Pharmacy Times

NOVEMBER 22, 2023

Additional doses for the prophylaxis of respiratory syncytial virus will immediately be distributed to physicians and hospitals through commercial channels and the Vaccines for Children Program.

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pharmaphorum

APRIL 27, 2021

The US has said it will share up to 60 million doses of its AstraZeneca vaccine with other countries as they become available, after criticism it was hoarding the shots while other countries desperately need it. The White House has said it expects to export the vaccines in the coming months after the outcome of a review by the FDA.

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STAT

JULY 17, 2023

1 cause of hospitalization of babies in this country. 3 to vote on whether to recommend the antibody, and on whether to add it to the Vaccines for Children program, which would require the federal government to pay for it for children without health insurance. A special meeting of the ACIP has been set for Aug. Read the rest…

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STAT

JULY 21, 2023

and around the world to obtain needed medicines the next time they visit a hospital, STAT explains. The tornado that struck parts of North Carolina on Wednesday not only damaged the immediate area, but could soon make it much harder for countless people across the U.S. Among the damaged buildings was a Pfizer plant in Rocky Mountain, N.C.,

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pharmaphorum

NOVEMBER 9, 2020

As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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pharmaphorum

APRIL 14, 2021

That is at the top end of the range of reductions achieved with monoclonal antibodies targeting SARS-CoV-2 that have been granted EUAs by the FDA, it says. Based on the findings, Romark says it is working with the FDA to try to get an EUA for NT-300. Severe disease was seen in 0.5% of the NT-300 group (one patient), compared to 3.5%

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Pharmaceutical Technology

SEPTEMBER 13, 2022

On 1 September, the US Food and Drug Administration (FDA) approved both Pfizer/BioNTech and Moderna's Omicron-specific Covid-19 vaccine boosters. These FDA approvals come as the latest Covid-19 wave in the US, driven by Omicron variants, is declining. Yet it should be noted that the US’s booster vaccine uptake remains poor.

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The Infectious Pharmacist

MAY 19, 2021

Many of my friends are concerned about starting “normal activities” after vaccination, the possibility of breakthrough infections, and the recent CDC guidance that fully vaccinated persons can go “maskless” in most situations. What is a person’s risk of COVID-19 infection if they have been fully vaccinated? This is a long post.

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pharmaphorum

MARCH 2, 2022

Pfizer’s vaccine for Clostridium difficile (C. Top-line efficacy for the vaccine was 49% at 12 months, 47% at 24 months and 31% at final analysis, said the drugmaker, which was forced to carry out the assessment after 42 cases of CDI, fewer than the 66 cases laid out in the trial protocol. With no approved vaccines to date, C.

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STAT

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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The Checkup by Singlecare

NOVEMBER 23, 2022

Food and Drug Administration (FDA) approved the first drug to delay the onset of Type 1 diabetes. Tzield received priority review from the FDA, a status given to drugs with the potential for “significant improvement” in the treatment, diagnosis, or prevention of a serious condition. 17, the U.S. RELATED: Type 1 vs. Type 2 diabetes.

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pharmaphorum

NOVEMBER 18, 2020

Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press reports. Bourla was speaking at a virtual conference hosted by the New York Times, without saying when the company expected to file for the Emergency Use Authorization with the FDA. “We

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pharmaphorum

JANUARY 16, 2023

Regulatory authorities in the US are investigating a possible link between the new Pfizer/BioNTech bivalent COVID-19 booster vaccine and strokes in people aged 65 or over, but still recommend the shots. The stroke signal has not been identified with the Moderna vaccine, said the CDC. The decision to seek authorisation of BA.4/BA.5-directed

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The Infectious Pharmacist

MAY 25, 2021

In the midst of the firestorm over the CDC’s “guidance” (sarcastic quotes deliberately inserted) about unvaccinated persons being safe without masks in most situations, the most common question I’ve received is, “What do I do with my kids who are too young to get vaccinated?”. My kids are too young to receive a COVID-19 vaccine.

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pharmaphorum

DECEMBER 1, 2021

An FDA advisory committee voted by 13 to 10 to recommend emergency-use authorisation for Merck & Co and Ridgeback’s oral antiviral molnupiravir for mild-to-moderate COVID-19, saying it would be useful for some high-risk patients. The post Merck’s oral COVID drug squeaks past FDA advisory committee appeared first on.

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pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. The post FDA fast-tracks Leap’s gastric cancer immunotherapy appeared first on.

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pharmaphorum

OCTOBER 27, 2020

Pfizer is one of the front-runners in the race to approve a COVID-19 vaccine but the US company has had to weather lower revenues for the third quarter due to the ongoing impacts of COVID-19. The drug had been given FDA fast track designation. Despite the decline, biopharma revenues increased overall.

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pharmaphorum

MARCH 28, 2022

GlaxoSmithKline and Vir’s Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity against new variants of the virus. 2 is emerging as the dominant strain of SARS-CoV-2, said the FDA. The post FDA restricts GSK’s Xevudy due to lower efficacy against BA.2

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pharmaphorum

SEPTEMBER 21, 2021

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The two companies have said they also intend to file for emergency approvals in the EU and UK shortly.

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pharmaphorum

FEBRUARY 21, 2022

A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. Twenty-three percent fewer clinical trials were launched from March through May 2020 because of the pandemic, and many clinical researchers switched to focusing on COVID-19 vaccines and treatments.

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The Checkup by Singlecare

MAY 16, 2024

According to the FDA , biologics are complex mixtures that cannot be easily characterized or identified, whereas nonbiologic drugs are made with chemicals and have a known structure. Before being FDA approved, biosimilars are clinically tested to ensure they are as safe and effective as the reference product. What are biosimilars?

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pharmaphorum

AUGUST 1, 2022

As of 22 July, there had been five reported deaths among the current outbreak, with around 10% of all cases requiring admission to hospital, mainly to manage the pain caused by the disease. That is a scale of outbreak never before encountered with the virus. The WHO formally declared monkeypox an emergency last week.

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Digital Pharmacist

OCTOBER 12, 2022

In order to reduce the number of hospitalizations due to pharyngitis and reduce financial burden for patients, one way is to get access to testing and get treated in the earlier stage of the infection. Early treatment of the disease may limit the duration of illness and as a result of less hospitalization. Benefits for Customers.

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European Pharmaceutical Review

JULY 21, 2023

A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. What are the top three supply-related challenges facing pharmaceutical manufacturers?

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The Checkup by Singlecare

OCTOBER 17, 2023

Clindamycin is available in various dosage forms, including capsules, oral solution, vaginal cream and gel, topical lotion and gel, and intravenous (IV) injections administered in a hospital setting. Certain vaccines interact with clindamycin , which can cause a diminished vaccine effect. diff (Clostridioides difficile) , CDC.

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The People's Pharmacy

APRIL 20, 2023

Now that the FDA and the CDC have approved new bivalent COVID boosters, who should get a second shot? Vaccine production has also been increased. Very few people are wearing masks and a lot of visitors to this website believe vaccines are the work of the devil. Another name for this variant is Omicron XBB.1.16.

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pharmaphorum

JUNE 17, 2022

It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19.” .

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ISPE

NOVEMBER 2, 2022

Vice President, Hospital Business Unit Global Supply Chain. Tom Cheslock, Vice President, Hospital Business Unit Global Supply Chain at Pfizer presented on “Integrated Manufacturing Excellence–Leading thru Uncertainty.” Pfizer “cleared runway to allow for large-scale vaccine manufacturing before we had a product!”

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pharmaphorum

NOVEMBER 26, 2021

of their value after the announcement, while Pfizer – already making big profits from its BioNTech-partnered COVID-19 vaccine – rose almost 6%. The timing of the MOVE-OUT update also comes just a couple of working days before molnupiravir is due to come in front of an FDA advisory committee. Shares in Merck lost 3.5%

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The Infectious Pharmacist

AUGUST 21, 2021

Pfizer vs. Moderna and a note on vaccine dosing and timing. You probably have read news reports about a preprint article stating that the Moderna vaccine appeared more effective than the Pfizer vaccine, at least several months after vaccination. Should I stick with the same mRNA vaccine I got for the first two doses?

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pharmaphorum

AUGUST 16, 2021

Gilead Sciences’ Veklury (remdesivir) is already being used to treat COVID-19, but as it is administered intravenously is approved only for people with severe COVID-19 being treated in hospital. The US government has already placed an order with Merck & Co to buy 1.7

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pharmaphorum

JANUARY 31, 2022

Regeneron’s rival antibody product was approved by the FDA to treat a genetic form of elevated cholesterol – homozygous familial hypercholesterolemia (HoFH) – and is also testing it in other, more common forms of dyslipidaemia and in acute pancreatitis prevention.

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Aureus Medical Group

NOVEMBER 30, 2022

The Centers for Disease Control and Prevention estimates that flu causes between 140,00 and 710,000 hospitalizations annually. Get vaccinated: The CDC states that vaccination is the best defense against these viruses. And each year, experts look at signs from the southern hemisphere, where flu season hits earlier than the U.S.,

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Hospital Pharmacy Europe

DECEMBER 13, 2023

Notably, 50% of the new drugs approved by the FDA in 2022 were biologics , underscoring the magnitude of this transformation. Imagine a future where patients can drink, eat, or inhale their medication instead of relying on injections or hospital visits. The implications of this extend beyond individual patient experiences.

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The Checkup by Singlecare

SEPTEMBER 22, 2023

This year, there are new vaccines to help at-risk populations ward off severe sickness, including that caused by RSV. Here’s what you need to know about the new FDA-approved RSV vaccine. Is there a vaccine for RSV? Not all vaccines work via the same science. Not all vaccines work via the same science.

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The Infectious Pharmacist

AUGUST 19, 2021

It does not merely refer to additional doses of a vaccine, but rather a booster dose refers to a dose with specific effects that is given after a “primary series” of a vaccine. After all, the original vaccine has maintained high rates of effectiveness against the variants that have emerged. What are booster doses?

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Pharmacy Friday Pearls

MARCH 4, 2022

18 years – affects bone & cartilage growth Not authorized for treatment of patients hospitalized for COVID-19Not authorized for use as pre/post-exposure prophylaxis for prevention of COVID-19Not authorized for use for ?5 hrs Half-life elimination: Nirmatrelvir: 6.05 ± 1.79 hrs & Ritonavir: 6.15 hrs Half-life elimination: 3.3

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