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Drug Discovery & Development
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MEI Pharma begins dosing in ME-344 Phase Ib trial for small cell lung and ovarian cancers
By PBR Staff Writer
US-based MEI Pharma has dosed the first patient in a cohort-expansion stage of its Phase Ib clinical trial of ME-344 in combination with topotecan to treat patients with small cell lung or ovarian cancer who failed initial therapy.
Drug Research > Drug Discovery & Development > News
Relmada adds $15m in capital to accelerate development of pain treatment drugs
Relmada Therapeutics, a biopharmaceutical firm with four novel pain treatment drugs currently under development in its pipeline, has received a healthy injection of more than $15m in capital last week that will assist the company in the advancement of its work to bring those products to the largest drug prescription market in the world - the treatment of pain.
Drug Research > Drug Discovery & Development > News
GxP Infrastructure Outsourcing
Infrastructure complexity is increasing and life sciences companies are under a constant pressure to cut costs. Outsourcing is a lever for cutting costs and freeing up internal resources for tasks other than daily operations. NNIT deliver integrated infrastructure outsourcing and application outsourcing that can improve your business processes to reduce costs, free up resources, minimise risk and shorten time to market.
Drug Research > Drug Discovery & Development > Products
Serialisation
Millions of people die every year due to erroneous treatment with counterfeit drugs. To break the cycle with counterfeit drugs, authorities in most major markets are putting regulations into place to enhance patient’s safety. NNIT and NNE Pharmaplan offer a full end-to-end Track and Trace programme covering all aspects of serialisation, from packaging to the point of dispense. Learn more about NNIT and find out how you comply with the serialisation requirements.
Drug Research > Drug Discovery & Development > Products
Quality Management
Effective quality management processes in the life science industry are critical to meet the intense regulatory requirements.NNIT can ensure you have the highest level of inspection readiness with full document compliance and validation, according to FDA and EMA requirements.
Drug Research > Drug Discovery & Development > Products
Regulatory Affairs
The burden of regulation imposed by national health system legislation and regulatory authorities is continually growing. NNIT can help you use IT to comply with new and upcoming regulations from drug development and regulatory submissions to post-marketing while ensuring that you can manage your data and improve collaboration across your organisation.
Drug Research > Drug Discovery & Development > Products
Drug Development
Transforming a compound into a drug is a massive investment. An integrated IT strategy across your clinical value chain can maximise this investment and speed up time to market.
Drug Research > Drug Discovery & Development > Products
Case Stories
NNIT started life as the IT department of an international pharmaceutical company. This has given us an insiders’ understanding of the way the life sciences industry works. Our people are united by a high level of IT expertise coupled with a commitment to deliver the highest level of quality. In short, we go out of our way to make sure your IT processes increase your business efficiency and support your organisational ambitions.
Drug Research > Drug Discovery & Development > Case Studies
Sign up to NNIT’s Newsletter
| By NNIT
Sign up to NNIT’s newsletter and receive inspiration on how IT can create value for life sciences companies. You'll get articles, whitepapers, cases and invitations to webinars. Sign up here: http://www.nnit.com/pages/news.aspx#/
Drug Research > Drug Discovery & Development > White Papers
Aileron Therapeutics secures $33m in series E financing to advance cancer drug development
Aileron Therapeutics, a clinical stage biopharmaceutical company that is developing first-in-class therapeutics based on its proprietary Stapled Peptide drug platform, has announced that it has secured $33m in an extension to its Series E equity financing, bringing the total raised in this round to $48m.
Drug Research > Drug Discovery & Development > News
Akebia reports positive top-line results from Phase IIb AKB-6548 anemia trial
By PBR Staff Writer
Akebia Therapeutics has reported positive top-line results from its Phase IIb placebo-controlled trial of its once-daily, oral therapy, AKB-6548, in non-dialysis patients with anemia related to chronic kidney disease (CKD).
Drug Research > Drug Discovery & Development > News
Imprimis reports positive clinical findings of dropless cataract surgery
Imprimis Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of proprietary sterile and topical compounded drug formulations, has reported clinical findings demonstrating the safety and benefits of Dropless cataract surgery and provided an update resulting from the recent American Academy of Ophthalmology (AAO) annual meeting held in Chicago, Illinois.
Drug Research > Drug Discovery & Development > News
Vaxart accelerates Ebola tablet vaccine development
Vaxart, a privately held company developing vaccines that are administered by tablet rather than by injection, has announced that the company is accelerating its Ebola tablet vaccine program.
Drug Research > Drug Discovery & Development > News
MabVax Therapeutics nominates HuMab 5B1 as lead clinical development candidate
MabVax Therapeutics Holdings, a clinical stage oncology drug development company, has formally nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer.
Drug Research > Drug Discovery & Development > News

PBR Supplier Recommendations

FeF Chemicals - Insulin Human and Benzalkonium Chloride Products
FeF Chemicals is a Novo Nordisk company that specialises in the supply of ingredients for the biopharmaceutical and pharmaceutical industries, such as insulin human for cell culture media and cGMP manufactured quaternary ammonium compounds (usually referred to as quats) such as benzalkonium chloride, cetrimide and cetrimonium bromide.... Drug Research > Drug Discovery & Development > Suppliers
Polipharma Industries - Pharmaceutical Product Manufacturer
Polipharma Industries is a GMP-certified drug manufacturer established in 2003, whose core business is the manufacturing of pharmaceutical products. We provide activities and services such as: research & development, out-licensing, contract manufacturing, contract development, batch release, analytical services and clinical trials.... Drug Research > Drug Discovery & Development > Suppliers
Alpex Pharma - High Quality Formulation Development & Manufacturing Company
Alpex Pharma is a pharmaceutical company active in Research & Development and Production of ODT (Orally Dispersible Tablet) called also "fast melt" and effervescent tablets. Alpex Pharma has developed a unique proprietary covering ODT technology.... Drug Research > Drug Discovery & Development > Suppliers
NNIT - The Full Service IT Consultancy Dedicated to Life Sciences
NNIT specialises in using IT to optimise the complex processes inherent in the life sciences industry. We are an international consultancy in the development, implementation, validation and operation of IT for the life sciences industry. ... Drug Research > Drug Discovery & Development > Suppliers
PolyPeptide Group - Proprietary and Generic GMP-Grade Peptides
The PolyPeptide Group is a privately-held group of manufacturing companies that focuses on proprietary and generic GMP-grade peptides for the pharmaceutical, cosmetic and biotechnological market.... Drug Research > Drug Discovery & Development > Suppliers
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PBR White Paper Recommendations

Sign up to NNIT’s Newsletter By NNIT
Sign up to NNIT’s newsletter and receive inspiration on how IT can create value for life sciences companies. You'll get articles, whitepapers, cases and invitations to webinars. Sign up here: http://www.nnit.com/pages/news.aspx#/ ... Drug Research > Drug Discovery & Development > White Papers Why You Should be Using Ultrasonic Cleaning By Natoli Engineering Company
Clean punches and dies are essential to maintaining the integrity and efficiency of your tooling investment, as well as the quality of your product. Ultrasonic cleaning has long been considered the most effective, nondestructive way to clean tools – from medical instruments to tablet tooling.... Drug Research > Drug Discovery & Development > White Papers Choose the Right Tooling By Natoli Engineering Company
Choosing the right tooling can increase tablet output, decrease waste and ultimately determine the success of a product launch.... Drug Research > Drug Discovery & Development > White Papers Eight Ways to Reduce Manufacturing Costs By Natoli Engineering Company
It’s no surprise that in today’s economy, companies are facing budget cuts across the board. In an effort to help our customers address these challenges, we put together this list of eight ways to reduce tablet manufacturing costs.... Drug Research > Drug Discovery & Development > White Papers Seven Inspections Points of Tablet Quality By Natoli Engineering Company
Inspecting tooling and press components for wear or defects could be the most important step in improving tablet quality. There are certain inspection points that are easy to overlook yet can cause significant tablet quality issues and limit tool life. Spend a little time checking the following items for wear or defects to quickly increase tablet quality and reduce tooling cost.... Drug Research > Drug Discovery & Development > White Papers See more
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