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Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Germany and Spain, researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose. Using data from the MS PATHS network in the U.S.,
During nearly all of 2021, FDA has been under the direction of an acting commissioner. COVID – 144 announcements were COVID-related in 2021, compared to 274 such announcements during 2020; Approvals – there were 77 announcements related to approvals this year, 22 of which were COVID-related announcements.
As one among the leading global vaccines companies, we still bring options which help protect people’s health round the world,” said Michael Greenberg, MD, MPH, Medical Head, Sanofi Pasteur North America. “As 4,5 The CDC recommends a primary dose of the MenACWY vaccine at 11-12 years old and a second dose at 16 years old. In the U.S.,
When our backs were against the wall, the biotech/biopharma community came together to create not one, but two vaccines currently approved for emergency use in the U.S. The last year, I think, is a very exciting year for cell therapy against cancer. This has earned the industry a lot of respect. Not because of the local tumor.
which demonstrated statistically significant data and completed enrollment of 390 patients in its Phase IIb/III trial in severe-to-critically ill COVID-19 patients with data to be released mid-January 2021. Novavax initiated the PREVENT-19 Phase III trial of its COVID-19 vaccine candidate, NVX-CoV2373. Vyrologix is a CCR5 antagonist.
Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. That said, BT would be a lagging indicator since it can be granted so early in the development process. Fewer meetings – more approvals.
25, 2021 — Giving melanoma patients a “personalized” vaccine can prompt an anti-tumor immune response that lasts for years, an early study finds. So researchers gave them an experimental vaccine called NeoVax. Unlike traditional vaccines, it is not a one-size-fits-all jab. MONDAY, Jan.
6, 2021 — Cases of anaphylactic shock caused by COVID-19 vaccines are very rare, based on numbers from the first week and a half of vaccinations in the United States, federal public health officials said Wednesday. Seven out of 10 cases occurred within 15 minutes of vaccination. WEDNESDAY, Jan.
Testing Therapies, Antivirals and Vaccines. By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . One of the open questions about the various vaccines against COVID-19 has been how long the protection offered will last.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.
Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Pfizer and BioNTech completed the rolling submission of the BLA in May 2021. About Pfizer: Breakthroughs That Change Patients’ Lives.
Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. The accelerating gene therapy market is expected to grow globally by 16.6% As more therapies are moving out of the lab and into human clinical trials, this paradigm is changing.
Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Sanofi continued its growth trajectory.
Anderson Professor of Chemical and Biomolecular Engineering, and his colleagues, are reporting in iScience the event of an intranasal subunit vaccine that gives durable local immunity against inhaled pathogens. A fundamental limitation of intramuscular vaccines is that they’re not designed to elicit mucosal immunity.
The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.
econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4
29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Following final agreement, Novartis plans to start production in the second quarter of 2021.
government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. In a separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the U.S. This press release features multimedia. Eligible U.S.
Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.
EMERYVILLE, Calif.
In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV. About CureVac.
Dual payload ADCs As effective as therapies have been in treating solid and haematological cancers, tumour heterogeneity and resistance remain major clinical challenges. To overcome these obstacles, combination therapy, which delivers multiple small molecules, has emerged as a potential solution. 1 , 33–43 (2018). 102 , 1–6 (2016).
16, 2020 /PRNewswire/ — Cytiva , a global life sciences leader, is supporting Clover Biopharmaceuticals , a global clinical-stage biotechnology company, to help accelerate the development and manufacturing of a protein-based S-Trimer subunit vaccine candidate. .
SHANGHAI , Nov.
The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial.
Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.
The transaction was announced on July 19, 2021. The acquisition strengthens BioNTech’s cell therapy pipeline by accelerating the individualized solid tumor Neoantigen TCR cell therapy research and development program. Kite’s singular focus is cell therapy to treat and potentially cure cancer.
Posted 07 May 2021 | By Michael Mezher .
Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ).
Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ).
The US opened pandora’s box on IP waivers for Covid-19 vaccines. .
FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. Government to supply doses in 2020 & 2021.
Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.
immediately.
6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.
This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. g doses of the COVID-19 vaccine.
Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”. .–( BUSINESS WIRE )– Moderna, Inc.,
This week Pharma IQ looks at how the pharma industry is expanding its vaccine manufacturing and testing protocols to ensure the deadly Covid-19 outbreak yields in its spread around the globe. . BioNTech acquires Novartis GMP manufacturing site to expand Covid-19 vaccine production.
The FDA decision is informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants.
As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The combined analysis showed average efficacy of 70%.
The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with hemophilia A, a rare and life-threatening bleeding disorder, based on data from the pivotal XTEND-1 P hase 3 stud y.
Under the MoU, the companies and the IOC will coordinate with National Olympic Committees (NOCs) around the world to understand and work to help address the local need for vaccine doses for national delegations’ participation in the Games. We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”.
Product Name: The Neuro-Balance Therapy. Click here to get The Neuro-Balance Therapy at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors. Q: How quickly can I notice results with Neuro-Balance Therapy?
Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. In 2021, he assumed the role of Director in Protein Therapeutics at Gilead, driving biologics to prominence. Molecular Therapy 20 , 1831-1832 (2012). Nature 578 , 229-236 (2020).
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Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine.
Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. TAK-019 Clinical Trial.
Food and Drug Administration (FDA) granted Novartis ’ experimental drug iptacopan Breakthrough Therapy designation in paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder. Breakthrough Therapy designation will expedite the development and review of iptacopan for this indication.
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