Market News

AB-PA01 designed to broadly target both CF and non-CF Pseudomonas isolates and potentially eradicate the infection instead of merely keeping it at bay.

First US Patent issued to Vaxil since the company began developing its immunotherapies 10 years ago.

Subsidiary will be renamed Avara Pharmaceutical Technologies.

Increase will be driven by the growing use of recently approved and emerging branded T2DM therapeutics, in favour of lower-cost generic products, says GBI Research.

Continues Allergan's evolution into focused brand growth pharma leader.

Companies to pursue "off-the-shelf" cellular therapies in oncology.

Sale advances company's evolution into a focused branded growth pharma leader.

Acquisition combines Bamboo’s gene therapy portfolio, advanced vector design, and production technologies and capabilities with Pfizer’s global scale, research, development and commercialization experience.

People with radioiodine refractory differentiated thyroid cancer are overlooked as Lenvima is not scheduled for evaluation by NICE or the new Cancer Drugs Fund.

Steady growth will be driven by the uptake of novel oral anticoagulants, which represent important advances over warfarin, a cheap and established anticoagulant, says GlobalData.

Includes scale-up and GMP manufacturing of drugs in late-stage development.

Reduction is designed to reduce operating expenses while the company conducts a comprehensive evaluation of strategic options for galeterone and its pipeline.

If approved, SUN-101/eFlow will be the first nebulized long-acting muscarinic antagonist (LAMA) for the long-term, maintenance treatment of airflow obstruction in patients with COPD.

The portfolio of products will be marketed by Xantis Pharma throughout Central and Eastern Europe.

Adlyxin is approved as Lyxumia in more than 60 countries.

Enzyme developed with CodeEvolver technology for preclinical therapeutics program exceeds agreement requirements.

GSK accused of patent infringement.

Cytokinetics to receive $65 million in upfront payments and $30 million in additional sponsored R&D; potential for more than $100 million in payments associated with the exercise of the option.

Company's ND0701 formulation intended for chronic therapy of Parkinson's disease and is developed for continuous subcutaneous administration by a small, low-volume, disposable patch-pump.

Investment in advanced manufacturing of new respiratory and biopharmaceuticals portfolio.

Ricks will assume President and CEO roles on 1 January 2017, and become chairman of Lilly's board on 1 June 2017.

Oncology, infectious diseases and central nervous system disorders accounted for a combined 68% of the overall pharmaceutical industry pipeline as of Q1 2016, says GBI Research.

FDA reports deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility.

Functionalized gold nanoparticles for easy, fast covalent conjugation of antibodies.

HyQvia is the only subcutaneous IG treatment for primary and certain secondary immunodeficiencies that can be administered in one site, once a month.

The financing will be used to expand the company's leading precision medicine decision support solutions in oncology.

Company has received a Notice of Allowance for an additional U.S. patent covering RHB-105, expected to be valid until 2034 once granted.

New Orencia ClickJect Autoinjector offers accurate dose self-injection with push button operation, and confirmation that the full dose has been injected.

The stem cells field is still surrounded by a wide variety of obstacles, most notably the high cost of research, according to key opinion leaders.

Ann Flodin will be responsible for managing daily operations in Recipharm in Research Triangle Park and will focus on expanding and strengthening the development services Recipharm offers its customers in the US.

Pharma&Biotech’s outstanding operational performance across all assets bolstered the strong half-year results.

Various tools help drug companies establish successful global launch plans.

Enhancements to Thermo Scientific Finnpipette F1 and F1-ClipTip pipetting systems improve comfort.

Designation will enable increased access to vaccine in world’s poorest countries.

While the Vietnamese market is seen as attractive for pharmaceutical companies, drug prices are high compared with average incomes, says GlobalData.

Expanded indication now includes treatment-naïve adults.

Product is a generic version of Zegerid - an acid reflux treatment.

The apparatus facilitates the manufacture of authentic cannabinoids that are purer in form and more cost effectively produced than what is currently available in the marketplace.

Enables explorations of new technologies and solutions to address development and manufacturing challenges.

The company is focusing on enabling technology, designed to link antibodies to drugs or toxins to produce pure and homogeneous ADCs.

Company provides insights into its long-term expansion plans that include the purchasing of property in the City of Des Plaines

Acquisition expands bioanalytical portfolio of Lab Products & Services division.

The charity will now also be able to pursue exciting novel research and development collaborations with new partners.

The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab.

This impressive expansion can be attributed to a growing population, rising wealth levels, and demand for patented pharmaceutical products, says GlobalData.

The collaboration will evaluate the use of Avacta’s Affimer technology in combination with Glythera’s PermaLink conjugation chemistry.

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.