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. CEO and Co-founder of BioNTech. “We We are pleased to work with U.S.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

DrugBank

MAY 6, 2024

Unlike conventional chemical-based medicines, biologics offer targeted therapies derived from living cells, which can result in more effective and personalized treatments. A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals.

FDA Approval 66

FDA Approval Therapies Treatment Clinical Trials 66

The Pharma Data

MAY 7, 2021

. 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 ). Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ).

Vaccine 52

Vaccine Compounding Pharmacies Regulations Drugs 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. KENILWORTH, N.J.–(BUSINESS

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

The Pharma Data

MARCH 15, 2022

Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D.,

FDA Approval 52

FDA Approval FDA Production Pharmaceuticals 52

The Pharma Data

JANUARY 29, 2021

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.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 29, 2021

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.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

The Pharma Data

JANUARY 6, 2021

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.

Vaccine 52

Vaccine Virus Clinical Trials Government 52

The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

Vaccine 52

Vaccine FDA Clinical Trials FDA Approval 52

The Pharma Data

APRIL 7, 2023

Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. “It Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”

FDA 40

FDA FDA Approval Production Vaccine 40

The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. ERLEADA ® is an androgen receptor (AR) inhibitor indicated for the treatment of patients with nmCRPC and for the treatment of patients with mCSPC. 10 months. [5]

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

Agency IQ

JUNE 17, 2024

And even if not, the doctor must participate in the medical treatment that facilitates an abortion. The Doctors allege that being made to provide this treatment conflicts with their sincerely held moral beliefs and violates their rights of conscience. They were not subject to any direct regulation by the FDA related to mifepristone.

FDA 40

FDA Doctors Testimonials Regulations 40

The Pharma Data

APRIL 27, 2021

Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” said Christopher Arendt, head, Oncology Therapeutic Area Unit, Takeda. “We We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines.

FDA 52

FDA Treatment Pharmaceutical Companies FDA Approval 52

Agency IQ

DECEMBER 1, 2023

Over the course of the PHE—which spanned more than three years—the FDA used its expanded authority extensively to issue new direct-to-final guidance documents, creating over 80 in total. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

FDA 40

FDA Clinical Trials Vaccine Trials 40

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).

Drugs 52

Drugs Trials Clinical Trials Treatment 52

The Pharma Data

JULY 21, 2021

mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. Bayer also issued a news release earlier today announcing the EC approval. In the EU, VERQUVO (2.5

Treatment 52

Treatment Production FDA Approval Hospitals 52

The Pharma Data

JUNE 18, 2021

Efficacy data reported based on randomized treatment. RINVOQ can be an important treatment option to help rheumatologists provide their patients with long-term maintenance of improvements in disease activity.” The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment.

Treatment 40

Treatment Therapies Clinical Trials Disease 40

The Pharma Data

APRIL 26, 2022

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population. director of the FDA’s Center for Drug Evaluation and Research.

FDA Approval 52

FDA Approval FDA Treatment Vaccine 52

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. The regulation of dietary supplements in the U.S.

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

NOVEMBER 12, 2021

Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. Today, the U.S.

FDA Approval 40

FDA Approval FDA Disease Treatment 40

The Pharma Data

APRIL 28, 2021

Second EU approval in less than 12 months for Sarclisa in combination with a standard of care regimen for the treatment of relapsed or refractory MM. This marks the second EC approval of Sarclisa in combination with a standard of care regimen in less than 12 months. “ This EC approval closely follows the U.S.

Therapies 40

Therapies Clinical Trials Treatment Disease 40

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.,

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

JUNE 18, 2021

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

Treatment 40

Treatment Disease FDA Vaccine 40

Drug Discovery World

MAY 11, 2023

Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases. In these cases, injection of the viral vector vaccines induced the production of antibodies recognising platelet factor 4 (PF4) found on patients’ platelets 1.

Production 130

Production Vaccine Immune Response Therapies 130

The Pharma Data

JUNE 18, 2021

“We are dedicated to helping more people living with rheumatoid arthritis reach their treatment goals aimed at remission or low disease activity,” said Mudra Kapoor, M.D., Efficacy data reported based on randomized treatment groups. 100PY on HUMIRA, including non-treatment emergent deaths. years of treatment.

Treatment 40

Treatment Disease Therapies Clinical Trials 40

The Pharma Data

DECEMBER 30, 2020

30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. This is the first authorisation for this vaccine.

Vaccine 52

Vaccine Clinical Trials Virus Government 52

Drug Discovery World

AUGUST 1, 2023

Also from Alnylam, in September 2022, the European Commission (EC) has granted marketing authorisation for the company’s AMVUTTRA (vutrisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis. Though some genetic mutations are harmful, others can be protective.

RNA 130

RNA Vaccine Drugs Disease 130

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.

Production 115

Production Clinical Trials Trials Therapies 115

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

JUNE 18, 2021

. “We are encouraged by these promising results, which indicate ibrutinib and venetoclax combined has the potential to serve as an important chemotherapy-free, fixed-duration treatment option for people living with CLL,” said Dr. Paolo Ghia , M.D., 95% irrespective of subsequent randomized treatment ( Wierda, ASH 2020 ).

Treatment 40

Treatment FDA FDA Approval Therapies 40

The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. The issuance of an EUA is different than an FDA approval.

FDA 40

FDA Treatment Hospitals Vaccine 40

The Pharma Data

NOVEMBER 21, 2020

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. SILVER SPRING, Md. , Hahn , M.D.

FDA 40

FDA Treatment Hospitals Clinical Trials 40

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. .

Therapies 130

Therapies Clinical Trials Production Trials 130

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

DECEMBER 8, 2020

“Our vision is to discover and deliver life-transforming treatments guided by our commitment to patients, our people and the planet,” said Christophe Weber, Takeda president and chief executive officer. To date, it has received both Breakthrough Therapy designation and Orphan Drug designation from the FDA.

Pharmaceutical Companies 52

Pharmaceutical Companies FDA Approval Therapies Vaccine 52

The Pharma Data

JUNE 18, 2021

The safety profile of I+V was generally consistent with the safety profile of the single agents and tolerability profiles were consistent with CLL treatment in the enrolled patient population. Three months after the completion of treatment uMRD was observed in 51.9% and 17.1%, respectively. vs. 11.4%) (p < 0.0001). .

Treatment 52

Treatment Therapies FDA FDA Approval 52

Drug Discovery World

APRIL 17, 2023

She said it is not always feasible to offer treatment that will permit the mother to live long enough for the pregnancy to reach viability. Read more here. overall response rate. On the other hand, Dr Virginia Borges shared insight on the importance of reproductive rights for pregnant women facing cancer.

Research 130

Research FDA Approval Therapies Treatment 130