Farxiga, AstraZeneca) Priority Review to treat new or new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).

Farxiga,a first-in-class, oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor, has been used to improve glycemic control in adults with T2D for around 10 years, AstraZeneca said in a 

Jardiance to get new heart attack prevention indication

“This decision brings us a step closer to delivering this new treatment option for the millions of patients living with chronic kidney disease in the U.S.,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca. “Farxiga has the potential to be a truly transformational medicine across a breadth of diseases, including type 2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease.”

In the U.S., 37 million people are estimated to have CKD, and the condition is associated with a heightened risk of heart disease or stroke or the need for dialysis or kidney transplant.

Blockbuster diabetes drug snags new heart indication

FDA’s decision to grant Priority Review was based on a Phase 3 trial showing that Farxiga

 on top of standard of care consisting of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), reduced the risk of the composite of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% in patients with CKD Stages 2-4 and elevated urinary albumin excretion.

It also significantly reduced the risk of death from any cause by 31% compared to placebo, AstraZeneca said.

Last October, FDA granted Farxiga Breakthrough Therapy Designation in the U.S. for patients with CKD with and without T2D. FDA will set its Prescription Drug User Fee Action date for this indication for Farxiga during the second quarter.

Drug’s indication expanded to reduce heart attack, stroke risk

Articles

AstraZeneca’s leading diabetes medication could be approved to treat chronic kidney disease for patients with and without type 2 diabetes.

Diabetes med Farxiga nabs FDA Priority Review for Chronic Kidney Disease

MarcoGenics says its new breast cancer treatment will be available in March.

Margenza, in combination with chemotherapy, is used treat patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

Blockbuster Keytruda gains new breast cancer indication

“Early detection and treatment have had a positive impact on the survival of patients with breast cancer, but the prognosis for people diagnosed with metastatic breast cancer remains poor, and additional treatments are needed,” said 

, MD, professor of medicine and director of Breast Oncology and Clinical Trials Education at University of California-San Francisco Helen Diller Family Comprehensive Cancer Center, in a 

“As the only HER2-targeted agent to have shown a PFS improvement versus trastuzumab in a head-to-head Phase 3 clinical trial, Margenza with chemotherapy represents the newest treatment option for patients who have progressed on available HER2-directed therapies,” Rugo added.

FDA’s approval was based on safety and efficacy results from the pivotal Phase 3 SOPHIA trial.

FDA okays novel breast, colorectal cancer treatments

The study, which included 536 patients, showed a statistically significant 24% reduction in the risk of disease progression or death with Margenza plus chemotherapy compared with trastuzumab (Herceptin, other brand names) plus chemotherapy.

The objective response rate for Margenza plus chemotherapy was 22%, and the ORR for trastuzumab plus chemotherapy was 16%. The final Overall Survival (OS) analysis is expected in the second half of 2021, according to MacroGenics.

Margenza includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity. In addition, the medication can cause infusion-related reactions (IRRs). IRRs occurred in 13% of patients treated with Margenza, with the majority reported as Grade 2 or less.

The recommended dosage of Margenza is 15 mg/kg, administered as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.

New treatment for metastatic HER2-positive breast cancer is called Margenza.

MacroGenics treatment for HER2-positive breast cancer to be available in March

Many pharmaceutical manufacturers are raising prices this year, but at a lower rate than in the past couple of years, according to a new analysis.

On January 1, about 70 pharma makers raised prices on their products, according to an analysis from Rx Savings Solutions, 

However, the average increase of 3.3% was less than the price increases in previous years. In January 2020, manufacturers raised prices a significant 5.8%, and raised them 6.3% on average in 2019.

This year, Pfizer had the most price increases, raising prices by 5% or less on more than 200 products.

However, in 2020, brand name drug net prices dropped for the third consecutive year and brand name drug list prices grew at their slowest rate in at least 20 years, according to a 

U.S. government secures remdesevir supply for COVID-19 patients

Brand-name drug list prices grew by 4.2%, but net prices declined by -2.2%. So, the gross-to-net gap in prices was -6.0%, Drug Channels said.

“As list prices rise, the dollar value of the manufacturer’s rebates and discounts grows. The manufacturer provides larger rebates to offset the increase in list prices,” Drug Channels said. “Hence, the total value of the gross-to-net bubble expanded to an astounding $175 billion for 2019, despite the slowing growth in list prices and the negative growth rates for net price.”

COVID-19 drug price skyrockets, clinical trials begin

Many pharmaceutical manufacturers are raising prices this year, but at a lower overall rate than in the past couple of years, according to a new analysis.

Drugmakers raising prices in 2021 but at lower rate

FDA approved the first generic version of an emergency kit to treat low blood sugar. The result could be competition for Eli Lilly and other pharma companies that have dominated the market with their brand-name products.

FDA granted the approval of glucagon for injection USP 1 mg/vial, packaged in an emergency, kit to 

 to treat severe hypoglycemia, which may occur in patients with diabetes mellitus.

FDA clears first ready-to-use insulin for IV injection

The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel and colon when diminished intestinal motility would be advantageous, FDA said in a 

“Glucagon for injection has been approved for use in the U.S. for more than 20 years, but until today, there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar,” said 

, Ph.D., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Today’s approval reflects the FDA’s continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand-name counterparts.”

Overall U.S. sales of brand products containing glucagon for injection, 1 mg, were approximately $306 million for the 12 months ended September 30, 2020, according to IQVIA, while sales for Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, 1 mg, were approximately $144 million for the same time period, Amphastar said in a 

“Using a dedicated process and sophisticated characterization technology, we demonstrated to the Agency that our highly purified synthetic peptide product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is an rDNA product,” Amphastar CEO and President 

Amphastar plans to have the glucagon emergency kit available within two months.

Cybersecurity Glitch Wreaks Havoc On Insulin Pump

Amphastar Pharmaceuticals’ generic version will offer stiff competition to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar.

FDA clears first generic for treatment for severe hypoglycemia

FDA has cleared a new biosimilar to Rituxan rituximab (Rituxan), which when it gets on the market may further erode sales of Roche's blockbuster treatment for non-Hodgkin's lymphoma (NHL) and other cancers.

Amgen recently achieved FDA approval for rituximab-arrx (Riabni) to treat non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA) (Wegener's Granulomatosis), and microscopic polyangiitis (MPA).

FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment

The biosimilar is expected to be available in January. Sales of Roche's Rituxan reached $6.54 billion in 2019, so any competitor to Rituxan has much to gain.

Riabni’s wholesale acquisition cost (WAC) in the U.S. is nearly 24% lower than Rituxan at $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, according to an Amgen  

FDA fast-tracks investigational leukemia treatment

The FDA approved Celltrion's rituximab-abbs (Truxima), the first biosimilar to Rituxan, in 2018. The agency approved Pfizer's Ruxience (rituximab-pvvr) a year later.

Riabni, a CD20-directed cytolytic antibody, was proven to be highly similar to Rituxan based on a totality of evidence, which included comparative analytical, nonclinical and clinical data, with no clinically meaningful differences in safety or effectiveness, Amgen said.

FDA grants full approval for combination leukemia treatment

The biosimilar to Rituxan is expected to erode market share of the mainstay cancer drug for Roche.

Biosimilar to Rituxan expected to hit market in January

Relugolix (Orgovyx, Myovant Sciences) works by blocking the pituitary gland from making luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make, FDA said in a 

First prostate cancer imaging drug approved

Current FDA-approved hormone treatments for advanced prostate cancer of this type are injected or placed as small implants under the skin.

“Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

“This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic,” Pazdur added.

Prostate cancer drug poised to generate big sale

The safety and efficacy of Orgovyx was evaluated in a randomized, open-label trial in men with advanced prostate cancer. The patients randomly received either Orgovyx once daily or injections of leuprolide, another hormone-targeting drug, every 3 months for 48 weeks.

In the 622 patients who received Orgovyx, the castration rate (measuring testosterone levels) was 96.7%.

The most common side effects of Orgovyx include: hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of certain liver enzymes.

FDA fast-tracks novel MAB neuroblastoma treatment

Orgovyx, the first oral drug in its class, may help reduce clinic visits for men with prostate cancer. Fewer visits may be important during the COVID-19 pandemic.

The FDA recently approved a monoclonal antibody treatment for both pediatric and adult patients to treat neuroblastoma in bone marrow.

Naxitamab-gqgk (Danyelza, Y-mAbs Therapeutics) 40mg/10ml is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), as a treatment treat pediatric and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

FDA cleared Danyelza under Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations. Y-mAbs said in a 

 that the drug would be available in the “coming weeks”.

Danyelza is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. It is administered to patients 3 times in a week in an outpatient setting.

“We believe that Danyelza in combination with GM-CSF is a much-needed treatment for patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow who have historically not had approved treatments available,” said 

FDA clears first treatment for mesothelioma in 16 years

FDA is requiring a boxed warning for Danyelza, noting that it has been shown to cause serious infusion reactions including anaphylaxis, cardiac arrest, bronchospasm, stridor, and hypotension. In addition, the medicine can cause severe pain and hypertension.

The agency’s approval is supported by clinical evidence from 2 pivotal studies in patients with high-risk neuroblastoma with refractory or relapsed disease. “Danyelza appears to be well tolerated with few discontinuations of treatment in the clinical trials and adverse events were clinically manageable,” YmAbs said.

Blockbuster Keytruda earns new breast cancer indication

The monoclonal antibody medicine treats neuroblastoma in the bone and bone marrow.

Moderna’s experimental COVID-19 vaccine is “highly effective”, FDA said, which will likely lead to an official Emergency Use Authorization (EUA) approval by the agency very soon.

In addition, the Department of Health and Human Services (HHS) and the Department of Defense (DoD) will purchase an additional 100 million doses of Moderna’s mRNA-1273 vaccine, HHS said in a 

Pfizer COVID-19 vaccine results positive, but questions remain

“If authorized by the FDA for emergency use as outlined in agency guidance, doses of the vaccine will begin shipping immediately. The vaccine would be provided at no cost to Americans,” HHS said.

 EUA to Pfizer-BioNTech’s COVID-19 vaccine on December 11, and the vaccine has already been administered to some healthcare professionals.

 on Moderna’s 30,000-person clinical study along with the agency’s own analysismahead of its advisory committee review of the vaccine candidate on Thursday.

FDA grants emergency use for COVID-19 treatment

Moderna found that the vaccine was 94.1% effective in protecting people against COVID-19, and new documents suggest that the vaccine begins to prevent asymptotic infections after the first dose. After the first dose, there were about two-thirds fewer cases of asymptomatic coronavirus infections among those who received the vaccine than among those who received a placebo, 

In addition, the research suggested benefit of the vaccine in preventing severe COVID-19.

The FDA found no specific safety concerns that would preclude its authorization of the vaccine, 

 reported. Severe adverse reactions were rare but occurred more frequently after the second dose of the vaccine than after the first dose.

FDA clears Regeneron’s COVID-19 monoclonal antibody treatment and a home test

FDA deemed Moderna’s vaccine candidate “highly effective,” so the agency  may grant an emergency use authorization later this week. 

Moderna COVID-19 vaccine approval expected soon

After positive Phase 3 trial results, Karyopharm Therapeutics expects FDA to clear its Xpovio to treat multiple myeloma.

The pharma maker evaluated once weekly Xpovio, its oral Selective Inhibitor of Nuclear Export (SINE) compound, in combination with 

bortezomib (Velcade) and low-dose dexamethasone against standard twice weekly Velcade in adult patients with multiple myeloma who had received 1 to 3 prior lines of therapy.

New subcutaneous multiple myeloma treatment available

, demonstrate that the once-weekly regimen of Xpovio and Velcade, with low-dose dexamethasone (SVd) reduced the risk of disease progression or death by 30% and induced a higher rate of overall and deep responses compared to patients receiving a standard twice-weekly Velcade and low-dose dexamethasone regimen (Vd), Karyopharm said in a 

Xpovio received accelerated FDA approval last year for patients with penta-refractory multiple myeloma, and its supplemental New Drug Application for Xpovio as a treatment for patients with multiple myeloma who have received one prior line of therapy has been accepted by the agency. It is assigned a PDUFA action date of March 19, 2021.

“We are working closely with the regulatory authorities in both the U.S. and Europe to make this potential new treatment option, with a completely novel mechanism of action, available to patients as quickly as possible, if approved,” said Sharon Shacham, PhD, president and chief scientific officer of Karyopharm.

New Multiple Myeloma Treatment Works By Targeting Cells

The trial results were achieved despite the use of approximately 40% less Velcade, 25% less dexamethasone, and around 35% fewer clinic visits on the SVd arm as compared with the standard Vd therapy arm, Karyopharm said.

“Encouragingly, the efficacy of the SVd regimen was consistent and noteworthy across several key subgroups, including patients who were frail or 65 years and older, patients with high-risk cytogenetics, patients with moderate renal impairment and patients who had either prior bortezomib or lenalidomide treatment," said Paul Richardson, MD, co-author of the Lancet article and clinical program leader and director of Clinical Research at the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute.

After positive Phase 3 trial results, Karyopharm Therapeutics expects FDA to clear Xpovio.

Pharma maker expects myeloma drug approval after positive results

FDA authorized the first diagnostic test for at-home collection of patient samples to detect both COVID-19 and influenza A and B.

Quest Diagnostics’s RC COVID-19 +Flu RT-PCR Test is available via prescription with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu, FDA said in a 

The test is for patients who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by their healthcare provider. With the prescription, patients can collect a sample at home and ship it to a Quest Diagnostics lab for analysis.

“Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans” said FDA Commissioner Stephen M. Hahn, MD.

“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

FDA also recently granted an EUA for the 

first COVID-19 diagnostic test for self-testing at home

 and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit (Lucira Health) is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, the agency said in a 

As of December 1, 295 COVID-19 tests are authorized by FDA under Emergency Use Authorization (EUA). These include 227 molecular tests, 61 antibody tests, and 7 antigen tests.

U.S. government, AstraZeneca team up on COVID-19 preventative med

The test is for patients to use at home, with a prescription, to detect both COVID-19 and influenza A and B. 

FDA okays first combo COVID-19 and flu test

FDA approved the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

The University of California, Los Angeles and the University of California, San Francisco garnered FDA’s okay for Gallium 68 PSMA-11 (Ga 68 PSMA-11), a radioactive diagnostic agent administered via intravenous injection.

“Ga 68 PSMA-11 is an important tool that can aid healthcare providers in assessing prostate cancer,” said Alex Gorovets, MD, acting deputy director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research, in a 

. “With this first approval of a PSMA-targeted PET imaging drug for men with prostate cancer, providers now have a new imaging approach to detect whether or not the cancer has spread to other parts of the body.”

Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. The imaging drug is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels.

While computed tomography (CT) scans, magnetic resonance imaging (MRI) scans and bone scans are conventional methods commonly used to image patients with prostate cancer, they are limited in detection of prostate cancer lesions, according to FDA.

F 18 fluciclovine and C 11 choline are two other PET drugs that are approved for prostate cancer imaging. “However, they are only approved for use in patients with suspected cancer recurrence,” FDA said.

The safety and efficacy of Ga 68 PSMA-11 were evaluated in 2 prospective clinical trials with a total of 960 men with prostate cancer who each received one injection of Ga 68 PSMA-11.

No serious adverse reactions were attributed to Ga 68 PSMA-11. However, there is a risk for misdiagnosis, FDA said, because Ga 68 PSMA-11 binding may occur in other types of cancer as well as certain non-malignant processes which may lead to image interpretation errors.

FDA okayed the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer.

FDA cleared the first treatment for rare genetic diseases of obesity.

The agency approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) injection for chronic weight management in adults and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.

Pharma maker pulls weight loss drug over FDA concerns

“With Imcivree, we are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the melanocortin-4 (MC4) receptor pathway.” said David Meeker, MD, chair, president and CEO of Rhythm, in a 

Rhythm expects the treatment to available in the first quarter of 2021.

Obesity due to POMC, PCSK1 or LEPR deficiency are ultra-rare diseases caused by variants in 

 genes that impair the MC4 receptor pathway — a pathway in the hypothalamus that is responsible for regulating hunger, energy expenditure and consequently body weight, Rhythm explained.

“Many patients and families who live with these diseases face an often burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, ND, pediatric endocrinologist at University of Florida Health.

“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” Miller added.

The FDA approval is based on Phase 3 clinical trials in which 80% of patients with obesity due to POMC or PCSK1 deficiency achieved greater than 10% weight loss. In addition, 45.5% of patients with obesity due to LEPR deficiency achieved greater than 10% weight loss after one year of treatment with Imcivree.

The drug is the first FDA-approved therapy for these rare genetic diseases.

FDA clears treatment for rare obesity diseases

FDA expanded the approved indication for baloxavir marboxil (Xofluza, Genentech) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu.

In addition, the drug, previously available only in tablet form, is now available as granules for mixing in water, FDA said in a 

Gottlieb optimistic about COVID-19 end after positive Moderna vaccine results

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Americans will have to be more vigilant than ever as these viruses spread concurrently.”

 in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

Pfizer: COVID-19 vaccine likely ready late November

Xofluza’s safety and efficacy for post-flu exposure prevention is supported by one randomized, double-blind, controlled trial.

The trial included around 600 subjects who were exposed to a person with influenza in their household. The trial’s primary endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from day 1 to day 10. Of those who received Xofluza, 1% of subjects met these criteria compared with 13% of those in the placebo group.

FDA approves game-changing influenza drug

FDA official says the approval is important because of the combination of the flu season and the COVID-19 pandemic.

Xofluza, flu drug, snags new indication

FDA has cleared the monoclonal antibody treatment for COVID-19 that President Donald Trump was treated with in October. The agency also gave the go-ahead late last week to the first home self-test for the pandemic disease.

The agency issued an emergency use authorization (EUA) for casirivimab and imdevimab (Regeneron) to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kg.) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

Earlier this month, FDA issued an EUA for the another monoclonal antibody therapy, bamlanivimab (Eli Lilly and Company), to treat mild-to-moderate COVID-19 in adult and pediatric patients.

“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our healthcare system,” said FDA Commissioner Stephen M. Hahn, M.D., in a 

. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together via IV infusion, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared with placebo.

However, FDA said that the combination therapy is not authorized for patients who are hospitalized with COVID-19 who require oxygen therapy because of the disease; in fact, the agency said the treatment might worsen the condition of such patients.

“A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” FDA said.

FDA also granted an EUA for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit (Lucira Health) is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, the agency said in a 

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn said.

The Lucira COVID-19 All-In-One Test Kit test, available by prescription only, is authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their healthcare provider.

It is also authorized for use in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages. However, samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old.

Regeneron's investigational treatment was administered to President Donald Trump in October when he was treated for COVID-19.

 FDA clears Regeneron's COVID-19 monoclonal antibody treatment and a home test

The COVID-19 pandemic could “effectively” be ended in 2021, said Scott Gottlieb, MD, former FDA commissioner, after Moderna announced very positive results from its vaccine trial.

 that its Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has an efficacy of 94.5%. Its COVE study enrolled more than 30,000 participants in the U.S.

Pfizer and BioNTech’s first interim analysis also found that their vaccine candidate, BNT162b2, 

 against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.

Pfizer expects the FDA to grant emergency approval for the vaccine later this month.

"If these full data sets hold, when the full data comes out, we may have two highly effective vaccines against Covid," Gottlieb, a board member of Pfizer, said on CNBC’s “Squawk Box."​ 

"Once we get these vaccines in sufficient qualities heading in 2021, the combination of the fact that a lot of the population will have already had COVID, combined with the fact that we'll be vaccinating the public with a highly effective vaccine, we could effectively end this pandemic in 2021 with our technology," Gottlieb said.

Michael Breen, Ph.D., director of infectious diseases and ophthalmology at GlobalData, praised the efficacy date for both Moderna and Pfizer’s vaccine candidates.

“While the efficacy of Moderna’s offering is slightly higher than that reported for Pfizer/BioNTech’s candidate, the more pressing point is the fact that these vaccines achieved this outcome at all. One candidate seeing significantly more impressive results than the FDA’s usual bar was great news, but two is unprecedented,” Breen said in a press release.

One key difference between the vaccines is that Moderna’s vaccine does not require deep-freeze storage, while Pfizer’s does, Breen said. “This creates significant logistical difficulties that could easily give the advantage for COVID-19 vaccines to Moderna.”

“More data are needed for both vaccines that might highlight differences between them and inform how each should be used. It is entirely possible that both vaccines have similar efficacies across all groups, in which case they should both be rolled out as rapidly as possible,” Breen added.

FDA approved a new indication for Merck’s blockbuster cancer drug, pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).

Sales of Keytruda, approved to treat several different types of cancer including non-small-cell lung cancer, soared 21%, to $3.7 billion, in the third quarter of 2020.

Merck’s Keytruda snags another cancer indication

“Today’s approval is a significant milestone, as it represents the first approval for Keytruda in the breast cancer setting,” said Roy Baynes, M.D., senior vice president and head of global clinical development, chief medical officer of Merck Research Laboratories, in a 

In the phase 3 trial supporting the approval, Keytruda in combination with paclitaxel, nab-paclitaxel or gemcitabine and carboplatin, significantly improved progression-free survival for patients with advanced triple-negative breast cancer whose tumors express PD-L1 with combined positive score (CPS) greater than or equal to 10 compared with the same chemotherapy regimens alone, Baynes added.

Keytruda, in combination with the chemotherapy agents, reduced the risk of disease progression or death by 35% for patients whose tumors express PD-L1 versus the same chemotherapy regimens alone

The multicenter, double-blind, randomized, placebo-controlled trial included 847 patients with locally recurrent unresectable or metastatic TNBC, regardless of tumor PD-L1 expression, who had not been previously treated with chemotherapy in the metastatic setting.

FDA granted accelerated approval for the indication based on progression-free survival (PFS), so continued approval for that indication may be contingent upon verification and description of clinical benefit in the confirmatory trials, Merck said.

“Approximately 15 to 20% of patients with breast cancer are diagnosed with triple-negative breast cancer, which is a difficult-to-treat and aggressive cancer,” said Dr. Hope Rugo, director of Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center. “The approval of Keytruda in combination with chemotherapy gives physicians an important new option for appropriate patients.”

Merck earned a new indication for pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).


FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab (Eli Lilly and Company) to treat mild-to-moderate COVID-19 in adult and pediatric patients.

Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 88 pounds and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

“This includes those who are 65 years of age or older, or who have certain chronic medical conditions,” FDA said in a 

Trump Fauci spar over U.S. coronavirus response

"This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients — adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," said David A. Ricks, Lilly's chairman and CEO, in a 

Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, which will distribute it as directed by the U.S. government's allocation program.

The EUA is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization, FDA said.

“While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” FDA said.

"The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," said Daniel Skovronsky, MD, PhD, chief scientific officer for Lilly and president of Lilly Research Laboratories.

The frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. Infusion reactions and other allergic hypersensitivity events have been reported, and the EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.

Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. “Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” FDA said.

The investigational monoclonal antibody therapy bamlanivimab treats mild-to-moderate COVID-19 in adult and pediatric patients.