Market News

IHAT, a novel synthetic material, is a commercially viable alternative to ferrous salts for iron supplementation.

With support from the CRO, TopiVert has been able to accelerate scale-up and produce GMP batches, which are now being used in clinical trials.

Company announces investments, the sale of several products and a proposal to close a UK manufacturing site.

Overseas buyers at CPHI Korea double in the past 2 years.

Investment follows demand for the company's AseptiSafe and PharmaSafe product ranges, which transfer APIs in small- and large-scale pharmaceutical manufacturing environments.

Nerlynx is the first extended adjuvant therapy for patients with HER2-positive breast cancer.

Shire obtains worldwide license to pursue development and commercialization of a novel, potentially differentiated, pre-clinical bi-specific antibody candidate for Hemophilia A.

Company has experienced double digit growth across its automation, MES and managed services offering.

The service offers quick and efficient path from late-stage discovery to Phase I clinical trials.

Company expects to launch by the end of the year.

Company expects to supply up to 40 million doses across both vaccines for the US market in the 2017-18 season.

The system's new, variable transport system avoids bottlesnecks or delays in workflow.

Company to invest €90 million and cut 200 jobs.

Patients in Scotland will now join those in England and Wales and be able to benefit from this potentially life-extending immunotherapy on the NHS.

Acquisition adds recombinant-based influenza vaccine to Sanofi Pasteur's portfolio.

Cobalt's portfolio of solutions accelerates entry into high-growth Raman spectroscopy market and expands Agilent’s value proposition for pharmaceutical and biopharma customers.

The 2017 awards include eight new categories - celebrating outstanding achievements in the pharma industry.

Selexipag is an innovative, oral treatment that specifically targets the prostacyclin pathway.

NEXUS 17 attendees claim the greatest serialization challenge thus far has been line vendors’ inability to deliver a solution on time and within scope.

Actavis's products directly infringe Lilly's vitamin regimen patents in the UK, France, Italy and Spain.

The new 5-axis machine will speed up the production and delivery of larger diameter valves up to 350 mm.

IH-TMS Tool Management System and the company's latest tool coating solutions interest exhibition visitors.

Acquisition create leading integrated solutions provider to the global pharma and consumer healthcare industries.

Company has immediately initiated commercialization activities.

Label update includes 52 week data from CLEAR study demonstrating long-term superiority of Cosentyx versus Stelara in psoriasis.

Pharma clients now have direct and immediate access to a fully compliant safety database without needing to invest in their own system or use an interim solution to ensure compliance.

Brilliance tubes provide a user-friendly and attractive all-in-one solution.

First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate to severe plaque psoriasis.

Idifarma, a Spanish CDMO, has expanded its GMP manufacturing offering with the installation of new automatic capsule filling capabilities at its EU-GMP approved plant in Pamplona, Spain.

In clinical studies, baricitinib has demonstrated significant improvement in the signs and symptoms of RA compared to standard-of-care therapies.

Three new TurboVap evaporation systems increase laboratory reliability.

Developed to support assay development and validation for detection of anti-drug antibodies.

Pre-clinical collaboration focused on up to 10 targets nominated by GSK.

Investments in commercial and development spray drying, and flexible manufacturing solutions.

Strengthens leadership in rare blood disorders with first-in-class candidate to treat cold agglutinin disease, a chronic autoimmune hemolytic anemia with no approved therapies.

The Chaim Sheba Medical Center now offers the hydrogel spacer to reduce side-effects during prostate cancer radiation therapy.

Company's modification makes the SPU 2000 a more cost effective laboratory tool.

New world-scale ibuprofen production plant in Ludwigshafen; additional capacity expansion of ibuprofen plant in Bishop, Texas.

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.