UK life science competitiveness indicators 2022: measuring what matters most?
The latest life science competitiveness indicators (LSCIs) were published by the Office of Life Sciences (OLS) in July 2022. The indicators did not bring universal […]
regulation
Walgreens helped fuel San Francisco’s opioid crisis, judge finds
Walgreens helped fuel the opioid epidemic in San Francisco by dispensing hundreds of thousands of prescriptions without performing adequate due diligence, a federal judge ruled […]
ODM standard for CRF design
Over the last few years, our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA […]
Minnesota jury rules that pharmacist who denied woman morning after pill didn’t violate her rights
A jury in Minnesota ruled on Friday that a pharmacist did not commit discrimination when he did not fill an emergency contraception prescription for a […]
Why Home Care Providers May Need to Rethink No-Hire Clauses
Home care providers have always taken measures to ensure that they’re able to hold on to staff – especially amid labor shortages – through clauses […]
Why An Active Public Health Emergency Is Beginning to Hurt, Not Help, Providers
The public health emergency (PHE) was once considered an oasis of sorts, both for home health agencies and health systems looking to deliver hospital-level care […]
CDC ends reporting of COVID cases on cruise ships
The Centers for Disease Control and Prevention (CDC) announced this week that it would be ending its monitoring program for COVID-19 cases on cruise ships. […]
Texas sues Biden administration over hospital abortion guidance
Texas is suing the Biden administration over its recent guidance reminding hospitals and physicians that federal law requires them to provide abortions if there is […]
Judge allows abortions to resume in Louisiana
A federal judge has ruled that abortion services can resume in the state of Louisiana, blocking the state from enforcing its so-called trigger ban. Judge […]
DOJ creates new Reproductive Rights task force
The Department of Justice (DOJ) on Tuesday announced the creation of a new Reproductive Rights Task Force aimed at protecting abortion access and enforcing federal […]
FDA guidance on patient-focused drug development
FDA wants drugs to be more targeted to factors that impact patient’s lives in ways that they care about. To achieve this goal, last month […]
Abortion providers challenge bans in Oklahoma
Abortion providers in Oklahoma filed a lawsuit challenging the state’s two abortion bans on Friday, just a week after the Supreme Court overturned the constitutional […]
Medical Devices and IVD Conference
SAE Media Group’s Inaugural Conference… Medical Devices and IVD 2022 14 – 15 November 2022 London, UK http://www.medicaldevices-ivd.com Navigating The MDR and IVDR and Best […]
Ohio abortion clinics challenge state ban
A group of abortion clinics and abortion rights organizations filed a lawsuit in the Ohio Supreme Court on Wednesday seeking to block the state’s six-week […]
New Oncology, Primary Care Models Could Offer Risk-Based Avenues for Home-Based Care Providers
The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) are taking steps to improve oncology care […]
Juul says FDA overlooked key data in e-cigarette application before banning sales
E-cigarette giant Juul argued in court documents filed on Tuesday that the Food and Drug Administration (FDA) had overlooked a mountain of data that it […]
Abortion rights proponents file wave of lawsuits challenging bans
Abortion rights activists have quickly filed a slew of lawsuits in states with trigger bans on abortions that went into effect following the Supreme Court’s […]
Supreme Court sides with doctors convicted of over-prescribing pain medications
The Supreme Court on Monday sided with two doctors challenging their convictions on drug distribution charges for over-prescribing opioid medications in a decision that could […]
Supreme Court’s abortion ruling is watershed moment
The Supreme Court’s extraordinary decision to eliminate the universal right to abortion is a watershed moment in the American experiment, ending half a century when […]
Next big fight looms over abortion pills
Abortion pills are likely to become the next major front of the fight over reproductive healthcare in the wake of the Supreme Court’s decision overturning […]
Biden administration plans to reduce nicotine levels in cigarettes
The Food and Drug Administration (FDA) is set to propose limits on the levels of nicotine tobacco companies can place in traditional cigarettes in an […]
‘The Stability of Home Health Care Is at Risk’: CMS Proposes 4.2% Decrease to Provider Payments in 2023
The U.S. Centers for Medicare & Medicaid Services (CMS) released its FY 2023 home health proposed payment rule late Friday. It comes with a decrease […]
Home Health Providers in HHVBP Demo States Struggled to Achieve Financial Upside
Despite being a significant regulatory change to the home health care industry, some providers aren’t so sure whether the Home Health Value-Based Purchasing (HHVBP) Model […]
Data-driven policy and market access firm Avalere joins Fishawack Health
June 7, 2022, Washington DC – Fishawack Health (FH) announces the acquisition of leading healthcare consulting and advisory firm Avalere Health (Avalere) from Inovalon, which […]
Confusion Around Face-to-Face Documentation Remains for Home Health Providers
Face-to-face encounter documentation remains a pain point for home health providers. It makes sense why, too. The rules and regulations around it are often inconsistent, […]
A ‘Persistence of Patient Harm’: Hospital Failures Highlight Need for Home-Based Care Investments
The traditional brick-and-mortar hospital system is broken, often leaving patients in a condition that’s worse than when they first arrived. That’s according to a May […]
‘Medicare Advantage on Steroids’: Advocates Push Back on ACO REACH Model
Home health care providers and Medicare-for-all advocates certainly agree on their general disliking of Medicare Advantage (MA). The one problem is that these advocates are […]
What HHVBP Means for Managed Care, SNF Utilization
With the nationwide rollout of the Home Health Value-Based Purchasing (HHVBP) Model inching closer, home health agencies are feeling confident about their ability to adapt. […]
FDA rolls out new import guidelines, manufacturer flexibilities to boost infant formula supply
The Food and Drug Administration (FDA) on Monday announced a series of measures aimed at increasing the domestic U.S. supply of infant formula to counteract […]
Harris warns the ‘rights of all Americans are at risk’ if Roe overturned
Vice President Harris on Tuesday warned the rights of all Americans are at risk if the Supreme Court weakens the right to privacy by overturning […]
Biden: ‘Range of rights’ in question if abortion opinion in leaked draft is final
President Biden on Tuesday said that other rights, including same sex marriage and access to birth control, are in question if a leaked Supreme Court […]
Ocasio-Cortez: Supreme Court ‘isn’t just coming for abortion’
Rep. Alexandria Ocasio-Cortez (D-N.Y.) on Monday warned progressives that the Supreme Court “isn’t just coming for abortion” after a leak of a Supreme Court draft […]
Planned Parenthood: Draft Supreme Court ruling striking down Roe v. Wade ‘devastating’
Planned Parenthood reacted with horror and dismay to the Monday publication of a draft Supreme Court ruling that would strike down Roe v. Wade, the […]
Rural Home-Based Care Remains Both Necessary and Extraordinarily Challenging
Aging in place is difficult for many Americans, but it’s even more difficult for those living in rural areas. Things are additionally hard on in-home […]
Questions Linger as Home-Based Care Shifts Toward Value-Based Care
It would be silly to have an argument over whether value-based care is a good principle. That’s unless, of course, you had to parse out […]
When does FDA extrapolate clinical trial results to a broader indication
When new drugs are approved, FDA limits their on-label use to the treatment of specific diseases. A key question is whether the definition of a […]
Federal judge halts Kentucky’s restrictive new abortion law
A federal judge on Thursday temporarily blocked a restrictive new abortion law in Kentucky, handing a win to abortion providers challenging the measure. In a […]
HHS Renews Public Health Emergency, Keeping Key Home Health Waivers in Place
The U.S. Department of Health and Human Services (HHS) on Wednesday opted to renew the COVID-19 public health emergency (PHE), keeping in place several regulatory […]
Federal appeals court upholds Biden admin vaccine mandate for federal workers
A federal appeals court on Thursday ruled to uphold the Biden administration’s vaccine mandate for federal workers, ordering that a preliminary injunction issued against the […]
NASEM Report Slams ‘Ineffective’ Nursing Home System, Highlights Post-Acute Care Utilization Shifts
The National Academies of Sciences, Engineering and Medicine (NASEM) on Wednesday released its long-anticipated report on how to improve nursing home care in the U.S. […]
Making Sense of a Unified Post-Acute Value-Incentive Program
Home health agencies have had to navigate several changes since 2020, from the payment mechanics of the Patient-Driven Groupings Model (PDGM) to the new policies […]
How the PE Nursing Home Crackdown Could Affect the Home Health Industry
Pushed by the White House, federal watchdogs have a new directive – cracking down on private equity in health care. While they’ll largely be targeting […]
Key Barriers Could Limit Adoption of Home-Based Care Models
Over the past few years, the U.S. health care system has learned that home-based care companies are well-positioned to respond to unique challenges, with at-home […]
Government Watchdogs Looking to Ding Home-Based Care Providers
This article is an exclusive feature available as a part of your subscription to HHCN + With the light at the end of the COVID-19 […]
New bill moves to tighten accelerated approval regulation in US
US House Energy & Commerce Committee Chair Frank Pallone (D-NJ) has introduced a new bill to enhance the Food and Drug Administration’s (FDA) authority to […]
FDA Guidance: Methods for identifying what is important to patients
What disease components are most burdensome to patients? How do researchers find this information out? To answer this question, the Food and Drug Administration (FDA) […]
Why Political Roadblocks Threaten Home Health Care’s Biggest Policy Objectives in 2022
Policy concerns in home-based care are considered timely and critical for those in the industry. The issue is, unfortunately, they aren’t always viewed in that […]
Several Government Agencies are Increasingly Targeting Home Care Agencies
The next year will be a big one for home care. There will be increased opportunities for agencies with a larger national spotlight shone on […]
The future of regulatory labeling compliance depends on technology adoption
The life sciences industry is more quickly adapting to new methods, standards and requirements. The focus is now on how to drive greater data governance […]
Home-Based Care Can Help Turn Around CMS’ Investment Portfolio, Former Administrator Says
Former U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma is bullish on a lot. Speaking at the Home Care 100 conference Tuesday, […]
Home-Based Care Workers ‘More Comfortable’ Bringing Lawsuits Against Current, Former Employers
Four home care operators in Portland, Maine, were indicted on counts of wage fixing and labor market allocation charges, the U.S. Department of Justice (DOJ) […]
HHCN+ Report: The Pros and Cons of Certificate of Need Regulations in Home Health Care
This article is an exclusive feature available as a part of your subscription to HHCN + Certificate of Need (CON) laws for home health agencies […]
Japan approves Pfizer COVID vaccine for children aged 5 to 11
Japan’s health ministry has authorised the use of Pfizer and BioNTech COVID-19 vaccine in children aged between five and 11. The vaccine, Comirnaty, is claimed […]
Scotland backs AstraZeneca drug as first-line treatment for NSCLC
Scotland has approved AstraZeneca’s Tagrisso (osimertinib) as a monotherapy for the for the first-line treatment of adult patients with locally advanced or metastatic non-small cell […]
Two new drugs added to WHO list of COVID-19 therapies
A World Health Organization (WHO) panel has given the green light to two new drugs to treat COVID-19. US-based Eli Lilly’s baricitinib (Olumiant), a Janus […]
Positive Reimbursement Environment, Diverse Payer Mix Creating Tailwinds for Aveanna
Aveanna Healthcare Holdings (Nasdaq: AVAH) has been bullish on its plans to expand into a leading provider of senior home health services since it went […]
Overview of FDA Drugs Approved in 2021
In 2021, the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved 50 new drugs, either as new molecular entities (NMEs) under […]
Supreme Court Seems Skeptical on OSHA Rule, More Receptive to CMS Mandate
The U.S. Supreme Court on Friday listened to arguments regarding the issue that has been top of mind for most home-based care providers for the […]
Nine for 2022: International issues that are compelling, new or changed in 2022
The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a […]
Insights from the WHO’s Global Strategy on Digital Health event
The World Health Organization (WHO) recently held a virtual panel discussion during Digital Health Week with speakers from around the world to talk about global […]
OSHA Mandate Reinstated, Noncompliance Penalties to Begin in January
The U.S. Occupational Safety and Health Administration (OSHA) regulation requiring workers at companies with 100 or more employees to be vaccinated against COVID-19 or undergo […]
Majority of US States Again Subject to CMS Vaccine Mandate After New Court Ruling
On the last day of November, a nationwide injunction was issued by a federal judge in Louisiana to freeze the COVID-19 vaccine mandate from the […]
Supreme Court Keeps NY Vaccine Mandate Alive. Here’s What Home Health Providers Should Know.
On Monday, the Supreme Court refused to block New York state’s requirement that health care workers must be vaccinated against COVID-19. For home-based care providers, […]
‘It’s Now for the Wealthy’: Regulation Creating Cost Barriers for Live-In Home Care Services
This article is an exclusive feature available as a part of your subscription to HHCN + In 2013, the Obama administration included live-in caregivers in […]
Federal Judge Halts Health Care Worker Vaccine Mandate Nationwide
The health care worker vaccine mandate is now on ice. A federal judge on Tuesday issued a preliminary injunction to stop the start of the […]
CMS Vaccine Mandate Blocked in 10 States
First it was the COVID-19 vaccination mandate from the U.S. Occupational Safety and Health Administration (OSHA). Now, it’s the one from the Centers for Medicare […]
‘We Will Hold You Accountable’: New York Home Health Agencies to Pay $18.5 Million
One of the largest home health groups in New York has agreed to pay millions of dollars to resolve wage-and-hour violations. The home health group […]
OSHA Cracking Down on Workplace Violence Against Home-Based Care Workers
Due to the nature of the job, home-based care workers face the risk of experiencing workplace violence. It’s paramount for providers to enact measures that […]
‘The Waiver Program Is Tough’: Issues with the CMS Hospital-at-Home Program
The proliferation of hospital-at-home models has been one of the major home-based care trends during the COVID-19 crisis, and players on all sides are bullish […]
An overview of CDISC standards
Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it […]
‘We’ve Got to Have Set Standards’: Increased Standardization Likely Coming to Home Care
With more eyes than ever on the home care industry, experts are trying to read the tea leaves to determine if greater standardization will eventually […]
HHS Releases $25.5B in Provider Relief Funds, Promises Increased Audits Around M&A Activity
The U.S. Department of Health and Human Services (HHS) announced Friday that it is releasing another $25.5 billion under the Provider Relief Fund (PRF). Since […]
Impact of Certificate of Need on Health
An interesting paper from Kevin Chiu in the Journal of Health Economics looks at the relationship between certificate of need laws and health outcomes: Certificate […]
FDA: Why we approved Prograf based on real-world data
Recently, the Food and Drug Administration (FDA) approved Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection for […]
FDA faces big questions as it takes a closer look at AI regulations
An action plan shared by the FDA earlier this year showed how the regulator is thinking about future regulations for AI and machine learning in […]
FDA extends tie-up with CN Bio to test ‘lung-on-a-chip’ tech
The FDA has extended a collaboration with the UK firm CN Bio to investigate a “lung-on-a-chip” model to investigate inhaled drugs. In a statement the […]
Formedix Expedites Clinical Trial Build with New Cloud Clinical MDR Suite
Glasgow, UK – (March 29, 2021) – Formedix, a leading provider of clinical trial software solutions, announces the launch of ryze, an innovative all-in-one cloud-based […]
EU starts rolling review of Sinovac’s COVID-19 vaccine
Europe’s regulator has begun a rolling review of Sinovac’s COVID-19 vaccine, known as Vero Cell. The vaccine is based on an inactivated SARS-CoV-2 virus, which […]
Tecentriq can stay as therapy for triple-negative breast cancer, FDA experts say
Roche’s Tecentriq can stay on the US market as a therapy for triple negative breast cancer, advisers to the FDA have said as part of […]
HHS reverses previous administration’s push to deregulate more than 80 medical devices
In the final days of the Trump Administration, the Department of Health and Human Services sought to deregulate 83 different types of medical devices, citing […]
EU safety regulators clear J&J COVID shot despite tiny clot risk
The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. In a decision […]
FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting
After a long and troubled development the fate of Pfizer/Lilly’s tanezumab painkiller injection is in the balance ahead of a key meeting of advisers later […]
Xavier Becerra Confirmed as HHS Secretary
The U.S. Senate on Thursday narrowly confirmed California Attorney General Xavier Becerra as the next secretary of the Department of Health and Human Services (HHS). […]
What is the FTC’s stance on pharmaceutical mergers?
The answer to this question likely will be shaped in part by a new multilateral working group that will include not only representatives from the […]
Analysis: Most hospitals not complying with price transparency rule
The federal price transparency rule for hospitals went into effect Jan. 1, but a new analysis shows that a majority of providers studied were “unambiguously […]
CMS Could Target LUPAs, Functional Impairment in Future PDGM Adjustments
Despite the once-in-a-generation COVID-19 pandemic, the home health industry’s transition to the Patient-Driven Groupings Model (PDGM) was pretty seamless. Looking into the not-too-distant future, the […]
EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports
European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its […]
Budget 2021: Sunak focuses on vaccine development to restart economy
UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with […]
How representative are clinical trials of the US population?
Diversity in clinical trials Recently, the FDA’s Center for Drug Evaluation and Research’s (CDER’s) released its 2020 Drug Trials Snapshots Summary Report. Part of the […]
Use of real-world evidence for regulatory decision-making
How do you evaluate treatment efficacy and safety outside of the clinical trial setting? This is not just a question of academic interest. In last […]
China approves Sinovac’s coronavirus vaccine
China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical […]
Dilemma for Biden as Woodcock’s audition for FDA chief stumbles
The change of administration in the US has also seen a new leader at the FDA, with Dr Janet Woodcock appointed as interim commissioner by […]
White paper reveals pathway for digital therapeutics use in Italy
A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith […]
Novavax’s COVID-19 shot effective against UK strain
Novavax’s COVID-19 vaccine could be added to the UK’s growing arsenal of shots against the disease after it showed 89.3% efficacy in a late-stage trial. […]
RxSource optimizes clinical labeling process with PRISYM 360 cloud-based solution
The Covid-19 pandemic has put further pressure on clinical trial suppliers to be fleet of foot in getting products dispatched when a new patient is […]
AZ has ‘constructive talks’ with EU leaders after vaccine row
AstraZeneca has said it has had “constructive talks” with European leaders in a bid to cool the row over vaccine supplies to the EU. The […]
Biden likely to ditch Trump’s plans to relax digital health regulations
President Joe Biden looks likely to ditch the previous administration’s move to create a quicker route to market for digital health products and other devices […]
Biden Administration Includes ‘Home Care Workforce Crisis’ in New Pandemic Plan
President Joe Biden focused on the ongoing COVID-19 pandemic during his first full day in office Thursday. In doing so, he once again drew attention […]
In the final days of Trump administration, agencies clashed over how to regulate medical AI
The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the […]
Biden appoints veteran Woodcock as interim FDA commissioner
Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden to replace outgoing Trump appointee Stephen Hahn. Woodcock has […]
DOL Guidance Could Lead to More Home Care Companies Providing Live-In Services
The U.S. Department of Labor (DOL) recently issued an opinion letter allowing home care agencies to implement consistent shift rates that include pre-payment of overtime […]
Top Home Health, Home Care Legal Concerns for 2021
Wage-and-hour litigation, confusing state-level regulations and an increase in federal audits were among the biggest legal trends of 2020. While many of these issues will […]
At CES, experts say transparency key to ensuring AI tools work as intended
AI tools increasingly occupy a regulatory gray area in healthcare. For clinicians to assess whether they are trustworthy, they need transparency on how they work, […]
UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine
The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK […]
Getting gene therapies to market faster
The FDA approval process is slow. Even for COVID-19 vaccines, the process can be time consuming. However, regulators around the world do have some expedited […]
‘Highly likely’ BioNTech vaccine will work against new strain, says CEO
BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the […]
No Funding, Closures and Limited Capacity: Adult Day Providers in Dire Need of Help
In late November, the aging-focused advocacy organization LeadingAge wrote a note to Congress, calling for relief on behalf of the 5,500 adult day service providers […]
FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel
Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that […]
Biden Picks California Attorney General Becerra to Lead HHS, COVID-19 Response
President-elect Joe Biden has picked Xavier Becerra, the current attorney general of California, to lead the U.S. Department of Health and Human Services (HHS), according […]
Latin America: How pharma can navigate a complex market
Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and […]
What is the impact of FDA review time on pharmaceutical R&D investments?
This is the question that a recent paper by Chorniy et al. (2020) attempt to answer. This issue is clearly very relevant as the UK […]
Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval
Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world […]
Non-Physician Certification in Home Health Care Blocked by State-Level Barriers
Over the past several years, it seems as though the home health industry has been inching closer and closer toward the elimination of Medicare’s strict […]
CMS’s Stark Law Changes Could Mean More Value-Based Business for Home Health Operators
In an effort to boost value-based care, the U.S. Centers for Medicare & Medicaid Services (CMS) recently announced that it has finalized changes to the […]
CMS Launches ‘Unprecedented’ Hospital-at-Home Strategy to Manage Latest COVID-19 Surge
In an effort to increase hospital capacity amid the current COVID-19 surge, the U.S. Centers for Medicare & Medicaid Services (CMS) on Wednesday announced “unprecedented” […]
FDA approves Alnylam’s ultra-rare disease drug Oxlumo
The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder. Oxlumo […]
How long does it take to bring a vaccine to market?
Given the incredible speed in which vaccine development for COVID-19 is occurring, it merits thinking back on the typical development and approval time of previous […]
UK could get COVID-19 vaccines early next year, ahead of European countries
COVID-19 vaccines could be approved and available early next year in the UK ahead of European countries, after its national regulator began its own rolling […]
Late RAPs Could Trigger Immediate 20% Payment Reduction in 2021
The U.S. Centers for Medicare & Medicaid Services (CMS) released its final home health payment rule for CY 2021 on Thursday, with essentially no changes […]
HHS Loosens Provider Relief Fund Restrictions, Allows Agencies to Cover Lost Revenue
In response to ongoing opposition from both lawmakers and providers, the Department of Health and Human Services (HHS) recently announced it has made changes to […]
FDA’s use of real-world data
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 […]
Pfizer to wait until after election to file COVID-19 vaccine in US
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 […]
Accelerating the digital approval process
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 […]
Why intelligent automation is the future for regulation
There are a host of new, previously unimaginable tools and techniques – from analytics to robotic process automation (RPA) and artificial intelligence (AI) – available […]
European regulators begin rolling review of AZ’s COVID-19 vaccine
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. […]
Exclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020
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 […]
BioMarin files achondroplasia drug after rejection for haemophilia therapy
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” […]
NS Pharma takes on Sarepta as FDA approves DMD drug
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 […]
CMS: True Telehealth Change Will Require Congressional Action
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 […]
Dombi: Regulatory Flexibilities Mean More Competition for Home Health Providers
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 […]
August to Usher in Onslaught of Home Health Audits
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, […]
PPP Loans Have Helped Save More Than 160K US Home-Based Care Jobs
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 […]
PPP Tax Debate Could Cost Home-Based Care Agencies in the Long Run
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. […]
UK patients get early access to Alnylam’s ultra-rare disease drug lumasiran
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 […]
How Are Regulatory Agencies Reacting to the Use of Real-World Evidence?
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 […]
