Market News

US Patent and Trademark Office has ruled in favour of Mylan in its inter partes review proceeding.

Unique product and service portfolio extensively covers all steps from cell line development to commercial manufacturing processes.

The CDMO has expanded its capabilities with a new automatic vial filling line to meet increased demand.

The artificial nose can sniff out Pulmonary Arterial Hypertension on a person’s breath as the disease alters its signature.

The new facility will be the global Center of Excellence for Extractable Studies and Impurities Profiling, as a hub across the global network of laboratories.

Company will discuss common tabletting problems such as increasing output without capital expenditure, eliminating sticking and abrasion, minimising headwear and corrosion, all of which can be done through innovative means.

The agreement comprises technology transfer and commercial manufacturing of the products Entocort and Asacol.

With the addition of Agrippal and Fluad, PaxVax is building a robust portfolio of vaccines for the Swiss market.

Merger creates global leader in life science and advanced technology materials.

World’s first wireless, miniature implantable device hailed by doctors and patients as a long-term therapy breakthrough.

Informing the pharmaceutical drug development, manufacturing and commercialization industry.

List price of $300 per generic EpiPen two-pack carton, which represents a discount of more than 50% to the Mylan list price.

Xiidra is the only prescription eye drop approved by the FDA for the treatment of both signs and symptoms of dry eye disease.

Companies will collaborate to develop and commercialize four generic products - two CNS stimulants and two beta blockers.

Patent expected to be valid until 2032, once granted.

Potential for 100 mg blister cards being packaged in 200 mg containers.

Approximately 40,000 women in England seek hospital treatment for uterine fibroids every year.

New Webinar Hosted by Xtalks.

USPTO has ruled in favour of Mylan in its inter partes review proceeding and found all claims of two related Copaxone 40 mg/mL patents to be unpatentable.

The investment will see the introduction of a new lyophiliser for vials, increasing the facility’s capacity by approximately 20%.

Mylan doubling the eligibility for patient assistance, effectively eliminating out-of-pocket expense for uninsured and under-insured patients.

A number of pipeline T2DM therapeutics are anticipated to be significant contributors to market growth over the forecast period, with some even expected to reach blockbuster status.

Patient centricity, combination products, packaging innovation and biotherapeutics showing promise at the forefront of the industry’s development.

Will invest more than $80 million.

Recall due to presence of iron oxide particulate matter.

Under this partnership, BioTechnique will manufacture a commercially available vaccine product in a new, shelf-stable dosage form.

Used by eight out of the top 10 global pharmaceutical companies, ERM’s newest version includes the industry’s first triple federated search engine.

Recognized for innovation and advancements in cell therapy.

Topics covered include why, how and when instruments should be calibrated to ensure they are delivering accurate measurement.

Despite the restoration and maintenance of sinus rhythm being a common practice in the management of atrial fibrillation, the available antiarrhythmic drugs are of modest efficacy and have unfavorable safety profiles.

A component of Regeneron's Rapid Response program, which is also targeting Zika and Ebola.

Medivation agrees to transaction valued at $81.50 per Medivation share in cash, for a total enterprise value of approximately $14 billion.

GBI Research’s analyses identifies 129 first-in-class programs in active development.

Expansion is the result of the demand for the company's automation, process control and serialization technology services.

Products now approved in seven countries.

Cut in staff due to failed clinical study of CRLX101.

Partner to fully fund development of new production routes for a family of APIs.

Patent broadly covers pharmaceutical compositions for microbiome therapeutics based on bacterial consortia.

Product is therapeutically equivalent to Spectrus Pharmaceuticals' reference listed drug Fusilev Injection.

The vast reforms seen throughout Turkey’s pharmaceutical market create a number of opportunities for pharmaceutical manufacturers.

Transmembrane conductance regulator modulating therapies - of which there are currently only two and both are developed by Vertex - are set to have a substantial clinical and commercial impact.

Falling stock markets, political uncertainty and continued global economic weakness all contributed to a mixed first half, says market intelligence firm, Evaluate.

Cresemba (isavuconazole) is an injectable and oral anti-fungal product.

State-of-the-art pharma manufacturing campus will be a showcase for the company and the production of injectable generics.

Cytokine and cytokine receptors, as well as protein kinases, largely dominate.

Acquisition will provide Piramal with HPAPI capabilities in North America.

Trend could jeopardize the affordability of life-saving orphan drugs for patients with rare diseases and conditions.

The VOYAGER II is the only commercially available pipette range where the tip spacing can be changed electronically,

Trial will look to explore the benefit of combining CV301 with Opdivo in patients with previously treated non-small cell lung cancer.

New product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.

Strengthens Lonza’s specialty nutritional ingredients portfolio.

New plant aims to double SRF’s capacity for chloromethanes to 80,000 tonnes per annum.

Preparations underway for the first human trials involving patients with antibiotic resistant lung infections.

Acquisition adds global ights to non-invasive ocular ring in development for glaucoma and other eye conditions.

Growth attributed to launches of the first proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors), Repatha and Praluent by 2016, the launch of ETC-1002 by 2021, and increases in the global prevalence of ACS.

New regulations speeding up growth with exports to Japan targeted.

CPHI Pharma Awards’ panel doubles in size and welcomes top experts from around the world.

Expanded partnership provides capacity and cost structure supporting Celsion's global commercial strategy for GEN-1.

Expansion will enable the company to more than double its commercial manufacturing capacity for nucleic acid APIs.

The Ultravap Levante will appeal to the budget-conscious laboratory who may wish to automate their sample dry-down bottleneck in the future.

Angiogenesis modulators and gene therapies to boost overall revenue within the forecast period.

Bioverativ will focus on accelerating innovation for people living with hemophilia and other blood disorders.

Cherwell to offer expert insight in environmental monitoring and process validation to both NHS and industrial pharmaceutical manufacturers.

Vonvendi is a significant advancement for the treatment of adults with von Willebrand disease.

SkinJect Microneedle Patch to deliver drug to treat and immunize skin cancer patients.

Through this partnership, the academic institutions in the Consortium will have access to Charles River’s early discovery and drug development resources and services to accelerate their early-stage drug development processes.

The portfolio is a mix of six ANDAs pending approval, one approved ANDA and one ANDA with tentative approval, and comprises complex generic products across diverse dosage forms.

Opdivo (nivolumab) now recommended to treat Scottish NHS patients with advanced skin cancer.

Valeant obtains the rights to develop and commercialise NER1006 Powder for Oral Solution.

With the addition of Meda, Mylan now has six $1 billion therapeutic franchises.

Natco receives approval for generic Tamiflu.

Fully automated data transfer improves diabetes management.

Another Rx-to-OTC Switch from GSK Consumer Healthcare to help allergy sufferers find more complete relief.

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.