The Pharma Data

JULY 29, 2021

It has been studied in over 4,000 patients in 41 clinical trials across a number of eosinophilic indications and has been approved under the brand name Nucala in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA. It is not currently approved for use in COPD anywhere in the world.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

pharmaphorum

APRIL 6, 2022

The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July. FDA clears Vijoice for rare overgrowths.

Drugs 52

Drugs Licensing Licensing FDA Approval 52

XTalks

FEBRUARY 20, 2024

“The results of the Phase II trial in patients with IgA nephropathy have been encouraging, and we look forward to completion of the Phase III trial and submission of the Biological Licensing Application (BLA) to the US FDA and other global regulatory authorities,” said Brian J. Pereira, MD, chief executive officer of Visterra Inc.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Symbicort brought in worldwide sales of $2.7 billion last year, with $1.1

FDA Approval 57

FDA Approval Generic Drugs Marketing Drug Delivery 57

Pharmacy Checkers

FEBRUARY 12, 2021

Simple summary: Canada’s brand drugs are priced much lower and states want access to them. The channel of importation is confined to a wholesaler in Canada exporting FDA-approved drugs to a state-licensed wholesaler in the United States. These state laws have largely been confined to wholesale drug importation.

Drugs 71

Drugs Pharmacy Licensing Licensing 71

Pharmaceutical Technology

NOVEMBER 9, 2022

Known by the brand name Roctavian, BioMarin’s haemophilia A therapy valoctocogene roxaparvovec could be fairly priced in the range of $1.95–1.96 An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. CSL Behring has a commercialisation and license agreement to develop EtranaDez.

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec.

Licensing 40

Licensing Licensing Production Development 40

pharmaphorum

FEBRUARY 9, 2021

Rukobia works by targeting the first step of the HIV lifecycle and doesn’t have cross-resistance with other currently licensed antiretroviral classes, re-establishing virus control in patients who are at risk of disease progression and death.

FDA Approval 91

FDA Approval Licensing Licensing Branding 91

pharmaphorum

DECEMBER 14, 2020

Ruxolitinib is already FDA approved under the brand name Jakafi to treat the bone marrow diseases myelofibrosis, polycythemia vera and graft-versus-host disease. Originally developed by Incyte, Novartis licensed in the drug for development and marketing outside the US.

Trials 52

Trials FDA Approval Licensing Licensing 52

Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. This figure represents a 2.4% increase over the 2016–2020 period average.

Drugs 130

Drugs Pharma Companies Sales Production 130

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials In-Vitro 52

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments.

Licensing 52

Licensing Licensing Drugs Gene 52

The Pharma Data

MAY 2, 2022

Teva Branded Pharmaceutical Products R&D, Inc. Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances.

Production 52

Production Containment Medicine FDA Approval 52

XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

Filler 92

Filler FDA Approval Dermatology Production 92

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1.

Medicine 52

Medicine Scientist Production Regulation 52

The Pharma Data

AUGUST 6, 2020

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

Production 52

Production Branding Marketing Licensing 52

The Pharma Data

NOVEMBER 5, 2020

With these new exclusive and parity formulary positions, Xtampza ER will be the exclusive branded ER oxycodone for more than 92 million lives and will be in a parity position for approximately 22 million lives. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc.

Production 52

Production Marketing Sales Manufacturing 52

XTalks

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

AUGUST 3, 2021

New-to-brand prescription (NBRx) volumes grew 10% year-over-year, even as patient visits to dermatologists remained 15% below pre-pandemic levels. LUMAKRAS received accelerated approval based on overall response rate and duration of response. In the U.S., Otezla continued to maintain first-line share leadership in psoriasis.

Sales 52

Sales Production Antibody Development 52

Delveinsight

AUGUST 12, 2021

LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. Zebra Medical is anticipated to be run as a wholly-owned subsidiary under the Nanox brand. AbbVie reported the success of two phase 3 trials of its drug trial in October and filed for FDA approval in February.

Trials 97

Trials Clinical Trials Clinical Trials Regulation 97

The Pharma Data

OCTOBER 20, 2020

With drug resistance and safety concerns continuing to rise with currently available treatment options, oteseconazole has the potential to differentiate itself from the azole drugs considered standard of care, and be the first FDA approved drug to help women with RVVC who have been largely ignored for too long.”.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Production 52

Pharmacy Checkers

DECEMBER 12, 2019

When it comes to the approval of new drugs, brand and generic, the systems of the U.S. The two agencies almost always agree on which drugs should be approved, although there is some dialog of a potential growing divergence. drug regulatory system, see: How FDA Approves Drugs and Regulates Their Safety and Effectiveness.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

Pfizer

OCTOBER 20, 2022

Food and Drug Administration (FDA) approved PREVNAR 20® for the prevention of invasive disease and pneumonia in adults age 18 years or older. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay.

Vaccination 40

Vaccination Vaccine Containment Immune Response 40

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). Growth was offset by declines in Established Medicines and mature Ophthalmology brands.

Sales 40

Sales Medicine Production Manufacturing 40

The Pharma Data

APRIL 27, 2021

due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Dupixent ® total prescriptions (TRx) increased 51% ( year-over-year ) and new-to-brand prescriptions (NBRx) grew 16% despite fewer in-person physician visits which remain below the pre-COVID level. Sarclisa ® is already approved in the U.S

Sales 52

Sales Vaccination Vaccine Medicine 52

Pharmacy Checkers

OCTOBER 11, 2019

It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. The discussion below applies to brand-name (not generic) drugs. After all, they are either “FDA-approved” or not.

FDA Approval 55

FDA Approval Drugs Manufacturing Pharmacy 55

Delveinsight

AUGUST 13, 2020

Approval History: In September 2017, FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Mometasone furoate is exclusively licensed to Novartis from a subsidiary of Merck & Co.,

Antibody 40

Antibody Medicine Trials Development 40

Pharmacy Checkers

JANUARY 4, 2020

The FDA states: “Contributing to public frustration on this issue is the disparity between prices that Americans pay for brand name medications as compared with other developed countries…For instance, in 2017, Canada’s Patented Medicine Prices Review Board (PMPRB) found that patented medicines (i.e., 15 and 16).

Drugs 58

Drugs Pharmacy Medicine Regulation 58

The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). If approved, TicoVac would be the first vaccine in the U.S.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

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Doctors Doctor Drugs Sales 242

Pharmacy Checkers

AUGUST 2, 2019

Before diving into Trump’s drug importation plan more fully, please take note that this plan actually allows for the importation of what the FDA has called “foreign unapproved drugs,” ones that they have said they don’t want Americans ordering online and importing for their own use. The FDA-approved version of a 40 mg pill is in capsule form.

Drugs 69

Drugs FDA Approval Pharmacy Cosmetics 69

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. Part J is written in three sections.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41