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 »
Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.
PMV Pharmaceuticals has its first clinical data showing that its lead therapeutic candidate can hit p53, a tumor-suppressing protein long thought to be undruggable. After reporting the preliminary data during ASCO, PMV said it plans to continue Phase 1 study with the goal of advancing to Phase 2 early next year.
Becton Dickinson is getting into pharmacies with a more than $1.5 billion acquisition of Parata Systems, maker of robotics technologies that automate pharmacy tasks. The deal comes two months after BD completed the spinoff of its diabetes business as a separate, publicly traded company.
A Rocket Pharmaceuticals gene therapy for the rare immune disorder leukocyte adhesion deficiency-I has met the survival goals of a pivotal study, paving the way for regulatory submissions that the company expects to file in early 2023.
Oral delivery of messenger RNA is one of the capabilities of Matinas BioPharma’s technology. BioNTech will explore that feature among others under a new research alliance with Matinas, a clinical-stage biotech that also has an ongoing collaboration with Genentech.
The second quarter of 2022 kicked off with a new life sciences company joining the public markets, but not via an IPO or merger. Becton Dickinson on Friday completed the spinoff of its diabetes care business, Embecta, which now trades on the Nasdaq.
Anti-infective drug discovery startup ArrePath has launched with $20 million in seed funding to advance the development of molecules that use a dual mechanism to kill bacteria. The Princeton University spinout says its approach could overcome the drug resistance bacteria are developing to currently available products.
El certificado estadounidense no cabe en la billetera, así que no es de extrañar que lo hayas extraviado.
El certificado estadounidense no cabe en la billetera, así que no es de extrañar que lo hayas extraviado.
It never quite fit in your wallet, so it’s no surprise you may have misplaced it by now.
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.
El 11 de enero, la Clínica Cleveland de Weston, en el sur de la Florida, estaba tratando a 80 pacientes con covid-19, 10 veces más que a fines diciembre. Casi la mitad fueron hospitalizados por otras razones médicas. El aumento impulsado por la extremadamente infecciosa variante omicron abrumó al hospital de 206 camas: ahora tiene …
The Cleveland Clinic in Weston, Florida, on Jan. 11 was treating 80 covid-19 patients — a tenfold increase since late December. Nearly half were admitted for other medical reasons. The surge driven by the extremely infectious omicron variant helped push the South Florida hospital with 206 licensed beds to 250 patients. The rise in cases …
Incidental Cases and Staff Shortages Make Covid’s Next Act Tough for Hospitals Read More »
Johnson & Johnson announced it plans to separate its consumer health products into a separate company, leaving the remaining business to focus on the more research-oriented pharmaceuticals and medical devices business segments. The announcement follows similar moves made by other large pharmaceutical and medical device companies.
Organon’s proposed acquisition of Forendo Pharma is the company’s third the company since spinning out of Merck in the summer. Clinical-stage Forendo is developing a new, potentially more targeted approach to treating endometriosis.
Nursing homes receive billions of taxpayers’ dollars every year to care for chronically ill frail elders, but until now, there was no guarantee that’s how the money would be spent. Massachusetts, New Jersey and New York are taking unprecedented steps to ensure they get what they pay for, after the devastating impact of covid-19 exposed …
3 States Limit Nursing Home Profits in Bid to Improve Care Read More »
The New Jersey-based health system initially partnered with Google in 2019. It has now migrated to Google Workspace, providing thousands of Chrome OS devices to remote workers, and is using Google Cloud AI capabilities to detect diseases like breast cancer and Covid-19.
An Oyster Point Pharma drug for dry eye disease has won FDA approval, the first treatment for the condition that comes as a nasal spray. In addition to that drug approval, the FDA on Monday rejected two drugs, one from Omeros and the other from United Therapeutics.
Merck is looking for products that diversify its portfolio beyond reliance on cancer drug Keytruda, and it sees a potential blockbuster cardiovascular drug from Acceleron Pharma as fitting the bill. The pharma giant is paying $11.5 billion to acquire the biotech, and executives say they’re still on the hunt for more deals.
The American Hospital Association and Association of American Medical Colleges have filed an amicus brief in support of the New Jersey health systems that are appealing a court decision to delay their merger following a legal challenge from the FTC.
A previous investigation by MedCity News found that ElectrifAi was touting an improperly-developed algorithm during the earliest phase of the Covid-19 pandemic, with both the company and CEO defendants in an employment discrimination lawsuit. A year later, lawsuits are piling up as more former employees complain that the company and CEO lied about its AI …
Racism, sexism and now fraud: Lawsuits pile up at New Jersey ‘AI’ firm Read More »
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.
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.
Vaxneuvance, a Merck pneumococcal vaccine, is now approved by the FDA. The intramuscular shot protects against 15 pneumococcal strains—five fewer than the 20 covered by a Pfizer pneumococcal vaccine that the FDA approved in June.
Provention Bio needs to show the FDA that the drug substance produced from its contract manufacturer is comparable to the Eli Lilly-made drug substance that was evaluated in clinical trials. A larger study testing the prospective type 1 diabetes therapy teplizumab is ongoing and could provide the information the agency needs.
The FDA has approved Brexafemme, a Scynexis antifungal drug, for treating vaginal yeast infections. The drug is the biotech’s first FDA-approved product and it also represents the first new antifungal drug class in 20 years.
Becton Dickinson is known worldwide for its diabetes products. Now the medical technologies giant plans to spin off its diabetes care business as a separate, publicly traded company, leaving BD to focus on its other core segments.
Last summer, Global Plasma Solutions wanted to test whether the company’s air-purifying devices could kill covid-19 virus particles but could find only a lab using a chamber the size of a shoebox for its trials. In the company-funded study, the virus was blasted with 27,000 ions per cubic centimeter. This story also ran on CNN. …
Mark Gottlieb’s life changed in an instant when another driver crashed into his car, damaging four vertebrae in his upper spine and smashing six teeth. In the months following that January 2019 crash, Gottlieb got the teeth crowned and, for debilitating neck pain, tried injections, chiropractic care and physical therapy. The treatments were all covered …
After Accident, Patient Crashes Into $700,000 Bill for Spine Surgery Read More »
Merck is discontinuing work on one Covid-19 drug for treating hospitalized patients after the FDA said it needs more clinical data. Another Merck drug candidate is moving forward only in outpatient testing after independent clinical trial observers concluded the antiviral was unlikely to help those in the hospital.
Merck agreed to pay $215 million up front to acquire Alydia Health, a startup that has commercialized a medical device that controls bleeding during childbirth. That product will join the portfolio of Merck spinout company Organon.
Alexandra Sierra carried boxes of food to her kitchen counter, where her 7-year-old daughter, Rachell, stirred a pitcher of lemonade. This story also ran on USA Today and GateHouse Media. It can be republished for free. “Oh, my God, it smells so good!” Sierra, 39, said of the bounty she’d just picked up at a …
Need Amid Plenty: Richest US Counties Are Overwhelmed by Surge in Child Hunger Read More »
Merck’s top immunology drugs face biosimiliar competition. The $1.85 billion acquisition of Pandion Therapeutics gives the pharma giant an opportunity to build up its immunology pipeline with a new approach to treating autoimmune disorders.
Amicus Therapeutics CEO John Crowley said the totality of data support the Pompe disease therapy’s submission to the FDA. That rolling application is on track for completion in the second quarter.
After a scathing report from short-seller Hindenburg claiming that Clover faced a False Claims Act investigation, the insurance startup’s stock plummeted. Clover went public last month after merging with a special-purpose acquisition company under billionaire investor Chamath Palihapitiya.
Many pharma companies already donate drugs to charity. But the New Jersey-based entrepreneurs have developed a technology platform that makes the process easier to manage and opens up new opportunities.
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 salud, con formación en el extranjero, que no se aprovecha …
Estados permiten contratar profesionales de salud extranjeros por la pandemia Read More »
The New Jersey-based health system’s culturally nuanced social determinants of health program will screen all patients for social and behavioral factors that impact their health, in the hopes of improving outcomes and encouraging appropriate use of healthcare services.
Medicare Advantage startup Clover Health will go public in a blank-check acquisition led by billionaire Chamath Palihapitiya. The deal will value Clover at $3.7 billion.
The drugmaker emphasized the full global rights it would acquire to Momenta’s lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.
Analysts noted that Evrysdi would be priced significantly lower than Biogen’s Spinraza or Novartis’ Zolgensma. While this will provide a market advantage, it would also yield lower per-patient revenues.
Under the agreement with BARDA and the Department of Defense, the drugmaker would supply 100 million doses of its vaccine, for which it published preclinical data last and is currently running a first-in-human clinical trial.
The company said the CareStart Covid-19 MDx RT-PCR test is designed to detect RNA from the SARS-CoV-2 virus and produce results within 83 minutes.
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