Market News

Invent Farma develops, manufactures and markets generic drugs.

Its likely that a number of firms will relocate their services to mainland Europe or Ireland.

New facility will house multiple general labs, cleanrooms, and small batch manufacturing rooms.

The company's investment reflects the strong market demand for small molecule APIs.

Seres to use Emulate's Intestine-Chip technology to identify promising new microbiome therapeutic candidates for inflammatory bowel disease.

FDA guidance states that genotypic methods have been demonstrated to be more accurate and precise than traditional biochemical and phenotypic methods.

The plant will manufacture biosimilars and construction is scheduled to start in early 2017, with full operations expected to commence in the third quarter of 2018.

Eligible patients in Scotland will be the first in the UK to access this life-extending treatment and will be ahead of those patients in England and Wales.

SP Scientific's LyoModelling Calculator enables those developing freeze drying cycles to calculate the time required for primary drying and the maximum product temperature.

Amgen's Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge) provides a new, monthly single-dose administration option.

According to a New Market Report Published by Persistence Market Research, the Global API market is estimated to reach $186 billion by 2020, with North America accounting for 35% revenue shares..

Thermo Scientific Nunc Edge 2.0 plate is designed to cost effectively increase cell consistency and productivity in cell-based assays.

Government initiatives driving biosimilars and health foods sectors, with increased international partnerships.

Fast small-volume clarification that does not add leachables or extractables to the original sample.

First therapy indicated in the EU for use in patients aged one year and above with Short Bowel Syndrome, a rare gastrointestinal condition.

With cost pressures burdening many health systems, competitive pricing is a strategy that other companies are likely to adopt with me-too drugs in late-stage development, says GlobalData.

Sanofi agrees to standstill and to withdraw consent solicitation.

In-depth profiling of IgG glycosylation coupled with ADCC assays enables generation of robust biosimilar comparability data.

Transaction to expand SSB’s bioprocessing product portfolio with innovative single-use centrifuges.

Decision comes despite nivolumab being accepted for the Early Access to Medicines Scheme (EAMS) based upon some impressive Phase III clinical trial results.

Rizaport was recently approved for marketing in Germany under the European Decentralized Procedure; RedHill and IntelGenx continue to work together to secure additional commercialization partners for Rizaport in the US, Europe and other territories.

With the acquisition of Penetran-Plus, MHC expands into the OTC pain relief market.

The investment will bring the total number of lines to eight, to meet the growing demand of the service.

Gains full-rights to Cormorant’s HuMax-IL8 antibody program and lead asset HuMax-IL8 in Phase I/II development.

Company now able to offer a one-source solution for a complete range of pharmaceutical processing equipment.

New facilities will provide greater flexibility.

The appointment comes as the pharmaceutical industry faces the challenge of complying with new legal requirements for the authentication and barcoding of licensed drug products.

The facility currently manufactures seven oral products for the Group's partners.

Collaboration combines Merck’s leadership in immuno-oncology with Moderna’s pioneering mRNA vaccine technology and rapid cycle time, small-batch GMP manufacturing capabilities.

In addition to the main guidelines, appendices on validation and qualification are included.

Additional cost reductions implemented to support development program prioritisation.

International-domestic pharma partnerships to drive next wave of growth, alongside emerging Chinese multinational CMOs.

The partnership covers potential new medicines for atopic dermatitis and psoriasis.

Bremelanotide is designed to treat hypoactive sexual desire disorder, the most common form of FSD, in premenopausal women.

This significant site addition to Siegfried’s production network strengthens the company’s long-term competitiveness.

With this acquisition, the company will have three API facilities for the regulated markets.

Should the MenABCWY vaccine perform well in upcoming Phase III studies, it has the potential to become market leader, says GlobalData.

New targets need to be identified and converted into improved therapeutic options, particularly in order to develop therapies more aligned with the underlying disease pathophysiology, says GBI Research.

Unique technology for cell analysis in Biopharma applications.

Collaboration will improve manufacturing processes to deliver greater yield, allowing higher recovery and providing higher purity vaccines.

Agreement is the latest in a series of acquisitions and strategic collaborations that have bolstered Novartis' deep and diverse immuno-oncology pipeline.

State-of-the-art facility will foster the continued development of the biotechnology industry in China, further supporting national healthcare reforms.

New service meets the increasing demand for speed and flexibility in global clinical trials.

The deal will mean Merck acquires Afferent’s lead candidate, AF-219, which is currently in Phase II trials in IPF patients with persistent cough, says GlobalData.

The new FOG 27 closure can be opened in about a third of the time — and with 70% less physical effort compared with conventional closures.

Investments of more than USD 1 billion in state of-the-art biomanufacturing facilities, backed by industry-leading capabilities as part of Novartis, positions Sandoz to deliver biosimilars at unprecedented scale.

Product is indicated as monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related sur...

Project will deliver second cell line for manufacture of immuno-oncology antibody ADC-1015 following ADC-1013 success.

Cipla agrees to transfer API manufacturing technology reqired for HIV and Hepatitis C drugs.

A new analysis published in JAMA Cardiology is the first to quantify the possible impact of Entresto's potential benefit in reducing death.

A new commentary published in The American Journal of Pharmacy Benefits argues that the value of specialty pharmaceuticals — to patients, employers and society at large — has been left out of the discussion.

Latest addition to the company's suite of tablet manufacturing equipment enables the CDMO to produce single and bi-layer tablets in multiple tooling formats.

The CDMO has formed a global partnership with Marchesini, SEA Vision and TraceLink to introduce new serialisation capabilities.

First drug to use Catalent’s proprietary OptiShell capsule technology to achieve extended release profile.

Of the three major indications within hematological cancer, namely leukemia, lymphoma and myeloma, leukemia has the largest pipeline, with 798 products in active development.

Entry submission is now open: the awards bestow recognition on the industry’s most outstanding achievements.

He will lead the company's Worldwide Markets in addition to a new Worldwide Commercialization team.

The agreements include the return to Impax of its rights to its pending abbreviated new drug application for the generic equivalent to Concerta (methylphenidate hydrochloride).

Growth will primarily be driven by increased use of expensive therapies, a rise in diagnosed prevalent cases of IPF, and the launch of two novel therapies, says GlobalData.

43,500-sq-ft plant next to Los Angeles International Airport will support production of engineered CAR and TCR cancer immunotherapies.

New service offers analysis of potential extractable and leachable contamination within pharmaceutical products.

Move approves the use of contract manufacturing organisations.

Site provides Famar with capacities and expertise in the production of solid dosage forms with high-potency APIs, which represents new technology for the company.

Key outcome of the strategic review is a commitment to commercializing brigatinib in the US, subject to approval by the FDA.

Pharmaceutical licensing deal values increased by 37.1% year-to-year, from $33.7 billion in 2014 to $46.2 billion in 2015, driven primarily by Sanofi.

This represents one of the fastest ever approvals by NICE – UK patients will be the first to benefit across Europe.

“As a result of applying the wrong appraisal process, approximately 2,700 people in England who could benefit from Orkambi are being forced to continue waiting for access.”

Vast majority of Zika vaccine products are currently in early preclinical trials, indicating that it will take many years until one of them receives market approval, says GlobalData.

This operation is part of Reig Jofre's internationalization plan, by which 60% of company sales are now made outside Spain, with a target of 70% in 2019.

PHAC orders a total of 360,000 doses of the smallpox vaccine.

Expansion will introduce a new commercial spray dryer unit to complement the existing pilot unit and this installation will be specifically designed to handle potent APIs

Internal functions are key for companies' committees across stages of development.

New expandable benchtop workstation with unique single-use bioreactor design offers a simple approach to process development for fermentation and cell culture.

Researchers show how an AF4-ICP-MS system is able to obtain valuable information on the multi-element speciation and absolute molecular mass of human plasma proteins such as Albumin and Transferrin.

Next 5 years will see more outsourcing, vaccine, biotech development and harmonisation in MENA region.

A Brexit in the upcoming EU referendum could directly damage the UK pharmaceutical industry, according to NonStop Recruitment.

Cellca’s cell line and upstream process development services now integrated.

The launch of Roche’s recently-approved PD-1 immune checkpoint inhibitor Tecentriq will usher in a dramatic change in the treatment paradigm of metastatic bladder cancer, says GlbalData.

'Imperatives for pharmaceutical companies include reducing product development costs, maximizing the annual product revenue, and optimizing the life cycle of a drug,' says GBI Research.

Offers a fast and cost-effective solution for manufacturers to reduce the risk of virus contamination resulting from raw materials during fermentation.

New AutoFinisher moves manufacturing jobs from scale to label in under one second.

The portfolio being acquired is a mix of filed ANDAs pending approval and an approved ANDA.

Afferent Pharmaceuticals is a leader in the development of therapeutic candidates targeting the P2X3 receptor for the treatment of common, poorly-managed, neurogenic conditions.

Company welcomes new customers with promise to provide seamless support for genomics research.

Agreement provides bluebird bio with a path to commercial supply including dedicated production suites within Lonza’s state-of-the-art facility, which is currently under construction.

Agreement expands commercial reach for anaesthetics and supports the Company’s sharp focus on innovative new medicines in its three main therapy areas.

Total fund size doubled to up to €300 million.

The new facility will significantly increase Alvotech’s production capacity enabling the group to produce higher yields at lower costs.

New business models and behavioural shifts create opportunities for growth.

Divest two oral solid dosage manufacturing facilities to Frontida BioPharm.

The collaboration will optimise the manufacture of AAV vectors to support gene therapy and regenerative medicine.

The provision of a single vaccine that can protect the population against all prevalent serogroups is the most important opportunity for companies hoping to access a large market share, says GlobalData.

New approaches for mitigating risk associated with new growth strategies.

New multi-action, multi-strain anti-infectives needed to win battle against AMR.

The site will serve the needs of both domestic and global clinical trial sponsors.

Company will be one of the first service providers to offer HDX-MS in a cGMP environment.

Enables Fujifilm Diosynth’s customers to benefit from MSD’s strong track record with large-scale microbial operations.

Japan is a strategic market for Hovione where the company is growing both its off-patent APIs and its contract manufacturing businesses.

New drug delivery and bioavailability technology driving growth globally.

Product is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci and staphylococci.

Combined company expected to deliver double-digit compound annual top-line growth with over $20 billion in annual revenues by 2020.

Powder fills from 50 mg to 75 g, with an accuracy of up to +/- 1% of fill volume, are now possible, including those for highly potent compounds.

While Anacor’s crisaborole will benefit from Pfizer in terms of marketing power, its release will subsequently pave the way for Pfizer to launch its own candidate, a topical form of Xeljanz, says GlobalData analyst.

GSK puts drug affordability before IP protection in low-income countries.

The acquired multi-story building is divided into laboratory, production, storage and office areas and provides a set of cleanroom GMP-compliant suites.

Addition of a Bioreactor 3PACK production facility to its Copenhagen facility provides additional flexible solutions for clients.

Certified leading upstream platform powers China’s biopharmaceutical development.

The drug has been hailed as new standard of care in mRCC due to promising survival outcome rates and objective response rates, say GlobalData analysts.

All-new addition for 2017 designed to let innovative young pharma firms benefit from valuable networking and learning opportunities

Deal demonstrates the impact Horizon's Reference Standards are having in supporting the rapidly growing Next Generation Sequencing (NGS) market.

Tooling products focused on increasing productivity for the tablet manufacturer.

Combination would create the global leader in rare diseases.

Foundation Stone Laying Ceremony of new $10 million Centralized Laboratory Services building attended by Deputy State Secretary Kristóf Altusz from the Hungarian Ministry of Foreign Affairs and Trade, and Mayor Mr Róbert Kovács

Stempeutics puts India on the 'World map of Regenerative Medicine'.

Company announces key appointments and a new sales office in Korea.

Adoption of digital transformation to drive patient outcomes may improve competitive position for pharma R&D organizations.

Targets $289 billion annual cost to US healthcare system.

Company also advances co-operation to offer superior functional coatings for pharmaceutical tablets.

Gemlen tableting launches series of videos discussing the key principles of tableting.