The Checkup by Singlecare

SEPTEMBER 12, 2023

Luckily, there’s a shot to help prevent it: Shingrix, the shingles vaccine. The Shingrix vaccine triggers the immune system to respond to the varicella virus and suppress the outbreak of shingles,” says David Cutler , MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California.

Vaccines 105

Vaccines Immunization Pharmacy Program Director Chemotherapy 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.

Vaccines 108

Vaccines Documentation Compounding FDA 108

pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

Vaccines 125

Vaccines Documentation FDA 125

pharmaphorum

DECEMBER 17, 2020

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR).

Vaccines 105

Vaccines FDA Immunization Hospitals 105

pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

FDA 135

FDA Chemotherapy Immunization Vaccines 135

pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. Both vaccines will be provided free of charge to recipients. The overall 94.5%

FDA 98

FDA Vaccines Documentation 98

pharmaphorum

NOVEMBER 20, 2020

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. On the efficacy side, the filing will highlight a vaccine efficacy rate of 95% in a phase 3 study testing patients with and without previous infection with SARS-CoV-2.

Vaccines 96

Vaccines Documentation FDA 96

pharmaphorum

JUNE 11, 2021

Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. — FDA Biologics (@FDACBER) May 25, 2021. . — FDA Biologics (@FDACBER) May 25, 2021.

FDA 83

FDA Vaccines Packaging 83

Outsourcing Pharma

JANUARY 4, 2021

As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.

FDA 55

FDA Vaccines 55

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.

Vaccines 98

Vaccines FDA Immunization Chemotherapy 98

Pharmaceutical Technology

OCTOBER 28, 2022

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.

Vaccines 64

Vaccines FDA Immunization 64

Pharmaceutical Technology

APRIL 11, 2023

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. The approval enables the company to manufacture and market azithromycin to treat infections such as bronchitis, pneumonia and sexually transmitted diseases (STDs).

FDA 52

FDA Immunization Vaccines 52

pharmaphorum

OCTOBER 26, 2020

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial. Moderna shared demographic data from the study at an FDA committee meeting today which showed that it included some of the groups most at risk from COVID-19.

Vaccines 111

Vaccines FDA 111

Pharma Times

NOVEMBER 26, 2021

The Food and Drug Administration (FDA) granted approval for emergency use of the Comirnaty vaccine in children in October 2021.

Vaccines 52

Vaccines FDA 52

pharmaphorum

DECEMBER 2, 2020

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effective in a phase 3 trial.

Vaccines 88

Vaccines FDA 88

pharmaphorum

JANUARY 8, 2021

The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for several weeks. The UK government has ordered 17 million doses of the new vaccine, but none will be available before March, when Moderna is able to bring new production capacity online.

Vaccines 64

Vaccines FDA 64

pharmaphorum

OCTOBER 30, 2020

Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 That is the basis for filing for emergency use authorisation (EUA) of the vaccine in the US, according to criteria set out by the FDA. billion in deposits for the shot.

Vaccines 100

Vaccines Immunization FDA 100

pharmaphorum

FEBRUARY 11, 2021

AstraZeneca is aiming to get a next-generation vaccine targeting emerging variants approved and into the arms of patients by the autumn, company representatives said in a press conference. While the vaccine is approved in Europe, the UK and several other countries, FDA approval hangs on a study in the US.

Vaccines 78

Vaccines FDA 78

pharmaphorum

JULY 27, 2022

Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that they hope will offer greater and broader protection against SARS-CoV-2 variants. 1 subvariant of Omicron. Pfizer and Moderna have both started regulatory filings for approval of their BA.1-containing

Vaccines 122

Vaccines Immunization FDA 122

Pharma Marketing Network

JULY 7, 2021

Pfizer’s size, solid manufacturing capability and experience running large scale vaccine trials combined with BioNTech’s strong science created a synergistic effect that resulted in the first COVID-19 vaccine approved by the FDA for emergency use in December 2020, just 336 days after the genetic blueprint of the virus was published.

Vaccines 59

Vaccines FDA 59

pharmaphorum

SEPTEMBER 1, 2022

Dr. B was founded in 2021 to connect providers with leftover COVID vaccines to the patients seeking to receive them. at the height of the COVID crisis to save lives by getting vaccines to people who needed them. The post Dr. B: Expanding the business model from COVID vaccines to antiviral medications appeared first on.

Vaccines 98

Vaccines FDA Insurance Patient Care 98

European Pharmaceutical Review

DECEMBER 7, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Comirnaty ® , the Pfizer/BioNTech COVID-19 vaccine for infants and children aged six months to four years in Great Britain. The common, expected side effects were within expectations for a vaccine in this age group.

Vaccines 82

Vaccines Immunization FDA 82

pharmaphorum

JANUARY 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. Add to this the fact that the world missed the WHO targets for global vaccination by the end of 2021 and will likely continue to miss targets in 2022.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Vaccines FDA 98

pharmaphorum

MAY 5, 2021

Pfizer expects revenues from its BioNTech-partnered COVID-19 vaccine to reach an eye-watering $26 billion this year, catapulting it to the top of the world’s biggest-selling medicines. . The vaccine made $3.5 The vaccine made $3.5 The sales forecast for 2021 is based on contracts to deliver 1.6 billion. .

Vaccines 105

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 105

The FDA Law Blog

SEPTEMBER 10, 2023

This finalized a draft guidance issued in December 2021, largely similar in substance. For example, as the guidance states, “FDA must be confident. Even though the draft guidance was issued in 2021 after the onset of the COVID-19 pandemic, the Agency’s thinking now appears to be more reflective of this recent experience.

FDA 108

FDA Documentation Vaccines 108

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. The first therapy that delays the onset of type 1 diabetes received approval from the U.S.

FDA 93

FDA Documentation Compounding Pharmaceutical Companies 93

Pharma Mirror

OCTOBER 16, 2023

The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021. Globally, the COVID-19 pandemic has significantly accelerated the development of mRNA technology platforms and mRNA industry chains.

Immunization 52

Immunization Vaccines FDA 52

The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021.

Labelling 40

Labelling FDA Vaccines Communication 40

European Pharmaceutical Review

MARCH 11, 2024

For example, rising ambient temperatures and ingress of mould from items entering cleanrooms, has resulted in some vaccine and pharmaceutical companies in Europe experiencing increased contamination. The authors also shared: “in the last three years [since 2023], the US FDA has recalled several drugs due to fungal contamination.”

Sterile Compounds 83

Sterile Compounds Compounding Packaging Pharmaceutical Companies 83

Pharmaceutical Technology

FEBRUARY 8, 2023

The 13 top players experienced significant growth over 2022 despite the decline in demand for COVID-19 vaccines and therapeutics, as well as uncertainty surrounding pricing due to the newly passed Inflation Reduction Act in the US. billion between Dec 31, 2021 and Dec 31, 2022, owing to expansion in its vaccine and oncology portfolio.

Vaccines 78

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 78

pharmaphorum

JANUARY 5, 2022

GlaxoSmithKline places shingles vaccine Shingrix is among its top prospects, with peak sales potential of almost $6 billion. Shingrix was dubbed the “crown jewel” of GSK’s vaccine franchise at the company’s latest R&D update. Now, Pfizer and BioNTech are joining forces to try to grab a slice of the market.

Vaccines 105

Vaccines Immunization FDA 105

pharmaphorum

MARCH 17, 2021

At the start of the pandemic GlaxoSmithKline made its vaccine booster tech available looking for collaborations with other vaccine developers – but GSK has been lagging behind rivals like Pfizer and AstraZeneca after its big tie-up with Sanofi hit technical troubles. micrograms of the vaccine are administered 21 days apart.

Vaccines 105

Vaccines Immunization FDA 105

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

FDA 52

FDA Immunization Hospitals Vaccines 52

pharmaphorum

JULY 29, 2021

billion in sales from its COVID-19 vaccine Vaxzevria in the first half of this year, but making it available at no profit had weighed on its profit margins. billion from its one-dose vaccine. A delayed FDA filing – held up by data requests from the US regulator – should take place before the end of the year, according to the CEO.

Vaccines 98

Vaccines FDA 98

Pharmaceutical Technology

SEPTEMBER 5, 2022

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We Prior to this, the FDA had granted Enhertu regulatory approval for breast cancer treatment.

FDA 114

FDA Vaccines 114

Pharmaceutical Technology

JULY 14, 2022

This analysis covers late April to May and is based on a list of CMOs impacted by regulatory decisions by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities like the UK’s National Institute of Health and Care Excellence (NICE). Covid-19 vaccines stay in the spotlight.

Vaccines 52

Vaccines Packaging FDA Pharmaceutical Companies 52

pharmaphorum

JUNE 22, 2022

Dominance of the pneumococcal vaccine category is a race between Merck & Co and Pfizer, and while the latter is comfortably in front at the moment with its Prevnar franchise, Merck has multiple runners in the running. The new vaccine has already started its first late-stage trials. Sales dipped to $5.2

Vaccines 52

Vaccines FDA Immunization 52