FDA

US moves to stretch limited monkeypox vaccine supply

The Biden administration on Tuesday announced a new strategy to stretch the limited available doses of the Jynneos monkeypox vaccine by changing how the vaccine is injected. The new method would split up the doses and use one-fifth as much vaccine per shot. The partial dose of the vaccine would be injected into the upper …

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AZ gets FDA nod for Enhertu in first HER2-low cancer

The FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu as the first targeted therapy for HER2-low breast cancer, a new category of the disease that was once lumped under the HER2-negative classification. It has the potential to be a sizeable new indication for Enhertu (trastuzumab deruxtecan), a HER2-targeting antibody-drug conjugate, and central to AZ and …

AZ gets FDA nod for Enhertu in first HER2-low cancer Read More »

FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.

FDA considering dividing Jynneos doses into fifths to increase vaccine supply

The Biden administration is considering splitting doses of the smallpox vaccine, which are being used to prevent monkeypox amid the current outbreak, into five smaller doses, the head of the Food and Drug Administration (FDA) said Thursday. FDA Commissioner Robert Califf said during a briefing that his agency was looking into possible solutions to increase …

FDA considering dividing Jynneos doses into fifths to increase vaccine supply Read More »

Mira Launches Ovum Wand to Predict Menopause and Monitor Fertility Status

What You Should Know: – The FDA has listed Mira’s new Mira Ovum Wand as an over-the-counter tool to detect the follicle-stimulating hormone (FSH) in urine. Starting October 2022, the product will be available to U.S. customers. The wands help monitor FSH levels to predict approaching menopause. They can also be used to monitor fertility …

Mira Launches Ovum Wand to Predict Menopause and Monitor Fertility Status Read More »

With ‘bold experiment’ in drug pricing, Arcutis aims to stand out in plaque psoriasis

The FDA approved Arcutis Biotherapeutics drug Zoryve, a topical treatment for plaque psoriasis. With the decision, the company will proceed with a pricing strategy it believes will speed up insurance coverage and patient adoption of the new treatment for the chronic inflammatory skin disorder.

FDA hits pause on Beam Therapeutics’ off-the-shelf cell therapy for blood cancers

Beam Therapeutics’ application to begin human testing of a cell therapy made with base-editing technology is now under an FDA clinical hold. In other clinical hold news, the FDA lifted a hold on a Celyad Oncology cell therapy clinical trial that was halted in March.

U.S. government places $1.74B order for Moderna’s new Covid-19 vaccine boosters

The U.S. government has signed a supply agreement securing 66 million doses of Moderna’s Covid-19 vaccine booster shots, which are designed to address the omicron subvariants driving new cases of infection. The agreement follows a similar supply agreement reached with Pfizer and BioNTech.

Foods That Improve Sexual Function in Women

Addyi (flibanserin), the drug marketed for “hypoactive sexual desire disorder,” is ineffective and unsafe. What about dietary approaches for female sexual dysfunction? “The creation and promotion of ‘female sexual dysfunction’ [as a mental disorder] is a textbook case of disease mongering by the pharmaceutical industry,” harkening back to the first edition of The Diagnostic and …

Foods That Improve Sexual Function in Women Read More »

FDA verdict on Enhertu in HER2-low breast cancer due before year-end

AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer – an indication which could drive the drug into multibillion-dollar sales territory. The two partners said this morning that the FDA will review Enhertu (trastuzumab deruxtecan) under its real-time oncology …

FDA verdict on Enhertu in HER2-low breast cancer due before year-end Read More »

FDA Awards 510(k) Clearances for ZEUS System/Zio Watch

What You Should Know: – Today, iRhythm (a digital health company) and Verily (Alphabet’s life sciences research organization) announced joint FDA 510(k) clearances for the ZEUS System and Zio Watch. Together they create an integrated, prescription-based solution that will improve clinician workflows, care pathways and the patient experience.  – The ZEUS System is the AI algorithm and …

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Oncoustics Raises $5M for AI-Driven Point-of-Care Diagnostics

What You Should Know: – Oncoustics, San Francisco, CA-based ultrasound-based tissue characterization solutions announces the initial close of a $5 million+ seed round of funding to advance its SaMD (software as a medical device) technology for the low-cost assessment of structural diseases at the point of care. – Oncoustics’ first products will focus on liver disease, one …

Oncoustics Raises $5M for AI-Driven Point-of-Care Diagnostics Read More »

RapidAI Awarded FDA Clearance for AI-Powered CT Scans to Identify Intracerebral Hemorrhage

What You Should Know: – RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity, the newest addition to the RapidAI platform. – The tool empowers physicians to quickly assess the severity of injury in patients with acute neuro conditions …

RapidAI Awarded FDA Clearance for AI-Powered CT Scans to Identify Intracerebral Hemorrhage Read More »

As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. However, many firms were hit hard by the pandemic and are facing ongoing challenges with supply chain and weather-related disruptions, as well as shortages of raw materials, packing materials, and active ingredients. As a result, …

As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever Read More »

Parents Become Drug Developers to Save Their Children’s Lives

Maggie Carmichael wasn’t developing like other kids. As a toddler, she wasn’t walking and had a limited vocabulary for her age. She was diagnosed with PMM2-CDG, potentially fatal gene mutations that cause abnormal enzyme activity — and affect fewer than 1,000 people worldwide. Her parents, Holly and Dan Carmichael, raised $250,000 for scientists to screen …

Parents Become Drug Developers to Save Their Children’s Lives Read More »

Health Care — Senate chair ‘concerned’ with monkeypox response

This pet chicken from Vermont managed to travel more than 10 miles away from home in one piece and has now been reunited with her family after crossing the road — and running into a good Samaritan.  Today in health care, a letter from Senate Health Committee Chair Patty Murray is adding to pressure on the Biden …

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FDA seeks external review of food safety, tobacco offices

The Food and Drug Administration will undergo an independent external review of its tobacco and food safety programs, commissioner Robert Califf announced Tuesday. The announcement comes as the agency is facing scrutiny and criticism from lawmakers and the public over its role in the infant formula shortages and its regulation of e-cigarettes, particularly Juul. Without …

FDA seeks external review of food safety, tobacco offices Read More »

Caption Health Receives CE Mark for AI Ultrasound Tech

What You Should Know: – Caption Health, the leader in using artificial intelligence (AI) and services to improve heart ultrasound access, today announced that it has received a CE Mark for its Caption AI™ technology platform. – This certification represents the first step in making Caption Health’s industry-leading technology platform available outside the US, and …

Caption Health Receives CE Mark for AI Ultrasound Tech Read More »

Engaging change: Connecting patients and regulators can move the dial on drug development

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. In the United States, learning how to navigate forums such as the FDA’s listening sessions and patient-focused …

Engaging change: Connecting patients and regulators can move the dial on drug development Read More »

As Big Pharma Loses Interest in New Antibiotics, Infections Are Only Growing Stronger

Forget covid-19, monkeypox, and other viruses for the moment and consider another threat troubling infectious disease specialists: common urinary tract infections, or UTIs, that lead to emergency room visits and even hospitalizations because of the failure of oral antibiotics. There’s no Operation Warp Speed charging to rescue us from the germs that cause these infections, …

As Big Pharma Loses Interest in New Antibiotics, Infections Are Only Growing Stronger Read More »

FDA warns synthetic vaping companies, but sidesteps total crackdown

The Food and Drug Administration (FDA) on Wednesday sidestepped a major crackdown on companies that make popular synthetic nicotine products, drawing ire from Democrats and anti-tobacco advocates. Synthetic nicotine is made in a lab and enabled companies to skirt FDA regulation since the agency previously did not have the ability to regulate it like it …

FDA warns synthetic vaping companies, but sidesteps total crackdown Read More »

Wysa Secures $20M for AI-Powered Mental Health Chatbot

What You Should Know:  – Wysa, a Boston, MA-based AI digital platform for mental health, today announces it has secured $20M in financing led by HealthQuad, who along with British International Investment (BII), the UK’s development finance institution, joins earlier investors W Health Ventures, Kae Capital, Google Assistant Investments, and pi Ventures amongst others. – …

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KHN’s ‘What the Health?’: Life After ‘Roe’ Is … Confusing

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts. The Supreme Court’s decision overturning the federal constitutional right to abortion has left confusion in its wake. State abortion laws are in constant flux, patients and providers …

KHN’s ‘What the Health?’: Life After ‘Roe’ Is … Confusing Read More »

FDA delay means BeiGene, Novartis must wait longer for cancer drug decision

The FDA has deferred a regulatory decision on an esophageal cancer drug from partners BeiGene and Novartis, citing the need to complete inspections of the China-based facilities where the drug is made. The agency said Covid-19 travel restrictions have prevented it from conducting those inspections.

Patients With Epilepsy Navigate Murky Unregulated CBD Industry

In 2013, Tonya Taylor was suicidal because her epileptic seizures persisted despite taking a long list of medications. Then a fellow patient at a Denver neurologist’s office mentioned something that gave Taylor hope: a CBD oil called Charlotte’s Web. The person told her the oil helped people with uncontrolled epilepsy. However, the doctor would discuss …

Patients With Epilepsy Navigate Murky Unregulated CBD Industry Read More »

FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics

What You Should Know: – Today, Eko, a digital health company advancing heart and lung disease detection, has announced the FDA has issued clearance for its Eko Murmur Analysis Software (EMAS), the first and only machine learning algorithm to screen for valvular heart disease (VHD). – The next generation of Eko’s murmur detection capabilities grants Eko the first and only smart stethoscope on the market that …

FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics Read More »

Fauci: Take new subvariant seriously, but don’t ‘let it disrupt our lives’

Anthony Fauci, the government’s top infectious disease expert, said Tuesday that a new omicron subvariant on the rise is something to take seriously but should not be a cause for panic.   The subvariant, known as BA.5, is now the majority of COVID-19 cases in the United States. It is even more highly transmissible than earlier variants of …

Fauci: Take new subvariant seriously, but don’t ‘let it disrupt our lives’ Read More »

Biomarkers and surrogate endpoints are critical tools for drug development

We are committed to engaging a wide range of audiences and having a dialogue on opportunities to create a better health care system. We believe health literacy can not only help patients make appropriate decisions about their own health but also help enable constructive conversations on how we can support a regulatory and policy environment …

Biomarkers and surrogate endpoints are critical tools for drug development Read More »

Pfizer, BioNTech Covid-19 vaccine gets full FDA approval for adolescents

The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers for an antiviral and Novavax’s European marketing authorization has been expanded to an additional age group.

FDA backs pharmacist prescribing of Paxlovid for COVID

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. The regulator has revised the emergency use authorisation (EUA) for Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to patients, providing …

FDA backs pharmacist prescribing of Paxlovid for COVID Read More »

With new gene therapy data in hand, Sarepta talks with FDA about approval pathways

Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.

FDA working to allow overseas formula makers to stay in US market

The Biden administration is working on a plan that will allow foreign manufacturers of infant formula to keep their products on the market in the U.S. long term, the Food and Drug Administration announced Wednesday. The move would diversify the supply chain and is aimed at preventing another situation like the current shortage, which occurred …

FDA working to allow overseas formula makers to stay in US market Read More »

FDA issues limited authorizations for pharmacists to prescribe Paxlovid

The Food and Drug Administration (FDA) on Wednesday issued a revision to its emergency use authorization (EUA) for Pfizer’s COVID-19 antiviral Paxlovid that will allow pharmacists to prescribe the treatment with certain limitations. Under the original EUA from the FDA, only physicians, advanced practice registered nurses and physician assistants were permitted to prescribe Paxlovid to …

FDA issues limited authorizations for pharmacists to prescribe Paxlovid Read More »

Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan

The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that keep them ahead of closest rival Eli Lilly. The US regulator has been reviewing lecanemab as a treatment for patients with early-stage Alzheimer’s and amyloid plaques in the brain under …

Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan Read More »

Are timely access and robust safety mutually exclusive?

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts. A new cross-sectional study has …

Are timely access and robust safety mutually exclusive? Read More »

Path to Predictive Patient Data: Silencing The Noise of Healthcare

Shane Cooke, CEO and President of Etiometry As the healthcare industry is experiencing major changes in the wake of the pandemic, how do we cut through the noise of beeping monitors and the constant influx of data each patient produces in a given moment to ensure optimal care, especially for critically ill patients? Instead of …

Path to Predictive Patient Data: Silencing The Noise of Healthcare Read More »

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 FDA released a third guidance document on patient focused drug development generally applicable to a variety of clinical outcome assessments (COAs), including patient-reported outcome (PRO), observer-reported outcome (ObsRO), clinician-reported outcome …

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How Pfizer Won the Pandemic, Reaping Outsize Profit and Influence

The grinding two-plus years of the pandemic have yielded outsize benefits for one company — Pfizer — making it both highly influential and hugely profitable as covid-19 continues to infect tens of thousands of people and kill hundreds each day. Its success in developing covid medicines has given the drugmaker unusual weight in determining U.S. …

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Novartis pays $100M to get Mallinckrodt’s ticket for a speedier FDA drug review

Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. The $100 million price tag is in the neighborhood of the going rate for these vouchers, which grant a company a shorter regulatory review timeline for a drug that addresses a rare or neglected disease.

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

KHN’s ‘What the Health?’: A World Without ‘Roe’

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts. It’s been less than a week since the Supreme Court struck down the constitutional right to abortion and each passing day has produced more questions than answers. …

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FDA: Omicron-specific boosters must target new strains

New COVID-19 booster shots should be tailored to target omicron’s BA.4 and BA. 5 subvariants as well as the original strain in order to give people the broadest possible protection, U.S. regulators advised drugmakers on Thursday. The announcement from the Food and Drug Administration (FDA) comes two days after an agency advisory panel recommended tailoring …

FDA: Omicron-specific boosters must target new strains Read More »

Pfizer asks for full FDA approval of COVID pill

Pfizer on Thursday announced it had submitted an application to receive full approval from the Food and Drug Administration (FDA) for its COVID-19 antiviral Paxlovid for use in high-risk individuals. The FDA in December issued an emergency use authorization for Paxlovid to be used as treatment of mild-to-moderate COVID-19 in adults and children over the …

Pfizer asks for full FDA approval of COVID pill Read More »

Feds commit $3.2B to lock in Covid-19 vax supply ahead of fall vaccination campaign

New Covid-19 vaccine booster shots are coming and they’ll likely include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering 105 million doses of the Pfizer/BioNTech vaccine for a planned vaccination campaign in the fall.

Analysis: How Will The Roadmap for Diagnostic Cardiology Devices Develop?

Like most healthcare markets, the diagnostic cardiology market has had a bumpy ride in recent years. The COVID-19 pandemic saw global revenues for Resting ECG devices increase in 2020, whilst ECG Management Systems, Stress ECG and Traditional Holter ECG solutions saw a market decline. Country lockdowns resulted in reduced cardiology services during the peak of …

Analysis: How Will The Roadmap for Diagnostic Cardiology Devices Develop? Read More »

FDA rejection of Spero’s tebipenem ‘raises resistance threat’

The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst. The FDA delivered a blow to Spero’s hopes of bringing the carbapenem to market in a complete response letter (CRL) delivered this week, …

FDA rejection of Spero’s tebipenem ‘raises resistance threat’ Read More »

US panel backs Omicron-targeting vaccines for booster campaigns

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). After hours of deliberation, the panellists voted by 19 to two in favour of using redesigned booster shots, rather than simply using the currently authorised vaccines …

US panel backs Omicron-targeting vaccines for booster campaigns Read More »

FDA panel votes to greenlight updating COVID vaccines for omicron

An expert advisory vaccine panel for the Food and Drug Administration (FDA) on Tuesday voted in favor of recommending updated COVID-19 vaccines specifically designed to combat the omicron variant. Among the voting members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), 19 voted in favor of recommending an omicron-specific booster while two …

FDA panel votes to greenlight updating COVID vaccines for omicron Read More »

Two for two: Sanofi snares twin European nods for enzyme replacement therapies

Sanofi won European Commission approval for two therapies that treat rare enzyme deficiencies. Xenpoyzme is the first treatment for acid sphingomyelinase deficiency (ASMD) while Nexviadyme is a successor to a blockbuster Sanofi drug for Pompe disease.

ITC Judge Finds Apple Infringed AliveCor Patents

What You Should Know: – Today, an International Trade Commission (ITC) judge issued an Initial Determination that Apple infringed AliveCor’s valid patented technology – a finding that may result in a limited exclusion order that will prohibit the import of infringing Apple Watches into the United States. – AliveCor initially filed its complaint with the ITC in April 2021, alleging that Apple infringed AliveCor’s patented technology. Based on the judge’s recommendation, the ITC will …

ITC Judge Finds Apple Infringed AliveCor Patents Read More »

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 had included in its application that demonstrated its products’ benefit to public health and said the decision to ban them was based on “deeply flawed reasons.” In the court documents, …

Juul says FDA overlooked key data in e-cigarette application before banning sales Read More »

BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy

The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.

How the US’s pending PIE Act will improve patient access to medication

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process.    The AMCP backed bill (H.R. 7008), which …

How the US’s pending PIE Act will improve patient access to medication Read More »

Sarepta shares yo-yo as FDA places hold on Duchenne trial

Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of its new-generation Duchenne muscular dystrophy candidate, after a patient had a serious safety incident. The FDA has ordered a clinical hold on Sarepta’s SRP-5051 (vesleteplirsen) drug candidate after one patient in the study developed very low levels …

Sarepta shares yo-yo as FDA places hold on Duchenne trial Read More »

AWS & MATTER Launches Incubator for EMEA Healthcare Startups Entering US Market

– Amazon Web Services (AWS) and MATTER, the premier healthcare incubator and innovation hub, announced the launched of a new incubation program called AWS Expand. – The program supports startups entering the US market from Europe, the Middle East, and Africa (EMEA) by providing expert guidance, mentorship, client connections, an extensive network within the healthcare …

AWS & MATTER Launches Incubator for EMEA Healthcare Startups Entering US Market Read More »

KHN’s ‘What the Health?’: The FDA Goes After Nicotine

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts. The FDA this week launched a crackdown on smoking and vaping — ordering the vaping device Juul to be taken off the market and announcing its intention …

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Google Cloud exec: Real-world data could eliminate the need for placebos in clinical trials

The speed of Covid-19 vaccine trials should inspire the pharmaceutical and medical device industries to accelerate its clinical testing, according to Shweta Maniar, Google Cloud’s director for healthcare and life sciences. She argued that harnessing real-world data will make faster clinical trials achievable for all therapeutics and devices, possibly even eliminating the need to recruit …

Google Cloud exec: Real-world data could eliminate the need for placebos in clinical trials Read More »

Advocates cautiously optimistic over report of Juul ban

Anti-smoking advocates said they are cautiously optimistic following a report that the Food and Drug Administration (FDA) is preparing to remove Juul’s vaping products from U.S. shelves. The move from FDA, as reported Wednesday by The Wall Street Journal, would bring an end to the two-year review of the company’s request to sell tobacco and …

Advocates cautiously optimistic over report of Juul ban Read More »

US frets over pharma supply chain security

The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. Ben Hargreaves finds out how the issue of foreign manufacturing has become a major US political talking point and how this could influence the pressures facing the industry. In a …

US frets over pharma supply chain security Read More »

New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results

First came the “edible billboard,” which appeared last year during the holidays in New York’s East Village loaded with cake treats. Then, in late January, came the national marketing campaign, with TV and digital media promoting the idea that trying to lose weight doesn’t mean a person can’t enjoy eating. Those advertising messages are pushing …

New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results Read More »

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 attempt to make them less addictive, according to a notice published in the agency’s biannual regulatory agenda. Proponents think the rule could save millions of lives from cancer and other …

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AbbVie’s blockbuster drug Skyrizi gets FDA nod for treating Crohn’s disease

AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation. In other drug decision news, the Rhythm Pharmaceuticals product Imcivree added the rare disease Bardet-Beidl syndrome as a new approved indication.

FDA panel turns down Acadia’s Nuplazid for Alzheimer’s psychosis

Acadia Pharma’s attempts to extend the indications of its Nuplazid drug in the US to include Alzheimer’s disease-related psychosis have suffered another major setback. Nuplazid (pimavanserin) is already FDA-approved to treat psychosis caused by Parkinson’s disease, but Acadia’s hope to expanding that use to the Alzheimer’s population were shot down by a complete response letter …

FDA panel turns down Acadia’s Nuplazid for Alzheimer’s psychosis Read More »

Pfizer, Moderna Covid-19 vaccines are now authorized for kids as young as 6 months

Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease Control and Prevention signs off on these shots this weekend, these pediatric vaccines could become available for distribution early next week.

FDA signs off on COVID vaccines for kids age 5 and younger

The Food and Drug Administration on Friday gave the green light to COVID-19 vaccines for children ages 5 and younger, a key step towards making the shots available to the youngest group of kids. The agency authorized the vaccine from Pfizer and BioNTech for kids ages 6 months to 4 years old, as well as …

FDA signs off on COVID vaccines for kids age 5 and younger Read More »

Six months after authorization, what do we know about Paxlovid?

It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe …

Six months after authorization, what do we know about Paxlovid? Read More »

A Proposal to Import Drugs from Other Countries Creates an Unusual Alliance in the Senate

Harmony is not often found between two of the most boisterous senators on Capitol Hill, Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.). But it was there at Tuesday’s Senate Health, Education, Labor and Pensions Committee markup of legislation to reauthorize the Food and Drug Administration’s user fee program, which is set to expire Sept. 30. …

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KHN’s ‘What the Health?’: Closing In on Covid Vaccines for ‘The Littles’

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts. Children younger than 5 are the only population not eligible for a covid-19 vaccine in the U.S. But that may be about to change as an advisory …

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How IoT Data Integration Helps Deliver Improved At-Home Healthcare in 2022

Patricia (Pat) Black, Director of Technical Solutions at Cardinal Peak When it comes to your health and treatment, hospitals leverage a variety of sensors and instruments to collect the necessary information to monitor and diagnose your health status. With essential health data integrated into one platform, healthcare professionals are able to quickly and easily monitor …

How IoT Data Integration Helps Deliver Improved At-Home Healthcare in 2022 Read More »

Will the US Overcome Its Covid Complacency Even as the Threat Returns?

A few months ago, it seemed as though the country was poised to finally tame the pandemic, after two years of restrictions and tens of billions in government spending. The Biden administration in March released the first national covid-19 preparedness plan to help Americans safely “return to normal,” a strategy to live with the continued …

Will the US Overcome Its Covid Complacency Even as the Threat Returns? Read More »

FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials

China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. …

FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials Read More »

Pfizer-BioNTech vaccine effective for children under 5: FDA staff

A Food and Drug Administration (FDA) briefing document released Sunday said that Pfizer and BioNTech’s COVID-19 vaccine is safe and effective for children under 5.  The document comes before a meeting scheduled for Wednesday during which the FDA’s independent experts will consider emergency use authorization of the vaccine for young children, which could quickly pave …

Pfizer-BioNTech vaccine effective for children under 5: FDA staff Read More »

Second unanimous FDA adcomm vote boosts bluebird bio

bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern. By the end of the week, it was two for two, with both recommended for approval by a unanimous vote. Thursday saw the Cellular, …

Second unanimous FDA adcomm vote boosts bluebird bio Read More »

4 Steps for Operationalizing the FDA’s Call To Improve Health Outcomes for All Patients

C.K. Wang, Chief Medical Officer of COTA, Inc. In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. More specifically, Califf made clear that our current healthcare …

4 Steps for Operationalizing the FDA’s Call To Improve Health Outcomes for All Patients Read More »

FDA panel backs bluebird’s CALD gene therapy, despite safety worries

The FDA may have safety concerns abut bluebird bio’s gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far outweigh the risks. Members of the agency’s Cellular, Tissue and Gene Therapies advisory committee voted 15 to 0 in favour of approval of elivaldogene autotemcel – also known as eli-cel …

FDA panel backs bluebird’s CALD gene therapy, despite safety worries Read More »

KHN’s ‘What the Health?’: Taking a Shot at Gun Control

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts. The House passed a package of bills to restrict the availability of assault weapons to minors and other measures to curb gun violence, but talks in the …

KHN’s ‘What the Health?’: Taking a Shot at Gun Control Read More »

TytoCare & Carilion Clinic Partner to Expand Telehealth Offerings

What You Should Know: – TytoCare has partnered with Carilion Clinic, a not-for-profit health care organization serving Virginia’s Blue Ridge and Southwest Virginia regions. – The integration of TytoCare into Carilion’s current virtual care offerings enhances the health system’s ability to diagnose and treat patients remotely with in-depth, physical examinations during virtual visits. Shortage of Primary Care Physicians in Rural Communities Rural …

TytoCare & Carilion Clinic Partner to Expand Telehealth Offerings Read More »

FDA panel gives nod to Novavax COVID-19 shot

An outside advisory panel voted overwhelmingly to recommend the Food and Drug Administration (FDA) authorize a COVID-19 vaccine made by Novavax for use in adults, a move that could lead to adding a fourth vaccine to the U.S. arsenal. The FDA’s vaccine advisory panel voted 21-0, with one abstention. The FDA does not have to …

FDA panel gives nod to Novavax COVID-19 shot Read More »

Misinformation Clouds America’s Most Popular Emergency Contraception

A brand of specialty mozzarella cheeses. A collection of natural-gas storage terminals. And America’s top-selling emergency contraception. At a moment when half of U.S. states stand poised to outlaw or sharply curtail abortion services, the last-ditch pill for women aiming to stave off an unwanted pregnancy rests in the unlikely stewardship of two private equity …

Misinformation Clouds America’s Most Popular Emergency Contraception Read More »

Building a national cybersecurity infrastructure is ‘virtually impossible’ without better federal collaboration

The federal government has established various departments and initiatives to promote cybersecurity among healthcare organizations, but experts say these efforts require more cross-agency collaboration in order to be effective. Most urgently, many cybersecurity experts are calling for the FDA to spend more time collaborating with other federal agencies on cybersecurity recommendations for medical devices.

Watchdog opens investigation into FDA response to formula recall

A federal watchdog on Thursday said it will investigate whether the Food and Drug Administration (FDA) properly inspected an infant formula manufacturing plant operated by Abbott Nutrition. The Department of Health and Human Services’ Office of Inspector General (OIG) said it will investigate the FDA’s actions leading up to the February recall at the Abbott …

Watchdog opens investigation into FDA response to formula recall Read More »

Skirmishes Over Medication Abortions May Renew Debate on State Vs. Federal Powers

As the Supreme Court appears poised to overturn Roe v. Wade, the landmark decision that guarantees the constitutional right to an abortion, reproductive rights advocates are considering new ways to protect nationwide access to the procedure. One strategy involves preserving the availability of the medication used to initiate an abortion in states poised to restrict …

Skirmishes Over Medication Abortions May Renew Debate on State Vs. Federal Powers Read More »

Akili + Roblox Form First of Its Kind Digital Treatment Partnership

What You Should Know: – Akili’s EndeavorRx, the first and only FDA-cleared video game ADHD treatment for kids, is uniting with Roblox’s global virtual universes forming a first-of-its-kind partnership.  – Initially, the partnership will establish an exclusive Roblox reward exchange for patients that complete their medically prescribed EndeavorRx treatment. The rewards will enable patients to redeem items via the exchange …

Akili + Roblox Form First of Its Kind Digital Treatment Partnership Read More »

Novavax hopes FDA go-ahead will boost lagging US vaccinations

Federal regulators appear poised to finally authorize a COVID-19 vaccine from Novavax in the coming weeks, a move that the company hopes can help improve the lagging U.S. vaccination effort.   But winning over even a small number of eligible people who haven’t yet been vaccinated could be a difficult task. It’s not clear how much …

Novavax hopes FDA go-ahead will boost lagging US vaccinations Read More »

Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more

Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee meeting scheduled to discuss the use of that vaccine and Moderna’s in kids. In other Covid news this week, the CDC issued a health advisory for Pfizer’s antiviral Paxlovid and …

Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more Read More »

Healthcare — Formula shortage could last until July

Welcome to Thursday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here:   K-pop superstars BTS are heading to the White House next week to help spotlight anti-Asian hate crimes and discrimination, as well as discuss “the importance of diversity and inclusion.”  Food and Drug Administration …

Healthcare — Formula shortage could last until July Read More »

KHN’s ‘What the Health?’: A(nother) Very Sad Week

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts. This week’s mass shooting of elementary schoolers in Texas (just 10 days after a racially motivated mass shooting at a Buffalo, New York, grocery store) has reignited …

KHN’s ‘What the Health?’: A(nother) Very Sad Week Read More »

Formula shortage won’t end until July, FDA chief says

The nation’s infant formula shortage likely won’t be fully resolved until late July, the head of the Food and Drug Administration (FDA) told senators Thursday. During a Senate Health Committee hearing, FDA Commissioner Robert Califf said it will take time to get to the point when store shelves are fully stocked but that eventually there …

Formula shortage won’t end until July, FDA chief says Read More »

Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors

Novavax hitched its wagon to the global coronavirus pandemic. Before most Americans truly grasped the scope of the danger, the small Maryland biotech startup had secured $1.6 billion in U.S. funding for its covid vaccine. Its moonshot goal: delivering 2 billion shots to the world by mid-2021. Although the U.S. commitment eventually expanded to $1.8 …

Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors Read More »

FDA chief admits slow response to formula shortage

The Food and Drug Administration’s response to multiple reports of contamination at a baby formula manufacturing plant was delayed due to a COVID-19 outbreak and numerous logistical failures, the agency’s director told a House panel Wednesday. FDA Commissioner Robert Califf admitted the agency had a number of missteps that helped exacerbate a nationwide shortage of …

FDA chief admits slow response to formula shortage Read More »

Heart trouble report & clinical hold spell end of Antios, Assembly Bio HBV alliance

A clinical hold on an Antios Therapeutics drug has led to the end of a collaboration with Assembly Biosciences less than a year after their alliance began. The partners had hoped pairing their drugs with an approved Gilead Sciences antiviral would produce a combination hepatitis B treatment with the potential for a cure.

FDA approves Roivant drug, the first novel topical plaque psoriasis med in 25 years

Plaque psoriasis drug Vtama is now approved by the FDA, making it the first novel topical treatment for the chronic autoimmune disorder in a generation. Roivant Sciences subsidiary Dermavant Sciences acquired the drug from GlaxoSmithKline in 2018.

High-Tech’s Business Model Hasn’t Worked for the Cue Covid Test

“I’ve got this,” coos Gal Gadot in Cue Health’s Super Bowl TV commercial. Cue hired the “Wonder Woman” actress to be the voice of the company’s new high-tech covid-19 testing device. The ad pushes the notion that the at-home covid test produces results equal in accuracy to a lab-based PCR test and surpasses it in …

High-Tech’s Business Model Hasn’t Worked for the Cue Covid Test Read More »

FDA sounds caution on Foghorn cancer drug with a partial hold after patient death

The lead cancer drug candidate of Foghorn Therapeutics is now under a partial clinical hold following a patient death. According to the biotech, the patient may have experienced a side effect that is a known complication of leukemia drugs.

Here are the Republicans who bucked the party on baby formula bills

A handful of Republican lawmakers bucked their party on Wednesday in votes on two separate bills aiming to address the nationwide baby formula shortage causing rising concern for parents across the country. The main bill, dubbed the Infant Formula Supplemental Appropriations Act, passed in a 231-192 vote that mainly broke along party lines. Four Republicans …

Here are the Republicans who bucked the party on baby formula bills Read More »

Google gives ex-FDA digital health head Bakul Patel strategic role

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Bakul Patel Patel – who is currently director for digital health at the FDA – said on social media that he is “looking forward to learning …

Google gives ex-FDA digital health head Bakul Patel strategic role Read More »

Here’s the latest on the baby formula shortage

A nationwide shortage of baby formula has been at the top of the news cycle in the U.S. for weeks now as parents stress and struggle to find the products to feed their children. The infant formula first started disappearing from store shelves due to supply chain issues and a massive recall of products produced …

Here’s the latest on the baby formula shortage Read More »

As Red Cross Moves to Pricey Blood Treatment Method, Hospitals Call for More Choice

Americans generally don’t spend much time thinking about the nation’s blood supply. That’s mainly because the collection and distribution system is safe and efficient. But there’s a new behind-the-scenes challenge, according to some hospital officials, who fear a change in how blood platelets are handled will sharply increase the cost — and, in some cases, …

As Red Cross Moves to Pricey Blood Treatment Method, Hospitals Call for More Choice Read More »

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 the current shortage, including temporary import guidelines and flexibilities for companies that don’t normally sell formula. The FDA said it will temporarily “not object” to the importation of certain infant …

FDA rolls out new import guidelines, manufacturer flexibilities to boost infant formula supply Read More »

Abbott says deal reached to restart baby formula plant

Baby formula manufacturer Abbott Nutrition on Monday said it has reached an agreement with the Food and Drug Administration (FDA) on a path to restart operations at its Sturgis, Mich., plant. The facility has been shuttered for more than three months while the FDA investigated whether powdered formula from the plant caused four babies to …

Abbott says deal reached to restart baby formula plant Read More »

Claiming Akebia agreement breach, Otsuka seeks to end anemia drug pact

Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, vadadustat, and asked for another clinical trial. Otsuka alleges unspecified breaches of the agreement by Akebia, and ending the alliance early could spare it from spending hundreds of millions of …

Claiming Akebia agreement breach, Otsuka seeks to end anemia drug pact Read More »

Novel drug to tackle inflammatory diseases begins trial

An early-stage drug that is being developed to tackle inflammatory and autoimmune diseases has been approved by the US regulator. Inmagene Pharma’s investigational new drug (IND) application for the drug candidate IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase (BTK) inhibitor, can now proceed to a phase 1 clinical trial, following the green light from …

Novel drug to tackle inflammatory diseases begins trial Read More »

UCB’s FDA setback delays competition in U.S. with blockbuster J&J psoriasis drug

The FDA cited manufacturing issues in turning down UCB’s application seeking approval for bimekizumab, an antibody drug developed to treat moderate-to-severe plaque psoriasis. Bimekizumab is already approved and available in other markets around world, but the FDA rejection delays UCB’s antibody drug from competing in the U.S. for now.

FDA rejects UCB’s psoriasis therapy bimekizumab

The FDA has delivered a blow to UCB’s late-stage pipeline, after saying it is unable to approve its latecomer IL-17 inhibitor bimekizumab for moderate-to-severe plaque psoriasis. The Belgian biotech said today it had received a complete response letter from the US regulator “cannot approve the application in its current form” because observations in FDA inspections …

FDA rejects UCB’s psoriasis therapy bimekizumab Read More »

Should You Worry About Data From Your Period-Tracking App Being Used Against You?

It’s estimated that millions of people in the U.S. use period-tracking apps to plan ahead, track when they are ovulating, and monitor other health effects. The apps can help signal when a period is late. After Politico published on May 2 a draft opinion from the Supreme Court indicating that Roe v. Wade, the law …

Should You Worry About Data From Your Period-Tracking App Being Used Against You? Read More »

Analysis: Seeking Balance in the Hyperactive Mental Health Tech Market

The prevalence of mental and behavioral health conditions has been on the rise in recent decades, further aggravated by the pandemic in the last two years. Social isolation, grief from the loss of loved ones, fear of contracting the virus, and financial worries were all major stress factors that increasingly affected the mental wellbeing of …

Analysis: Seeking Balance in the Hyperactive Mental Health Tech Market Read More »

KHN’s ‘What the Health?’: The Invisible Pandemic

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. Covid-19 cases are on the rise again, but you couldn’t tell from the behavior of the public (rushing back to normal), as well as public health and …

KHN’s ‘What the Health?’: The Invisible Pandemic Read More »

Ensuring timely reauthorization of PDUFA and BsUFA

Today, the House Energy and Commerce Subcommittee on Health will be hosting a markup session on the comprehensive legislative package to reauthorize the human drug user fee programs, including the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III). In February, PhRMA had the opportunity to testify before the …

Ensuring timely reauthorization of PDUFA and BsUFA Read More »

Digital Documentation: How PDFs Can Help Providers Expedite Care

Deboshree Sarkar, Product Marketing Manager, PDF Editor Product line at Foxit We live in an increasingly digital world. Across industries, companies and consumers have come to rely on the rapid exchange of digital information. Healthcare, however, has been an outlier in this regard. While the healthcare digital transformation has been in play for years, it’s …

Digital Documentation: How PDFs Can Help Providers Expedite Care Read More »

How cell & gene therapy startups can warm up to investors in this “biotech nuclear winter”

Cell and gene therapy research has been hot the past few years but the overall market has cooled down in recent months. During the World Medical Innovation Forum in Boston, a panel of venture capitalists discussed capital formation and what biotech firms need to do to win over investors and advance their research.

Regulatory recap: J&J vaccine limits, full Enhertu approval, a Vertex hold & more

The FDA amended emergency authorization of Johnson & Johnson’s Covid-19 vaccine. In other regulatory news this past week, drug approvals include a cancer drug that converted its accelerated regulatory approval to a full regulatory nod, while several companies dealt with rejections or clinical trial setbacks.

KHN’s ‘What the Health?’: Leaked Abortion Opinion Rocks Washington’s World

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. People who pay attention to the Supreme Court have been expecting the justices to scale back the right to abortion when they issue their ruling on a …

KHN’s ‘What the Health?’: Leaked Abortion Opinion Rocks Washington’s World Read More »

FDA finds ‘no evidence’ that second Pfizer pill stops repeat COVID-19 symptoms

While Pfizer’s COVID-19 antiviral Paxlovid does offer a reduction in hospitalization and deaths, there is currently “no evidence” to suggest that prolonging and repeating a course of the drug has any more benefit according to an FDA official. John Farley, director of the Food and Drug Administration’s (FDA) Office of Infectious Diseases, said on Wednesday …

FDA finds ‘no evidence’ that second Pfizer pill stops repeat COVID-19 symptoms Read More »

Vivalink Launches Multi-Vital Blood Pressure Patch for Remote Patient Monitoring

What You Should Know: – Vivalink, a leading provider of digital healthcare solutions launches a multi-vital blood pressure patch for remote patient monitoring is now available for research and development. – The advanced multimodal continuous signal processing patch captures ECG trace, heart rate, respiratory rate, systolic and diastolic blood pressure on a single device. Cuffless …

Vivalink Launches Multi-Vital Blood Pressure Patch for Remote Patient Monitoring Read More »

How the Life Sciences Industry Can Boost Diversity and Inclusion Efforts

Although it is well established that diversity improves outcomes and drives excellence, implementing diversity lags behind in many industries, including life sciences and healthcare.  Diversity is lacking across the entire field, from academic research to clinical work, composition of the workforce, and medical practice. This leads to worse health outcomes and fewer professional opportunities for …

How the Life Sciences Industry Can Boost Diversity and Inclusion Efforts Read More »

Hello Heart Raises $70M to Expand Heart Health Solutions

What You Should Know: – Hello Heart, the only digital therapeutics company focused exclusively on heart disease, announced a $70M Series D funding round led by Stripes to support its rapid growth in the employer market  – The funding round will specifically support the increase in employer market demand for Hello Heart’s technology as a …

Hello Heart Raises $70M to Expand Heart Health Solutions Read More »

Rochester Regional Health Taps TytoCare for On-Demand Virtual Visits

What You Should Know: – Rochester Regional Health, an integrated health system serving western New York, the Finger Lakes, and beyond, announced it has selected TytoCare, an all-in-one modular device and examination solution for AI-powered, remote medical exams. On-demand virtual visits via TytoCare are available starting today for Rochester Regional patients. – The integration of …

Rochester Regional Health Taps TytoCare for On-Demand Virtual Visits Read More »

Houston Methodist Taps BioIntelliSense to Advance Remote Care and Clinical Intelligence Solutions

What You Should Know: – Houston Methodist and Colorado-based BioIntelliSense, a continuous health monitoring and clinical intelligence company, today announced a new collaboration to advance remote monitoring and analytics technologies across the healthcare continuum, from in-hospital to at-home. – BioIntelliSense’s FDA-cleared BioSticker™ and medical-grade BioButton® wearable devices, along with its algorithmic-based data services, enable effortless …

Houston Methodist Taps BioIntelliSense to Advance Remote Care and Clinical Intelligence Solutions Read More »

FDA says no to two more China-developed cancer drugs

The FDA has declined to approve two more cancer therapies developed by drugmakers based in China, in what may be further evidence of a tough line taken by the regulator for drugs tested outside the US. The agency has sent a complete response letter (CRL) to Hutchmed indicating that its application to market multikinase inhibitor …

FDA says no to two more China-developed cancer drugs Read More »

Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease

Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.

FDA sets tentative June dates for meeting on young kids’ vaccine

The Food and Drug Administration (FDA) on Friday released tentative June dates for its advisory committee to meet to discuss authorizing COVID-19 vaccines for young children, offering a rough timeline for when authorization could come.   The agency said it is setting aside June 8, 21 and 22 for meetings of its advisory committee for …

FDA sets tentative June dates for meeting on young kids’ vaccine Read More »

Moderna asks FDA to authorize vaccine for kids under 6

Moderna on Thursday asked the Food and Drug Administration to authorize its vaccine for children under six years of age, becoming the first company to submit an application for young children.  There are currently no vaccines authorized for children under five, which has led to some frustration among parents over the pace as they are …

Moderna asks FDA to authorize vaccine for kids under 6 Read More »

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 disease should be narrower or broader. Make the disease definition too broad, then there may not be strong evidence from the clinical trial to support its use among these types …

When does FDA extrapolate clinical trial results to a broader indication Read More »

Pfizer requests FDA authorization for booster dose to children 5-11

Pfizer and BioNTech on Tuesday submitted an application to the Food and Drug Administration (FDA) requesting authorization to administer a booster dose of their COVID-19 vaccine to children aged 5-11. In its announcement, Pfizer cited data from a Phase 2/3 trial which it says indicated a “strong immune response” in the younger age group after …

Pfizer requests FDA authorization for booster dose to children 5-11 Read More »

Florida congressman says Aduhelm’s FDA approval ‘muddied the waters’ for future Alzheimer’s drugs

Rep. Neal Dunn (R-Fla.) on Tuesday said the controversial federal approval of the Alzheimer’s medication Aduhelm “muddied the waters” for other potential treatments for the disease. Dunn on Tuesday appeared at “Accelerated Approvals & the Pathway to Treatments,” a virtual event hosted by The Hill aimed at discussing the future of treatment for Alzheimer’s disease. …

Florida congressman says Aduhelm’s FDA approval ‘muddied the waters’ for future Alzheimer’s drugs Read More »

Clyburn requests briefing on status of COVID vaccines for young kids

House Majority Whip James Clyburn (D-S.C.) on Monday requested a briefing from the Food and Drug Administration (FDA) on the status of COVID-19 vaccines for young children. He cited the high hospitalization rates that were seen in children under the age of 5 during the omicron wave and the large number of children who are …

Clyburn requests briefing on status of COVID vaccines for young kids Read More »

Reify Health Secures $220M to Support Clinical Trial Diversity at $4.8B Valuation

What You Should Know: – Reify Health, a leading provider of solutions that empower the clinical trial ecosystem, announced a $220M Series D funding round dedicated to improving diversity in clinical research. The investment comes less than a year after its Series C and brings the company’s valuation to $4.8B.  – The Series C found was co-led …

Reify Health Secures $220M to Support Clinical Trial Diversity at $4.8B Valuation Read More »

Federal health agencies didn’t report political interference fearing retaliation: audit

Employees from four agencies within the Department of Health and Human Services (HHS) said they did not report possible political interference in their work due to fear of retaliation and a lack of framework to report it, according to a study released by the Government Accountability Office (GAO). For its study, the GAO’s conducted “semistructured …

Federal health agencies didn’t report political interference fearing retaliation: audit Read More »

Why Cheap, Older Drugs That Might Treat Covid Never Get Out of the Lab

In March 2020, Dr. Joseph Vinetz left the contemplative world of his Yale University infectious-disease laboratory and plunged into the covid ward at Yale New Haven Hospital, joining an army of health care workers who struggled to treat the deadly viral disease. There were no drugs against covid-19, and no way to predict which infected …

Why Cheap, Older Drugs That Might Treat Covid Never Get Out of the Lab Read More »

FDA’s tighter scrutiny on drug class leads TG Therapeutics to pull out of cancer

TG Therapeutics is pausing its cancer drug research and withdrawing the approved cancer drug Ukoniq from the market. The move comes as the FDA places greater scrutiny on Ukoniq’s drug class—concerns that will be discussed during an FDA advisory committee meeting scheduled for April 21.

FDA investigating Lucky Charms amid reports of illness

The Food and Drug Administration (FDA) says it is investigating Lucky Charms over dozens complaints it has received from customers who say they became ill after eating the cereal. In a statement provided to The Associated Press, the FDA said it “takes seriously any reports of possible adulteration of a food that may also cause …

FDA investigating Lucky Charms amid reports of illness Read More »

Covid news roundup: Boosters for kids, breath diagnostic, a vax approval & more

Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid news, a vaccine developer won marketing authorization in Europe while another one faces a regulatory setback.

FDA now able to regulate e-cigarettes that use synthetic nicotine

The Food and Drug Administration (FDA) now has oversight to regulate e-cigarette products from vaping companies operating under a loophole that was closed by a new law. The law, which took effect Thursday, gives the FDA authority to regulate e-cigarettes and other products that use synthetic nicotine, a move that targets vaping companies that use …

FDA now able to regulate e-cigarettes that use synthetic nicotine Read More »

KHN’s ‘What the Health?’: News You Might Have Missed

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. It’s been extra busy on the health policy beat lately, so a congressional recess provides a chance to explore some of the important stories that people might …

KHN’s ‘What the Health?’: News You Might Have Missed Read More »

Federal agencies warn of illegal online Adderall sales

The Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) on Tuesday issued warnings to two websites that the agencies said were illegally selling Schedule II stimulants, such as Adderall, without prescriptions. The two agencies said warning letters had been issued to Kubapharm.com and Premiumlightssupplier.com for selling Adderall without prescriptions and placing consumers …

Federal agencies warn of illegal online Adderall sales Read More »

Fitbit Receives FDA Clearance for New PPG Algorithm to Identify AFib

What You Should Know: – Fitbit announced it has received clearance from the FDA for its PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally.  – The algorithm will soon be available to users in the U.S. through Fitbit’s new Irregular Heart Rhythm Notifications feature on eligible heart-rate tracking devices. We can share the full list at feature availability. PPG AFib detection Benefits AFib …

Fitbit Receives FDA Clearance for New PPG Algorithm to Identify AFib Read More »

FDA gives Gilead reprieve on partial hold for cancer drug studies

An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead drug, magrolimab, is part of a class of cancer immunotherapies that address a hot target for the field.

3D printers have proved their value to hospitals for limb-saving surgery, Covid-19 supply chain issues, and more [Sponsored]

A recent webinar sponsored by Formlabs underscored the value of 3D printing from a clinical perspective and offered insight on how commercial and regulatory players are thinking about this space.

FDA clears Fitbit for passive heart rhythm monitoring

Google has announced that the Food and Drug Administration (FDA) has cleared its product, Fitbit, to use a new feature that will identify atrial fibrillation (AFib).  In a statement on Monday, Google said Fitbit’s new PPG AFib algorithm feature will assess user’s heart rhythm while they’re sleeping, adding that the new feature will alert users …

FDA clears Fitbit for passive heart rhythm monitoring Read More »

Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App

What You Should Know: – Arterys, the world’s leading vendor-neutral artificial intelligence (AI) platform, has announced several new modules to its already robust Cardio AI clinical application and an additional FDA AI clearance based on deep learning.  – Cardio AI is a comprehensive, cloud-based post-processing solution that leverages AI and deep learning to provide extremely …

Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App Read More »

Final CMS decision limits coverage of Biogen’s Aduhelm to those in clinical trials

Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.

EU says not enough evidence to warrant fourth COVID jabs

It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF). The official word from the EU authorities is that for now a fourth dose of Pfizer/BioNTech’s Comirnaty  or Moderna’s SpikeVax – the preferred …

EU says not enough evidence to warrant fourth COVID jabs Read More »

At-Home Testing is the Future, but Lab APIs are Stuck in the Past

David Stein, CEO of Ash Wellness The rise of telemedicine and virtual care options have primed at-home testing to make a significant impact on the future of healthcare. 70% of today’s medical decisions depend on laboratory test results, but lagging lab APIs hinder the widespread launch of remote diagnostics.  Since the start of the COVID-19 …

At-Home Testing is the Future, but Lab APIs are Stuck in the Past Read More »

FDA advisers meet to weigh future of booster doses, possible new strains

The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee met on Wednesday along with other health officials and experts from around the world to discuss the future of how the U.S. will handle the SARS-CoV-2 virus as cases dwindle and the necessity of future doses is debated. The all-day meeting was …

FDA advisers meet to weigh future of booster doses, possible new strains Read More »

Novartis cancer drug is now first approved therapy for group of rare, genetic diseases

A Novartis drug that stops abnormal cell growth in breast cancer now has an additional FDA approval treating a group of rare disorders characterized by overgrowth in various types of tissue. The regulatory decision makes the drug, Vijoice, the first approved therapy for these disorders termed “PROS.”

FDA, health experts to meet, discuss COVID-19 booster strategy

The Food & Drug Administration (FDA) and a panel of health experts will meet Wednesday to discuss the future of COVID-19 boosters in the U.S. and emerging variants of the virus. The FDA’s Vaccines and Related Biological Products Advisory Committee will host the all-day meeting with the health experts to discuss questions and concerns regarding …

FDA, health experts to meet, discuss COVID-19 booster strategy Read More »

Doctors Trying to Prescribe Abortion Pills Across State Lines Stymied by Legislation

Soon after Dr. Mai Fleming finished her medical residency in the San Francisco Bay Area, she got to work on her Texas medical license. The family medicine doctor had no intention of moving there but invested nine months to master Texas medical law, submit to background checks, get fingerprinted, and pay hundreds of dollars in …

Doctors Trying to Prescribe Abortion Pills Across State Lines Stymied by Legislation Read More »

FDA places partial hold on Curis cancer drug after patient death in clinical trial

The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The biotech company said the patient experienced a complication that is a known risk of the small molecule drug.

MemorialCare Taps TytoCare to Offer Virtual Exam Kits for Enhanced Telehealth

What You Should Know: – TytoCare, a provider of AI-powered, on-demand, remote medical exams has inked a partnership with MemorialCare, a health system in Orange and Los Angeles Counties, to bring patients diverse telehealth options and allow them to pursue comprehensive primary care options from home. – The integration of the TytoCare solution into MemorialCare’s current telehealth appointments enhances the health system’s ability to diagnose and treat patients through …

MemorialCare Taps TytoCare to Offer Virtual Exam Kits for Enhanced Telehealth Read More »

Five things to watch as the Biosimilars market heats up in 2022

As pressure mounts on the U.S. Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their promising potential to usher in competition, increase access, and drive down costs for patients—and the U.S. market is just beginning to heat up. In the latter half of 2021, there …

Five things to watch as the Biosimilars market heats up in 2022 Read More »

Safety concerns sink Akebia drug for anemia from chronic kidney disease

The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety concerns and asked for another clinical trial to show that the pill’s benefits outweigh its risks.

Patients dismayed as FDA advisors narrowly reject Amylyx’ ALS drug

By a narrow margin, an FDA advisory committee has voted against approval of Amylyx’ experimental medicine for amyotrophic lateral sclerosis until the company can provide more evidence that it is effective. The prospects of a positive vote on AMX0035 (sodium phenylbutyrate and taurursodiol) were looking dim after the FDA expressed its doubts about the efficacy …

Patients dismayed as FDA advisors narrowly reject Amylyx’ ALS drug Read More »

ConcertAI Raises $150M at $1.9 Billion Valuation for RWD Platform

What You Should Know: – ConcertAI, LLC (ConcertAI), the leader in enterprise AI and real-world data (RWD) solutions for life sciences and healthcare, announced the close of its $150M in Series C led by Sixth Street at a $1.9B valuation. – From its startup just five years ago, ConcertAI has emerged as one of the …

ConcertAI Raises $150M at $1.9 Billion Valuation for RWD Platform Read More »

Data and regulatory roundup: Pfizer’s feat, an ADHD miss, Eli Lilly’s CRL & more

A pharmaceutical giant reported a Phase 3 success for a potential blockbuster drug, while four other companies reported disappointing data from their respective clinical trials. Our recap of data readouts and regulatory news also includes one FDA rejection.

FDA knocks back MEI’s plans for drug in troubled PI3K class

MEI Pharma and partner Kyowa Kirin have had to abandon plans to file for approval of their PI3K inhibitor zandelisib in B cell lymphoma, after being “discouraged” by the FDA from making the attempt based on a phase 2 study. The partners said that the FDA has advised that a randomised trial is now needed …

FDA knocks back MEI’s plans for drug in troubled PI3K class Read More »

RedDress Donates FDA-Cleared Wound Care Solution to Aid Injured Ukrainians

What You Should Know: – RedDress, a Florida-based Israeli medical company is shipping revolutionary blood-clotting wound care systems to Ukraine to help with serious injuries and severe trauma wounds. – RedDress began shipments of 400 of their ActiGraft systems this week to multiple hospitals in Ukraine to help treat civilian casualties as a result of the indiscriminate Russian attacks. ActiGraft: Recreating the Natural Wound Healing Environment Chronic wounds—including diabetic …

RedDress Donates FDA-Cleared Wound Care Solution to Aid Injured Ukrainians Read More »

Podimetrics Secures $45M for SmartMat to Prevent Diabetic Amputations in High-Risk Patients

What You Should Know: – Podimetrics raises $45M to help at-risk providers and health plans prevent diabetic amputations in high-risk patients. – With this latest round of funding, Podimetrics plans to focus on hiring to build out their product development and research teams, while also expanding the breadth of services delivered by their nurse support …

Podimetrics Secures $45M for SmartMat to Prevent Diabetic Amputations in High-Risk Patients Read More »

Eko Unveils Newly Designed Heart Disease Detection App

What You Should Know: – Eko, a digital health company advancing heart and lung disease detection, today announced the launch of its newly-redesigned Eko App, which will transform patient interactions into an opportunity to screen for cardiovascular disease. Heart disease is the leading cause of death in the U.S., and there has not been an …

Eko Unveils Newly Designed Heart Disease Detection App Read More »

FDA approves Marinus Pharma drug for rare, genetic form of epilepsy

Marinus Pharmaceuticals drug Ztalmy is now FDA approved for treating the seizures in patients who have CDKL5 deficiency, an inherited form of epilepsy. The drug is the first approved treatment for the rare disorder and it’s also Marinus’s first approved product.

FDA sets August decision date for Provention’s type 1 diabetes drug

Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Armed with new data it has tried again, with the FDA due to make a decision on the new filing by 17 August. Provention is seeking approval of teplizumab as a treatment to delay …

FDA sets August decision date for Provention’s type 1 diabetes drug Read More »

BMS nabs FDA nod for first drug in new class of cancer immunotherapies

Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The drug is approved for advanced melanoma as part of a combination treatment that includes the already approved BMS cancer immunotherapy Opdivo.

Pfizer CEO Pushes Yearly Shots for Covid. Not So Fast, Experts Say.

When Pfizer CEO Albert Bourla said March 13 that all Americans would need a second booster shot, it struck many covid experts as a self-serving remark without scientific merit. It also set off spasms of doubt over the country’s objectives in its fight against the coronavirus. The decision on how often and widely to vaccinate …

Pfizer CEO Pushes Yearly Shots for Covid. Not So Fast, Experts Say. Read More »

physIQ, CellCarta Collaborate on Study to Revolutionize Vaccine

What You Should Know: – Today, digital medicine leader physIQ and CellCarta, a global leader in precision medicine services announced they are collaborating on a groundbreaking study that could revolutionize vaccine development. – The strategic collaboration advances the detailed study of early, individualized human responses to vaccinations as pharma companies race to deliver safe, effective vaccines sooner. physIQ, a pioneer in digital …

physIQ, CellCarta Collaborate on Study to Revolutionize Vaccine Read More »

The accelerated approval pathway: Helping patients with serious or life-threatening diseases

Today, the House Energy & Commerce Committee’s Subcommittee on Health will meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. This hearing comes at the same time members of Congress are considering the reauthorization of the user fee programs, the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar …

The accelerated approval pathway: Helping patients with serious or life-threatening diseases Read More »

HIMSS22 Day 2 Roundup: Google Partners with MEDITECH, Microsoft’s Health Cloud Strategy Expansions

Mergers & Acquisitions (M&A) Activity OptimizeRx Acquires EvinceMed, a Specialty Drug Prescription Initiation Platform OptimizeRx, a provider of point-of-care technology solutions helping patients start and stay on therapy announced a definitive agreement to acquire the EvinceMed platform and related assets. EvinceMed is a provider in delivering end-to-end automation for specialty pharmaceutical transactions. The acquisition includes …

HIMSS22 Day 2 Roundup: Google Partners with MEDITECH, Microsoft’s Health Cloud Strategy Expansions Read More »

Precision Medicine Startup Prenosis Raises $20M for Acute Care Solutions, Starting with Sepsis

What You Should Know: – Prenosis, Inc., a precision medicine company, announced a venture investment from PACE Healthcare Capital, an early-stage investment firm committed to improving health outcomes. This investment brings total funding in the company to over $20 million, including partnerships with Foxconn, Roche Diagnostics, the Defense Threat Reduction Agency, and others.   – Precision medicine company will use the funding to grow its industry-leading biological …

Precision Medicine Startup Prenosis Raises $20M for Acute Care Solutions, Starting with Sepsis Read More »

KHN’s ‘What the Health?’: Congress Shelves Covid Funding for Now

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. Congress is moving toward completion of its annual spending bills for the fiscal year that started last October, but a last-minute snag jettisoned from the bill the …

KHN’s ‘What the Health?’: Congress Shelves Covid Funding for Now Read More »

MediView XR Secures $9.9M for Augmented Reality Surgical Navigation Platform

What You Should Know: – MediView XR, Inc., raises $9.9M in SAFE financing syndicated by Inside View Investments, LLC, a private investment firm.  MediView has raised approximately $14.4MM in total funding to date. – Investment will support key technology development, commercialization and regulatory submissions. MediView XR Inc., a Cleveland-based medtech company that leverages augmented reality, remote connectivity …

MediView XR Secures $9.9M for Augmented Reality Surgical Navigation Platform Read More »

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 ensure products that receive accelerated approval are providing a clinical benefit to patients. Under the proposed Accelerated Approval Integrity Act, the FDA would be granted power to expedite the withdrawal …

New bill moves to tighten accelerated approval regulation in US Read More »

GoodRx Acquires Pharmacy Services Platform VitaCare for $150M

What You Should Know:– GoodRx announced that it will acquire vitaCare Prescription Services, a tech-enabled pharmacy services platform that expands GoodRx’s offering to pharma manufacturers while improving patient access and adherence to affordable brand drugs.   – Over 500 million brand prescriptions are written every year, yet only half are ever filled. This acquisition will give GoodRx the tools …

GoodRx Acquires Pharmacy Services Platform VitaCare for $150M Read More »

2022 Infusion Industry Outlook: Adapting Care Delivery to Meet New Realities

Roger Massengale, Chief Commercial Officer, Eitan Medical January 2022 marked two years since the outbreak of COVID-19, with the healthcare system still working to adjust to a very challenging new reality. However, these challenges have served as a catalyst for important shifts within the healthcare industry, some of which are poised to be a significant …

2022 Infusion Industry Outlook: Adapting Care Delivery to Meet New Realities Read More »

Alpine Immune Sciences cancer drug trial placed on partial hold after patient death

The FDA placed a partial clinical hold on a Phase 1 study testing experimental Alpine Immune Sciences cancer drug davoceticept in combination with Merck cancer immunotherapy Keytruda. The partial hold does not affect a separate study testing the Alpine drug as a monotherapy.

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) recently put out its second guidance document on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients. A few qualitative approaches they recommend to collect this information include: …

FDA Guidance: Methods for identifying what is important to patients Read More »

XRHealth Secures $10M to Expand Virtual Reality Treatment in the Metaverse

What You Should Know: – XRHealth, the gateway to the healthcare metaverse,  announced today that they raised $10M in funding to expand virtual healthcare treatment in the Metaverse. The funding was backed by HTC, Bridges Israel impact investment fund, AARP, and crowdfunding on StartEngine.com and existing investors. – XRHealth’s platform is FDA and CE registered and provides an immersive …

XRHealth Secures $10M to Expand Virtual Reality Treatment in the Metaverse Read More »

FDA rejects Reata Pharma chronic kidney disease drug; new trial needed

The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in patients who have the rare disease Alport syndrome. The regulatory decision follows an FDA advisory committee vote recommending against approval of the small molecule drug.

Viz.ai Awarded 510(k) Clearance for AI-Powered Cerebral Aneurysm Detection Solution

What You Should Know: – Viz.ai, a San Francisco-based provider of AI-powered intelligent care coordination for stroke, has received FDA 510(k) clearance for Viz ANEURYSM (formerly Viz ANX), the first and only AI-powered cerebral aneurysm detection solution designed to facilitate population screening and enhanced care management. – The new algorithm uses AI to detect suspected cerebral aneurysms, enabling hospital systems to ensure that once detected, patients are captured and …

Viz.ai Awarded 510(k) Clearance for AI-Powered Cerebral Aneurysm Detection Solution Read More »

Healthcare Is A Cyber Criminal’s Dream, But It Doesn’t Have To Be This Way

Vidya Murthy, Chief Operating Officer at MedCrypt Healthcare is a cyber criminal’s dream. It presents the intersection of a data treasure trove, weak security posture, limited resources, complicated supply chain, and patient care delivery. When faced with having to pick a priority to optimize for, healthcare will, of course, always pick delivering healthcare. This means …

Healthcare Is A Cyber Criminal’s Dream, But It Doesn’t Have To Be This Way Read More »

Sanofi, GSK Covid-19 vax is now ready for regulators; its future may be as a booster

Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster.

Medtronic, AWS to Provide Underserved Communities with AI-Assisted Colon Cancer Screening

Genius Intelligent Endoscopy Module What You Should Know: – Medtronic and AWS, today announced a partnership to provide underserved communities with artificial intelligence (AI)-assisted colonoscopy technology through AWS’s $40M Health Equity Assistance Program for colon cancer screening. – Amazon Web Services will support the effort to provide Medtronic GI Genius™ intelligent endoscopy modules to facilities …

Medtronic, AWS to Provide Underserved Communities with AI-Assisted Colon Cancer Screening Read More »

Connecting the Dots – Building Data Bridges for a Better Healthcare Future

Jen Goldsmith, President Tendo Systems Healthcare data is increasing at an exponential rate. Approximately one-third of the world’s data volume is being generated by the healthcare industry. By 2025, the compound annual growth rate of healthcare data will reach 36% – that’s 6% faster than manufacturing, 10% faster than financial services, and 11% faster than …

Connecting the Dots – Building Data Bridges for a Better Healthcare Future Read More »

Sirona Medical Acquires Nines Radiology AI Division

What You Should Know: – Sirona Medical, a software company with a cloud-native solution for radiologists, has announced its acquisition of Nines Radiology’s AI division. Sirona Medical did not acquire Nines’ teleradiology business, Nines Radiology. The terms of the deal were not disclosed. – This is Sirona’s first acquisition just months after its exit from …

Sirona Medical Acquires Nines Radiology AI Division Read More »

EarliTec Diagnostics Raises $19.5M to Advance Autism Diagnosis and Treatment in Children

What You Should Know: – EarliTec Dx, a digital health company developing novel diagnostic and therapeutic products for children with Autism Spectrum Disorder (ASD) and early childhood vulnerabilities, today announced a $19.5 million financing led by Bernie Marcus, with participation from the Georgia Research Alliance (GRA). – This round of financing will be used to …

EarliTec Diagnostics Raises $19.5M to Advance Autism Diagnosis and Treatment in Children Read More »

Agios strategy shift pays off with FDA approval of first drug for rare anemia

Agios Pharmaceuticals has its third FDA-approved product, and the first under its new rare disease strategy. The regulatory decision also marks the first approved treatment for pyruvate kinase deficiency, a rare disease that leads to chronic anemia.

KHN’s ‘What the Health?’: It’s Health Costs, Stupid (2022 Edition)

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. The pandemic may be showing signs of winding down, but health care costs are not. In Massachusetts, a fight is shaping up over whether one of the …

KHN’s ‘What the Health?’: It’s Health Costs, Stupid (2022 Edition) Read More »

Inside the Tactical Tug of War Over the Controversial Alzheimer’s Drug

The drug industry, patient advocates, and congressional Republicans have all attacked federal officials’ decision to decline routine Medicare coverage for a controversial Alzheimer’s drug. They’ve gone as far as to accuse them of tacit racism, ageism, and discrimination against the disabled — and hinted at a lawsuit — over the decision to pay only for …

Inside the Tactical Tug of War Over the Controversial Alzheimer’s Drug Read More »

Robert Califf confirmed as FDA commissioner in tight vote

It’s official – President Joe Biden’s choice for FDA commissioner, Robert Califf, has been confirmed to the role after a narrow 50 to 46 vote in the Senate that relied on crossover Republican votes. That bipartisan support proved to be essential, with six Republican senators casting their lot for Califf to outweigh the five Democrats …

Robert Califf confirmed as FDA commissioner in tight vote Read More »

2021 Annual Report on Generic Drug Approvals

Today, the Office of Generic Drugs (OGD) at the Food and Drug Administration (FDA) released its 2021 Annual Report. As noted in the report, 90% of all drugs dispensed in the US are generic. In 2021, there were 776 approved generic drugs through the Abbreviated New Drug Applications (ANDA) process. Approvals by month are below. …

2021 Annual Report on Generic Drug Approvals Read More »

Cuidado con este cóctel, puede ser peligroso para la salud

El popular cóctel conocido como Moscow Mule (“Mula de Moscú”) supuestamente debe parte de su sabor a la jarra de cobre helada en la que se sirve, porque el metal brillante se oxida ligeramente, mejorando el aroma y la efervescencia de la bebida. Pero el sabor no es lo único que aporta la jarra de …

Cuidado con este cóctel, puede ser peligroso para la salud Read More »

Don’t Nurse That Moscow Mule — It Could Be a Health Hazard

HELENA, Mont. — The popular cocktail known as the Moscow mule supposedly gets some of its flavor from the frosty copper mug it’s served in — the shiny metal oxidizes slightly and enhances the drink’s aroma and effervescence. Flavor, however, is not the only thing the copper cup imparts. A study published in the January/February …

Don’t Nurse That Moscow Mule — It Could Be a Health Hazard Read More »

Unswayed by a discount pledge, FDA adcomm rejects Lilly’s PD-1 drug

FDA advisors have voted against approval of Eli Lilly and Innovent Biologics’ cancer immunotherapy sintilimab, undermining hopes of a new, lower-priced option in the PD-1/PD-L1 inhibitor class. The Oncologic Drugs Advisory Committee (ODAC) followed the line laid out by the agency’s reviewer in briefing documents published earlier this week, and voted 14 to 1 against …

Unswayed by a discount pledge, FDA adcomm rejects Lilly’s PD-1 drug Read More »

KHN’s ‘What the Health?’: FDA Takes Center Stage

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. The FDA is still lacking a Senate-confirmed leader, but the agency is at the center of several major policy battles. Lawmakers this year must renew the bill …

KHN’s ‘What the Health?’: FDA Takes Center Stage Read More »

FDA won’t back Lilly’s PD-1 antibody based on Chinese data alone

The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday. In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not …

FDA won’t back Lilly’s PD-1 antibody based on Chinese data alone Read More »

Sanofi drug Enjaymo wins FDA approval to treat anemia from rare blood disorder

A rare disease drug that Sanofi added via its $11.6 billion Bioverativ acquisition is now approved for treating the blood disorder cold agglutinin disease. The regulatory nod makes the antibody drug the first approved treatment for this rare disease that leads to anemia.

Sanofi claims FDA okay for drug to treat rare blood disorder CAD

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. The complement C1s-targeting antibody – given the brand name Enjaymo – has been cleared decrease the need for blood transfusions in patients with …

Sanofi claims FDA okay for drug to treat rare blood disorder CAD Read More »

KHN’s ‘What the Health?’: Paging the HHS Secretary

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. Health and Human Services Secretary Xavier Becerra is becoming a target for both Democrats and Republicans over what they call a lack of coordination of covid efforts …

KHN’s ‘What the Health?’: Paging the HHS Secretary Read More »

The importance of timely PDUFA and BsUFA reauthorization

Today, PhRMA, along with the U.S. Food and Drug Administration (FDA) and other industry trade associations, will be participating in a congressional hearing with the House Committee on Energy and Commerce Subcommittee on Health discussing the user fee programs which are under consideration by policymakers for reauthorization this year. This follows the U.S. Department of …

The importance of timely PDUFA and BsUFA reauthorization Read More »

Califf pledges not to use ‘revolving door’ between FDA and industry

Robert Califf has made a series of commitments to try to win over senators reluctant to back his nomination as the next FDA commissioner, ahead of the deciding vote on his appointment. In a letter to one of those he needs to win over – senior Democrat Senator Elizabeth Warren – Califf has said he …

Califf pledges not to use ‘revolving door’ between FDA and industry Read More »

Gilead Sciences cancer drug hit with partial hold due to adverse event concern

Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, magrolimab. But this experimental cancer immunotherapy introduces a safety risk that’s a known problem for all drugs in this class.

ICYMI: New approvals by the FDA in 2021 offer greater treatment options for patients

The U.S. Food and Drug Administration (FDA) approved a total of 60 new drugs in 2021. A new report from the FDA catalogs 50 new approvals by the Center for Drug Evaluation and Research (CDER). Separately, the Center for Biologics Evaluation and Research (CBER) approved 10. These novel medicines offer to transform many debilitating diseases, …

ICYMI: New approvals by the FDA in 2021 offer greater treatment options for patients Read More »

Sierra succeeds where Gilead missed; FDA filing now planned for blood cancer drug

Sierra Oncology myelofibrosis drug momelotinib achieved the main and secondary goals of a pivotal test and the biotech now plans to seek FDA approval. Sierra acquired momelotinib from Gilead Sciences after that company stopped work on the drug due to mixed results in Phase 3 testing.

FDA stifles Merck’s cough drug gefapixant, asking for more data

The FDA has issued a complete response letter (CRL) to Merck & Co’s gefapixant candidate for refractory chronic cough, delaying the programme and giving Bayer an opportunity to close the gap with its rival eliapixant drug. Gefapixant is still out in front in the non-narcotic, orally administered selective P2X3 receptor antagonist class – having secured …

FDA stifles Merck’s cough drug gefapixant, asking for more data Read More »

Biotricity Awarded FDA 510(k) Clearance for Cardiac Monitoring Device

What You Should Know: – Biotricity, Inc. (NASDAQ:BTCY), a medical diagnostic and consumer healthcare technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Biotres Cardiac Monitoring Device, a three-lead device for ECG and arrhythmia monitoring that is intended for lower-risk patients. – Most remote cardiac monitors are …

Biotricity Awarded FDA 510(k) Clearance for Cardiac Monitoring Device Read More »

FDA rejects Merck chronic cough drug, asks for more info on efficacy

Merck is still at the front of the pack of companies developing new medicines to treat chronic cough, but the company was dealt a setback as the FDA turned down the pharma giant’s application and asked for additional efficacy data. No safety issues were raised, according to Merck.

FDA clears Gilead’s Veklury for COVID outpatients

The FDA has extended the emergency use authorisation for Gilead Sciences’ antiviral Veklury to include non-hospitalised patients with COVID-19, extending the uses of the drug. The green light means that intravenously-administered Veklury (remdesivir) is another option for non-hospitalised patients with mild-to-moderate COVID-19 who are at high risk of progression to severe disease, alongside oral antivirals …

FDA clears Gilead’s Veklury for COVID outpatients Read More »

Pfizer’s growth hormone deficiency drug comes up short at the FDA

The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health from competing against a newly approved human growth hormone drug from Ascendis Health that is also designed for once-weekly dosing.

Kura Oncology leukemia clinical trial to resume after FDA lifts partial hold

The FDA placed the partial hold on the study last November following a patient death suspected to be linked to a known complication of leukemia therapies. Kura Oncology said it has reached agreement with the FDA on a mitigation strategy for that complication.

Biliary tract cancer drug granted orphan drug designation in US

The US regulator has granted biliary tract cancer therapy Silmitasertib orphan drug designation. There are currently no treatments for this rare cancer, and the US food and Drug Administration (FDA) hopes that pharmaceutical firm Senhwa’s drug will meet the significant need for new biliary tract cancer options. First-line standard of care is currently a chemotherapy …

Biliary tract cancer drug granted orphan drug designation in US Read More »

FDA has no appetite for Levo’s metabolic disorder drug and asks for new trial

The FDA rejected the new drug application for a Levo Therapeutics treatment for the rare metabolic disorder Prader-Willi syndrome. According to Levo, the agency said the data submitted were insufficient to support approval and the regulator wants the company to run another clinical trial.

Novo Nordisk moves to strengthen obesity efforts

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Under the joint research plan, the Danish giant will work with EraCal to identify novel drug targets relevant for food intake regulation and additional metabolic phenotypes. Although specific details of the …

Novo Nordisk moves to strengthen obesity efforts Read More »

Senate panel backs Biden’s FDA selection Robert Califf

Robert Califf has cleared another stage on his return journey to the top job at the FDA, after the influential Senate committee on Health, Education, Labour and Pensions (HELP) voted by 13 to eight to support his nomination by President Joe Biden. Califf was nominated by Biden as FDA commissioner last November, ending a search …

Senate panel backs Biden’s FDA selection Robert Califf Read More »

FDA presses pause on test of Alzheimer’s drug from Denali before study even starts

The FDA placed a clinical hold on Denali Therapeutics’ application to begin Phase 1 testing of an antibody drug for Alzheimer’s disease. The Denali drug uses the biotech’s proprietary technology to deliver therapeutic cargo across the protective blood-brain barrier.

KHN’s ‘What the Health?’: Dealing With Drug Prices

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. Medicare officials have preliminarily decided to restrict reimbursement for Aduhelm, the controversial Alzheimer’s drug, to only patients participating in approved clinical trials. The FDA approved the drug …

KHN’s ‘What the Health?’: Dealing With Drug Prices Read More »

BeyondSpring is laying off 35% of staff in wake of FDA rejection of lead drug

BeyondSpring Pharmaceuticals’ corporate reorganization comes about six weeks after the FDA rejected the biotech’s drug for a complication experienced by cancer patients. The company still plans to develop the drug for that application and others, but it added that layoffs are needed to reduce expenses.

Amylyx Pharma’s IPO lands $190M as ALS drug begins FDA review

It’s the first week of the new year, and the life sciences sector continued the IPO momentum of 2021 as Wall Street welcomed three new biotech companies. Here’s a look at the IPOs of Amylyx Pharmaceuticals, CinCor, and Vigil Neuroscience, which raised a combined $482 million to support work on drugs addressing neurodegenerative and cardiovascular …

Amylyx Pharma’s IPO lands $190M as ALS drug begins FDA review Read More »

Avrobio shifts gene therapy priorities as data surprise shelves lead program

Avrobio is stopping enrollment in a clinical trial for its Fabry disease program after new results showed variability in how the gene therapy was taken up by patients. No safety problems were reported, but the biotech said it now plans to focus its other gene therapy candidates for rare metabolic disorders.

FDA clears Pfizer, BioNTech COVID booster for younger teens

The FDA has authorised the first COVID-19 booster vaccine for teenagers in the 12 to 15 age group, giving the okay for wider use of Pfizer and BioNTech’s Comirnaty shot as it tries to keep the Omicron variant under control. The US regulator has also reduced the time between completion of the first two doses …

FDA clears Pfizer, BioNTech COVID booster for younger teens Read More »

FDA expands Covid-19 boosters for kids using real-world data in much older adults

The FDA has expanded emergency authorization of Covid-19 boosters to include children 12 to 15 vaccinated with the Pfizer and BioNTech messenger RNA shot. The decision is based on a study that found boosting reduced deaths by 90%, but that Israeli analysis only evaluated these shots in people 50 and older.

FDA sets decision date for Amylyx Pharma ALS drug that improves neuron survival

The FDA has accepted Amylyx Pharmaceuticals’ submission for amyotrophic lateral sclerosis drug AMX0035 and it expects to issue a regulatory decision by late June. A lot will happen before then. Amylyx recently filed for an IPO and the company’s drug is slated for an advisory committee meeting ahead of an FDA decision.

Leo Pharma’s FDA nod adds a challenger to Dupixent’s dominance in eczema

With FDA approval for its atopic dermatitis drug Adbry, LEO Pharma will reach the U.S market ahead of an Eli Lilly atopic dermatitis drug that addresses the same target. LEO will also able to offer patients an alternative to the blockbuster Sanofi/Regeneron Pharmaceuticals drug Dupixent.

Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of …

Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA Read More »

FDA authorizes Merck antiviral, which joins Pfizer pill as oral option for Covid-19

Merck antiviral drug molnupiravir received emergency authorization, joining Pfizer’s Paxlovid as the only authorized oral antiviral drugs for treating Covid-19. Though the Merck and Pfizer antivirals appear to work against the omicron variant, FDA officials stressed that these drugs are authorized only for certain patients and they are not a substitute for vaccination.

FDA sets out its stall on digital tools for remote clinical trials

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The new guidance sets out the regulator’s current thinking on how …

FDA sets out its stall on digital tools for remote clinical trials Read More »

FDA nod for Novartis sets up cholesterol drug showdown with Amgen, Regeneron

Novartis drug Leqvio now has the FDA’s green light, making it the first RNA interference medicine approved for lowering cholesterol. The regulatory decision sets the stage for competition against cholesterol medicines from Amgen and Regeneron that also address liver protein PCSK9.

Pfizer pips Merck to first oral COVID antiviral okay in US

Pfizer’s Paxlovid has become the first oral antiviral for COVID-19 to be authorised for emergency use by the FDA, as the US braces itself for a surge in Omicron cases over the holiday period. The green light means that Paxlovid – based on nirmatrelvir (formerly PF-07321332) and ritonavir – has been cleared for use in …

Pfizer pips Merck to first oral COVID antiviral okay in US Read More »

‘An Arm and a Leg’: The Rapid-Test Edition: Who’s Making a Buck?

Can’t see the audio player? Click here to listen. Click here for a transcript of the episode. Rapid, at-home covid-19 tests are close to essential if you want to see friends and family this holiday season, and do your best to stay safe.  But they’re freaking expensive and can be hard to find. What the heck …

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Relief for AZ, Amgen as FDA okays severe asthma hope tezepelumab

The FDA has approved AstraZeneca and Amgen’s severe asthma hope tezepelumab, exonerating the drugmakers’ decision to press ahead with a regulatory filing despite a failed phase 3 trial. Another phase 3 study supported the efficacy of the first-in-class TSLP inhibitor as an add-on treatment for people aged 12 and over with severe asthma, as did …

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The Vaccine Rollout Was a Success. But Events Within and Beyond Biden’s Control Stymied Progress.

Eleven months ago, President Joe Biden assumed office during one of the most critical moments of the covid-19 pandemic. Case counts and death rates were shockingly high. The vaccine rollout, which had started under former President Donald Trump, was disjointed. People were generally sequestered in their homes, and kids were relegated to remote learning. Biden …

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FDA approval of Argenx neuromuscular disease therapy is first in new drug class

Myasthenia gravis patients now have a new FDA-approved biological treatment. Argenx drug Vyvgart provides a treatment alternative for patients who have the rare autoimmune disorder and also marks the first approved product in a new class of medicines.

KHN’s ‘What the Health?’: Oh, Oh, Omicron

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts. This week, the U.S. passed the milestone of 800,000 dead from covid-19, as hospitals are starting to fill following the Thanksgiving holiday and the ominous omicron variant …

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Biogen projects confirmatory study for Alzheimer’s drug will take four years

Six months after Biogen was awarded regulatory approval for its Alzheimer’s disease drug Aduhelm, the company the company is laying out a timeline for the post-marketing study to confirm whether the drug works. The projected four-year study will enroll more than 1,300 patients and will include a placebo control arm.

BMS’ Orencia gets FDA nod for GvHD thanks to real-world data

Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia has been approved by the FDA to prevent graft versus host disease (GvHD), a serious complication of haematopoietic stem cell transplant (HSCT) used to treat leukaemias and other blood cancers. Orencia (abatacept) becomes the first drug to be approved to prevent GvHD, a condition in which donor immune cells …

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FDA decision for BMS drug Orencia marks a first for acute graft versus host disease

Bristol Myers Squibb has notched another FDA approval for its blockbuster immunology drug Orencia, this time for preventing acute graft versus host disease in bone marrow and stem cell transplant patients. The decision makes the BMS drug the first one approved for preventing this complication of transplant procedures.

FDA sets April date for verdict on Incyte’s vitiligo drug

Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo. The FDA has kicked off a priority review of Opzelura (ruxolitinib), a JAK1/JAK2 inhibitor it approved to treat atopic dermatitis in September, and …

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