BioPharma Reporter

APRIL 8, 2021

Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.

Antibody 96

Antibody Vaccination Vaccine Medicine 96

XTalks

APRIL 15, 2021

Federal authorities in the US have recommended pausing the administration of J&J’s COVID-19 vaccine as half a dozen cases of rare blood clots reported among women who received the vaccine are under investigation. Related: COVID-19 Vaccine Messaging: Why Vaccine Efficacies Can’t Be Compared and Shopped.

Vaccination 98

Vaccination Vaccine Regulation Drugs 98

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Pharmaceutical Technology

APRIL 24, 2023

Since then, the field of nanomedicine has steadily progressed to reach high points such as the successful use of nanotechnology to deliver messenger RNA (mRNA)-based Covid-19 vaccines. In the case of most mRNA vaccines, a lipid nanoparticle-based approach was chosen due to its ability to protect the mRNA in the body and prevent degradation.

Drug Delivery 147

Drug Delivery Vaccination Vaccine Research 147

STAT News

NOVEMBER 1, 2022

Pfizer’s maternal vaccine against the respiratory syncytial virus reduced the rate of severe illness in newborns by 81.8%, the company said Tuesday, meeting the goal of a pivotal study, STAT tells us. By giving the vaccine during pregnancy, researchers hope antibodies generated by mothers would be transferred to their babies.

Vaccination 98

Vaccination Vaccine Antibody Regulation 98

pharmaphorum

MARCH 9, 2021

Last year, Belgium’s ExeVir Bio raised 23 million euros ($27 million) to finance development of llama antibodies – and now it is ready to begin clinical development of a potential treatment that could be effective against emerging COVID-19 variants. ExeVir is not the first company to spin out of VIB to focus on camelid antibodies.

Antibody 98

Antibody Life Science Scientist Vaccination 98

pharmaphorum

AUGUST 11, 2022

Figures from the UK Office for National Statistics (ONS) have revealed that the number of people with higher levels of COVID-19 antibodies in their blood is declining quickly – leading to calls for booster vaccination campaigns to be started as soon as possible. 1 Omicron subvariant – are currently under review at the regulator.

Antibody 52

Antibody Immune Response Vaccination Vaccine 52

The Pharma Data

AUGUST 17, 2020

The Chinese Centre for Drug Evaluation (CCDE) has said that coronavirus vaccines must show 50 percent efficacy to be approved. . The CCDE also said companies would have to prove their vaccines could provide immunity from the virus for a minimum of six months and be effective for 70 percent of the population. . Conor Kavanagh.

Vaccination 52

Vaccination Vaccine Regulation Drugs 52

pharmaphorum

JUNE 9, 2022

Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. It has predicted sales of COVID-19 vaccines will be around $21 billion this year. Three-month data will be reported later this summer.

Vaccination 103

Vaccination Vaccine Containment Clinical Trials 103

pharmaphorum

JANUARY 15, 2021

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.

Vaccination 104

Vaccination Vaccine Immune Response Antibody 104

pharmaphorum

MARCH 30, 2021

Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week. . GSK and Vir say they are discussing emergency use authorisation of VIR-7831 with the EMA and other regulators, including possible co-administration with bamlanivimab.

Antibody 93

Antibody Protein Trials Regulation 93

Pharmaceutical Technology

FEBRUARY 1, 2023

Pharmaceutical companies have been working on developing vaccines and other prophylactics for respiratory syncytial virus (RSV) since its discovery in 1956. Despite strong efforts and scientific advances, a safe and effective vaccine for RSV has yet to be approved for any patient population.

Vaccination 162

Vaccination Vaccine Antibody Protein 162

XTalks

SEPTEMBER 23, 2021

NYSE: PFE ) and BioNTech SE ( Nasdaq: BNTX ) announced the very first results from a pivotal trial being conducted for their COVID-19 vaccine for children on Monday. The results showed that the vaccine was safe, well-tolerated and produced robust neutralizing antibody responses in children five to 11 years old. Pfizer Inc.

Vaccination 98

Vaccination Vaccine Trials Antibody 98

Pharmaceutical Technology

APRIL 5, 2023

It is a first-in-class monoclonal anti-human complement factor C5a antibody. Despite the availability of vaccines and other treatments for earlier disease stages of Covid-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation. “As

Licensing 246

Licensing Licensing Antibody Regulation 246

XTalks

AUGUST 16, 2022

Health regulators in the UK have become the first in the world to approve Moderna’s next generation COVID-19 vaccine booster that includes targeting of the Omicron variant. The primary series of Moderna’s COVID vaccine remains at two doses. Related: Menarini Diagnostics’ New COVID-19 Test Detects Variants Including Omicron.

Vaccination 98

Vaccination Vaccine Antibody Regulation 98

XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. Related: Could Pfizer and BioNTech’s COVID-19 Vaccine be Stored at Standard Freezer Temperatures?

Vaccination 111

Vaccination Vaccine Development In-Vitro 111

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . The post Altimmune ditches nasal COVID vaccine on weak trial data appeared first on.

Vaccination 97

Vaccination Vaccine Trials Immune Response 97

XTalks

SEPTEMBER 30, 2020

The research shows that the activity of the immune messenger type 1 interferon (IFN) protein is diminished, either by genetic mutations or an autoimmune attack by neutralizing antibodies against it, in a subset of COVID-19 patients. These rogue antibodies blocked interferon action and were not present in patients with mild COVID-19 cases.

Antibody 135

Antibody Genetics Research In-Vitro 135

pharmaphorum

MARCH 29, 2021

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences.

Antibody 76

Antibody Hormones Medicine Licensing 76

pharmaphorum

MAY 4, 2021

Europe’s regulator has begun a rolling review of Sinovac’s COVID-19 vaccine, known as Vero Cell. The vaccine is based on an inactivated SARS-CoV-2 virus, which has been killed and cannot cause COVID-19. The post EU starts rolling review of Sinovac’s COVID-19 vaccine appeared first on. pic.twitter.com/klVnkAjkcw.

Vaccination 52

Vaccination Vaccine Regulation Medicine 52

The Pharma Data

DECEMBER 20, 2020

Oxford University released new trial data last week that raises further questions about the most effective dosing regimen for Oxford’s COVID-19 vaccine candidate, AZD1222, that is being co-developed with AstraZeneca and how it came to pass that two different dosing regimens were pursued. AstraZeneca is leading the phase 3 U.S.

Antibody 52

Antibody Vaccination Vaccine Trials 52

The Pharma Data

JANUARY 27, 2021

On the treatment front, promising new data on two coronavirus antibody cocktails suggests these therapies can keep patients out of the hospital and even prevent illness altogether in some people. As for the antibody cocktails, they showed more mettle against COVID-19 than expected in early trial results.

Antibody 52

Antibody Trials Vaccination Vaccine 52

pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . At the moment the regulator is looking at the first batch of data from lab and animal studies as well as quality studies.

Antibody 52

Antibody Protein Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. The vaccine also produced a T-cell response within 28 days, a secondary outcome.

Immune Response 84

Immune Response Vaccination Vaccine Trials 84

pharmaphorum

MARCH 30, 2022

CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drug development, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up. ” The post CureVac and GSK try again with COVID-19 vaccine appeared first on. .

Vaccination 62

Vaccination Vaccine Protein Antibody 62

pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. The latest data from a phase 1 study in the US showed that seven days after a second dose at 30 micrograms, the vaccine produced 3.8

Vaccination 120

Vaccination Vaccine Antibody Regulation 120

XTalks

JUNE 30, 2021

is offering a comprehensive diagnostic for COVID-19 vaccine-induced blood clot testing to help in the accurate and prompt diagnosis of the rare but serious blood clots being seen after some individuals are vaccinated with viral vector COVID-19 vaccines such as those from AstraZeneca and Johnson & Johnson.

Vaccination 99

Vaccination Vaccine Antibody Development 99

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

XTalks

JULY 2, 2021

There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. Related: Moderna’s COVID-19 Vaccine Effective Against New Variants.

Vaccination 105

Vaccination Vaccine Protein Immune Response 105

XTalks

JANUARY 5, 2022

Amid skyrocketing cases of Omicron across the US and worldwide, the US Food and Drug Administration (FDA) has made a couple of amendments to the emergency use authorization (EUA) of Pfizer/BioNTech’s COVID-19 vaccine, including a booster dose for individuals between 12 and 15 years of age.

Vaccination 105

Vaccination Vaccine Antibody Regulation 105

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. Is it perfect?

Vaccination 76

Vaccination Vaccine Regulation FDA Approval 76

The Pharma Data

JANUARY 26, 2021

In what looks like a breakthrough for COVID-19 treatments, Regeneron’s monoclonal antibody cocktail REGEN-COV (casirivimab and imdevimab) cut infection rates in half and provided full protection against symptomatic COVID-19, according to interim results from a phase 3 trial evaluating the treatment as a passive vaccine.

Antibody 52

Antibody Vaccination Vaccine Trials 52

pharmaphorum

JANUARY 27, 2021

Regeneron is considering an emergency filing for its antibody cocktail REGEN-COV to protect people against COVID-19 after early trial results showed it conferred 100% protection against symptomatic infection. The post Regeneron and Lilly post new data backing COVID antibody cocktails appeared first on.

Antibody 57

Antibody Vaccination Vaccine Trial Funding 57

pharmaphorum

NOVEMBER 17, 2020

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements. The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials.

Vaccination 64

Vaccination Vaccine RNA Clinical Trials 64

Drug Discovery World

MARCH 31, 2023

As March draws to a close, this week’s key announcements have demonstrated the breadth of international approaches to tackling cancer, with vaccines, proenzymes, immunotherapies and antibody-based treatments all currently under investigation around the world.

Drugs 52

Drugs Antibody Vaccination Vaccine 52

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.

Vaccination 91

Vaccination Vaccine Clinical Trials Clinical Trials 91

pharmaphorum

JULY 26, 2021

The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.

Antibody 136

Antibody Immune Response Vaccination Vaccine 136