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 COVID-19 vaccine results positive, but questions remain

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.

Pfizer: COVID-19 vaccine likely ready late November

“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.

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

Articles

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

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

FDA okays novel breast, colorectal cancer treatments

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).


Blockbuster Keytruda earns new breast cancer indication

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 EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers.

For information regarding access to bamlanivimab, patients should speak with their health care providers, and health care providers should contact their state health department directly, Lilly said.

 FDA expands emergency use authorization for remdesevir to include all hospitalized COVID-19 patients

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

FDA grants emergency use for COVID-19 treatment

While Pfizer and BioNTech’s first interim analysis demonstrates the efficacy of their SARS-CoV-2 vaccine candidate, some questions remain.

The vaccine candidate, BNT162b2, demonstrated a 90% efficacy rate against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted by an external, independent Data Monitoring Committee (DMC), the pharmaceutical manufacturers said in a 


“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” said Albert Bourla, MD, Pfizer Chairman and CEO. “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

In addition, the DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned, Pfizer and BioNTech said.

While Pfizer and BioNTech’s vaccine candidate has “greatly exceeded the efficacy bar of 50% [for seasonal influenza vaccines] set by the FDA, several questions remain, said Philipp Rosenbaum, PhD, Senior Infectious Diseases Analyst at GlobalData, in a press release. 

“The efficacy percentage could still decrease in the final analysis, and important questions about how well the vaccine can prevent severe cases of COVID-19, its effect on carriage and transmission of the virus, and the long-term protection will take many more months to be answered,” Rosenbaum said.

In addition, with 50 million doses available by the end of the year and 1.3 billion in 2021, “concerns about the supply and distribution of COVID-19 vaccines, especially for mRNA vaccine such as Pfizer’s that require deep-freeze storage and have a rather short shelf-life at refrigerator temperatures, will only add barriers,” he added.

“Saying that, the speed of which this efficacy announcement has been made — a mere seven months after the companies started their first Phase I study — has been really quite impressive,” Rosenbaum said.

Dozens of other companies are also developing COVID-19 vaccines, and Phase 3 data from Moderna, AstraZeneca, and Johnson & Johnson, are expected soon, Rosenbaum added.

“Many manufacturing and supply deals have been made, and most of the companies already started manufacturing ahead of Phase III results. Having multiple vaccines available with even slightly lower efficacy would be immeasurably beneficial for controlling the outbreak, giving runway to ramping up manufacturing and bolstering of distribution channels for more effective vaccines,” Rosenbaum said.

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

Several months after the first metformin recall, Nostrum Laboratories this week said it is voluntarily recalling two lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level.

"The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day,” the company said in a 

The metformin — indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus — is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.

, when FDA found elevated NDMA levels in products from five different manufacturers.

At the time, Apotex Corp recalled all lots of its metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to the retail level.

Similarly, Amneal recalled all lots of metformin hydrochloride extended-release tablets, USP, 500 mg and 750 mg, within expiry to the retail levels. The affected products were distributed nationwide in the US directly to wholesalers, distributors, retailers, and repackagers.

Sun Pharma recalls 1 lot of metformin due to NDMA levels

 one lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL to the consumer level due to a higher than allowed level of NDMA.

NDMA is a probable human carcinogen and a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables, Nostrum said.

However, Nostrum has not received reports of adverse events related to the recall.

, including details about metformin products that have been recalled.

Two metformin products recalled, more on the way

Recalls of metformin products due to higher levels of the probable carcinogenic ingredient N-Nitrosodimethylamine (NDMA) than allowed continue.

Metformin recalls continue

President Donald Trump joked about potentially firing National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci after the election, as Fauci criticized the United States’ handling of coronavirus pandemic.

Fauci said the U.S. needs to make an “abrupt change” in public health practices and behaviors and is “in for a whole lot of hurt” heading into the winter season, 

The U.S. set a new daily coronavirus case record October 30, peaking at 98,859. The country could surpass 100,000 new cases a day and the death rate will also likely increase, according to Fauci.

Deaths from COVID-19 have surpassed 230,000 since the start of the pandemic.

However, leading up to the election, Trump has downplayed the pandemic and has praised his Administration’s response to it. “You live with [the coronavirus], and you know what to do — we understand it now, you’ve got to understand it. But we’re making that beautiful turn, and the vaccines are coming,” the president said at a rally recently, 

At a rally in Florida last week, when the crowd chanted, “Fire Fauci, Fire Fauci,” Trump responded, “Don’t tell anybody, but let me wait until a little bit after the election. I appreciate the advice,” 

Trump, Fauci disagree on the effectiveness of hydroxychloroquine

Meanwhile, Fauci warned Americans about the pandemic worsening.

“We’re in for a whole lot of hurt. All the stars are aligned in the wrong place as you go into the fall and winter season, with people congregating at home indoors,” he said in an interview 

 reported. “You could not possibly be positioned more poorly.”

Fauci also said the White House coronavirus task force meets less frequently and has far less influence as the president and his top advisers have focused on reopening the country. “Right now, the public health aspect of the task force has diminished greatly,” he said.

Fauci added he has not spoken to Trump since early October. “The last time I spoke to the president was not about any policy; it was when he was recovering in Walter Reed, he called me up,” he said.

Trump jokes about potentially firing NIAID Director Anthony S. Fauci.

Trump, Fauci spar over U.S. coronavirus response

TG Therapeutics was granted FDA Fast Track Designation for its investigational treatment for chronic lymphocytic leukemia (CLL).

The treatment is a combination of ublituximab, its investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon.

FDA grants full approval for combination leukemia treatment

The application for Fast Track was based on data from the UNITY-CLL Phase 3 study that TG announced earlier this year had met its primary endpoint of progression free survival.

"We are extremely pleased to have received Fast Track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL,” said Michael S. Weiss, executive chairman and CEO of TG Therapeutics, in a press release.

“This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL.” Weiss said.

 FDA approves new indication for leukemia drug

UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the U2 combination to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL).

The trial enrolled approximately 60% treatment-naïve CLL patients and 40% relapsed or refractory CLL patients.

 (Venclexta, Genentech) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC)to treat acute myeloid leukemia (AML).

Venclexta, specifically designated to treat newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy, was previously granted provisional approval under FDA’s accelerated approval program in late 2018.

FDA fast tracks investigational leukemia treatment 

After the FDA granted the first Investigational New Drug Application (IND) for a gummy medication, will more medicines be delivered via gummies in the future?

Seattle Gummy Company received the IND for its allergy gummy medication, IND 140312. The company’s gummy drug program delivers Active Pharmaceutical Ingredients (APIs) into a novel gummy matrix, “thus solving drug solubility, stability, and taste issues,” Seattle Gummy Company said in a 

FDA clears first treatment for mesothelioma in 16 years

With its initial focus on the most common OTC drugs, the company currently has several gummy drugs under review with the FDA.

Seattle Gummy Company’s gummy medication development program, which began three years ago, was inspired by the popularity of gummy vitamins, which are increasingly taken by both children and adults.

In fact, the global gummy vitamins market is valued at an estimated $5.9 billion in 2020 and is projected to reach $10.6 billion by 2025, MarketsandMarkets said in a 

“The increasing prevalence of vitamin deficiencies and undernourishment, along with growing demand and awareness for on-the-go supplements, supporting better health among consumers, is driving the majority growth of the global gummy vitamins market,” MarketsandMarkets said. “Apart from that, the hike in need for immunity boosting or supporting products, as a preventive healthcare measure, is further rocketing the growth of the gummy vitamins market.

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"I was so frustrated forcing these yucky and sticky syrup medicines into my son when he was sick. I kept telling myself that there has to be a better way of giving kids medications," said Dr. Connie Wan, founder and CEO of Seattle Gummy Company. “Then, when I saw a bottle of gummy vitamins in Costco, a light bulb went off.”

The manufacturer has a large pipeline of gummy drugs in development, from allergy and pain relief medications to fever reducers and cough suppressants, according to Wan.

“We are focusing on the pediatric and geriatric market. Did you know one-third of the senior population can't swallow tablets, and that medication non-adherence is the biggest problem in medicine? We are here to solve these problems.”

SGC formulates each medication into both regular and sugar-free versions and manufactures several dosage strengths of each medication.

Medical company secures Investigational New Drug Application from FDA for its gummy medication.

Is medicine delivered via gummies the future?

FDA granted full approval of venetoclax (Venclexta, Genentech) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC)to treat acute myeloid leukemia (AML).

“Today’s full approval is supported by the significant results that showed that Venclexta in combination with azacitidine extended overall survival for people with newly diagnosed acute myeloid leukemia who cannot tolerate intensive induction chemotherapy,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development for at Genentech, in a 

“We are very pleased that this application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this treatment option more rapidly to patients in the United States and other countries,” Garraway added.

The approval is primarily based on the results of two Phase 3 studies. Results of the VIALE-A study showed Venclexta plus azacitidine significantly reduced the risk of death by 34% compared to azacitidine alone (the median overall survival was 14.7 months vs. 9.6 months).

In addition, patients receiving Venclexta plus azacitidine had significantly higher rates of complete remission (CR) with 37% compared to 18% in people treated with azacitidine alone.

“Based on the results of this study, this treatment regimen represents a significant advance for older AML patients, including higher response rates, greater transfusion independence, longer durations of remission, and ultimately significantly improved overall survival compared to azacitidine alone,” said Courtney DiNardo, Md, associate professor of the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.

The National Comprehensive Cancer Network (NCCN) guidelines recently recommended Venclexta plus azacitidine as a Category 1 Preferred AML treatment regimen for patients ineligible for intensive chemotherapy, Genentech said.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and commercialized by AbbVie outside of the country.

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Venclexta was previously granted provisional approval by FDA in late 2018.

While President Donald Trump was optimistic that a COVID-19 vaccine would be ready prior to the presidential election, Pfizer says its vaccine candidate with partner BioNTech will likely be ready in late November.

“In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine,” wrote Pfizer Chairman and CEO Albert Bourla in an 

. “Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. “

Pfizer will apply for EUA soon after the safety milestone is achieved in the third week of November, Bourla wrote.

“All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency,” he wrote.

Meanwhile, Moderna's COVID-19 vaccine could receive FDA EUA in December, if the company obtains positive interim results in November, 

If positive interim results from a large clinical trial take longer to get, the EUA may not occur until early next year, Chief Executive Stéphane Bancel said during 

U.S. gov’t, Abbott team up to produce millions of rapid COVID-19 tests

In addition, Pfizer received FDA approval to enroll children as young as 12 years old in its COVID-19 vaccine trial, NPR 

Until now, children under 16 have not been included in any COVID-19 vaccine trials in the U.S., NPR said.

Meanwhile, Bourla explained that Pfizer and BioNTech may know wether their vaccine is safe and effective by the end of October. “To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates,” he noted.

The pharma maker plans to apply for FDA Emergency Use Authorization for the vaccine after the third week of November.

The United States government and AstraZeneca are teaming up to develop and produce the pharma maker’s preventive COVID-19 treatment.

U.S. Department of Health and Human Services (HHS) and the Department of Defense is partnering with AstraZeneca for late-stage development and large-scale manufacturing of the pharma maker’s COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies that may help treat or prevent infection with SARS-CoV-2, HHS said in a 

FDA expands emergency use authorization for remdesevir to include all hospitalized COVID-19 patients

“An effective monoclonal antibody that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups,” HHS said. “This includes people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine.”

Notably, If FDA authorizes use of AZD7442 for prevention of SARS-CoV-2, the federal government will distribute the doses at no cost. Howerver, “as is customary with government-purchased medical products, healthcare professionals could charge for the cost of administering the product,” HHS said.

The Biomedical Advanced Research and Development Authority (

), part of the HHS Office of the Assistant Secretary for Preparedness and Response, and the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command will provide around $486 million to AstraZeneca for clinical trials and related development activities, including a large-scale manufacturing demonstration project and supply of AZD7442 doses in the U.S.

AstraZeneca estimates 100,000 doses of AZD 7442 could be available for the high-risk population that may not benefit from a vaccine by December 2020.

"In addition to Operation Warp Speed's historic progress on vaccines, we are supporting promising monoclonal antibodies for prevention and treatment all the way through to supply, allowing faster distribution if trials are successful," said HHS Secretary Alex Azar.

One of the Phase 3 clinical trials of AZD7442 will evaluate safety and efficacy of the product to prevent infection for up to 12 months in approximately 5,000 volunteers. An additional Phase 3 clinical study will evaluate if AZD7442 can help prevent infection in people who have come in contact with someone with COVID-19 in a post-exposure prophylaxis setting.

The pharma maker aims to make the treatment available to the most vulnerable populations by December.

US government, AstraZeneca team up on COVID-19 preventative med

FDA expanded the indication for the rheumatoid arthritis (RA) medication golimumab (Simponi Aria, Janssen) to treat patients 2 years and older with active polyarticular juvenile Idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).

Simponi Aria is already approved Ito treat adults with moderately to severely active RA, active PsA, and active ankylosing spondylitis (AS).

Another RA drug starts testing to treat COVID-19

“This latest FDA approval of Simponi Aria for pediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development at Johnson & Johnson, in a 

“For far too long, children with pJIA or PsA have had limited treatment options,” said Seth D. Ginsberg, co-founder and president of the Global Healthy Living Foundation and CreakyJoints. “This approval represents an important step forward for these children and their families.”

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The approval was based on results from the GO-VIVA Phase 3 clinical trial, an open-label study in children with JIA with active polyarthritis. The children, ages 2 to 17 years old, had active arthritis in five or more joints despite receiving treatment with methotrexate for at least 2 months.

Trial results demonstrated that Simponi Aria was generally consistent with responses in adult patients with RA.

Simponi Aria is a fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of human TNFalpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation.

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Simponi Aria is now approved to to treat patients 2 years and older with active polyarticular juvenile Idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).

FDA cleared the first treatment for mesothelioma in 16 years: nivolumab (Opdivo) in combination with ipilimumab (Yervoy).

The Bristol-Myers Squibb medication is for adults with malignant pleural mesothelioma that cannot be removed by surgery.

The approval “provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” said Richard Pazdur, MD, director of the 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, in a 

Malignant pleural mesothelioma is a rare cancer with limited treatment options, said study investigator Anne S. Tsao, MD, professor, section chief of Thoracic Medical Oncology, and director of the Mesothelioma Program at The University of Texas M.D. Anderson Cancer Center, in a Bristol-Myers Squibb 

“When it is diagnosed in advanced stages, the five-year survival rate is approximately 10%. The survival results from the CheckMate-743 trial show that the combination of nivolumab and ipilimumab could become a new front-line standard of care option.”

This is the third indication for an Opdivo plus Yervoy combination in the first-line treatment of a form of thoracic cancer.

The combination is also approved by FDA as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) and in combination with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations regardless of PD-L1 expression.

Opdivo plus Yevoy was evaluated during a randomized, open-label trial in 605 patients with previously untreated unresectable MPM. Patients who received the combination treatment survived a median of 18.1 months, while patients who underwent chemotherapy survived a median of 14.1 months.

At two years, 41% of patients treated with Opdivo and Yervoy were alive, compared to 27% with chemotherapy.

Pharma maker seeks fast approval of lymphoma treatment

The combination therapy of Opdivo plus Yervoy will treat the cancer caused by inhaling asbestos fibers.



A pharma maker is expanding its earlier recall of metformin due to a higher content of the carcinogenic ingredient N-Nitrosodimethylamine (NDMA) than is allowed.

Marksans Pharma Limited in India is voluntarily expanding its earlier initiated recall in June to include an additional 76 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg. and 750 mg. to the consumer level.

“Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96 ng/day. Therefore, out of an abundance of caution, an additional 76 lots are being recalled,” the pharma maker said in a 

 in recent months due to the presence of NDMA. FDA said in a 

 in June that its testing found “certain extended release metformin products contain NDMA above the acceptable level.”

 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg. per 5 mL to the consumer level.

Another pharma maker recalls metformin over NDMA

In the Marksans recall, the recalled metformin was distributed by Time-Cap Labs in New York, nationwide to wholesalers that further distributed the medication to pharmacies.

Marksans is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement of recalled product lots.

The recall is attributed to higher levels of the carcinogenic ingredient NDMA than are allowed.

Metformin recalls expand

Pfizer snagged its fourth indication for the blockbuster medication tofacitinib (Xeljanz) for children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).

Xeljanz is already approved to treat adults with moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, adults with active psoriatic arthritis (PsA) after disease modifying 

 drug (DMARD) failure, and adults with moderately to severely active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure.

Now, Xeljanz is the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA, Pfizer said in a press release.

The FDA approved 2 formulations of the medication: a tablet and an oral solution, which Pfizer expects be available by the end of the first quarter of 2021. However, the 5 mg. tablets are available immediately.

“Polyarticular course juvenile idiopathic arthritis, or pcJIA, is debilitating as it can cause significant joint pain and limit participation in child appropriate activities,” said Dr. Hermine Brunner, director of the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center and scientific director of the Pediatric Rheumatology Collaborative Study Group.

“Although there are already several advanced treatments available, tofacitinib will be an appealing new option given it does not require injections or infusions. These can be quite burdensome to both children with pcJIA and their caretakers,” Brunner said.

Pfizer snags fourth indication for blockbuster Xeljanz

The FDA is requiring an update to the Boxed Warning on all benzodiazepines and new labeling that includes the medications’ risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions.

“Benzodiazepines can be an important treatment option for treating disorders for which these drugs are indicated. However, even when taken at recommended dosages, their use can lead to misuse, abuse, and addiction,” FDA said in its 

Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs, FDA added.

FDA is also warning that physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. “Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening,” the agency said.

In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies. Alprazolam (Xanax) was the most commonly prescribed in the class at 38%, followed by clonazepam (Klonopin) at 24%, and lorazepam (Ativan) at 20%.

“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence,” said FDA Commissioner Stephen M. Hahn, MD, in a 

In addition to requiring an update to the Boxed Warning, the FDA is requiring other changes to the Warnings and Precautions, Drug Abuse and Dependence and Patient Counseling Information sections of the prescribing information for all benzodiazepine products.

The agency is also requiring revisions to the existing patient Medication Guides for these medicines to help educate patients and caregivers about the risks.

FDA issues warning for certain hepatitis C drugs

Xanax and Ativan are among the medications impacted by FDA’s new requirements.

FDA requires new boxed warning on benzodiazepines

Sun Pharmaceuticals announced it is voluntarily recalling 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL to the consumer level, according to a company statement.

The recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake limit established by the FDA.

When reconstituted, metformin hydrochloride for ER oral suspension is packaged in a 16 oz (473 mL) round bottle. Each carton contains 1 bottle of drug pellets, 1 bottle of diluent, and 1 dosing up. The products can be identified by the bottles or carton labeled with the lot number AB06381, with an expiration date of October 2021.

Sun Pharmaceuticals is notifying its distributors and customers through its third-party Recall Coordinator, via FedEx standard overnight shipping, and will arrange for return of all recalled products.

Patients taking metformin hydrochloride for ER oral suspension, 500 mg per 5 mL, are advised to continue taking their medication and contact their pharmacist, physician, or medial provider for advice regarding an alternative treatment.

 including details about metformin products that have been recalled. According to the FDA, its testing has not shown NDMA in immediate-release metformin products.

Sun Pharmaceuticals issued a voluntary recall of 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL.
