The Pharma Data

FEBRUARY 24, 2022

If the EC grants the variation, the decision will be immediately applicable to all 27 EU member states, making booster vaccines available to everyone 12 years and older. . The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S. and Europe.

Vaccine 52

Vaccine FDA Small Molecule Immune Response 52

The Pharma Data

AUGUST 20, 2020

The Phase III study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate compared to Bexsero and Menveo. The investigational vaccine has the potential to reduce the number of injections and thereby improve completion rates.”. cases per 100,000 population in 2017.

FDA Approval 52

FDA Approval Trials Vaccine Licensing 52

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.

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

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. Please read more here. . Days after the U.S.

Vaccine 52

Vaccine FDA Approval FDA Clinical Trials 52

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).

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

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

Vaccine 40

Vaccine RNA Clinical Trials Government 40

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. It is approved in the U.S.

Licensing 40

Licensing Licensing Therapies Laboratories 40

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.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

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.

Vaccine 40

Vaccine Clinical Trials Trials FDA 40

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. Athenex and Almirall have a license deal with Almirall having the license to research, develop and commercialize the drug in the U.S.

FDA 52

FDA FDA Approval Licensing Licensing 52

The Pharma Data

NOVEMBER 9, 2021

TERMS OF THE ARRANGEMENT Biohaven and Pfizer are entering into a collaboration and license agreement and affiliated sublicense agreement pursuant to which Pfizer will acquire rights to manipulate rimegepant and zavegepant outside of theU.S. In addition to the tiered double- number royalties owed to Biohaven on net deals outside of theU.S.,

Licensing 52

Licensing Licensing Treatment FDA Approval 52

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are pleased to work with U.S. AUTHORIZED USE IN THE U.S.:

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

AUGUST 3, 2021

For more information about the authorized use of baricitinib in COVID-19 and mandatory requirements of the EUA, please see the FDA Letter of Authorization , Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers ( English ) ( Spanish ). Vaccinations: Avoid use of live vaccines with baricitinib.

Hospitals 52

Hospitals FDA FDA Approval Licensing 52

The Pharma Data

JULY 29, 2021

Essential safety information on the authorized emergency use of baricitinib includes warnings related to serious infections, thrombosis, abnormal laboratory values, vaccinations and hypersensitivity. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved in the U.S.

Hospitals 52

Hospitals FDA Laboratories Treatment 52

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. Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S.,

FDA 52

FDA Disease Trials FDA Approval 52

The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Source link: [link].

FDA 52

FDA Treatment Disease FDA Approval 52

Codon

APRIL 2, 2023

mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Read How well do different antibodies, created by people who got two or three doses of the COVID-19 mRNA vaccine, fight off new viral variants, such as BA.4 Andreano E. Nature Communications. Will Bedingfield. ” Clinical trials are underway.

DNA 52

DNA RNA Engineering Licensing 52

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.

FDA 52

FDA Biosimilars Science Production 52

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. Polio/Pertussis/Hib vaccines (incl. Influenza vaccines (incl. Meningitis/Pneumo vaccines (incl.

Vaccine 52

Vaccine Production FDA Disease 52

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.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. VACCINATIONS: Avoid use of live vaccines with Olumiant.

Trials 52

Trials Therapies Treatment Clinical Trials 52

Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

FDA 40

FDA FDA Approval Production Regulations 40

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.

Treatment 52

Treatment Clinical Trials Therapies Drugs 52

Agency IQ

MAY 31, 2024

For example, states a footnote, sponsors can already “leverage their own data previously submitted in an [investigational new drug] IND, [new drug application] NDA, or [biologic license application] BLA” while other applicants can “leverage certain information in an approved NDA or BLA (e.g., which would never be acceptable.

Science 40

Science FDA Production Licensing 40

Codon

JULY 14, 2024

Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. Hemopure, the only FDA-approved HBOC product, is a bovine hemoglobin that is chemically crosslinked (that is, several hemoglobin molecules are bound to each other) to improve its stability.

Production 131

Production Clinical Trials Trials Therapies 131

The Pharma Data

FEBRUARY 13, 2022

If approved, Dupixent will be the first biologic medicine available in the U.S. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Source link: [link].

FDA 40

FDA Disease Treatment FDA Approval 40

The Anticancer Fund

JUNE 23, 2023

In this small (n=10) proof of concept trial colorectal cancer patients undergoing surgical resection were injected intratumourally with flu vaccine. They screened 20 FDA approved AEDs against a panel of six patient-derived IDHmut glioma stem-like cells. The primary outcome was safety, which was confirmed.

Drugs 52

Drugs Trials Clinical Trials Treatment 52

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?

DNA 52

DNA Engineering Therapies Virus 52

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?

DNA 52

DNA Engineering Therapies Virus 52

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.

Licensing 52

Licensing Licensing Clinical Trials Trials 52

The Pharma Data

NOVEMBER 20, 2020

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. Casirivimab and imdevimab injection is not FDA approved for any use. Source: Regeneron.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

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).

Government 52

Government Vaccine Production Licensing 52

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.

Vaccine 52

Vaccine Clinical Trials Trials Licensing 52

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.

Biosimilars 40

Biosimilars FDA Production Treatment 40

Agency IQ

NOVEMBER 3, 2023

Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway. These reasons tend to become self-evident when the other regulatory classifications are understood.

Therapies 40

Therapies Science FDA Production 40

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.

Vaccine 52

Vaccine RNA Clinical Trials Science 52