The 21st Century Cures Act required the Food and Drug Administration (FDA) establish a program for evaluating the use of real-world data (RWD) to support the approval of new indications for drugs. Real-world data is typically data from either health insurance claims, electronic health records… Read More »FDA’s use of real-world data
Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available. The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late… Read More »Pfizer to wait until after election to file COVID-19 vaccine in US
The boom in digital tech over COVID means that pharma can move faster than ever – but the industry’s traditional processes for asset approval are still holding timelines back. David Reily examines how pharma companies are responding to the increased burden of asset approval with… Read More »Accelerating the digital approval process
There are a host of new, previously unimaginable tools and techniques – from analytics to robotic process automation (RPA) and artificial intelligence (AI) – available to help speed up processes and increase data accuracy. But for many life sciences organisations, these tools are either not… Read More »Why intelligent automation is the future for regulation
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines… Read More »European regulators begin rolling review of AZ’s COVID-19 vaccine
SMi reports: Alan Franklin, CEO, ForwardVue Pharma will be presenting at the Ophthalmic Drugs conference The 4th Annual Ophthalmic Drugs Conference taking place on the 23rd -24th November 2020, will explore new discoveries in the treatment of ocular disease, innovations in combination technologies, and the… Read More »Exclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020
US biotech BioMarin has hit back with a filing for a rare disease drug, after suffering what was described by analysts as a “major setback” when the FDA rejected its gene therapy for haemophilia A. California-based BioMarin said the US filing for vosoritide in achondroplasia… Read More »BioMarin files achondroplasia drug after rejection for haemophilia therapy
The FDA has approved a new therapy for the rare muscle wasting disease Duchenne muscular dystrophy (DMD) as Japan’s NS Pharma takes on Sarepta and its controversially approved rival. NS Pharma’s Viltepso (viltolarsen) has been approved in patients who have confirmed mutation of the DMD… Read More »NS Pharma takes on Sarepta as FDA approves DMD drug
The Centers for Medicare & Medicaid Services (CMS) has proposed a new rule that would make certain COVID-19-related telehealth flexibilities introduced over the past few months permanent for Medicare beneficiaries. The move comes in conjunction with an executive order from President Trump to improve rural… Read More »CMS: True Telehealth Change Will Require Congressional Action
Home-based care providers are at the forefront of the nation’s fight against the coronavirus; yet they still lack the full federal help they need to succeed. Meanwhile, regulatory flexibilities for hospitals and other health care providers are creating newfound competition for home health and home… Read More »Dombi: Regulatory Flexibilities Mean More Competition for Home Health Providers
For months now, home health providers have had to worry about an onslaught of new issues, from volume disruptions and personal protective equipment (PPE) shortages, to cash flow problems and lack of telehealth reimbursement. One long-time stressor they haven’t had to fret about, though, is… Read More »August to Usher in Onslaught of Home Health Audits
The Paycheck Protection Program (PPP) has helped home-based care providers who received less than $150,000 in loans save more than 160,000 jobs nationwide, according to data from the Small Business Administration (SBA). States such as Texas, California and Florida saw the highest number of home-based… Read More »PPP Loans Have Helped Save More Than 160K US Home-Based Care Jobs
Home-based care providers who received loans under the Paycheck Protection Program (PPP) could face unexpected expenses when it comes time to file their 2020 taxes. That is, unless the government intervenes. “Congress clearly intended that PPP funds would be nontaxable,” Leon LaBrecque — a lawyer,… Read More »PPP Tax Debate Could Cost Home-Based Care Agencies in the Long Run
The UK’s regulator has granted early access to Alnylam’s ultra-rare disease drug lumasiran, allowing patients with primary hyperoxaluria type 1 to gain access ahead of a regulatory decision by the European Commission. The Medicines and Healthcare products Regulatory Agency (MHRA) gave a positive opinion for lumasiran through its… Read More »UK patients get early access to Alnylam’s ultra-rare disease drug lumasiran
As we have discussed here previously, real-world data (RWD) and real-world evidence (RWE) offer many potential benefits in every stage of the drug discovery and development process, continuing on into post-market surveillance. With drug developers and other researchers becoming more interested in using RWD and… Read More »How Are Regulatory Agencies Reacting to the Use of Real-World Evidence?
