Drug Discovery World

MARCH 7, 2023

She has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. In 2023, the company revealed data from a Phase III trial which showed that its vaccine candidate DCVax-L more than doubled overall survival in glioblastoma patients.

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The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Testing Therapies, Antivirals and Vaccines. The approval marks the first drug approved by the U.S.

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The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

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The Pharma Data

JULY 29, 2021

First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation Fourth indication for mepolizumab in the US for eosinophil-driven diseases. CRSwNP accounts for 2-4% of the US population, affecting more than 5 million people.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. Ricks , Lilly chairman and CEO.

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The Pharma Data

APRIL 6, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. Pfizer Inc.

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The Pharma Data

NOVEMBER 20, 2020

billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date. by the middle to end of December 2020. participants are 56-85 years of age.

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The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. It was approved on December 15, 2020. The FDA completed a class 2 response in July 2020. Here’s a look. Most Read Today.

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The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

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The Pharma Data

AUGUST 3, 2021

“As additional data from COV-BARRIER become available, it is increasingly evident that treatment with baricitinib may help prevent death in some of the most critically ill COVID-19 patients and that baricitinib represents an important treatment option for this vulnerable group of patients in this constantly evolving pandemic,” said E.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. No new safety signals potentially related to the use of baricitinib were identified. In the U.S.,

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The Pharma Data

NOVEMBER 9, 2020

Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy 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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The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE.

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The Pharma Data

MAY 31, 2022

if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation. The target action date for the FDA decision is September 30, 2022. who are unable to control their disease with systemic therapy and are most in need of a treatment option.

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The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.

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The Anticancer Fund

JUNE 23, 2023

Treatment of immunocompetent mice with canagliflozin was associated with reduced tumour growth, to the same extent as treatment with immune checkpoint inhibitors. Additionally, the D+C had a higher rate of toxicity and 10 patients (24%) discontinued disulfiram treatment because of adverse effects. months, SOC vs D+C).

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The Pharma Data

FEBRUARY 13, 2022

If approved, Dupixent will be the first biologic medicine available in the U.S. Current treatment options in this age group are primarily topical steroids, which can be associated with safety risks and may impair growth when used long-term. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children. In the U.S.,

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The Pharma Data

OCTOBER 29, 2020

Interim analyses were conducted after patients completed 12 and 36 weeks of treatment, the latter for the primary endpoint of the Phase 2 part of the study. ” In March, the FDA granted Breakthrough Therapy designation to baricitinib for the treatment of AA based on positive Phase 2 results from BRAVE-AA1.

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Agency IQ

JANUARY 19, 2024

approval and discussion with the FDA, the company announced in December 2023 that it intends to re-submit the biologics license application in the U.S. FDA in October 2023. The product was approved in the E.U. received a CRL from the FDA in May 2023 due to manufacturing control issues. Based on the E.U.

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The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. In the U.S.,

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDA approval in February 2020. provided an update on its ongoing NASH program.

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Agency IQ

NOVEMBER 3, 2023

Because they focus on treatment of a specific condition, synthetic biotics must be studied under an investigational new drug application (IND). In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP.

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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

JANUARY 12, 2021

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. Patients, caregivers and healthcare providers can find sites with COVID-19 antibody treatments through these links to the HHS or National Infusion Center Association locator tools. . Schleifer , M.D., ” The U.S.

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The Pharma Data

JANUARY 9, 2021

• Anthrax Vaccines. Anthrax vaccine revenues are expected to be at a more normalized annual level and continue to primarily reflect procurement of AV7909 (Anthrax Vaccine Adsorbed, adjuvanted) under the Company’s existing contract with the Biomedical Advanced Research and Development Authority (BARDA).

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Drug Discovery World

SEPTEMBER 16, 2022

According to the Cell and Gene Therapy Catapult, the campus acts as a “vital focal point for companies looking to develop and commercialise advanced therapy treatments, as well as attracting significant investment from pharmaceutical companies and venture capitals firms.” . billion in funding. .

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Codon

JULY 14, 2024

The transfusion of platelets thus seems like an obvious treatment to stem bleeding. Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. As a clot forms, liquid blood becomes a solid plug that can stop bleeding in a matter of minutes.

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The Pharma Data

NOVEMBER 9, 2021

is the first and only oral CGRP (calcitonin gene- related peptide) receptor antagonist for the acute and preventive treatment of migraine Biohaven to receive tiered double-digit royalties on ex-U.S. owed under the Company’s license and backing agreements with Bristol-Myers Squibb Company and Royalty Pharma. and coequals outside theU.S.,

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The Pharma Data

JANUARY 26, 2021

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., It remains under review by the FDA. have reached record highs. . have reached record highs.

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The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination. Department of Health and Human Services.

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The Pharma Data

APRIL 27, 2021

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. Vaccines delivered growth in its core segments. reflecting lower treatment compliance during the COVID-19 pandemic. Q1 2021 sales increase of 2.4% In the U.S.

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Codon

APRIL 2, 2023

When delivered using AAV9 in mice, the treatment significantly improved motor function and extended average lifespan. mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms.

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The Pharma Data

NOVEMBER 21, 2020

21, 2020 /PRNewswire/ — First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2. Food and Drug Administration (FDA). The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

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The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) for the treatment of AA. There are currently no FDA-approved treatments for AA. “This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease.”

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The Pharma Data

APRIL 26, 2021

billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. Key innovation milestones: Entresto granted an expanded indication by the FDA in chronic heart failure patients (to include HFpEF). Coverage continued to expand, with more than 300 qualified treatment centers in 28 countries.

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