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Investors see promise in digital health — the challenge is adoption

VCs at MedCity INVEST Digital Health said there’s no shortage of interesting digital health companies, even ones that can prove their innovations are effective. The challenge is winning over insurers and physicians, and finding payment models that work. 

CMS grants quality reporting exceptions for facilities recovering from Hurricane Ida

The agency has granted certain Medicare quality reporting exceptions to healthcare facilities in areas of Louisiana, Mississippi, New York and New Jersey that were battered by Hurricane Ida. By providing the exceptions, CMS aims to enable facilities to direct their resources toward recovery.

Better late than never? Eczema drug now approved, Incyte says warning unwarranted

Atopic dermatitis patients now have a new option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the inflammatory skin condition, but the regulatory nod comes with a black box warning on the label that broadly covers the entire class of JAK inhibitors.

Healthcare leaders share lessons learned addressing social determinants of health

Leaders with insurers and health systems said that taking a holistic approach and partnering with community organizations is key to standing up a successful social determinants of health program at a panel discussion hosted by MedCity INVEST Digital Health. 

Unite Us acquires NowPow to bulk up SDOH screenings, referrals platform

Unite Us will integrate NowPow’s tools and community partners into its closed-loop referral system, which can be used to screen for social factors that negatively affect health, like food or housing insecurity, and then electronically refer patients to resources in their community.

Seagen, Genmab antibody drug conjugate gets FDA approval in cervical cancer

The Seagen and Genmab antibody drug conjugate (ADC), named Tivdak, is approved to treat cases of cervical cancer that have returned or spread following treatment with chemotherapy. Tivdak is Seagen’s third ADC; for Genmab, the drug will become its first commercialized product.

Consumerism is driving a bold new vision for home healthcare

Consumers want the healthcare industry to meet them where they are, and this shift in patient mindset has expanded the definition of home healthcare and who benefits from it, according to a panel at MedCity INVEST Digital Health conference.

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

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

Study: Resilience, emotional support key to helping healthcare workers fight stress

Along with daily surveys, a research team from Mount Sinai used Apple Watches to measure how stress impacted healthcare workers’ bodies and pinpointed the characteristics that were associated with lower stress levels over time.

Pfizer reports positive Covid-19 vaccine data in kids; FDA is filing coming

A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in an older age group. With these preliminary data, the companies said they plan to seek emergency use authorization of the shots.

INVEST Digital Health preview: The role of digital twins in life sciences

INVEST Digital Health kicks off today and runs through September 23. Held in a virtual format due to Covid-19, the healthcare conference brings together innovative investors across the healthcare spectrum, prominent industry players and the most promising digital health startups. Register today!

Repligen sees $150M Avitide acquisition as key to reaching gene therapy goals

Bioprocessing technologies company Repligen is acquiring Avitide, and its biologics purifying technology, in a $150 million cash and stock deal. Repligen said Avitide will help it meet growing demand for gene therapy solutions.

CMS suspends enrollment in UnitedHealthcare, Anthem MA plans

The agency has suspended enrollment in three UnitedHealthcare plans and one Anthem plan for 2022 because the plans did not spend enough of their premium incomes on medical benefits and claims. The payers can contest the suspension, though it is unclear if they plan to.

FDA panel backs booster shots in high-risk groups after rejecting broader proposal

An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots in certain high-risk groups, such as the elderly. Panelists want to see more information supporting the need for a booster, as well as data about a heart safety risk the …

FDA panel backs booster shots in high-risk groups after rejecting broader proposal Read More »

CareFirst unveils virtual-first primary care practice

The practice, which initially will only be offered to CareFirst BCBS commercial members, provides an array of services, including preventive care, insurance navigation and behavioral and mental health services. Patients will be referred to in-person care with local providers when needed.

Brain data startup Rune Labs reveals $23M, plans to rev up neuro drug R&D

Rune Labs developed software that aggregates brain data, providing insights for clinical care and clinical research. Health systems are starting to adopt the technology, and the startup has now raised $22.8 million to grow that part of the business while also expanding use of the technology in drug development.

Hive is a new & potentially devastating type of ransomware. Here’s what you need to know.

This new type of ransomware — which was linked to a cyberattack against an Ohio-based health system in August — employs a multi-pronged approach, focusing not only on encrypting sensitive data but also on terminating backup processes to make it harder for organizations to recover from the attack.

Takeda therapy gets speedy FDA nod for lung cancers with rare genetic signature

Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.

INVEST Digital Health Preview: How Has RPM Reimbursement Evolved and Where Does it Need to Go?

INVEST Digital Health is set for September 20-23. Held in a virtual format due to Covid-19, the healthcare conference brings together innovative investors across the healthcare spectrum, prominent industry players and the most promising digital health startups.

Dice’s IPO roll comes up with $204M for R&D of oral drugs to rival biologics

Dice Therapeutics raised $204 million from its IPO to support development of oral drugs that could compete against biologic drugs that are injected or infused. Also debuting on the public markets were Tyra Biosciences and Procept BioRobotics.

Lawsuit: Aetna fertility coverage policy “an illegal tax” on LGBTQ people

The lawsuit alleges that an Aetna policy discriminates against LGBTQ people by requiring them to pay thousands in out-of-pocket costs for fertility treatments before becoming eligible for coverage. Though Aetna has agreed to pay the costs incurred by the plaintiffs, the suit aims to strike down the policy as a whole.

Analysis: Cost of care for unvaccinated Covid patients spikes to $5.7B

The cost of hospital care for unvaccinated Covid-19 patients has more than doubled, jumping from about $2 billion to $5.7 billion over the summer. And this figure may still be lower than the actual cost burden unvaccinated people represent to the healthcare system.

With $100M in new funding, Tia CEO says the ‘tide has turned’ for investing in women’s health

Tia, a concierge clinic combining primary care and OBGYN services, recently raised $100 million in funding. Amid a surge of financing into women’s health startups, CEO Carolyn Witte said investors’ perspectives are changing. 

Theravance’s lead drug fails in Phase 3, triggers a restructuring cutting 75% of staff

The clinical trial failure of Theravance Biopharma’s most advanced internal program, a drug for a rare blood pressure disorder, is leading to a companywide restructuring. Going forward, the biotech will focus on developing drugs for respiratory disorders.

Neuro startup Vanqua Bio emerges with $85M and a first focus on Parkinson’s

Vanqua Bio aims to treat rare form of Parkinson’s disease by boosting activity of an enzyme that is deficient in patients who have a particular genetic mutation. With $85 million in Series B financing, the biotech startup, which is based on Northwestern University research, aims to reach human testing within two years.

IncludeHealth strikes partnership with Google, Ohio-based health system for virtual PT

Cincinnati-based IncludeHealth launched a virtual physical therapy program using pose-estimation models developed by Google. It plans to offer this software to healthcare providers, starting with its largest partner to date, ProMedica Health System.

Astellas Pharma reports fourth patient death in gene therapy clinical trial

The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy for a rare neuromuscular disorder. Astellas said the cause of death is still under investigation, and the FDA has placed a clinical hold on the study.

Startup testing video-based treatment for ‘lazy eye’ touts Phase 3 results

Luminopia, a startup with a digital therapeutic for amblyopia, or lazy eye, recently published the results of a phase 3 study showing its TV-based treatment can improve vision in kids’ non-dominant eye. Patients don a headset where images are altered to make them use both eyes. 

INVEST Digital Health Pitch Perfect preview: Tech to Improve Payer/Provider Operational Efficiency

Who made the finals for this INVEST Digital Health Pitch Perfect track? Read about these digital health companies and check out the virtual event from September 20-23. Register today!

Babyscripts raises $12M, plans to expand to all 50 states

The maternal care startup is backed by major health systems including MemorialCare Health System, whose innovation arm led the most recent funding round. Babyscripts offers a mobile app providing education and resources for the pregnancy and postpartum journey.

Startup Walking Fish nabs $50M to run with B cell therapies for cancer & more

Walking Fish Therapeutics is developing cell therapies from B cells, a type of immune cell that produces prodigious amounts of proteins. Cancer, autoimmune disease, and regenerative medicine are among the targets of the preclinical-stage biotech, which unveiled $50 million in funding.

Evidence lacking for AI-based breast cancer screening  

A review of 12 studies about AI systems used to screen patients for breast cancer found that they lacked evidence to prove that they would work well in a clinical setting. Researchers highlighted concerns about study quality, including the fact that all of the studies were retrospective and many of them had a high risk …

Evidence lacking for AI-based breast cancer screening   Read More »

New HHS proposed rule requires payers to disclose broker rates, share air ambulance data

In a set of newly proposed rules, HHS wants insurers offering individual and short-term, limited-duration coverage to disclose to members the rates they pay to brokers who help people select health plans. The government also wants to collect air ambulance data to help curb the high and unexpected costs that arise from these services.

AbbVie makes another gene therapy move, paying $370M to partner with Regenxbio

AbbVie will take the lead on commercializing Regenxbio’s gene therapy in wet AMD and diabetic retinopathy. It’s AbbVie’s second major gene therapy deal this year, coming months after it committed $90 million to preclinical-stage Capsida Biotherapeutics.

We’re not out of the COVID woods yet. But what we’ve already learned is going to save millions of lives.

Covid-19 exposed serious weaknesses in the American healthcare system, and has taken an unfortunate personal and economic toll on the entire world. But in the end, I do believe that our healthcare system will emerge more accessible, affordable, and effective

The future of healthcare is dependent on securing AI-powered medical devices

As more connected medical devices are built on AI, cybersecurity risks will increase as well – and it’s more important than ever before for manufacturers to implement advanced security protections in the design phase to ensure the safety of healthcare organizations, providers and patients.

DotCom Therapy snags $13M to expand pediatric teletherapy services

The company, which partners with health systems and schools to provide virtual therapy services for kids, will use the Series A funds to expand. The round was led by New Capital Partners, with participation from LRVHealth and OSF Ventures.

FDA sets expectations for pediatric Covid-19 vaccines; decision could come mid-fall

Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing of a submission from vaccine developers. U.S. health officials told Reuters they expect the Pfizer/BioNTech vaccine will be the first one ready for an FDA submission.

Digital health companies debate: how much can we scale the human element in mental health?

Four digital health leaders debated the role of self care apps, coaches and therapists in mental health during a panel at “What’s Next in Health Care?” While some touted the broader reach of self-guided treatments, others noted it was critical to have a therapist available for patients who need it.  

FDA warns Kaleido Bio to test its Covid-19 candidate as a drug, not a medical food

The FDA issued a warning letter to Kaleido Biosciences alleging the company tested its experimental microbiome product in Covid-19 patients without submitting a formal clinical trial application. Kaleido claims the filing was not required because the product is a medical food, but the regulator doesn’t buy that argument.

Genetic meds pioneer James Wilson has a new startup, this time in gene editing

Biotech startup iECURE is based on work from the University of Pennsylvania scientist, who has been researching ways to use in vivo gene editing as a way to “knock in” healthy versions of a gene to treat rare liver diseases. The company, which will develop therapeutic candidates from Penn, has raised $50 million in Series …

Genetic meds pioneer James Wilson has a new startup, this time in gene editing Read More »

How tech can help solve the overpayments problem in healthcare RCM

When CMS overpays for services, providers and commercial payers are responsible for paying the agency back, and at times, they are on the hook for millions of dollars. But technology can help healthcare stakeholders catch the mistakes that lead to overpayments, thereby reducing unnecessary costs.

Reducing low-value care starts by understanding its drivers

There is no single driver of low-value care — providers, systems, and patients all play a role. But with the right tools, stakeholders can work together to re-align incentives and transform our healthcare delivery system into one that prioritizes value, eliminates waste and leads to better overall patient outcomes.

Startup A-Alpha Bio sets out to solve a major protein problem facing big pharma

A-Alpha Bio’s technology analyzes millions of protein-protein interactions simultaneously, a capability that speeds up drug discovery research. Biotech industry partners are already using the technology and now with $20 million in Series A funding, the startup plans to build machine-learning capabilities to crunch the data produced by all of those protein interactions.

Mayo Clinic, Google develop AI algorithm to enhance electrical brain stimulation

The algorithm maps interactions between different areas of the brain, which can help guide the placement of electrodes for stimulating devices to treat brain diseases, like epilepsy, and movement disorders.

Report: 60% of top 20 US hospitals do not offer online scheduling for new patients

Not only do a majority of the top 20 hospitals on U.S. News & World Report’s 2020-21 Best Hospitals rankings not offer online scheduling, but about 65% also do not provide new patients the option to schedule a virtual visit online, despite strong consumer preference for digital access to healthcare.

NorthShore University Health System to test Laguna Health’s new post-discharge recovery app

The app provides users with a personalized recovery plan, education materials and virtual access to a care team that includes behavioral health specialists. The NorthShore system will conduct a clinical trial to test the app after which it will decide whether to deploy the solution across its hospitals.

Roche bets $300M on Adaptimmune tech for off-the-shelf cell therapies for cancer

Roche is partnering with Adaptimmune Therapeutics to develop allogeneic cell therapies based on Adaptimmune’s technology. In addition to these “off-the-shelf” products, the partners will also develop a personalized allogeneic cell therapy designed specifically for a patient’s cancer.

As Delta surges, CMIOs’ focus on plans to provide vaccine booster shots, fight false information

Chief medical information officers are in a unique position to help their organizations fight the Covid-19 pandemic — from setting up IT systems to support Covid testing, care and vaccination to helping fight fast-spreading misinformation.

Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy

A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study showed that some mice developed liver tumors. Patients did not receive the same high dose that was given to the mice, and no one in the clinical trial has developed …

Cancer concerns lead FDA to place clinical hold on BioMarin gene therapy Read More »

The Post-pandemic future of clinical trials: How recruiting, participating and monitoring are changing

Unleashed from restrictive norms for recruiting and interacting with patients, researchers are finding ways to bring more people into trials by simply making enrollment and participation accessible beyond restraints like geography and availability during “business hours.”

Startup Modulus embraces AI to design better NK cell therapies for cancer

Modulus Therapeutics recently emerged from stealth with technology from various disciplines and seed funding that the startup is using to develop better cell therapies. Natural killer cells directed against breast cancer is Modulus’s initial focus, but the startup says its approach can apply to multiple types of immune cells and multiple types of cancer.

Should we do away with ACOs? The answer depends on who you ask  

In a new study, researchers suggest ACOs are not helping CMS save substantial amounts of money as they were expected to do, so the model should be eliminated. But other experts in the industry disagree, taking issue with the study’s methods and conclusions.

Impel NeuroPharma’s drug-device combo product nabs FDA nod for migraine

The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It marks the first approval for the Seattle company, which has developed a proprietary nasal delivery technology.

Feds slap UPMC, cardiothoracic surgery chair with billing fraud suit

The lawsuit alleges that UPMC and the chair of its cardiothoracic surgery department knowing submitted false claims for concurrent surgeries that violated regulations. But, according to UPMC, there is no regulation that prohibits overlapping surgeries or billing for them.

Novartis “one transplant for life” drug flunks test in kidney transplant patients

A Novartis drug intended to prevent organ rejection has failed to beat out the standard of care therapy in a Phase 2 study in kidney transplant patients. Other clinical trial failures announced ahead of the Labor Day weekend include a Forte Biosciences atopic dermatitis drug, as well a cancer therapy from Takeda Pharmaceutical.

Blood disorder biotech Disc Medicine gets $90M to bring two drugs into Phase 2

A Roche drug that failed as a treatment for neurological disorders is now the lead program for Disc Medicines. CEO John Quisel said Roche’s clinical data showed the small molecule’s promise addressing a rare blood disorder and now the biotech startup has $90 million to advance that drug and another one into Phase 2 testing.

Survey: 40% of health systems ramping up hiring efforts amid workforce shortage

A majority of organizations (93%) said they are focused on both attracting and retaining top talent, a new survey from Aon shows. They are offering various benefits to do so, including onsite or near-site health clinics for employees.

INVEST Digital Health Preview: Mapping the Digital Future of Pharma

INVEST Digital Health is set for September 20-23, and held in collaboration with Medical Alley. The healthcare conference, held in a virtual format due to Covid-19, brings together innovative investors across the healthcare spectrum, prominent industry players and the most promising digital health startups.

Assembly Bio drops hepatitis B drug after liver problems surface in clinical trial

Four patients dosed with an experimental Assembly Biosciences hepatitis B treatment developed high levels of liver enzymes, a sign of drug-induced liver toxicity. The biotech has decided to stop further work on that drug and focus instead on developing its other clinical-stage hepatitis B drugs.

Collaborative care with a virtual lens: enabling patients and providers to overcome the mental health crisis

By establishing a virtual relationship with consulting telepsychiatrists, psychiatric nurse practitioners, and licensed clinical social workers, PCPs and their behavioral care managers have access anytime to the appropriate support for patients’ mental health needs.

FDA cracks down on JAK drug class, calls for new warnings of heart, cancer risks

The FDA’s review of a post-marketing study for Pfizer blockbuster anti-inflammatory drug Xeljanz found a higher risk of cardiovascular problems and cancer, and the agency is requiring additional warnings flagging those risks. The updated warnings extend to AbbVie and Eli Lilly medicines in the same drug class.

Report: Medicare trust fund still expected to run out by 2026

The latest report from the Medicare Board of Trustees shows that the health insurance trust fund, also known as Medicare Part A, will run out in a mere five years, which is in line with reports released in 2018, 2019 and 2020, indicating that the Covid-19 pandemic has not hastened the fund’s depletion.

Asher Bio’s encouraging early data against rival cancer drug sparks $108M financing

Five months after raising $55 million to back a new technology and a promising lead cancer immunotherapy, Asher Biotherapeutics has reeled in $108 million more. CEO Craig Gibbs said investors were enticed by encouraging new data suggesting Asher Bio’s lead program is superior to a competitor’s.

Versanis Bio unveils $70M and a Novartis drug ready for Phase 2 test in obesity

Novartis was unsuccessful developing bimagrumab as a treatment for a rare muscle disorder, but additional tests showed encouraging results in fat reduction. Startup Versanis Bio licensed rights to the antibody and plans to use its Series A financing for clinical trials testing the drug in obese patients.

Sutter Health to pay $90M to resolve False Claims allegations

The California-based health system will pay a hefty price to resolve allegations that it knowingly submitted inflated diagnosis codes for certain Medicare Advantage beneficiaries to receive higher payments. Sutter Health does not admit any liability in the matter.

INVEST Digital Health Pitch Perfect Preview: Home Health

Read more to find out which finalists will present in the Home Health track of the startup pitch contest during the virtual conference, scheduled for September 20-23.

DeepMind has unlocked protein-based medicine – what does that mean for drug patents?

One of science’s great puzzles is being solved by artificial intelligence and the answers shared freely on the internet. How can life sciences companies make the most of DeepMind’s discoveries while protecting their own?

Catalent sees $1B Bettera deal as a key to growth in nutrition and consumer health

Tie-ups of candy makers and nutritional product companies into a single firm called Bettera has culminated in a $1 billion acquisition by Catalent. The global contract manufacturing giant plans to leverage Bettera’s ability to produce gummies and chewables as a way to offer its customers new formulation options for nutraceutical products.

Hackensack Meridian Health, Englewood Health appeal court decision to block merger  

The FTC sued to block the merger between the two New Jersey-based health systems and won a preliminary injunction earlier this month. But the providers believe that the merger would not raise prices or stifle competition — like the FTC alleges it would — and have filed an appeal.

Pfizer eczema contender beats Dupixent in study, but JAK drug class is still in limbo

Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the future of that drug and others might depend more on an FDA review of safety data for medicines in this class of so-called JAK inhibitors.

BioMarin stands tall with first approved drug for rare disease that causes dwarfism

The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.

A biotech startup’s hunt for elusive disease targets scores $60M for drug R&D

Atavistik Bio is one of several companies discovering and developing drugs that work by allostery, binding to less obvious sites of a target protein. Acting CEO John Josey said the startup aims to stand apart with its focus on understanding metabolic interactions, a path less trodden by others in allosteric drug discovery.

ADC Therapeutics strikes a $325M royalty deal to fuel its cancer drug strategy

The royalty agreement with HealthCare Royalty Partners will support ADC Therapeutics’ plans to commercialize its newly approved cancer drug and develop the next one in its pipeline. The biotech’s drug Zynlonta is the first of its type approved by the FDA as a treatment for diffuse large cell B-cell lymphoma

Report: Uninsured rate holds steady at 11% during pandemic despite job losses

The increase in access to public health insurance coverage — via legislation like the Families First Coronavirus Response Act that prevents states from disenrolling Medicaid beneficiaries — helped offset the loss of employer-sponsored insurance, the report from Robert Wood Johnson Foundation shows.

Eli Lilly aims for the next-generation of protein degraders via Lycia R&D alliance

Eli Lilly is entering the field of protein-degrading drugs through a partnership with Lycia Therapeutics, a startup whose technology goes further than the first wave of such drugs. Lilly paid $35 million to begin the alliance, which spans up to five drugs.

Mental health unicorns Headspace, Ginger merge into $3B company 

The two companies will merge to form Headspace Health, which will combine Headspace’s many meditation and wellness exercises with Ginger’s coaching and therapy services. The combined company will have more than 800 employees and a $3 billion valuation. 

Trinity Health Mid-Atlantic to deploy NeuroFlow’s mental health tools across 3 hospitals

Through a program funded by Independence Blue Cross Foundation, 1,800 frontline healthcare workers across the three Pennsylvania-based hospitals will gain access to NeuroFlow’s technology, which will measure and track their mental health symptoms and provide support via educational resources and a clinical care team.

Scant on details, J&J claims it has data supporting Covid-19 booster shots

As U.S. plans for Covid-19 booster shots unfold, Johnson & Johnson is angling to join the mix, reporting data that it says support a second shot of its vaccine. But the data the company points to are sparse and it’s not entirely clear they support booster shots.

Emulate CEO shares the organ-chip maker’s vision to understand and predict drug response

Each Organ-Chip is a transparent, flexible microenvironment that contains two parallel chambers that can be configured to grow human cells from an organ of interest, such as the liver, kidney proximal tubule, intestine, lung and brain

FDA approves first drug for severe itching in chronic kidney disease patients

Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the FDA’s nod green light for its injectable drug, Korsuva.

Theravance’s Janssen Biotech-partnered ulcerative colitis drug flops in Phase 2

The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to develop the JAK inhibitor for intestinal diseases. Following the Phase 2 failure, Theravance said it will minimize spending on that program.

Analysis: Care for the unvaccinated may be costing U.S. healthcare system $2.3B

The report, released by Kaiser Family Foundation and the Peterson Center on Healthcare, details the high cost of Covid care for the unvaccinated. In fact, the analysis indicates the figure could be even higher than $2.3 billion, as the authors did not take into account the cost of outpatient treatment for Covid-19.

Pfizer makes big move in blood cancers with $2.3B Trillium acquisition

Though Gilead Sciences leads the group of companies developing immunotherapies that target the cancer protein CD47, Pfizer contends that molecules it is getting through the Trillium Therapeutics acquisition have safety and efficacy advantages that could make them the best in this emerging drug class.

Insurer price transparency rule faces legal challenges: 4 takeaways

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

Pfizer, BioNTech Covid-19 vaccine is awarded full FDA approval

Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.

Four biotech startup reel in $238M in financing to ramp up for clinical trials

Vigil Neuroscience led the way with a $90 million round of funding, one of four biotech companies to close Series B financing rounds in the past week. The fresh capital comes as each of the companies looks ahead to bringing their respective drugs into the clinic.

AstraZeneca drug succeeds in Covid-19 prevention; regulatory filings on the way

An AstraZeneca antibody drug for Covid-19 has clinical data showing the drug reduced the risk of infection by 77%. With the results, the pharmaceutical giant pulls ahead of other companies developing injectable versions of antibody drugs for Covid-19 prevention.

AstraZeneca drug acquired in Alexion acquisition falls short in pivotal ALS trial

Alexion Pharmaceuticals drug Ultomiris is already approved to treat a rare blood disorder, but the company hoped the antibody’s approach could also work in amyotrophic lateral sclerosis. Despite failing in ALS, Alexion, recently acquired by AstraZeneca, brings additional clinical-stage programs for rare diseases.

Illumina’s Grail buyout beats deadline, but legal and regulatory hurdles remain

In closing its Grail acquisition before U.S. and European regulators sign off, Illumina is taking a chance the deal will pass regulatory muster. It’s a potentially pricey gambit, as Illumina could face fines for its early action and there are no assurances that regulators will agree that the deal is not anticompetitive.

Study: Private consultancies can influence hospital participation in CMS bundled payments model 

Partnering with private consulting firms can spur greater hospital participation in the Bundled Payments for Care Improvement initiative Advanced Model, in which hospitals earn rewards for spending less than CMS-set benchmarks on an episode of care or pay penalties if they spend more.

HHS cites real-world data for Covid-19 boosters; WHO says the science is still out

In announcing plans to offer Covid-19 booster shots, federal health officials cited declining vaccine efficacy shown by real-world studies. But the World Health Organization said the science is less than clear about booster shots, adding that it’s ethically wrong to give third shots when so many around the world are waiting for their first one.

Reports: 1 in 10 adults delayed care in spring amid trailing healthcare utilization levels

According to two new reports, hospital admissions were about 85% of what was expected based on historic patterns at the beginning of April, and in the same month, 11% of adults reported delaying care because of Covid, including 16% of Hispanic and 13% of Black adults.

Mass General Brigham is diversifying its innovation process. Here’s how.

Called the Innovator Community Expansion Initiative, the main goal of the effort is to pinpoint and remove obstacles keeping underrepresented groups, like women, out of the innovation process. The initiative will promote networking and education about the path to commercialization.

FDA decision for GSK drug opens door to treatment of more cancer patients

GlaxoSmithKline drug Jemperli is now FDA approved for treating solid tumors throughout the body as long as they have a particular genetic signature. Expanding the drug’s approval means the drug can treat more patients who have more types of cancer, and it also gives GSK a way to grow revenue in its thin oncology portfolio.

Verily adds to its clinical trials toolbox with acquisition of startup SignalPath

Verily’s recent moves have signaled the company’s interest in supporting decentralized clinical trials and real-world studies. Now the life sciences subsidiary of Alphabet is bolstering its capabilities in this these areas with the acquisition of startup SignalPath.

Gritstone secures CEPI funding to test Covid vaccine; first focus is South Africa

Gritstone bio is developing Covid-19 vaccines that use self-amplifying messenger RNA, which is intended to further boost the immune response compared to mRNA alone. The company also says its vaccine candidates may be able to protect against variants of the novel coronavirus.

INVEST Digital Health preview: The Next Phase of Digital Health Investment

INVEST Digital Health is set for September 20-23, and held in collaboration with Medical Alley. It brings together innovative investors across the healthcare spectrum, prominent industry players and the most promising digital health startups.

HiberCell’s Genuity buyout brings $100M, plus alliances with Ionis and AbbVie

Startup HiberCell has acquired Genuity Science, a marriage that brings together two companies that apply AI and machine learning to drug research. HiberCell says Genuity will help the company identify and validate new pathways in how cancer starts and progresses.

CareMax to add 50 new senior care centers through Anthem collaboration

The senior care provider currently operates 34 medical centers offering healthcare and social services, like transportation. Through the collaboration, the companies will bring more seniors into value-based arrangements with the goal of improving outcomes for Anthem patients.

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

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

Sesen Bio says rejected bladder cancer drug may need new clinical trial

For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen characterized the regulator’s rejection of the fusion protein as surprising, CEO Tom Cannell also revealed an earlier sign that another clinical trial may be necessary.

Leading hardtech innovation center mHUB opens MedTech accelerator for medical device startups [Sponsored]

The mHUB MedTech Accelerator is a six-month program, based in Chicago, run in partnership with Baxter and Edward-Elmhurst Health Venture Capital. The application deadline is Monday, August 23.

Merck drug acquired in $1B deal approved to treat tumors sparked by rare disease

FDA approval of the Merck drug, belzutifan, covers treatment of tumors caused by von Hippel-Lindau disease, an inherited disorder associated with several types of cancer. Merck added the small molecule to its pipeline two years ago as part of a $1.2 billion acquisition.

How payers, providers are tackling homelessness & extending care access

Homelessness, a key social determinant of health, is on the rise, prompting action from payers and providers. Though their efforts are varied, ranging from subsidizing housing to making it easier for those living in encampments or temporary housing to access care, they have a common goal.

UnitedHealth subsidiaries settle mental health parity allegations for $15.6M

UnitedHealthcare and United Behavioral Health agreed to the settlement to resolve allegations that they illegally denied coverage for mental health and substance use disorder treatments. The allegations are related to business practices they no longer use, parent company UnitedHealth Group said.

FDA authorizes Covid-19 booster shots, but only for the immunocompromised

Covid-19 vaccine booster shots are now authorized for organ transplant patients and others who have weakened immune systems. The FDA based its update on the results of two small studies that tested third shots of the mRNA Covid vaccines from Moderna and Pfizer/BioNTech.

Hackensack Meridian Health partners with NowPow to create SDOH referral program

The NowPow referral platform, which is integrated into the New Jersey-based health system’s EHR, will enable clinicians and other care team members to provide patients — whose socioeconomic conditions are negatively affecting their health — with referrals to community resources, like food banks or rental assistance.

As work went remote, cybersecurity teams doubled down on clear communication, flexibility

In a remote work environment, cybersecurity teams learned that they needed to support their organizations by providing workers with the information they needed to secure their data, while also remaining flexible to changing needs, panelists said at a HIMSS Digital session.

Second FDA clinical hold for Aprea cancer drug cites safety data in another study

For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form of cancer.

Widespread use of health IT can cause burnout but also help curb it

In a HIMSS 21 Digital session, panelists detailed the dichotomy of technology advancement for clinicians. Though technology has made it harder for them to disconnect from work leading to burnout, IT tools can also be used to identify pain points and implement solutions to alleviate stress.

HIMSS Digital: Future is bright for payer-provider-pharma collaboration

The pandemic made collaboration necessary between stakeholders that otherwise tend to be at odds with each other. But as partnerships grow, providers, payers and pharma companies must ensure they are working toward a clear-cut common goal, according to panelists at HIMSS 21 Digital.

INVEST Digital Health preview: Big Tech Unplugged

INVEST Digital Health is scheduled for September 20-23, and held in collaboration with Medical Alley. It brings together innovative investors across the healthcare spectrum, prominent industry players and the most promising digital health startups. It will be virtual due to Covid-19.