Industry news
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GP in Drug Quality Assurance from Development to Consumer
24 May 2019
“In the last three years, Minpromtorg of Russia and SID & GP have built rather an effective mechanism of controlling GMP compliance,” this is how the work of the agencies was assessed by the Deputy General Director of STADA Mr. Ivan Glushkov who was forecasting reinforcement and establishment of new good practices in the country in a couple of years.
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CMS aims to increase drug pricing transparency through price disclosure legislation
23 May 2019
In a presentation at the Rising Leaders Conference on Healthcare Policy, Kate Rawson discussed what to expect with the Direct-to-Consumer Price Disclosure Rule proposed by CMS. Proposed as a way to increase transparency on drug pricing, the Direct-to-Consumer Price Disclosure Rule allows HHS to “call on FDA to evaluate the inclusion of list prices in direct-to-consumer advertising,” Rawson, who is a senior editor at Prevision Policy LLC, said.
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The Role of Commercial Partners in Sales Strategy Development
22 May 2019
The pharmaceutical industry is in the midst of unprecedented change. Product portfolios are diversifying from mass market medications to include highly specialized therapies. Reimbursement is becoming more complex and successful commercialization means targeting multiple stakeholders before a prescription is even written.
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FDA Pushes for “Clear Global Policy Strategy”
22 May 2019
Concerns about the quality and safety of the growing volume of medicines imported to the United States, pressure to set international policies for genome editing of other scientific developments and escalating international trade disputes have prompted FDA to examine and update its programs for overseeing global operations and international affairs.
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Utilizing an Integrated, MultiChannel Approach Can Improve Access for Oncology Products
21 May 2019
Market access for a new oncology product was once a straight line from successful Phase 3 trials to FDA approval, payer coverage, formulary placement, and growing uptake by prescribers. This model began to shift as the first therapies with specific tumor indications were approved and specialty pharmacies emerged as key players in the oncology market.
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21 May 2019
There is no shortage of diseases and conditions for which a cure is desperately needed. Just think of cancer, Alzheimer’s, and autoimmune disease. Despite the strides made in recent years in developing treatments, the road to a cure for many of these conditions can be a meandering path beset with pitfalls, frustration, and failure to hit pay dirt.
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'Cornucopia' of biopharma innovation blurs drug launch forecasts, analyst laments
21 May 2019
Cell therapies, antibody-drug conjugates, mRNA drugs, gene therapies, CRISPR editors—new technologies are exploding in biopharma. But that has also provided a new challenge for analysts and investors: predicting how well drug launches will do.
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WHO Launched Health Product Profile Directory Tool
20 May 2019
WHO’s new Science Division launched an online resource to guide the development of new health products for which there are limited markets or incentives for research and development. An essential tool for realizing universal health coverage, the Health Product Profile Directory aims to promote research and development for products to combat neglected diseases and threats to global health, including antimicrobial resistance and diseases with pandemic potential.
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Antibacterial Nano-Material Discovered by Novosibirsk Scientists
20 May 2019
Researchers at the Institute of Cytology and Genetics (Novosibirsk) have discovered antibacterial properties in a nano-material developed by the Nikolayev Institute of Nonorganic Chemistry.
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International Harmonization Gains Importance for Global Pharmaceutical Industry
17 May 2019
Concerns about the quality and safety of the growing volume of medicines imported to the United States, pressure to set international policies for genome editing of other scientific developments and escalating international trade disputes have prompted FDA to examine and update its programs for overseeing global operations and international affairs. The Office of Global Policy and Strategy in the newly named Office of Policy, Legislation & International Affairs (OPLIA) aims to better link consideration of international policy and trade issues with the challenges in ensuring the quality of ever-more imported medical and food products.
