Fierce Pharma

OCTOBER 12, 2023

BioNTech in-licensed a HER3 antibody-drug conjugate from Chinese company MediLink Therapeutics. | BioNTech in-licensed a HER3 antibody-drug conjugate from Chinese company MediLink Therapeutics. GSK has tapped Chongqing Zhifei to distribute Shingrix in China. GSK has tapped Chongqing Zhifei to distribute Shingrix in China.

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pharmaphorum

DECEMBER 5, 2022

Valneva has moved a step closer to its goal of becoming the first company to file for approval of a vaccine against chikungunya virus in the US after reporting new clinical data today. Valneva estimates that the global market for vaccines against chikungunya could exceed $500 million annually by 2032.

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Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5-adapted bivalent vaccine.

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XTalks

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work? mL for intramuscular injection.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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pharmaphorum

JULY 18, 2022

MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, How it works.

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The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

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XTalks

NOVEMBER 4, 2022

Pfizer announced positive top-line data from a Phase III trial evaluating its respiratory syncytial virus (RSV) prefusion vaccine candidate, RSVpreF (or PF-06928316) for pregnant individuals to help protect their infants from RSV disease after birth. The efficacy against severe MA-LRTI was 81.8

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pharmaphorum

MAY 13, 2021

The UK government has got cold feet over plans to buy a million doses of AstraZeneca’s antibody treatment for coronavirus, according to a press report. Bloomberg quoted two sources close to the matter saying that the government is rethinking the plans as AZ prepares to announce late-stage data for the antibody called AZD7442.

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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.

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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.

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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.

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pharmaphorum

SEPTEMBER 8, 2022

A malaria vaccine developed by members of the University of Oxford team behind the AstraZeneca COVID-19 jab has been hailed as a possible game-changer in the fight against the deadly parasitic infection. The post High hopes as new malaria vaccine shows unprecedented efficacy appeared first on.

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pharmaphorum

SEPTEMBER 3, 2021

Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to bring the first licensed shot to market. At its recent business update, GSK said it was anticipating peak sales of more than $4 billion for its vaccine if approved.

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pharmaphorum

MARCH 7, 2022

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . of individuals in low-income countries have received their first dose.

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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?

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pharmaphorum

AUGUST 16, 2020

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

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The Pharma Data

NOVEMBER 3, 2020

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million investment announced in July. Earlier this year, CEPI provided $3.5 Jason Scott. Source link.

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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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Trials Clinical Trials Clinical Trials Licensing 264

pharmaphorum

FEBRUARY 11, 2021

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial. . The vaccine stimulated antibodies against the protein in all 32 patients with early-stage AD in the study at levels that AC Immune thinks should have a therapeutic effect.

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pharmaphorum

NOVEMBER 12, 2021

AstraZeneca has said it plans to start making a small profit from sales of its COVID-19 vaccine Vaxzevria, which brought in just over $1 billion in sales in the third quarter, after selling it at cost since it was first made available. That will help cover the costs of investment in its antibody for coronavirus infections, said the company.

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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?

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pharmaphorum

MAY 31, 2022

billion takeover of US biotech Affinivax, buying a pneumococcal vaccine candidate that is aiming to break into a market that for years has been dominated by Pfizer’s Prevnar franchise. The biotech says this can stimulate both B cell (antibody) and T cell immune responses with a single shot. GlaxoSmithKline has agreed a $3.3

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The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. Pfizer Inc.

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The Pharma Data

AUGUST 10, 2020

Novavax is partnering up with the Serum Institute of India Private Limited (SIIPL) in a licensing deal to development and marketing of up to one billion doses of its potential recombinant COVID-19 vaccine candidate, NVX?CoV2373. Negotiations are currently ongoing to have SIIPL manufacture the candidate within India. M adjuvant.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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The Pharma Data

AUGUST 6, 2020

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The vaccine was moved into phase 2/3 in May. That has changed.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.

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Delveinsight

DECEMBER 8, 2020

KaliVir, Astellas Pharma forms a licensing deal for VET2-L2 oncolytic virus. KaliVir Immunotherapeutics and Astellas Pharma entered into a worldwide exclusive licensing agreement for the development, research, and commercialization of VET2-L2 to widen the horizon of therapeutic approaches available in the Immuno-Oncology market.

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pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion. Despite the interest, there have already been some failures in the alpha-synuclein category.

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The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Pharmaceutical Technology

JUNE 9, 2023

The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. After a long period without any new approvals, in May, the FDA approved GSK’s vaccine Arexvy for the prevention of LRTD caused by RSV in individuals 60 and older.

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The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. We are proud to deliver the first vaccine to help protect people in the U.S. 45 years ago.

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Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,

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Pfizer

DECEMBER 8, 2022

FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. INDICATION & AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine, Bivalent, (Original and Omicron BA.4/BA.5) AUTHORIZED USE .

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XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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