10:21 p.m. May 3, 2021
AstraZeneca's Farxiga gets U.S. FDA approvalAstraZeneca PLC said Tuesday that the U.S. Food and Drug Administration approved Farxiga for the treatment of chronic kidney disease in patients at risk of progression with, and without, Type 2 diabetes.
9:04 a.m. March 10, 2021
- By Jaimy Lee
Vertex to begin Phase 1/2 trial of treatment for people with type 1 diabetesShares of Vertex Pharmaceuticals Inc. were down 0.2% in trading on Wednesday after the company said it started an early-stage clinical trial for its experimental treatment for people with type 1 diabetes. It also said the therapy received a fast-track designation from the Food and Drug Administration. The Phase 1/2, single-arm, open-label study will be conducted at multiple sites in the U.S. and aims to enroll 17 participants. Vertex gained access to the therapy through its roughly $1 billion acquisition of Semma Therapeutics Inc. in 2019. Vertex's stock is down 7.4% over the past year, while the S&P 500 has rallied 41.1%.
The clinical trial is a Phase 1/2, single-arm, open-label study in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. This will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different doses of VX-880. Approximately 17 patients will be enrolled in the clinical trial.
About Type 1 Diabetes
T1D results from the autoimmune destruction of insulin-producing islet cells in the pancreas, leading to loss of insulin production and impairment of blood glucose control. The absence of insulin leads to abnormalities in how the body processes nutrients, leading to high blood glucose levels. High blood glucose can lead to diabetic ketoacidosis and over time, to complications such as kidney disease/failure, eye disease (including vision loss), heart disease, stroke, nerve damage and even death.
Due to the limitations and complexities of insulin delivery systems, it can be difficult to achieve and maintain balance in glucose control in patients with T1D. Hypoglycemia often results because of the difficulty in balancing the different factors that impact glucose levels, including insulin, diet and exercise. Hypoglycemia remains a critical limiting factor in glycemic management, and severe hypoglycemia can cause loss of consciousness, coma, seizures, injury, and can be fatal. Over time, patients with T1D can develop impaired awareness of hypoglycemia, meaning they are no longer able to perceive the early signs of a hypoglycemic event, which can be dangerous and result in life threatening events.
There are currently limited treatment options beyond insulin for the management of T1D.
10:29 a.m. Nov. 11, 2020
- By Ciara Linnane
Coronavirus update: U.S. sets record for hospitalizations with 17 states at peak levels; ‘Wisconsin,’ pleads Gov. Tony Evers, ‘this is serious!’ North Dakota’s hospital system is at 100% capacity, and state is allowing health-care workers who have tested positive to stay on the job and treat COVID patientsThe U.S. case tally for the coronavirus illness COVID-19 climbed above 10.3 million on Wednesday, as hospitalizations set a record with Midwest hospitals now fuller than the South was during its summer peak.
11:43 p.m. Oct. 25, 2020
Bayer to pay up to $4 billion for Asklepios BioBERLIN -- Bayer AG said Monday it would pay as much as $4 billion for U.S. biotech firm Asklepios BioPharmaceutical Inc. to strengthen the German company's drugmaking arm, as Bayer continues to reel from its acquisition of crops giant Monsanto.
5:25 a.m. Oct. 24, 2020
- By Nicole Lyn Pesce
Jeff Bridges is one of the 85,000-plus lymphoma cases expected in the U.S. this year What to know about the most common type of blood cancer almost 800,000 Americans are living with or in remission fromWhat to know about the most common type of blood cancer almost 800,000 Americans are living with or in remission from
12:34 p.m. Oct. 1, 2020
- Associated Press
Flu vaccine expected to be in high demand as U.S. and Europe aim to ward off ‘twindemic’ A record number of doses are on the way — between 194 million and 198 million for the U.S. aloneA record number of doses are on the way — between 194 million and 198 million for the U.S. alone.
9:42 p.m. Sept. 23, 2020
- Associated Press
As Trump continues to press for coronavirus vaccine by Election Day, public health officials vow ‘no cutting corners’A huge international study of a COVID-19 vaccine that aims to work with just one dose is getting underway as top U.S. health officials sought Wednesday to assure a skeptical Congress and public that they can trust any shots the government ultimately approves.
12:03 p.m. Sept. 9, 2020
- By Bianca Flowers
How Black doctors are answering the call to reform medical education — and bringing COVID-19 vaccine trials to communities of color Patients of color have been ignored in medical textbooks for decades. Black doctors and students say the restructuring of the curriculum is necessary to change the culture of medicine in the classroom — and the examination room.Patients of color have been ignored in medical textbooks for decades. Black doctors and students say the restructuring of the curriculum is necessary to change the culture of medicine in the classroom — and the examination room.
5:57 a.m. Aug. 30, 2020
- By Quentin Fottrell
An analysis of data from 28,000 patients sheds more light on blood-pressure issues and COVID-19 ‘At the start of the pandemic, there was concern that specific medications for high blood pressure could be linked with worse outcomes for COVID-19 patients’‘At the start of the pandemic, there was concern that specific medications for high blood pressure could be linked with worse outcomes for COVID-19 patients.’
5:37 a.m. Aug. 15, 2020
- By Ronald D. Fricker Jr.
The ‘excess deaths’ tally in the U.S. is 204,691 in 7 months — so COVID-19 deaths might be undercounted The number of excess deaths exceeds the number attributable to COVID-19 by more than 16,000 peopleThe number of deaths through July 2020 is 8% to 12% higher than it would have been if the coronavirus pandemic had never happened.
5:11 a.m. Aug. 8, 2020
- By Jaimy Lee
This Seattle man volunteered to be injected with an experimental COVID-19 vaccine: ‘It was kind of my duty as a healthy individual to step up’ Neal Browning is one of the volunteers who signed up to receive Moderna’s experimental COVID-19 vaccineNeal Browning, a 46-year-old network engineer at Microsoft Corp., was one of the first people in the U.S. to receive a dose of Moderna Inc.’s experimental COVID-19 vaccine.
8:22 a.m. July 4, 2020
- By William Petri
Here’s the latest on what we know works — and doesn’t work — in treating coronavirus infections Steroids and Remdesivir have already been shown to help. It’s too early to judge on a couple of other possibilities.Steroids and Remdesivir have already been shown to help fight COVID-19. It’s too early to judge on a couple of other possibilities.
12:29 p.m. June 24, 2020
- By Jeremy C. Owens
Acceleron Pharma stock jumps after positive heart-drug studyAcceleron Pharma Inc. shares gained in after-hours trading Wednesday after the pharmaceutical company revealed positive results from a study of a drug for heart disease. The company announced that a phase 2 study of a drug called sotatercept helped patients with pulmonary arterial hypertension show "a statistically significant reduction in pulmonary vascular resistance." "Although the introduction over the past two decades of more than a dozen treatments for PAH has driven the development of today's combination-therapy strategies, the substantial morbidity still associated with PAH clearly signals the need for a new approach," Acceleron Chief Executive Habib Dable said in Wednesday's announcement, adding that the company will now work with authorities to move into phase 3 testing. Acceleron stock was halted ahead of the announcement while down 5.5%, but then gained more than 8% in trading immediately after the halt was listed in the extended trading session. Gains fell to about 3.2% later in the after-hours session.
7:25 a.m. June 23, 2020
- By Jaimy Lee
Researchers publish dexamethasone findingsResearchers on Monday published that led to the U.K.'s decision to approve the steroid dexamethasone as a treatment for some severely ill COVID-19 patients. The U.K. preliminary findings from the trial last week. The study is in preprint form and has not been peer-reviewed, which is considered the gold standard in clinical research. However, during the coronavirus pandemic, preprints have become a popular way to more quickly release scientific data about the virus and potential treatments. The U.K.'s randomized study assessed the use of dexamethasone in 2,104 patients. An additional 4,321 patients received the standard of care. About 21.6% of the patients who received the steroid died, compared with 24.6% of the patients who had the standard of care. Of the patients who received the steroid who were on mechanical ventilators, 29.0% died, compared with 40.7% of patients on ventilators receiving the standard of care. And among patients receiving oxygen and dexamethasone, 21.5% died, as compared to 25.0% of patients who received oxygen and the standard of care. The drug did not benefit COVID-19 patients who were not receiving oxygen or ventilation in the study. The mean age of the clinical study's participants was about 66 years old; about two-thirds of patients in the trial were men; and about half of the patients who received dexamethasone had a pre-existing condition, such as diabetes or heart disease. "Dexamethasone provides an effective treatment for the sickest patients with [COVID-19] and, given its low cost, well-understood safety profile, and widespread availability, is one that can be used worldwide," the University of Oxford researchers concluded.
6:36 a.m. June 13, 2020
- By Elisabeth Buchwald
Millions of African Americans and Native Americans were uninsured as pandemic hit: ‘Having COVID-19 is scary enough’ ‘The pandemic is laying bare the lethal inequality of American society and American health care’‘The pandemic is laying bare the lethal inequality of American society and American health care.’
10:05 a.m. June 1, 2020
- By Ciara Linnane
Coronavirus update: Global case tally tops 6 million as weekend protests spark concerns they will lead to an increase in infections The heads of Apple, Microsoft, Google, Netflix, Disney, AT&T and many others offered support for protesters The number of global cases of the coronavirus that causes COVID-19 climbed above 6 million on Monday, after a weekend dominated by protests across the U.S. at the death of an unarmed black man at the hands of a white police officer in Minneapolis last week.
2:03 p.m. May 20, 2020
- Associated Press
Trump says he’ll stop taking hydroxychloroquine ‘in a day or two’ ‘It’s gotten a bad reputation only because I’m promoting it,’ Trump says of the malaria drug, which he said he’s taking to prevent infection by the coronavirus; there is no proof that it is effective as a COVID-19 therapy or prophylaxis‘It’s gotten a bad reputation only because I’m promoting it,’ Trump says of the malaria drug, which he said he’s taking to prevent infection by the coronavirus; there is no evidence that it was as a COVID-19 therapy or prophylaxis.
7:58 a.m. May 19, 2020
- By Jaimy Lee
Can hydroxychloroquine prevent a COVID-19 infection? That’s Trump’s hope, it appears — and it is being looked into by researchers A series of medical studies, many of which haven't been peer reviewed, have concluded that hydroxychloroquine isn’t efficacious against COVID-19 infectionsPresident Donald Trump’s unprompted admission that he’s been taking hydroxychloroquine to prevent a COVID-19 infection fits into a broader trend of medical research that aims to understand if the controversial drug can prevent infections with the coronavirus in high-risk frontline workers.
4:35 p.m. May 18, 2020
- Associated Press
Trump says he’s been taking hydroxychloroquine to protect against coronavirus, though it’s not proven to help President says he requested anti-malaria drug; medical experts express alarmPresident says numerous frontline workers have been taking the drug similarly.