The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule.

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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

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

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. Days after the U.S. Organizational Actions/Announcements .

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The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Janssen Biotech, 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

JULY 29, 2021

Additionally, mepolizumab was the first biologic therapy indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and also the first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES). With 41 clinical trials, mepolizumab has been studied in over 4,000 patients.

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The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 million doses of Moderna’s vaccine candidate against COVID-19 , mRNA-1273. “As

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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. Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. Pfizer Inc.

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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. Increases of ALT ?5x

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The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

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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 submission included data from two positive pivotal Phase III trials.

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The Pharma Data

JULY 29, 2021

Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials. Essential safety information on the authorized emergency use of baricitinib includes warnings related to serious infections, thrombosis, abnormal laboratory values, vaccinations and hypersensitivity. Adverse Reactions.

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The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. The target action date for the FDA decision on this investigational use is August 3, 2022. The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved indications. In September 2020, the U.S.

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The Pharma Data

AUGUST 3, 2021

announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Vaccinations: Avoid use of live vaccines with baricitinib. It is approved in the U.S. Adverse Reactions. About COV-BARRIER Sub-Study.

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The Anticancer Fund

JUNE 23, 2023

However, this was not an efficacy trial and similar responses have been seen from chemo alone. More informative Phase 2 trials are necessary to assess whether metformin improves outcomes. Overall this trial does not support further evaluation of this combination in this patient population. months, SOC vs D+C).

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The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues. Increases of ALT ?5x

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The Pharma Data

FEBRUARY 13, 2022

If approved, Dupixent will be the first biologic medicine available in the U.S. The sBLA is supported by data from the pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis.

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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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Codon

MAY 18, 2023

The company also has licensing deals with Tropic Biosciences to make bananas that don't brown as fast and coffee with naturally low caffeine & high solubility (for instant coffee). link ) An mRNA vaccine for many types of flu viruses is now in a phase I clinical trial. No more designing new flu vaccines each year?

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Codon

MAY 18, 2023

The company also has licensing deals with Tropic Biosciences to make bananas that don't brown as fast and coffee with naturally low caffeine & high solubility (for instant coffee). link ) An mRNA vaccine for many types of flu viruses is now in a phase I clinical trial. No more designing new flu vaccines each year?

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The Pharma Data

MAY 4, 2021

” “Even as the world makes progress on vaccine roll-outs, it remains vital for treatments to be available that can make a meaningful difference for those fighting COVID-19,” said David A. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly.

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The Pharma Data

OCTOBER 29, 2020

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo. 10x ULN were observed in patients in Olumiant clinical trials.

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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. However, BeiGene announced that it is seeking approval in the U.S. Based on the E.U.

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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. A second liver biopsy will be performed after 18 months.

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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.

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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. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. Schleifer , M.D.,

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Agency IQ

NOVEMBER 3, 2023

In fact, the FDA has even developed a guidance document for “early clinical trials with live biotherapeutic products [LBPs].” 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

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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Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

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Drug Discovery World

SEPTEMBER 16, 2022

In 2021, the Cell and Gene Therapy Catapult estimated that there 168 ongoing clinical trials for advanced therapy medicinal products (ATMPs) taking place – representing 9% of all global trials in the space. The UK stands as one of the key markets for cell and gene therapies. billion in funding. . “The

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The Pharma Data

JULY 12, 2021

Rare cases of the neurological disorder, Guillain-Barré syndrome have been reported following vaccination with the Janssen COVID-19 vaccine. Most occurred within 42 days after vaccination. For further information on the safety of authorized COVID-19 vaccines, please visit: [link]. What Is the Janssen COVID-19 Vaccine?

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The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. Global Head, Janssen Research & Development, Johnson & Johnson.

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The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. million doses of the COVID-19 Vaccine Moderna. About the COVID-19 Vaccine Moderna.

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The Pharma Data

JANUARY 6, 2021

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. Novel drug products are defined as products that have never been approved for any indication.

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