FDA recently okayed a first-in-class treatment for HIV-1: fostemsavir (Rukobia, ViiV Healthcare).

Rukobia, available in 600 mg extended-release tablets, is a novel attachment inhibitor for the treatment of HIV-1 infection for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations, ViiV said in a 

Gilead snags approval for second HIV-1 prevention drug

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” said Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, in a separate FDA 

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection—helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives,” Murray added.

While significant advances over the past few decades have dramatically improved HIV treatment and for many, HTE adults — which account for approximately 6% of adults living with HIV who are on treatment — have little to no options left due to resistance, tolerability or safety considerations, ViiV said.

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS,” said Deborah Waterhouse, CEO of ViiV Healthcare. “The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind.”

The approval was supported by data from the phase 3 BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimized background therapy (OBT) in HTE adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry.

In the randomized cohort, 60% of individuals who received Rukobia in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through Week 96.

Rukobia was approved under the FDA’s Fast Track and Breakthrough Therapy Designations.

Articles

Drug helps with heavily-treatment experienced (HTE) adults with multidrug-resistant HIV-1 infection.

FDA clears first-in-class HIV-1 treatment

 that the US government supply of remdesivir for hospitalized COVID-19 patients could run out by the end of June, that is not the case.

The Department of Health and Human Services agreed to secure large supplies of the drug from Gilead Sciences through September, allowing American hospitals to purchase remdesivir in amounts allocated by HHS and state health departments.

“To the extent possible, we want to ensure that any American patient who needs remdesivir can get it. The Trump Administration is doing everything in our power to learn more about life-saving therapeutics for COVID-19 and secure access to these options for the American people,” HHS Secretary Alex Azar said in a 

HHS has secured more than 500,000 treatment courses of the drug for American hospitals through September.

FDA pulls hydroxychloroquine for COVID-19, warns about other drug interaction

Hospitals will pay no more than Gilead’s Wholesale Acquisition Price (WAC) — approximately $3,200 per treatment course, HHS said.

However, remdesivir could be priced up to $5,080 per course based on benefits shown in COVID-19 patients, the Institute for Clinical and Economic Review (ICER) said in a 

HHS allocates product to state and territorial health departments based on COVID-19 hospital burden, and health departments allocate it to hospitals. The delivery of the purchased remdesivir will be streamlined, going directly to the hospital, per the state’s allocation decision, rather than going first to the state health departments for subsequent delivery to hospitals, HHS said.

FDA: Fraudulent COVID-19 medical products abound

Price of the drug to treat hospitalized patients revealed.

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

In the past week, FDA cleared two novel cancer treatments — one for breast cancer and the other for colorectal cancer.

FDA cleared a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf (Phesgo, Genentech) for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body. Phesgo also treats adult patients with early HER2-positive breast cancer.

Pharma maker seeks fast approval of lymphoma treatment

“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an out-patient option for patients to receive trastuzumab and pertuzumab,” 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 

“As part of the FDA’s ongoing commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease,” Pazdur added. “At this critical time, we continue to expedite oncology product development. This application was approved about four months ahead of the FDA goal date.”

The FDA’s approval was based on the results of a non-inferiority study in patients with HER2-positive early breast cancer, which demonstrated Phesgo had comparable efficacy and safety as IV pertuzumab and IV trastuzumab, except for administration-related reactions, which were higher with Phesgo due to the subcutaneous route of administration.

Prescribing information for Phesgo includes a boxed warning to advise health care professionals and patients about the risk of potential heart failure, fetal harm and lung toxicity. Health care professionals should use similar monitoring parameters as those used with IV pertuzumab and IV trastuzumab, FDA said.

FDA also approved pembrolizumab (Keytruda, Merck & Co.) for IV injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

“This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy,” FDA said in a 

“Metastatic colorectal cancer is a serious and life-threatening disease with a poor prognosis. Available current therapy with chemotherapy combinations and other biologics are associated with substantial toxicity. Having a non-chemotherapy option available for selected patients is a noteworthy paradigm shift in treatment,” Pazdur said.

FDA’s approval was based on the results of one multicenter, international, open-label, active-controlled, randomized trial that compared Keytruda with chemotherapy treatment in 307 patients with MSI-H or dMMR metastatic colorectal cancer. The study demonstrated a statistically significant improvement in progression-free survival (PFS): median PFS was 16.5 months in the Keytruda group and 8.2 months in the standard of care group, FDA said.

“Longer-term analysis is needed to assess for an effect on survival,” the agency added.

Colorectal cancer drug is the first immunotherapy administered as a first-line treatment and without chemotherapy.

FDA okays novel breast, colorectal cancer treatments

While there are numerous drugs in the pipeline, pharmacy benefit manager OptumRx singled out three top medications expected to have the most impact on payers on patients in the second half of 2020.

Pipeline Insights Report: 3 Drugs to Watch

, OptumRx highlights treatments for breast cancer, spinal muscular atrophy, and Duchenne muscular dystrophy. Here are the top 3 drugs to watch in the second half of this year:

1. Sacituzumab govitecan-hziy (Trodelvy, Immunomedics) was approved in late April to treat patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease.

TNBC is an aggressive breast cancer that accounts for up to 20% of all breast cancer cases.

Trodelvy is a novel antibody-drug conjugate (ADC), which combines both biologically engineered antibodies andtraditional chemotherapy drugs, OptumRx said. It is administered intravenously on a weekly basis over a 21-day cycle.

“Trodelvy is the first ADC targeted therapy for TNBC. There is a high unmet need for treatments in this subtype of breast cancer because of the size of the overall breast cancer population and the aggressive nature of TNBC,” OptumRx said.

In fact, analysts estimate that Trodelvy could reach $1.44 billion in global sales in 2024 global sales, initially as a third-line treatment for late-stage TNBC. The drug is also being evaluated in earlier settings and other cancers.

2. The investigational drug risdiplam (F. Hoffmann-La Roche, PTC Therapeutics, SMA Foundation) would be the first oral therapy to treat spinal muscular atrophy (SMA).

SMA is a rare group of severe neuromuscular disorders that leads to progressive muscle weakness and atrophy. It is the most common genetic cause of infant mortality and one of the most common rare diseases, affecting approximately one in 11,000 babies, OptumRx said.

Express Scripts report: Top drug classes driving spending growth

“There is an unmet need for treatments for SMA, and especially for an all-oral option. There are currently only two FDA- approved drugs for SMA,” OptumRx said.

Nusinersen (Spinraza, Biogen) requires repeated, invasive injections into the cerebrospinal fluid in the spinal cord. The other alternative isonasemnogene abeparvovec (Zolgensma, AveXis) which is a one-time IV-infused gene therapy.

FDA is expected to approve the medication on or before August 24, 2020, according to OptumRx.

“While Spinraza does require invasive spinal injections, it has been widely used in SMA patients since its market entry. Practically speaking, the competitive advantage for risdiplam will rest mainly in its oral route of administration, and perhaps, a lower cost,” OptumRx said.

3. Viltolarsen (Nippon Shinyaku) is in development to treat specific forms of Duchenne muscular dystrophy (DMD). DMD is a rare genetic disorder that affects young boys.

There is a significant unmet need for treatments for DMD since it is associated with substantial sickness and death,” OptumRx said.

If approved, viltolarsen would be the third exon-skipping drug for DMD, and the second specifically for the 8% of patients with a specific mutation.

Golodirsen (Vyondys 53TM, Sarepta Therapeutics) is also approved for the mutation, but there is limited efficacy data and unknown clinical benefit with its use, OptumRx said.

The FDA is expected to make a decision on whether or not to approve viltolarsen in the third quarter of this year.

Read more: 

These are the top 3 drugs recently approved — or soon to be approved by FDA — to watch in 2020.

Top 3 drugs to watch in second half 2020

TG Therapeutics completed the rolling submission of a New Drug Application (NDA) to FDA, requesting accelerated approval of umbralisib to treat certain types of lymphoma.

The investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon will treat patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).

FDA previously granted umbralisib breakthrough therapy designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

"The completion of this NDA submission marks an important milestone in bringing us one step closer to providing umbralisib as a potential treatment option for patients with relapsed/refractory MZL and FL,” said Michael S. Weiss, TG Therapeutics’ executive chairman and CEO in a 

TG Therapeutics is evaluating umbralisib in the UNITY-NHL trial , a multicenter, open-label Phase 2b trial.

In February 2019, the company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients. The results met the company’s target guidance of 40-50% ORR.

FDA clears novel generic thyroid cancer treatment

Investigational treatment will target marginal zone lymphoma (MZL) and follicular lymphoma (FL). 

 (EUA) for chloroquine phosphate and hydroxychloroquine sulfate in hospitalized COVID-19 patients, and warned about a potential drug interaction with the investigational antiviral drug remdesivir and hydroxychloroquine.

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” FDA said in a 

The FDA is also concerned about the “ongoing serious cardiac adverse events and other potential serious side effects,” it said. “The known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The FDA granted the EUA on March 28 based on the science and data available at the time. “Today, in consultation with the FDA, Biomedical Advanced Research and Development Authority (BARDA) sent a letter to the FDA requesting revocation of the EUA based on up to date science and data,” the agency said.

Since the EUA was granted, new data on heart risks associated with the medication have been revealed.

In addition, FDA said that recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery. “This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. The totality of scientific evidence currently available indicate a lack of benefit.”

Meanwhile, FDA also warned healthcare providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir, it said in a 

“The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” FDA said.

In addition, FDA revised the fact sheet for healthcare providers to clarify dosing and administration recommendations and to provide additional safety data and supporting data from clinical trials conducted by both the National Institutes of Health and the drug sponsor, Gilead Sciences.

 was also updated to include additional information about possible allergic reactions and to alert patients to tell their healthcare providers if they are taking chloroquine phosphate or hydroxychloroquine sulfate.


While the safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, preliminary clinical trial results have shown that, on average, patients treated with remdesivir had more rapid time to recovery, FDA said.

The agency revoked its emergency use authorization (EUA) for the drug, while warning about a dangerous interaction with remdesivir.

FDA cleared a unique pediatric HIV-1 medication in dispersible tablet formulation.

Dolutegravir (Tivicay PD, ViiV Healthcare) tablets for oral suspension are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients.

FDA expands hepatitis C treatment to children

“For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults,” said Debra Birnkrant, MD, director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research, in a 

. “While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV.”

Patients taking the drug must be treatment-naïve (or -experienced but INSTI- naïve), at least 4 weeks old, and weigh at least 3 kg. Viiv also received an extended indication to expand the use of the already approved Tivicay 50 mg film-coated tablet in paediatric HIV patients weighing 20 kg and above.

Tivicay is the first integrase inhibitor available as a dispersible tablet for oral suspension for children as young as 4 weeks of age and weighing at least 3 kg, Viiv said in a 

. Prior to this, dolutegravir was indicated in the US for children from 6 years of age and weighing more than 30 kg.

“This step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children,” ViiV said.

Gilead snags approval for second Hiv-1 prevention drug

“I am delighted that our innovative approach to science has enabled us to achieve FDA approval of the first-ever dispersible tablet formulation of dolutegravir, now making it easier for young children to take this medication by dispersing the tablet in water,” ViiV CEO Deborah Waterhouse said. "The development and availability of age-appropriate formulations is essential in ensuring children have access to life-saving HIV treatments from an early age and as they grow.”

There are 1.7 million children living with HIV1, and the majority of AIDS-related deaths among children still occur during the first 5 years of life, ViiV said. “Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals,” the pharma maker said.

The safety and effectiveness of Tivicay and Tivicay PD were supported by a trial that included 75 HIV-1–infected infants, children and adolescents 4 weeks to less than 18 years old. At 24 weeks, 62% of pediatric patients taking Tivicay or Tivicay PD had an undetectable viral load (the presence of virus in the blood) and at 48 weeks, 69% had an undetectable viral load, FDA said.

Also, on average, study subjects had higher levels of certain cells (CD4 cells) that help the body fight off infection.

The unique formulation is a dispersible tablet for children.

New pediatric HIV med available

Five pharma makers are recalling their extended-release metformin tablets due to high levels of the carcinogenic ingredient N-nitrosodimethylamine (NDMA).

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

Two metformin products recalled, more on the way

Soon after Apotex Corp and Amneal Pharmaceuticals 

 their metformin hydrochloride extended-release tablets, Teva Pharmaceuticals and Marksans Pharma Limited, India have issued recalls. The fifth manufacturer has not been named by the FDA.

 14 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, as well as 100 and 1000-count bottles.

More ranitidine recalled, plus another big drug recall

 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, lot #XP9004.

 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 repackaers.

Apotex Corp is recalling all lots of metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to retail level. However, Apotex stopped selling this product in the U.S. in February 2019, and there remains only a limited amount on the market, it said in a 

Pharma maker recalls drug over undeclared anti-hypertensive drug

Five pharma markers are recalling the diabetes medication due to the presence of a carcinogenic ingredient.

Major Metformin recalls underway

The U.S. government's current supply of remdesivir will run out at the end of this month, CNN 

The amount of people who need the medication outnumbered the supply by a 2-to-1 ratio, according to 

. Gilead Sciences and the Department of Health and Human Services distributed remdesivir for between 40,000 and 74,000 hospitalized patients.

The government’s last shipment of remdesivir will go out the week of June 29, Robert Kadlec, MD, assistant secretary for preparedness and response at HHS, told CNN.

"Right now, we're waiting to hear from Gilead what is their expected delivery availability of the drug as we go from June to July," Kadlec said. "We're kind of not in negotiations, but in discussions with Gilead as they project what the availability of their product will be,” Kadlec said.

"Whatever the supply may be, there may not be enough for everyone who may need it,” he added.

However, the government has been working to help Gilead "with some of their supply chain challenges in terms of raw materials and being able to accelerate the process,” Kadlec told CNN.

 to have more than 500,000 remdesivir treatment courses available by October, and more than a million by December.

COVID-19 vaccines could be ready this year, plus other top news

HHS says supply could run out by the end of this month.

Remdesivir for COVID-19 in short supply

FDA cleared imipenem-cilastatin and relebactam (Recarbrio, Merck)

to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. 

Recarbrio was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options. The drug is administered intravenously by a healthcare professional.

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

“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments,” said Sumathi Nambiar, MD, MPH, director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA’s Center for Drug Evaluation and Research. In a 

. “These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible.”

The safety and efficacy of Recarbrio for the treatment of HABP/VABP were evaluated in a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due gram-negative bacteria in which 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam (Tazocin, other brand names), another antibacterial drug. 

Overall, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam died through Day 28 of the study.

The most common adverse reactions observed in patients treated with Recarbrio for HABP/VABP included increased aspartate/alanine aminotransferases (increased liver enzymes), anemia, diarrhea, hypokalemia (low potassium) and hyponatremia (low sodium).

FDA clears generic asthma inhaler, inhaled corticosteroid

The agency welcomes another option for serious bacterial infections.

New antibiotic for hospital-acquired pneumonia available

FDA approved guselkumab (Tremfya, Janssen Pharmaceutical Companies) for adult patients with active psoriatic arthritis (PsA).

Tremfya is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA, Janssen said in a 

Rheumatoid arthritis drug poses fatal side effects

Tremfya is already approved to treat severe plaque arthritis.

“Tremfya is the first and only selective IL-23 inhibitor approved for both active psoriatic arthritis and moderate to severe plaque psoriasis, as well as the only biologic approved for the treatment of psoriatic arthritis to have improvement in fatigue…,” said David M. Lee, MD, PhD, therapeutic area head, Immunology, Janssen Research & Development, LLC.

“Psoriatic arthritis is a complex multi-faceted disease and, for many patients, additional biologic options are very much needed,” said Philip J. Measei, MD, DISCOVER-2 Lead Study Investigator and director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine in Seattle, WA.

The approval is "exciting for both patients and their physicians, as there is now a new approach available to help manage the symptoms of active psoriatic arthritis that patients face day to day,” Measei added.

 FDA switches 3 drugs from prescription to OTC use

The treatment is administered as a 100 mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4.

The safety and efficacy of Tremfya in PsA were demonstrated in two pivotal Phase 3 clinical trials. The results, recently published in 

, showed that a significant percentage of patients treated with Tremfya reached the studies’ primary endpoint of ACR20a at 24 weeks.

Fifty-two percent and 64% of patients achieved an ACR20 response compared to 22% and 33% in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.

Tremfya improved patients’ symptoms, which included skin manifestations of psoriasis, physical functioning, and soft tissue (enthesitis and dactylitis). It also resulted in improvement of fatigue, Janssen said.

Popular HIV-1 med successful, particularly in older adults

The drug is the first treatment approved for active psoriatic arthritis that selectively inhibits interleukin (IL)-23.

FDA clears novel psoriatic arthritis treatment

In a new lawsuit, the State of Ohio claims PBM Express Scripts overcharged the state millions of dollars for services it didn’t deliver.

, Ohio Attorney General Dave Yost said Express Scripts misclassified generic drugs as brand drugs in order to charge higher prices, failed to meet the pricing discount and dispensing fee guarantees, and overcharging for generic drugs by failing to timely adjust generic pricing lists to accurately reflect the lowest available pricing.

Physicians group wants PBM drug price transparenc

“This particular PBM egregiously charged for services it didn’t deliver. Its repeated breaches cost Ohioans millions, and we want our money back,” Yost said in a 

“It’s no secret that PBMs have been keeping secret their prescription pricing in order to evade public scrutiny and rake in revenue,” Yost added. “I intend to shed light on their business model and bring true transparency to the process — they need to answer the tough questions and repay what is owed.”

The complaint was filed on behalf of the Ohio Highway Patrol Retirement System (HPRS). In each year of its contract with HPRS except 2011-12, Express Scripts failed to satisfy the pricing guarantees in the then-applicable pricing schedule, thereby overcharging HPRS on thousands of claims, according to Yost.

The lawsuit alleges that “breaches were committed knowingly in bad faith and with the intent to deprive HPRS of the benefit of its bargain” and that “HPRS was regularly charged commercially unreasonable prices for generic drugs throughout the term of the agreement.”

Yost also filed a complaint against OptumRx last year, alleging that the PBM overcharged the Bureau of Workers’ Compensation $16 million. That case awaits a judge’s ruling on several key motions.

Express Scripts reveals Medicare savings plan for 2020

The PBM overcharged for generic drugs, among other offenses, a new lawsuit claims.

Express Scripts accused of overcharging millions of dollars

Sandoz will supply critical injectable generic medicines to hospitals to “help reduce supply shortages and ensure acute care settings can deliver optimal patient care,” the pharma maker said in a 

Sandoz entered into a five-year agreement with Civica Rx, a non-profit committed to making quality generic medicines available and affordable to its 1,200 hospital members.

Generic EpiPen for kids may help with shortage

Sandoz will supply six injectable medicines widely used at Civica’s U.S.member hospitals — currently in higher demand due to COVID-19. They include antibiotics, acid reducers, blood thinners, blood pressure regulators, and medicines required in the operating room.

“Frequent supply shortages of critical generic medicines result in additional pressure for hospitals and their staff and often lead to sub-optimal patient care. Our partnership with Civica is delivering on a shared purpose to help ensure patient access to critical, high-quality medicines for years to come,” said Carol Lynch, president of Sandoz.

“Our associates are inspired every day to deliver on this purpose, even more so during this time of increased demand due to the global healthcare crisis,” Lynch added.

U.S. accuses generic drug makers of price collusion

The manufacturer will start shipping the medications to Civica later this year.

Seventy percent of hospital pharmacy managers said in a 2018 survey that, on at least 50 occasions in the prior year, they were unable to provide hospitals with medicines needed to treat their patients because of shortages, Sandoz said.

The pharma maker is partnering with the nonprofit Civica Rx to help reduce shortages in hospitals.

Sandoz to supply critical generic injectable meds

Not long after five manufacturers recalled numerous lots of metformin for type 2 diabetes due to N-nitrosodimethylamine (NDMA) levels above the acceptable daily limit, another manufacturer is recalling certain lots of metformin.

Granules Pharmaceuticals is voluntarily recalling 12 lots of its Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100-count, and 500 count bottles within expiry to the consumer level due to the detection of NDMA.

“Granules’ test results showed NDMA levels above the FDA acceptable limit in 1 out of the twelve 12 batches distributed to the U.S. market,” the pharma maker said in a 

. However, all other batches continue to remain within the specifications, the manufacturer said.

 their extended-release metformin tablets due to high levels of NDMA.

Granules said it has not received any reports of adverse events “that have been confirmed to be directly related to this recall as of the date of this letter,” the company said.

Granules Metformin Hydrochloride Immediate-Release Tablets USP, 500 mg, 850 mg, and 1000 mg and Metformin Hydrochloride Extended-Release Tablets USP, 500 mg are not affected by the recall.

The lots were distributed nationwide to distributors and retailers.

Five other manufacturers have recalled the popular diabetes medication due to the presence of a the carcinogenic ingredient.


Another pharma maker recalls metformin over NDMA

New data demonstrates that the popular HIV-1 treatment bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (Biktarvy, Gilead Sciences) effectively maintained virioglical suppression, particularly in older adults who switched to the medication.

, July 6 to  10, Biktarvy was effective in virologically suppressed adults ages 65 and older, including those with common comorbidities such as diabetes, hypertension, cardiovascular disease, and dyslipidemia, Gilead said in a 

At 48 weeks, 92% of those who switched to Biktarvy maintained virologic suppression.

“As the number of older adults living with HIV grows, it’s critical to optimize therapy to fit the unique needs of this key population, including those with chronic conditions who may be on multiple medications,” said Moti Ramgopal, MD, medical director of Midway Immunology and Research Center, in the release.

“By 2030, it is projected that up to 70% of people living with HIV will be 50 years or older, the majority of whom will have at least one other comorbidity,” Ramgopal added.”The data presented at AIDS 2020: Virtual showed that adults 65 years and older who switched to Biktarvy maintained viral suppression without a significant impact on lipid levels such as cholesterol, weight, or interactions with other drugs they may be taking for comorbidities.”

These data were evaluated as part of a pooled analysis of four international trials.

Gilead also announced a new data analysis from multiple studies evaluating drug resistance, including the first study to investigate a switch to Biktarvy in virologically suppressed study participants in which some of the participants had a history of treatment failure or suspected pre-existing nucleoside reverse transcriptase inhibitor resistance (NRTI-R).

The study showed infrequent and similar viral blips (when study participants experienced a temporary viral load at or above 50 copies/mL) among study participants switching to Biktarvy, as compared to the comparator arm.

“The results support further evaluation of whether the once-daily, single tablet regimen Biktarvy may potentially be an effective and well-tolerated option for adults with a history of treatment failure or pre-existing resistance,” Gilead said.

Gilead will present new data on virologic suppression in adults 65 years and older at AIDS 2020: Virtual this week.

FDA clears novel psoriatic arthritis treatment

Express Scripts accused of overcharging millions of dollars

Sandoz to supply critical generic injectable meds

Express Scripts accused of overcharging millions of dollars

Sandoz to supply critical generic injectable meds

Another pharma maker recalls metformin over NDMA

Popular HIV-1 med successful, particularly in order adults

FDA clears first-in-class HIV-1 treatment

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

FDA okays novel breast, colorectal cancer treatments

Top 3 drugs to watch in second half 2020

Pharma maker seeks fast approval of lymphoma treatment

FDA pulls hydroxychloroquine for COVID-19, warns about other drug interaction

New pediatric HIV med available

Major Metformin recalls underway

Remdesivir for COVID-19 in short supply

New antibiotic for hospital-acquired pneumonia available