Market News

Company eligible for 180-days marketing exclusivity on a first-to-file Para-IV ANDA.

Sanquin is now licensed to produce bulk material for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU) for the European Union, I...

Flooding caused by heavy rain.

Strengthening business platform in China to address diverse medical needs.

The company showcases the innovative Syrina 2.25 auto-injector that brings the flexibility to design a unique form factor and also the full Syrina platform accommodating multiple primary containers and high viscous, high volume injections.

Companies to identify new therapeutic concepts, biomarkers and develop breakthrough medicines to treat pancreatic cancer.

Easy-access webinar e-course from PTI helps pharmaceutical manufacturers implement successful Quality by Design strategies.

Acquisition increases capacity to deliver high quality, locally manufactured oligos.

Receiving up to $38,000,000 plus royalties for licensing deal and $12,000,000 for equity investment at $10.39 per share

Collaboration reinforces Propeller Health's leadership in respiratory digital health and creates a joint opportunity to advance treatment of respiratory disease through digital innovation.

After a series of clinical studies showed positive effects of the patented albumin coating technology, there was a strong demand among physicians to use this graft.

Several of Allergan's flagship products are in the therapeutic areas of dermatology and aesthetics, including brands such as Botox and the cosmetic treatment Juvéderm.

In addition to the Legalon API, Euromed currently supplies high quality products to over 350 customers worldwide accounting for around 70% of its sales.

Pfizer will be responsible for developing and commercialising any potential therapeutic agents (small molecules or biologics derived from StaR antigens) for each target and will have exclusive global rights to any potential resulting agents.

Agreements with three global companies for test development and validation.

Acquisition aimed at strengthening ReproCELL’s pharmaceutical industry-targeted drug discovery services.

Flexible processing of pre-sterilized syringes.

The EU-CTR replaces the EU Clinical Trials Directive and is designed to improve harmonisation on conducting clinical trials of medicinal products for human use throughout the EU.

Company admits no liability, has released its counterclaims against New York, and has agreed to make a payment of approximately $172,000.

SP Scientific has announced their next series of educational events to be held during 2016 for scientists involved with lyophilization.

Idera is eligible to receive approximately $100 million in development and regulatory milestone payments, including a $2.5 million upfront payment.

A changing pharmaceutical industry needs diversity, new thinking and multi-sector experience, all of which were delivered in spades at Pharma Integrates 2015.

As a result of the combination with Allergan and subsequent integration of the two companies, Pfizer now expects to make a decision about a potential separation of the combined company's innovative and established businesses by no later than the end of...

Attractive financial profile highlighted by expected 2016 net sales of greater than $90 million.

Products include the XDF (eXtended Dwell Flat) — a novel patented elliptical head form, which has been designed to increase dwell time on an existing press without the need for expensive modifications.

Expands oncology capabilities of Charles River Discovery Services.

Technology convergence through partnerships, mergers and acquisitions is yielding a stream of strong candidates, finds Frost & Sullivan.

Civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements.

Company believes the resolution of the Warning Letter will enable it accelerate the introduction of new products to the market.

State-of-the-art biologics facility approved by FDA to manufacture bulk drug substance for ADVATE [Antihemophilic Factor (Recombinant)], Baxalta’s market leading treatment for hemophilia A.

Transactions are consistent with the evolution of BMS’s strategic focus, including the decision to discontinue its discovery efforts in virology announced in June.

Rapidly reveals the factors to consider when using ADCC assays for producing precise biosimilar comparability data.

Coated stoppers for sensitive and high-value injectables.

New Gamlen products demonstrated during the show included the Gamlen PCA-500 and TTA systems for Pharmaceutical Research and Development use and the GTP-2 manufacturing model.

Bulk production facility enables company to support large diagnostics customers.

Company’s preliminary investigation indicates tha the incidents of out-of-place softgel capsules in several product batches could be related to a deliberate action by one or more individuals.

Cleaver Scientific has supplied a UV Sterilization Cabinet to Touchlight Genetics (Hampton, UK) who had sought a sterile workspace for the preparation of their RNA and DNA samples and templates.

Perrigo will immediately commence its previously announced $2 billion repurchase of Perrigo shares and plans to complete $500 million of the planned repurchase by the end of 2015.

Exiting four sites to optimise capacity utilisation will affect approximately 1,200 positions.

Four independent production lines to support clinical batch production and commercial scale manufacturing.

Daewoong has secured exclusive rights in Korea and Thailand to sell both the original product and to register and market all the new formulations, based on Erdosteine, which are currently under development at Edmond Pharma.

The MBO will support future growth by driving innovations for customers and building new strategic partnerships to further expand market position as a leader in host cell assay development.

The company now offeres the first nine antibodies in its Validated Antibody programme which are H3, RNA pol II (S), RNA pol II (S5), H3K9me3, 5mC, AcH3, AcH4, AR and Sin3a

The vaccines division of Sanofi presents at the World Vaccine Congress in Spain.

Six major launches expected to generate aggregate peak sales of €12 billion to €14 billion.

High elasticity and crack bridging ensure durability of the membrane even in contact with unstable substrates.

Company’s fifth formulation plant and the second API Plant.

Company on track to deliver its 25% revenue growth target for this year.

Global leadership position in specialty amines strengthened.

Sterile manufacturing specialist Symbiosis Pharmaceutical Services has appointed Joanne Anderson as its new Business Development Director to help drive its commercial growth.

Describes general principles and a recommended format for inspection reports for use by organizations performing pharmaceutical inspections.

The facility will produce medicines for the treatment of diabetes and obesity.

The system offers parallel processing and walk-away control of 24 micro bioreactors.

The new Syrina 2.25 is one of the most compact versions of auto-injector available today utilising the standard 2.25 mL PFS, based on Bespak’s proprietary VapourSoft technology.

New building to feature collaboration-focused workspace.

Strengthens BMS’s pipeline and strategic focus on heart failure.

Lead pipeline product, DX-2930, is a Phase III-ready asset, offering potentially transformative prophylactic therapy for HAE.

AMSBIO launches a range of recombinant prokaryotic lectins.

Allegations concerning the activities of Philidor raise questions about the company’s business practices.

Under the settlement agreements, Warner Chilcott Sales will pay a total of approximately $102 million, plus interest, to the federal government and the states to resolve civil claims.

Trastuzumab development and transfer for first Indonesian on-site production.

Team honored for its innovative approach to the scientific discovery and development of its PD-1 immune checkpoint inhibitor, Opdivo, in the treatment of advanced melanoma and squamous non-small cell lung cancer.

Sanofi has received 26 reports of suspected device malfunctions in the US and Canada.

First commercial CAPGo-derived laminin, LN-521, expected to be globally available in 2016.

Collaboration will utilize Affinivax’s novel MAPS Vaccine Technology Platform.

Instrumentation using uses FMS for headspace oxygen analysis of biopharmaceutical container closure systems, and icIEF for analysis of charge distribution and heterogeneity in biopharmaceuticals

The new expansion also includes new dedicated receiving, dispatch and packaging areas.

Rx-360’s first CEO will lead the consortium to its next phase of growth.

Pollutants and contaminants can now be detected at previously undetectable levels.

Titan Enterprise's latest issue of fLowdown highlights differential flowmeters.

Transaction includes the European Union, Switzerland, Turkey and the Commonwealth of Independent States.

AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), will be combined with Lilly molecules that target the immune system.

Management team completes buy out of specialist ion channel research business from Xention.

Corporate restructuring to result in an 11% workforce reduction.

Merck Millipore to provide Provantage End-to-End solution for development and manufacture of biosimilars.

In a clinical study, patients report significant reduction in dry eye symptoms in just 30 days of usage.

Wetteny Joseph chosen to lead the company’s Clinical Supply Services Business.

Faster flow rates than most sterilizing-grade filters, reducing footprint.

The company’s $224 million investment in the development, is the largest foreign investment in the construction of a new pharmaceutical facility in the country.

With four programs currently in clinical trials and five more expected to enter the clinic by the end of 2016, Novartis has rapidly built a robust portfolio of programs focused on stimulating the body's immune system to combat cancers.

Raheen site will be largest capacity biopharmaceutical production facility in Ireland.

Acquisition will create a platform for further growth into emerging markets.

Expansion of Bioprocess Solutions stronger than expected yet again; positive development in Lab Products & Services.

Company plans to refile lifitegrast submission in the first quarter of 2016.

Company to outsource all existing and future clinical and commercial manufacturing operations.

The facility will be engineered to enable to work with highly potent APIs and moisture-sensitive compounds.

XEN45 approved in global markets and in in late-stage development in the US.

The new medium is chemically-defined, animal component free, and has been specifically designed to support sustained, high growth with increased transfection efficiency that can yield gram-scale protein expression.

The company reorganizes its US Commercial operations to support upcoming specialty pipeline.

Xcelodose enables Juniper Pharma Services to accurately fill API directly into capsules

Commemorative bottles specially labelled to denote the batch containing the four billionth bottle were produced for the occasion.

The OptiShell softgel technology uses plant-derived polysaccharides providing scientists with new formulation opportunities.

New state-of-the-art manufacturing facility will include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill finish including lyophilization.

Seven prestigious and worthy winners picked from over 70 entries.

New S80 film features consistent cell growth, robustness and high quality.

Merck Serono and Merck Millipore become Merck

CPHI expert warns without urgent regulatory change improving quality is a fool’s game.

CPHI experts warn USA trade laws are too heavily in favour of big pharma

CPHI experts predict continuous manufacturing for all within 10-years, but the raw material black swans have not gone away.

A powerful binder designed to avoid peroxide formation.

The chromatographic tool of choice for in-process and final control of IgG purified from cell culture supernatant or human plasma.

The online drug development course provides an interactive platform for students to explore the fundamental principles of drug development, learn about the regulatory environment that govern the biopharmaceutical industry, and identify the roles of key...

The enhancements help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission.

He will be responsible for all aspects of construction of the Suzhou manufacturing facility, and will lead manufacturing operations for BeiGene’s small-molecules, including production, engineering, quality operations, supply chain and logistics.

Expansion will power immuno-oncology discovery and research collaborations.

One of the largest pharmacy benefit managers to provide access to cholesterol-lowering medication Repatha (evolocumab) for millions of patients in need.

Horizon will exploit its translational genomics and combination sciences platform to define optimum approaches to treatment and identify cancer patient populations most likely to respond.

Manufacturers plan to implement premium pricing strategies for commercial use of albumin as an excipient.

$2.575 billion spent on a provider of compounded sterile preparations to strengthen AmerisourceBergen’s core business.

‘Enterprise Zone’ Building will house company’s expanding R&D operation.

Protein supplement for gamete and embryo manipulation in assisted reproduction.

The company is preparing for commercialization of this product through Impax's generic division.

Services include feasibility studies, process and analytical development and scale-up.

Agreement with BioMarin, a leading company in the treatment of genetic and rare diseases, also includes returning option to develop and commercialize Peg-Pal.

Kybella first FDA-approved non-surgical injection for submental fullness bolsters Allergan's facial aesthetics portfolio.