Dr. Leora Horwitz treats fewer and fewer covid patients at NYU Langone Medical Center in New York City. Still, she thinks there are too many. And they almost all have something in common. “I’ve only had one patient who was vaccinated, and he was being… Read More »Unvaccinated, Homebound and Now Hospitalized With Covid in New York City
Rachel Blank, former director of strategy at digital health unicorn Ro, left to start her own digital health company. Her new startup, Allara is focused on helping people manage polycystic ovary syndrome (PCOS).
The FDA has approved Prevnar 20, a Pfizer vaccine that protects against 20 pneumococcal strains—seven more than the company’s blockbuster Prevnar 13. But others are on Pfizer’s heels with vaccine candidates that aim to match or even beat the Pfizer pneumococcal vaccines.
The at-home testing startup plans to launch a broader virtual care offering after raising $150 million in funding. It plans to roll out virtual visits and offer prescription medications, in addition to building out its array of tests.
Stablix Therapeutics is developing technology that uses small molecules to stabilize a protein, keeping it from going to a cell’s built-in disposal system. The startup now has $63 million in funding to further invest in the technology and advance its first molecules toward the clinic.
Emergency authorization of Regeneron Pharmaceuticals’ Covid-19 antibody drug now includes an injectable version, which is a more convenient option for patients. The drug developer plans to seek full FDA approval of its antibody cocktail later this summer.
The startup, which currently has four direct-to-consumer brands, recently passed a $1 billion valuation. It plans to use the funds to market its services to a new customer: health plans.
Noom, a weight loss app that uses health coaching, raised $540 million in a funding round led by Silver Lake Capital. It plans to expand into a wider range of conditions, including stress and diabetes.
As the world of healthcare benefits becomes increasingly fragmented, Cedric Kovacs-Johnson sees a need for benefits administration to keep up. His startup, Flume, recently made its debut with $10 million in funding.
Bristol Myers Squibb reported Phase 3 data that show its experimental cancer immunotherapy relatlimab, combined with the company’s blockbuster drug Opdivo, was better at stopping melanoma from progressing. BMS will present the data at the upcoming annual meeting of the American Society of Clinical Oncology.
Healthcare payments startup Cedar acquired another billing startup, OODA Health, for $425 million. The deal would bring together billing tools for providers and payer onto one platform.
Perceptive Advisors has $515 million for its second fund investing in biotech startups. Portfolio Manager Chris Garabedian says Perceptive Xontogeny Ventures Fund II is looking to make Series A investments in early-stage companies with assets that can show a path to clinical testing.
Headway, a startup working to build a network of therapists covered by major insurers, raised $70 million in funding. The startup manages claims, credentialing and other administrative work for independent practices.
Founded by former hedge fund manager Vivek Ramawamy, Roivant Sciences set out to redefine drug development by acquiring overlooked drugs and advancing their development. The merger deal that will take it public reveals how much new technology changed the company’s vision and its strategy.
INVEST Pitch Perfect winner spotlight: Oshi builds digital approach for oft-overlooked GI conditions
As awareness grows around GI conditions, startup Oshi Health is building a platform to connect people to teams of clinicians and health coaches to better manage their symptoms. Judges picked the startup as the health services winner for MedCity INVEST’s Pitch Perfect contest.
Sesame, a startup building a cash-pay marketplace for healthcare, raised $24 million. The sudden adoption of telehealth by the broader public led the startup to grow faster than expected.
Kaia Health, a startup providing app-based programs for musculoskeletal conditions and COPD, recently raised $75 million in funding. As competitors look to round out their platforms with other services, Kaia is looking to strike partnerships with clinicians.
The FDA placed a clinical hold on a KalVista Pharmaceuticals drug being readied for mid-stage studies in a rare, inherited disorder. Meanwhile, the FDA has some questions about the historical data Y-mAbs used as the control in a clinical trial for its antibody cancer drug.
A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug developer, along with partner Roche, plan to ask regulators to expand the drug’s authorization to include disease prevention.
As Covid-19 cases started escalating last April, providers in hotspot states, like New York, California and Washington, had to quickly pivot their IT plans. These are some of the decisions that five health IT leaders made — aside from expanding telehealth — that helped their… Read More »The key IT decisions that helped providers survive April 2020
Do mobile phones cause brain tumors? Whenever a trillion-dollar industry is involved—whether it’s Big Food, Big Tobacco, Big Pharma, or Big Telecom—there’s so much money that the science can get manipulated. When it comes to the potential human health effects of cell phone use, certainly,… Read More »Can Cell Phone Radiation Damage Your DNA?
Volastra Therapeutics is developing drugs for cancer metastasis, the cause of the vast majority of cancer deaths. The startup has $44 million in funding and an R&D partnership with Microsoft to develop new digital tools to detect and predict metastasis.
The startup, which provides primary care services to Medicaid patients, plans to use the funds to expand into new states and add maternity and pediatrics services lines. It also recently launched a vaccination site in conjunction with the New York Department of Health.
The FDA has approved a Bristol Myers Squibb cell therapy made by engineering a patient’s immune cells to target a cancer protein called BCMA. The regulatory decision for Abecma in multiple myeloma gives BMS its second approved CAR-T therapy.
Komodo, a data analytics startup building out information on patient encounters and outcomes, raised $220 million in funding. It plans to use the funds to build out its platform and further integrate it in users’ workflows.
Hawaii, Florida, Seattle and the South of France are on the minds of New York City college students. Those are some of the destinations that undergrads mentioned when asked where they’d go for spring break, if they weren’t grounded by covid-19. This story also ran… Read More »Some Dream — Others Scheme — To Find a Vaccine Before Spring Break
Happify Health, a startup building digital health tools, raised $73 million in funding. The company plans to use the funds to build out more specialized solutions for health plans and pharma companies.
Unite Us, a New York-based technology company that makes coordination of care software, passed a $1.6 billion valuation. It build networks with local providers and works to connect members with community resources.
A Brainstorm Cell Therapeutics therapy for Lou Gehrig’s disease failed a pivotal study, but the company points to better results in a subgroup. The FDA took the unusual step of publicly stating that study’s results do not show the stem cell therapy helps patients.
Takeda Pharmaceutical gains full rights to a small molecule that has shown promise treating seizures in several rare forms of epilepsy. Meanwhile, Ovid Therapeutics gains cash to support its pipeline of neurological disease drug candidates.
The plaudits have faded for New York Gov. Andrew Cuomo. Once hailed as a paragon of pandemic governing, he’s since come under scorching criticism for undercounting the state’s covid deaths among nursing home residents by as much as half. The tallying flap drew attention to… Read More »Sorting Out How Politics, Policies Figure in Flap Over New York Nursing Home Covid Death Rates
Athenex’s bid to offer an oral version of an intravenous chemotherapy has stalled after the FDA rejected the drug. Among the remedies proposed by the regulator is another Phase 3 study.
After a year of record growth, Teladoc set expectations for limited growth in its paid memberships and visits in 2021. But the company still sees long-term opportunities with a primary care pilot it is launching and its acquisition of Livongo.
Roivant Sciences is expanding its drug discovery and design capabilities via a stock deal to acquire Silicon Therapeutics. The Boston startup uses physics-based modeling to simulate proteins and the small molecules that bind to them.
This story also ran on The Guardian. It can be republished for free. In his 17 years as an emergency medical provider, Anthony Almojera thought he had seen it all. “Shootings, stabbings, people on fire, you name it,” he said. Then came covid-19. Before the… Read More »‘It Doesn’t Feel Worth It’: Covid Is Pushing New York’s EMTs to the Brink
Insurance startup Oscar Health plans to price its IPO between $32 and $34 per share. The New York-based startup plans to trade on the New York Stock Exchange under the ticker “OSCR.”
Pfizer and BioNTech say they have data supporting two-week storage of their vaccine at temperatures found in medical-grade freezers. They say FDA approval of an additional temperature option would give vaccination sites more flexibility.
A physician started a business to eliminate long appointment wait times. But when the pandemic hit, she found a new use for it in helping keep patients out of busy waiting rooms.
The FDA approval clears Regeneron’s drug, Evkeeza, as a treatment for the rarer of two forms of an inherited disease that causes high cholesterol levels. The company already markets Praluent, which treats the more common form of familial cholesterolemia.
Zocdoc, which had built its business as an online scheduling platform for doctors, quickly pivoted at the beginning of the pandemic to offer telehealth visits. The company recently raised $150 million from Francisco Partners.
Oscar Health filed preliminary paperwork for an IPO on Friday. The health insurance startup is betting that its technology can give it an edge as it fights for market share with bigger competitors.
After some setbacks and delays, the FDA approved Bristol Myers Squibb’s Breyanzi for certain lymphomas. It’s the third CAR T treatment to win the regulatory nod and the first under a new regenerative medicine designation.
Digital health startup DarioHealth bought musculoskeletal startup Upright for $31 million. The company makes adhesive devices users can stick to their back to track their posture.
Loki Therapeutics is advancing research that leverages the immune system’s ability to recall childhood vaccinations and direct it against cancer. The company’s lead therapy candidate could enter phase 1 clinical trials this year.
Cuando los hospitales de todo el país luchan contra la nueva ola de la pandemia, no son camas ni ventiladores lo que escasean. Son las personas que cuidan de los enfermos. Pero existe mano de obra altamente calificada de médicos, enfermeras y otros trabajadores de… Read More »Estados permiten contratar profesionales de salud extranjeros por la pandemia
K Health raised $132 million in funding, which it plans to use to expand its platform into pediatric patients. The company has built a symptom-checker app and lets patients text a primary care physician for an additional fee.
Paige, a New York-based computational pathology startup, raised $100 million in a series C funding round. The company develops clinical decision support algorithms for oncology.
In an effort to ensure the efficient and orderly distribution of the Covid-19 vaccine, governors from New York, California and Florida are warning that they will take action against providers who are conducting vaccinations too slowly or healthcare workers who undercut priority guidelines.
Judges picked TrialSpark as the winner on the life sciences track of the pitch competition at MedCity’s virtual precision medicine conference. While the company is focused on improving clinical trials for others, it hopes eventually to bring drugs of its own to market.
This story also ran on The Guardian. It can be republished for free. Workers at Garfield Medical Center in suburban Los Angeles were on edge as the pandemic ramped up in March and April. Staffers in a 30-patient unit were rationing a single tub of… Read More »As the Terror of COVID Struck, Health Care Workers Struggled to Survive. Thousands Lost the Fight.
No single municipality in the country suffered more in the first wave of the pandemic than New York City, which saw more than 24,000 deaths, mainly in the spring. Medical staff in New York know precisely how difficult and dangerous overwhelmed hospitals can be and… Read More »NYC Hospital Workers, Knowing How Bad It Can Get, Brace for COVID 2nd Wave
Spring Health, a startup that offers mental health services as an employee benefit, raised $75 million in funding. The New York-based startup matches employees with therapy and other mental health services.
Not long after the world learned that President Donald Trump had lost his reelection bid, states began issuing a new round of crackdowns and emergency declarations against the surging coronavirus. Taking action this time were Republican governors who had resisted doing so during the spring… Read More »Trump’s Lame-Duck Status Leaves Governors to Wing It on COVID
The New York based startup is working to build a network of therapists and other mental health providers. It recently raised a $26 million series A round led by Thrive and GV.
NEW YORK — Mike Angevine lives in constant pain. For a decade the 37-year-old has relied on opioids to manage his chronic pancreatitis, a disease with no known cure. But in January, Angevine’s pharmacy on Long Island ran out of oxymorphone and he couldn’t find… Read More »Patients Struggle to Find Prescription Opioids After NY Tax Drives Out Suppliers
As COVID-19 cases surge in the U.S., one Texas veterinarian has been quietly tracking the spread of the disease — not in people, but in their pets. Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from… Read More »Lions and Tigers and Anteaters? US Scientists Scan the Menagerie for COVID
As trust in the Food and Drug Administration wavers, several states have vowed to conduct independent reviews of any COVID-19 vaccine the federal agency authorizes. But top health experts say such vetting may be misguided, even if it reflects a well-founded lack of confidence in… Read More »Distrusting Trump, States Plan to Vet COVID Vaccines Themselves. Bad Idea, Say Experts.
The companies expect the deal to close in the fourth quarter. MyoKardia’s lead drug candidate is mavacamten, which it is developing for hypertrophic cardiomyopathy and plans to submit to the FDA in the first quarter of next year.
The data from a Phase II pilot and an extension study of soticlestat, also known as OV935 or TAK-935, showed short- and long-term reductions of seizure frequency in patients with CDKL5 deficiency disorder and Dup15q syndrome.
The company said that those who received the two-antibody cocktail REGN-COV2 showed a lower viral loads and faster alleviation of symptoms than those who received placebo.
Molina announced it will acquire the assets of Affinity Health Plan, a New York-based Medicaid managed care organization. It’s one of several Medicaid MCO purchases the insurer has announced this year.
Dr. Reza Chowdhury didn’t charge copays when his patients were low on cash. He gave them his home phone number and answered their medical questions at all hours. Once, when Chowdhury’s daughter, Nikita Rahman, struck up a conversation with a New York taxi driver, it… Read More »They Cared for Some of New York’s Most Vulnerable Communities. Then 12 Died.
The healthcare analytics company said it had raised the extension funding from three new investors and would use it to accelerate development of its real-world evidence technology.
On the first night of the Democratic National Convention, New York Gov. Andrew Cuomo was among the first in a weeklong parade of speakers to issue scathing critiques of the Trump administration’s coronavirus response. Cuomo’s criticisms drew a quick reply in a tweet from Michael… Read More »Is Cuomo Directive to Blame for Nursing Home COVID Deaths, as US Official Claims?
The companies also said their Phase II/III study, slated to enroll about 30,000 participants, had already dosed more than 11,000.
The deal brings Roche’s considerable manufacturing heft to Regeneron’s efforts to develop the two-antibody cocktail, REGN-COV2. Regeneron will distribute the drug in the U.S., while Roche will distribute it ex-U.S.
Nearly all of the states, plus five territories and the District of Columbia, are seeking an aggregate of $2.156 trillion from the maker of the opioid painkiller OxyContin, according to documents filed in the U.S. Bankruptcy Court Monday.
Thirty Madison, which owns direct-to-consumer pharmacy brands for hair loss, migraines and acid reflux, raised $47 million in a series B round. Polaris Partners led the round, and Johnson & Johnson participated as an investor.
The company plans to train 250 new racially and ethnically diverse clinical trial investigators and extend the reach of its trials to underserved rural and urban communities.
Health workers across the country looked on in horror when New York became the global epicenter of the coronavirus. Now, as physicians in cities such as Houston, Phoenix and Miami face their own COVID-19 crises, they are looking to New York, where the caseload has… Read More »‘Is This When I Drop Dead?’ Two Doctors Report From the COVID Front Lines
Vilified, threatened with violence or in some cases suffering from burnout, dozens of state and local public health officials around the U.S. have resigned or have been fired amid the coronavirus outbreak, a testament to how politically combustible masks, lockdowns and infection data have become.… Read More »Public Health Officials Are Quitting or Getting Fired in Throes of Pandemic
Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.
Insurance startup Oscar Health plans to expand to 19 new markets next year, pending regulatory approval. The company will offer individual and family health plans in four new states, and will expand its presence in existing states.
The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.
The companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III study and days after Pfizer and BioNTech signed a nearly $2 billion vaccine supply deal with the federal government.
NEW YORK — As the coronavirus spread silently through New York City early this year, Deborah Koeppel had an appointment with her cardiologist and two visits with her primary care doctor. Both physicians are members of Concorde Medical Group, a practice in Manhattan with an… Read More »Last Thing Patients Need During Pandemic: Being Last to Know a Doctor Left Network
In a panel discussion during MedCity INVEST Thursday, investors discussed how the Covid-19 pandemic and social distancing requirements have impacted the way they interact with companies.
The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are… Read More »Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine
Kaia Health, a startup making an app to help users manage back pain, touted the results of a large, randomized controlled trial using its app. The company currently markets its system to employers, but hopes to make it available as a covered benefit in the… Read More »Digital health startup Kaia hopes to win over insurers with results of back pain study
Israel Shippy doesn’t remember much about having COVID-19 — or the unusual auto-immune disease it triggered — other than being groggy and uncomfortable for a bunch of days. He’s a 5-year-old, and would much rather talk about cartoons, or the ideas for inventions that constantly… Read More »Why Doctors Keep Monitoring Kids Who Recover From Mysterious COVID-Linked Illness
Medly, a New York-based digital pharmacy startup that offers same-day prescription delivery, raised $100 million in a series B round.
In exchange for a $20 million upfront payment and up to $212.5 million in milestones, Italy-based Angelini will gain exclusive development, manufacturing and commercialzation rights in Europe for OV101, a drug for Angelman syndrome.
The companies anticipate releasing more clinical data from the BNT162 messenger RNA vaccine program and potentially starting a 30,000-participant Phase IIb/III study this month.
MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron
Bari Kowal, vice president of global clinical operations at Regeneron Pharmaceuticals, gives an update on the clinical trials ongoing to develop drugs to fight Covid-19 and provides insights on how the clinical trials landscape and pharma overall must change in the next episode of MedCity… Read More »MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron
The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.
The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.