Policy

Health apps could face big fines if they don’t disclose privacy breaches 

The agency reminded health apps and wearables companies that they must disclose any breach of users’ health information, even if they are not a HIPAA covered entity. Companies that fail to disclose a breach could face thousands of dollars per day in fines.

Policies|Techies|VCs: What’s Next For Health Care–Virtual Conference is Sept 7-10

Policies|Techies|VCs: What’s Next For Health Care? is the conference bringing together the CEOs of the next generation of virtual & real-life care delivery, and all the permutations thereof. You can register here or learn how to sponsor. This is a big week. We are one week out and we’ve started pre-recording a few sessions and they’ve been fascinating. Keynotes …

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Insurer price transparency rule faces legal challenges: 4 takeaways

Two lawsuits, filed by the U.S. Chamber of Commerce and the Pharmaceutical Care Management Association, allege that portions of the price transparency rule governing insurers are unlawful and would drive up healthcare prices, contrary to the rule’s stated aim.

Judge blocks HHS from requiring religious providers to perform gender-transition, abortion procedures

The permanent injunction prevents HHS from interpreting a section of the ACA, which bans discrimination, to include gender identity and pregnancy status. This move prohibits the federal agency from penalizing religious providers for refusing to perform or provide insurance coverage for gender-transition surgeries and abortions.

Only 5% hospitals are compliant with price transparency rule. Here’s how they did it.

The hospitals that were found to be fully compliant with the federal price transparency rule had a few strategies in common, including picking the right technology partner and beginning their efforts early — in some cases before the rule was even proposed.

CMS proposes fining hospitals up to $2M annually for not following price transparency rule

CMS’ latest proposed rule, which includes stringent penalties for hospitals that are found to be flouting the price transparency rule, comes on the heels of an analysis showing that a vast majority of hospitals are not in compliance with the regulation that went into effect on Jan. 1.

Regulated digital health explained: What you need to know to stay compliant [Sponsored]

Digital health thought leader Mark Tarby, BrightInsight vice president of regulatory and quality management systems, shared his take on what the EU MDR means for connected devices, Software as a Medical Device (SaMD), and the go-to market strategies for the companies behind them.

UnitedHealthcare nixes some out-of-network coverage for non-emergencies

Per a policy update that went in to effect July 1, the health insurance giant is not covering non-emergency services that members receive at out-of-network facilities that are outside of their service area. This update mainly affects residential treatment facilities, inpatient rehabilitation and other non-hospital-based services.

Government to introduce health and care bill in parliament

The government will present its health and care bill to parliament on 6 July setting out major NHS reforms that include scrapping CCGs, formalising the role of integrated care systems and increased powers for the health secretary.

Government to introduce health and care bill in parliament

The government will present its health and care bill to parliament on 6 July setting out major NHS reforms that include scrapping CCGs, formalising the role of integrated care systems and increased powers for the health secretary.

Government to introduce health and care bill in parliament

The government will present its health and care bill to parliament on 6 July setting out major NHS reforms that include scrapping CCGs, formalising the role of integrated care systems and increased powers for the health secretary.

ONC Chief: Data standardization key to integrating public health into info-sharing infrastructure

The Covid-19 pandemic shone a harsh light on how siloed the public health infrastructure is, and the ONC is working along with other government agencies to integrate it with the existing data-sharing ecosystem. According to Dr. Micky Tripathi, head of the agency, standardizing data will be essential to this integration.

Providers watch legislation that would extend telehealth treatment for substance use

Temporary policy changes during the Covid-19 pandemic let people access substance use treatment over telehealth for the first time. Now, healthcare providers and policymakers are watching legislation that would allow patients to continue to access these services virtually.

Supreme Court upholds ACA, dismissing constitutional challenge

The Supreme Court upheld the Affordable Care Act, dismissing the lawsuit brought by Texas, 17 other states and two individuals on the grounds that they were not able to prove they were harmed by the law. Industry stakeholders celebrated the court’s long-awaited decision.

Discharged into debt: A chronic ciagnosis  

Given the complex and systemic nature of the country’s crisis, no single solution or course of action can be expected to serve as a panacea. A multi-pronged approach — including digital health tools — that enlists both public and private health stakeholders and addresses each stage of the medical debt life cycle will be required.

Providers win deadline extension for use of CARES funds, but it may cause some confusion

The HHS has extended some of the deadlines for using provider relief funds and reporting on that use. Though the move is mostly positive for providers — who were clamoring for this extension — there may be some additional work required to prevent confusion.

Study: Bots amplified pandemic misinformation on social media 

Bots may have played a significant role in circulating misinformation during the Covid-19 pandemic, according to a study published in JAMA Internal Medicine. The study found that Facebook posts in groups most affected by bots were more than twice as likely to misstate the results of a study about masks or share conspiracies. 

Emergency physicians oppose new UnitedHealth policy enabling retroactive ED claims denial

UnitedHealthcare is instituting a new policy beginning July 1 that changes how the payer assesses emergency department claims, allowing it to retroactively deny ones it deems “non-emergent” or not an emergency. The American College of Emergency Physicians has made its opposition clear, stating the policy may violate federal law.

Hit hard by the pandemic, one California county looks to vaccinate its most vulnerable

Often overshadowed by its larger, more affluent neighbors to the west, Imperial County had few testing and vaccination resources early on. Now, flush with vaccines, groups in the county are taking targeted efforts to reach vulnerable communities.

100+ workers sue Houston Methodist over mandatory Covid-19 vaccination policy

The lawsuit alleges that the policy is akin to forcing employees to participate in a medical experiment as none of the vaccines available have received full FDA approval. But Houston Methodist rebutted these claims saying the vaccines are safe and effective, and requiring employees to get vaccinated is in the best interest of the patient.

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 healthcare. But the agency still has several big questions to address as it prepares to roll out new guidance.

Building affirming spaces for LGBTQ youth saves lives, according to Trevor Project survey 

Having access to affirming spaces and living with people who respected their pronouns made a big difference in LGBTQ kids’ mental health, according to a survey conducted by the Trevor Project. Youth living with people who respect their pronouns were half as likely to report attempting suicide than those who didn’t. 

Zing Health Acquires Medicare Advantage Plan Provider Lasso Healthcare

What You Should Know: – Zing Health Enterprises, a physician-founded and led provider of Medicare Advantage health plans, has signed definitive documents to acquire Harrisburg, PA-based Lasso Healthcare Insurance Co. – Lasso Healthcare offers Medicare Advantage (MA) plans in 34 states and the District of Columbia. Its insurance offerings currently cover over 6,000 members. Lasso …

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Providers, payers & startups are all looking for key pieces to solve the maternal care puzzle

America’s abysmal record on maternal care outcomes and equity has spurred the rise of startups as well as innovative strategies from providers and payers, each trying to solve a piece of the larger problem. But these entities will also need the help of policymakers to truly improve care in this arena.

32 hospitals in non-Medicaid expansion states sue HHS over payments for low-income patients

The hospitals are pushing HHS to recognize patients eligible for Medicaid under the ACA as “low-income” when calculating Medicare disproportionate share hospital payments in states that did not expand Medicaid. The agency’s refusal to do so resulted in the hospitals receiving lower reimbursements for three years, the lawsuit claims.

Providers to HHS: ACO quality reporting changes create undue burdens

Eleven provider organizations sent a letter to HHS urging them to reconsider the new rules around quality measurement and reporting for ACOs. One of the reasons these rules are burdensome and should be revised is the lack of EHR interoperability, they said.

CMS finalizes new rules for ACA exchanges in 2022: 5 key provisions

CMS has adopted several new rules that will change how the Affordable Care Act exchanges operate next year. These include rules that will lower out-of-pocket consumer spending by $400 and widen eligibility for gaining health coverage outside of the designated ACA open enrollment period.

Survey: Large employers want more government action to curb healthcare costs

Executives at large companies feel that the cost of providing employee health benefits will become unsustainable within the next decade, a new survey shows. They want the government to play a bigger role in providing coverage and lowering costs.

CMS’ price transparency rule offers providers, payers a win, too

Patients are not the only ones who will benefit from the price transparency rule — providers and payers can also gain competitive advantages as a result of the regulation. These include being able to deepen relationships with patients and support payment contract negotiations.

CMS proposes putting $2.5B into hospitals’ coffers, eliminating part of price transparency rule

CMS has released its proposed inpatient payment rule for fiscal year 2022, which includes a payment bump that could increase reimbursement for hospitals by $2.5 billion. Further, in a win for hospitals, the proposal aims to repeal a part of the price transparency rule related to Medicare Advantage plans.

Some proposed HIPAA changes could inadvertently expose the data it’s supposed to protect

The government’s proposed changes to HIPAA aim to provide guardrails against data breaches and misuse, but some of the modifications may not work as intended. Three healthcare experts delved into the ways in which certain proposals could provide inappropriate access to health data during a recent panel discussion.

More than half of FCC telehealth awards went to equipment for providers

After the Federal Communications Commission awarded $200 million to help healthcare providers purchase telehealth equipment, more than half of the awards went to equipment for providers and staff at clinics and hospitals. Just a quarter of awards were to help patients overcome the digital divide. Now, the FCC is preparing to open applications for a …

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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 a lack of reported adverse events. But the Food and Drug Administration put an end to the sudden reversal, saying the proposed exemptions were “flawed.” 

3 Strategies to Up-Level Medicare Advantage Enrollment Before it is Too Late

Trey Keller, VP of Product Management at Edifecs Aaron Fulner, Sr. Director at Edifecs With a new administration looking to reshape healthcare policy and additional special enrollment periods already underway, now is the time to ensure Medicare enrollment systems are ready for the unpredictability, and potential opportunities, ahead. While Medicare is the fastest growing segment …

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Public health, racial equity, climate action drive Biden’s budget requests for healthcare

President Joe Biden has submitted his discretionary budget for 2022 to Congress. Among its healthcare provisions are funding requests for the CDC, mental health and social determinants of health programs. But there are some unusual requests as well, such as funding for an Office of Climate Change and Health Equity.

How CMS final rule will impact E/M coding and documentation requirements

Historically, providers had to meet certain criteria and address three key areas in the patient’s progress notes: patient history, physical exam and medical decision making. CMS has eliminated the history and exam components as required elements for billing purposes, so medical decision making is now the sole driver of the level-of-service.

Family of Dr. Lorna Breen pushes for mental health protections for physicians

The family of Dr. Lorna Breen, an emergency physician working on the front lines of the pandemic who died of suicide, is working with Congress to introduce legislation that would make it easier for phyiscians to seek out mental healthcare. At the state level, licensing boards are also reevaluating application questions to not discourage physicians …

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The “biggest thorn in President Trump’s side” is now HHS Secretary. What’s next?

California Attorney General Xavier Becerra may have won a narrow confirmation to be the Department of Health and Human Services Secretary, but if his past is any indication, his agenda will be bold when it comes to reining in pharma companies, boosting the Affordable Care Act and scrutinizing hospital consolidation.

Biden’s American Rescue Plan Act aims to bolster the ACA. Here’s how.

President Joe Biden recently signed the $1.9 trillion Covid-19 relief package into law. The American Rescue Plan Act includes several provisions to boost coverage under the ACA, like widening eligibility for premium tax credits.

Addressing Vaccine Hesitancy in Communities of Color [OpEd]

Addressing Vaccine Hesitancy in Communities of Color [OpEd] The numbers are sobering: In just over a year since the coronavirus first appeared in the United States, global deaths have exceeded 2.5 million, according to Johns Hopkins data, with the US death toll surpassing the grim milestone of 500,000 in Late February. Vaccine rollout is picking …

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In rebuke of One Medical’s alleged vaccine antics, CA counties sever relationship

Several California counties and Washington state dropped One Medical as a partner in distributing vaccines after reports that it let people who weren’t eligible for the vaccine jump the line. A House panel is also launching an investigation into the company’s practices.  

FDA issues warning on pulse oximeter limitations, but says little about racial disparities

In an alert on Friday, the Food and Drug Administration warmed that pulse oximeters might be inaccurate in some circumstances. The agency listed skin color among other factors that may affect the accuracy of a reading, but didn’t mention research that has demonstrated the devices miss low blood oxygen levels more often in Black patients.

Kathleen Sebelius at Health Datapalooza: To push ACA forward, forget bipartisanship

At a Health Datapalooza session, former HHS head Kathleen Sebelius looked back on lessons learned in 2009 when the Affordable Care Act was moving through Congress. She cautioned the Biden administration against leaning on bipartisanship when restoring the healthcare law.

Why hospitals want CMS, FTC to examine two UnitedHealthcare policies

Two UnitedHealthcare policies have raised several concerns among providers, including that they may display anti-competitive behavior and could block patient access to certain healthcare services. The American Hospital Association is asking the FTC and CMS to review and potentially block these policies.

Pharmacies to start offering a limited number of Covid-19 vaccines

Walgreens, CVS, Walmart and dozens of other pharmacies will start administering a limited number of vaccines as part of the Federal Retail Pharmacy Program. It will offer vaccines in medically underserved areas to healthcare workers, people ages 65 and older, and essential workers, according to local guidelines.

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 FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”

46 hospitals file suit to reverse HHS bad debt policy

A group of hospitals have sued HHS Secretary Alex Azar, arguing he should reverse a policy that prevents hospitals from getting reimbursed for Medicare-related bad debts pending at outside collection agencies. The policy has raised hospital debt payments by about $1.35 million, the lawsuit claims.

Regence, MultiCare Health System to Deploy HL7 Da Vinci Member Attribution List for Value-Based Care Arrangements

What You Should Know: – Regence and MultiCare ink first-in-the-nation value-based care partnership to deliver improved health outcomes at lower costs. Health insurance provider Regence and MultiCare Health System, an independent accountable care organization (ACO) have partnered to deploy a first-in-the-nation value-based model that delivers better health outcomes to members at lower costs while simplifying …

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FDA gives nod to Moderna vaccine for Covid-19

The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

THCB Book Club: Rosemarie Day – Marching Towards Coverage

Rosemarie Day has been a long time health care consultant and operator, most prominently as the COO of the Massachusetts Health Connector–the first real state exchange that was created as part of Romneycare (which with a few twists later became Obamacare!) Following the 2017 Women’s March, Rosemarie decided to write her own book, Marching Towards …

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New study ties pharma payments to prescription practices

Recent efforts to improve transparency haven’t made much of a difference, one author noted. But earlier reforms made a dent the “most egregious” practices.

White House Coronavrius Task Force Doubles Down on Rapid Testing Strategy

What You Should Know: – White house coronavirus task force doubles down on rapid testing strategy to fight the coronavirus as some states say they don’t have the supplies to comply with the federal government’s advice. – This article was originally published by the Center for Public Integrity, a nonprofit investigative news organization based in Washington, …

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With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race

The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.

Intermountain, Sanford Health Signs Intent to Merge

What You Should Know: – Intermountain Healthcare and Sanford Health sign a letter of intent to merge that will created a combined health system employing more than 89k people at 70 hospitals and 435 clinics across seven states. Intermountain Healthcare and Sanford Health, one of the nation’s leading systems in rural health care delivery and …

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CMS Direct Contracting Model Options for Value-Based Care

Vanessa Kuhn, Director of Health Policy, PatientPing The Centers for Medicare and Medicaid Innovation (CMMI) created the Direct Contracting Model to expand opportunities for more diverse providers and healthcare organizations to participate in value-based care arrangements for Medicare fee-for-service (FFS) beneficiaries. The goal of the new model is to create the next generation of risk-sharing …

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Report: 21M people could lose insurance if ACA is overturned

With a new nominee as the Supreme Court prepares to hear a case that could determine the future of the Affordable Care Act, the health law’s future has been thrown into question. According to the Robert Wood Johnson Foundation, the number of uninsured could increase by 70% if the ACA is overturned.

A “bald-faced lie” on LinkedIn followed by revisionist history of CMMI at HLTH panel

HLTH aimed to reflect on the success of the decade-old Center for Medicare and Medicaid Innovation (CMMI) by a panel discussion with its directors. Except the first director was never included while his successor tried claiming the mantle of the “inaugural director” riling former colleagues eager to set the record straight.

Humana, Fresenius Medical Care Expand Partnership to Improve Care Coordination for Medicare Advantage Members

What You Should Know: – Humana Inc. and Fresenius Medical Care North America (FMCNA) today announced an agreement to broaden their collaboration toward improving the health of eligible Humana Medicare Advantage members – The agreement between Humana and Fresenius Medical Care North America goes into effect Jan. 1, 2021. Humana Inc. and leading renal care …

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FDA issues Covid-19 vaccine guidance as White House reportedly relents

The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.

Walmart to Offer Medicare Insurance Plans During 2020 Open Enrollment

What You Should Know: – Walmart announced it will begin selling Medicare insurance plans during this year’s annual enrollment period, Oct. 15 through Dec. 7. Today, Walmart announced the launch of Walmart Insurance Services, LLC, a licensed insurance brokerage, which will assist people with enrolling in insurance plans—and simplify what’s historically been a cumbersome, confusing …

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Amid mixed messages about his Covid-19 diagnosis, Trump looks like a one-man clinical trial

While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.

A debate on reimagining health insurance: Video from MedCity Invest Digital Health

In the latest video installment from INVEST Digital Health, venture capitalist Michael Yang, Managing Partner, OMERS Ventures, and healthcare entrepreneur Shawn Wagoner, Chief Revenue Officer, Bind Benefits, go head to head to debate the future of health insurance.

Molina Healthcare Acquires Affinity Health Plan for $380M

What You Should Know:  – Molina Healthcare acquires New York-based Medicaid managed care organization Affinity Health Plan for $330M in cash serving members in New York City, Westchester, Orange, Nassau, Suffolk, and Rockland counties.  – As of August 31, 2020, Affinity served approximately 284,000 Medicaid members. Affinity’s premium revenue for the trailing twelve months ended …

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Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study

Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.

Policy makers should ‘set their sights higher’ on U.S. drug pricing regulations, researchers say

A review published in JAMA found that bills introduced into the House and Senate don’t go nearly as far as existing drug pricing regulations other countries. The researchers listed eight key lessons from six nations.

Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend

The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.

FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science and data alone – may have played a role.

Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19

Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.

Report: FDA halted move to authorize convalescent plasma for Covid-19 over evidence concerns

The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.

District judge blocks HHS rule that would end transgender health protections

A U.S. district judge blocked a rule by the Department of Health and Human Services that would end anti-discrimination provisions protecting transgender patients. In his decision, U.S. District Judge Frederic Block said that the rule violated a recent Supreme Court decision protecting LGBTQ workers’ rights.

Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine

The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.

Report: Russia says its Covid-19 vaccine ready for market despite no Phase III data

Russian President Vladimir Putin said a vaccine developed at a Moscow research institute that appears to still be in Phase I development among fewer than 100 participants had undergone all necessary tests.

Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients

Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.

Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to Japan

Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.

Sanofi, GSK nab $2.1B deal from federal government to provide Covid-19 vaccine

The companies will provide 100 million doses of their jointly developed vaccine. But with a Phase I/II study planned in September, it is behind in development compared with those of Moderna and Pfizer and BioNTech, which have already started late-stage clinical testing.

Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial

The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.

FDA guidance eases some Covid-19 vaccine concerns, but others remain

Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.

Russian hackers suspected in Covid-19 vaccine intellectual property theft, report says

A joint report by cybersecurity agencies in the U.K. and Canada, endorsed by their U.S. counterparts, states that the hacker group Cozy Bear had been targeting organizations involved with Covid-19 vaccine development efforts.

FDA raises concerns over ocular toxicity from GSK’s potential first-in-class myeloma drug

The FDA’s Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug’s first-in-class potential, the briefing document for the meeting raised concerns about eye toxicity and questions about its risk-benefit profile.

Why Medical Translation and Medical Interpretation Services are Key in Quality Healthcare

Why Medical Translation and Medical Interpretation Services are Key in Quality Healthcare All industries need translators and interpreters who are trained in different languages. Although some items, symbols, and/or actions may be universally understood, you still need to convey subtle meanings and instructions across cultures. It is especially important to overcome language barriers in healthcare. …

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NIAID launches clinical trial network for preventive drugs, vaccines against Covid-19

The NIAID create the Covid-19 Prevention Trials Network by combining four existing ones, primarily focused on HIV and AIDS, which will continue that work in addition to their new focus on Covid-19.

BARDA, DoD give Regeneron $450M contract for Covid-19 antiviral drug

The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.