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Inflectra will be the first biosimilar monoclonal antibody (mAb) to be available in the US.

The terms of the settlement do not provide for any finding of wrongdoing on the part of Mylan Inc. or any of its affiliated entities or personnel.

Company to continue to operate as one company with two distinct and complementary businesses to retain operating strength and financial flexibility.

Comprehensive roadmap lays out key commitments the pharmaceutical companies pledge to deliver by 2020 to reduce antimicrobial resistance.

Investment in advanced manufacturing of new respiratory and biopharmaceuticals portfolio.

This milestone marks the sixth Breakthrough Therapy Designation for Opdivo.

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

Brings more than three decades of leadership and operations experience in healthcare.

Allergan reiterates strong standalone growth profile and strategy following termination of Pfizer transaction.

New tablet attaches to the lining of the GI tract, resists being pulled away.

The Board will now conduct a formal search for a successor and will consider internal and external candidates for the role.

The CMA has fined a number of pharmaceutical companies for anti-competitive conduct and agreements in relation to the supply of paroxetine.

Combination creates leading global biotechnology company projected to deliver double-digit top-line growth with over $20 billion in annual revenues by 2020.

World’s largest pharma event sees record exhibitor numbers in Madrid.

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...

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

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.

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.

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

New building to feature collaboration-focused workspace.

Corporate restructuring to result in an 11% workforce reduction.

Phase III trial terminated due to insufficient efficacy.

Prize awarded for mapping, at a molecular level, how cells repair damaged DNA and safeguard the genetic information.

The FTC filed its amicus brief in a private antitrust action in which Mylan Phamraceuticals Inc. alleges that Warner Chilcott PLC/Mayne Pharma Group maintained a monopoly in the market for its antibiotic Doryx by suppressing generic competition through...

The new centre will provide companies with open access facilities and expertise to help them develop, prove and commercialise new and improved processes and technologies for biologics manufacture.

Winners from all 7 categories will be unveiled live at the event in Madrid.

Decision by Swiss Health Authority follows FDA approval of Entresto in July, and serves as an important reference approval for multiple other health authorities.

Vraylar is an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.

If approved, Vesneo will be the first nitric oxide donating prostaglandin receptor agonist available for patients with open angle glaucoma or ocular hypertension.

The plant will manufacture FlexPen prefilled devices.

Envigo has been created through the integration of Huntingdon Life Sciences, Harlan Laboratories, GFA, NDA Analytics and LSR associates.

MIT biological engineers have developed a modular system of proteins that can detect a particular DNA sequence in a cell and then trigger a specific response, such as cell death.

Allergan's ANDA product is a generic version of Impax Laboratories' Rytary.

HHS will provide initial funding of approximately $17 million to support preclinical development and antibody manufacturing. This initial funding is designed to support an Investigational New Drug application with the FDA.

Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company's Jardiance (empagliflozin) significantly reduced the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14% when added to standard of...

Girish Malhotra believes the pharmaceutical industry should be allowed to commercialise process improvements without regulatory re-approval.

Processes improvements for original patented products need to be considered, as do improvements beyond even DMF and ANDA submission.

Frost & Sullivan webinar reveals stem cell therapy pipeline and treatments innovating regenerative medicine.

Findings from a head-to-head trial comparing Victoza (liraglutide) and lixisenatide, both in combination with metformin, demonstrated a significantly greater reduction in HbA1c of -1.83% for liraglutide vs -1.21% for lixisenatide in adults with type 2 ...

First generic product approved from Hayward manufacturing facility following recent resolution of Warning Letter

Omarigliptin was found to be non-inferior to Merck’s once-daily DPP-4 inhibitor, Januvia (sitagliptin), at reducing patients’ A1C levels from baseline, with similar A1C reductions achieved in both groups.

BioInject is a state-of-the-art facility that will be used to manufacture pre-filled syringes and devices for both Sandoz’s biosimilars and Novartis Pharma’s novel biologics.

The 5-year base subcontract covers studies to improve the manufacturing process and establish long-term storage of MVA-BN Filo bulk vaccine. The contract also includes options for an additional USD 24 million to implement process development activities...

Pharmaceutical professionals must develop wider commercial and business skills if they want to continue to secure the top jobs, according to NonStop Recruitment.

Dezima's lead molecule is TA-8995, an oral, once-daily cholesteryl ester transfer protein (CETP) inhibitor.

This is the fourth Breakthrough Therapy Designation granted for Opdivo by the FDA

Genevac has developed a suite of proprietary technological solutions to facilitate post purification sample handling, including reformatting.

The terms of the license cover commercial use of a genetically-engineered Chinese Hamster Ovary (CHO) cell line, developed by Horizon and adapted to manufacturing conditions by LakePharma.

The LakeCentre facility, located in Boulder, Colorado will increase manufacturing and production capacity to support the company’s extensive portfolio of biologics medicines.

The one-day conference, entitled “Safety and Efficacy — Clinical Trials Solutions”, will bring together experts from SGS Life Services and the wider pharmaceutical industry, to discuss advances in biopharmaceutical research and development and combine ...

The expanded documentation and regulatory information facilitates drug product manufacturers' risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality guidelines as well...

Under the terms of the agreement, Aragen gains the rights to apply this technology to the development of recombinant cell lines with significantly enhanced commercial production levels compared to current methods.

Education can help to allay patients' concerns over participating in clinical trials

Scientists are a step closer to a universal flu vaccine

A class of pharmaceuticals seem to prevent Alzheimer's disease

US scientists have discovered certain biomarkers for IBD

Phase IIa clinical trial suggests asthma treatment may be effective

Natural ingredients specialised nutrition company Newtricious has appointed its first supervisory board.

The Alzheimer's disease drug is now available in US pharmacies.

A phase three clinical trial of eribulin mesylate suggested it may be the optimal treatment in certain patient populations.

The subsector experienced growth of three per cent between 2010 and 2012.

High levels of the G6P metabolite could disrupt pump function and cause heart failure.

Generic drugs account for more than 70% of prescriptions dispensed in the U.S. and that figure is expected to grow as brand drugs come off patent and face generic competition.

Researchers have developed a new approach to restoring nitric oxide to blood, paving the way for significant developments.

Iroko Pharma has announced that it will withdraw its initial public offering.

A one billion dollar pharmaceutical deal in the Middle East has been jeopardised by anti-government protests in the region.

Approval has been granted for Wockhardt to market generic Lamotrigine tablets in various dosages.

Roche has announced a new process for making its clinical trial data more transparent.

Scientists are confident that they are making progress in the treatment for type 1 diabetes, developing a new vaccine that effectively shuts down the immune system.

The UK Biomedical Catalyst Fund has granted £2.4 million funding for the development of DMD treatment.

XTANDI is a treatment option for prostate cancer patients who are resistant to first-line therapy.

The computer model should facilitate the design of superior AD clinical trials.

Clinical research experts believe that employers should take a more broad-minded approach to recruitment.

Operating to remove the fallopian tubes could cut the risk of ovarian cancer.

Success for health product specialist Cyanotech in the third quarter of fiscal 2013.

The drug prevents tumour growth through inhibition of HSP90.

The unique hTee technology can aid patient management for those undergoing heart surgery.

Oncologists may omit vital chemotherapy doses when supplies are low.

The KKL-35 antibiotic could treat anthrax and tuberculosis by disrupting trans-translation.

Fat has been shown to trigger rheumatoid arthritis

Despite previous clinical trials suggesting that antioxidants can help women conceive, a new review says that this is not enough. Women who undergo fertility treatment are often encouraged to take dietary supplements that contain antioxidants. Yet th...

New data is helping improve immunisation strategies in the treatment of dengue fever.

A common treatment for epilepsy has been launched in the UK in liquid form

Scientists have discovered how to manipulate a mutant protein to kill cancer

A breakthrough on how T cells operate after stem cell transplants could lead to improvements in the process

A figure-8 valvuplasty balloon catheter has received 510(k) clearance in the US

US pharma firm Achaogen has signed a new deal to push forward its research into plazomicin.