a significant barrier to compliance with European FMD,

US business will be organized into two entities - a US Generics Division and a US Injectables Division.

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multi-national company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular ...

The addition enables the CDMO to scale-up early-phase bench top processes to support later stage clinical development and niche, low volume manufacturing requirements.

Arcinova has invested in a Uniqsis FlowSyn continuous flow reactor enabling them to develop and simplify the scale-up of a challenging API batch process.

Compared with other small-scale R&D freeze dryers, the LyoCapsule lyophilizer is the only system that can monitor and independently control the wall temperature via use of the center vial product temperature.

The manufacture of solid dosage form pharmaceutical products would be transferred from the Osaka Plant to the new plant.

Compounded Sodium Bicarbonate PF 8.4% 50mEq per syringe is expected to help alleviate chronic drug shortage impacting the nation's hospitals.

The compound has the potential to be used as a monotherapy or in combination with approved therapies to address unmet needs in cancer treatment.

iOnctura is set up to develop a pipeline of assets targeting immunosuppression in the tumour microenvironment.

Actelion will now become part of the Janssen Pharmaceutical Companies of J&J.

Sandoz now has four biosimilars approved in Europe - more than any other company.

Company shifts manufacturing focus in Ireland to reflect growing biologics portfolio with ongoing investment in Cruiserath biologics facility.

Delegates at the recent FlyPharma Conference pick out collaboration as their main goal for the coming year.

Preliminary findings from pilot study validate use of wearable technologies to collect data and manage clinical trials more effectively and efficiently.

Investment will focus on new innovations in therapeutics for neurodegeneration, antibiotic resistance, cancer and respiratory diseases.

Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference medicine.

Extends EMEA sales team with addition of two new regional sales leaders in DACH and Southern Europe regions.

Enables labs around the world to generate more useful information from complex proteins, antibodies, polypeptides and polysaccharides.

Company adds fifth building in Southern California.

Company's CFO leaves to join another biopharma company.

Investment allows company to increase its capacity to handle E&L projects for applications including container testing, medical device evaluation and testing equipment used in pharmaceutical production.

Argus improves the quality and timeliness of safety case processing and reporting, and reduces operational risks for both clinical trial and post-marketed pharmacovigilance data.

Espranor represents the first major advance available in opioid substitution therapy for 10 years.

Application "addresses a critical information gap that has existed for decades between pharmaceutical companies, pharmacists and patients."

Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatit.is C

As of today, all major brands of nasal decongestant topical sprays in the US come with Aptar Pharma’s child-resistant feature.

Investments will strengthen the excipients, polymers, drug formulation and manufacturing, and medical device contract manufacturing capabilities throughout the company's global facilities.

Selling iNova part of Valeant's efforts to simplify and strengthen its balance sheet.

Collaboration to focus on a potential new class of treatments for metabolic disorders.

Using the solution stable enzyme can eliminate unnecessary waste and cost.

NOVA-EM is Novatek's solution dedicated to managing all aspects of an automated environmental monitoring program.

Removes burden of validating software updates for Life Sciences Cloud customers.

Phase I/II study to evaluate the combination of Opdivo (nivolumab) and Opdivo +Yervoy (ipilimumab) regimen with Mekinist (trametinib) in patients with colorectal cancer.

Expanding market for biosimilars and biobetters is anticipated to pronounce the demand for contract development and manufacturing support.

Lonza has successfully completed the acquisition of PharmaCell, a cell and gene contract manufacturer in Europe with employees in Maastricht and Geleen (NL). In 2016, PharmaCell had sales of EUR 11 million.

Continuous manufacturing process will enable improved quality control and cGMP compliance, while reducing energy consumption, waste and raw material.

The new technical service laboratory is the company's 20th across the world.

QbD studies in upstream processing more rapidly performed.

Collaboration will use real-world patient data and cognitive computing with aim of improving outcomes in advanced breast cancer.

Porvair Glass Vial Deep-well plates are precisely manufactured to ensure complete compatibility with automated equipment.

Agreement provides access to Orkambi for people who have two copies of the F508del mutation and expands access to Kalydeco for all eligible patients.

Pharmaceutical companies should play a larger role in patient support programs.

Deal adds the first plasma-derived treatment to Hima's product offering.

Microdermics has successfully demonstrated the initial safety of its microneedle system, and is planning Phase I human clinical trials for vaccine and therapeutic delivery, to be initiated in 2017.

The expansion is part of an ongoing strategic campaign to invest in small molecule API manufacturing across the company's global network of facilities.

Acquisition of Jaco enables Sanner to operate as a system supplier.

Under the terms of this new agreement, PCT will provide GMP-compliant manufacturing services for Orchard’s lead product, OTL-101, an autologous ex-vivo gene therapy for the treatment of ADA-SCID.

Shabbir Mostafa to join the CDMO as Director, Business Management, with responsibility for driving sales of Recipharm’s manufacturing services.

Recall due to out of sequence tablets and missing expiry/lot information.

New webinar hosted by Xtalks focuses on extracting the most value from data assets.

First initiative is to eliminate visible particles from parenteral products,

The addition of this antibody targeting tau will complement Merck’s portfolio of candidates being investigated for the treatment of Alzheimer's disease.

First clinical study using a patent protected minocycline API and formulation developed by Hovione.

Aplidin is PharmaMar's second most advanced anticancer drug currently under development for the treatment of multiple myeloma and angioimmunoblastic T-cell lymphoma.

Strengthens pipeline with lead candidate TNT009 in cold agglutinin disease, a rare and chronic autoimmune hemolytic anemia with no approved therapies.

Kevzara is now available to US patients.

Patheon provides entry into the attractive, high-growth CDMO market.

It is the first and only biopharmaceutical manufacturing site established by a multinational active pharmaceutical company in China.

Product adds to the company's non-injectables portfolio in the US.

Phase III-ready program complements Biogen’s ongoing development efforts in stroke.

New medium designed for hematopoietic cell culture for cell-based therapies.

Accelerates development timelines with faster, easier selection and scale up of clones.

Research used to produce a global ranking of countries’ pharma reputation, market growth potential, innovation and competitiveness.

Expansion part of global investment in testing capabilities.

Unique tool will allow massive quantities of cell culture data to be collected during upstream processing QbD studies.

Certification covers the manufacture and packaging of hard and soft gel capsules, liquids for external use, semi-solids such as ointments and film coated tablets.

New company name reflects diverse market opportunities.

The e-Lockout device being the first and only fully integrated electronic nasal drug delivery device to be approved by a US or European regulatory authority.

Catalent Biologics will use its proprietary GPEx technology to produce different protein variants for Therachon,

Allows customers to achieve a more optimal output than they would using conventional batch or fed-batch processes.

Many companies currently unprepared because they lack the internal resources to devote to serialization.

Discontinuation due to the vaccine supplier’s (GSK) decision to discontinue global production.

Thermo Fisher Scientific helps research service providers and their customers optimize protein identification and quantitation.

Status marks the company as the first multi-site excipient supplier to achieve global EXCiPACT accreditation across its production facilities.

Kit increases efficiency of residual protein A ligand detection.

Goldfinch Bio’s researchers select StarDrop to guide successful drug discovery.

Xermelo is a first-in-class orally administered therapy for the treatment of carcinoid syndrome diarrhea.

Highly precise dosing of smallest amounts of API.

Inside Rx, a new initiative from Express Scripts, partners with GoodRx, drug manufacturers and drug stores to save Americans an average of 34% at 40,000 pharmacies

A key focus on Cherwell’s Stand A49 will be the microbiology requirements for pharmacy aseptic manufacturing, preparation and dispensing.

New ProSolus commercial team will provide potential partners throughout the pharmaceutical industry direct access to the state-of-the-art research, development, and manufacturing capabilities.

Company will be responsible for the GMP preparation and filling of AB569 into glass vials.

This chemistry testing offer complements the company’s existing range of off-the-shelf biological assays for biosimilar products, providing a complete solution from one contract partner.

Combined expertise is likely to have a significant impact in reducing the costs and complexity of ophthalmic clinical trials.

Library claimed to offer "the most efficient route to therapeutic antibody lead identification".

Expansion doubles manufacturing capacity and includes the introduction of new facilities.

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.

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.

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.

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

Transactions provide access to attractive pharmaceutical growth markets.

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,

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.

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.

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

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

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.

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

Two separate agreements with Biogen and Roche.

Efficient alternative to distillation.

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