The Pharma Data

SEPTEMBER 6, 2020

Basel, 7 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

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The Pharma Data

SEPTEMBER 28, 2020

Today’s approval gives these patients access to biologic treatment for the first time and demonstrates our commitment to maximising Nucala’s impact on eosinophil-driven diseases. “. It also received approval in 2019 to treat severe eosinophilic asthma in children. .

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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Advarra

AUGUST 16, 2022

A rare, or orphan, disease by definition affects a small percentage of the population — fewer than 200,000 people in the U.S. But the numbers add up, and taken together, rare diseases impact an estimated 30 million Americans. Food and Drug Administration (FDA) approval. The FDA Since 1983. FDA Expedited Programs.

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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]

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The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer. Gilead Sciences, Inc. Source link: [link].

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The Pharma Data

OCTOBER 31, 2020

Kuo-Lung Huang , the Chairman and CEO of TaiGen notes, “Influenza is a life threatening disease with significant unmet medical needs and high medical burden. With the IND approval in place, we are ready and eager to extend the clinical study of TG-1000 to the U.S. billion USD in 2019 and is estimated to reach 5.03

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The Pharma Data

AUGUST 31, 2020

Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV – from appropriate counseling on disease differences to targeted therapy. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2

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The Pharma Data

MAY 6, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. For more than 170 years, we have worked to make a difference for all who rely on us.

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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The Connected Lab

APRIL 8, 2020

For patients suffering from an illness with no approved treatment, the wait can be unnerving. To this day, more than 400 million people suffer from rare diseases and 95% of rare diseases lack an FDA approved treatment 3. Billion; Approval Rate for Drugs Entering Clinical Development Is Less Than 12%.”

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The Pharma Data

FEBRUARY 25, 2022

Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

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Agency IQ

MAY 17, 2024

The Creating Hope Reauthorization Act would reauthorize the FDA’s Rare Pediatric Disease Priority Review Voucher program. The markup hearing comes three months after the E&C Committee last held a hearing on 18 bills related to rare diseases, including all four of the above-mentioned bills. DORIS MATSUI (D-Calif.)

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The Pharma Data

JANUARY 20, 2021

Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet ® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021. Since its U.S. Esbriet U.S.

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Alta Sciences

APRIL 17, 2024

Ketamine is a dissociative anesthetic approved in 2019 by the U.S. Food and Drug Administration (FDA) as a nasal spray called esketamine, for treatment-resistant depression. Gene Therapy Gene therapy is currently considered for diseases, often rare, that have no other cures.

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The Pharma Data

SEPTEMBER 8, 2020

OCREVUS CHIMES study exclusively focused on disease insights and more tailored care for minority populations with MS. We remain committed to advancing the science in MS by investigating potential new medicines such as fenebrutinib, with the ultimate goal of halting progression of this disease,” said Levi Garraway, M.D.,

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The Pharma Data

APRIL 4, 2023

Food and Administration (FDA) approval for nmCRPC in February 2018, and received U.S. FDA approval for mCSPC in September 2019.To About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. Source link: [link]

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The Pharma Data

SEPTEMBER 10, 2020

75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to OCREVUS in open-label Phase IIIb CASTING study. About multiple sclerosis Multiple sclerosis (MS) is a chronic disease that affects nearly 1 million people in the U.S.

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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). The approval marks the first drug approved by the U.S. Organizational Actions/Announcements .

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New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] June 2019). 1] It is taken by mouth. [1] PMID 36871574. ^ July 2022).

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The Pharma Data

NOVEMBER 8, 2021

. “Amgen is dedicated to helping the millions of people who live with this debilitating neurological disease get back to what’s important to them while living with more migraine-free days.” 4,5 Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor.6

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The Pharma Data

JANUARY 7, 2021

Securities and Exchange Commission (the “SEC”) on September 27, 2019 and declared effective on October 24, 2019, and the accompanying prospectus contained therein. Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases.

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The Pharma Data

AUGUST 6, 2020

Our second quarter results reflect the passion and focus of our employees, who continue to introduce new medicines, support patients with serious diseases and deliver strong results during the COVID-19 pandemic,” said Giovanni Caforio, M.D. Otezla® Divestiture) occurred on January 1, 2019 and exclude foreign currency hedge gains and losses.

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New Drug Approvals

DECEMBER 16, 2023

2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. 2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. April 2019). 1] It is a complement factor B inhibitor that was developed by Novartis. [1] 5 December 2023.

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The Pharma Data

SEPTEMBER 28, 2021

Our goal is to still lead the way in developing transformative medicines for neuromuscular diseases. We are grateful for the partnerships that are helping us to develop new therapies for people impacted by these devastating rare diseases.”. About SMA SMA may be a severe, progressive neuromuscular disease which will be fatal.

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Drug Target Review

JULY 5, 2024

Since brain organoids can be derived from either diseased or healthy patients, they can recapitulate human (patho)physiology making them a better choice compared to mammalian cell systems that often fail to recapitulate the human phenotype. 22:669-679 (2019). Companies using organoids and focused on cross-therapeutic areas.

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The Pharma Data

NOVEMBER 12, 2020

The CALAVI programme comprised two Phase II trials investigating acalabrutinib plus BSC versus BSC alone in hospitalised patients with COVID-19 disease. Results from the CALAVI Phase II trials do not impact approved indications or pending approvals for Calquence in patients with blood cancers. Wu J, Zhang M & Liu D.

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The Pharma Data

JULY 12, 2021

Evidence has demonstrated that Johnson & Johnson’s single-shot COVID-19 vaccine offers protection against COVID-19 disease and prevents hospitalization and death, including in countries where viral variants are highly prevalent. There is no FDA-approved vaccine to prevent COVID-19. What Is the Janssen COVID-19 Vaccine?

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The Pharma Data

APRIL 8, 2021

“While COV-BARRIER did not hit the primary endpoint based on stages of disease progression, the data show that baricitinib meaningfully reduced the risk of mortality above and beyond the recommended standard of care, without additional safety risks. Wesley Ely, M.D., and 14.7%, respectively) and placebo (44.4% Warnings and Precautions

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The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

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The Pharma Data

DECEMBER 9, 2020

The targeted indication is for treatment of adult and paediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).

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The Pharma Data

NOVEMBER 9, 2021

The forthcoming civil multidistrict action (MDL) presently listed for October 2019 includes multiple defendants and a number of different claims. Food and Drug Administration (FDA)-approved and since launch, have reckoned for lower than one percent of total opioid conventions in Oklahoma as well as the United States.

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The Pharma Data

JUNE 26, 2021

Libtayo is now approved for three advanced cancers in the European Union, following the EC’s concurrent approval of Libtayo for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumor cells have ?50% 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.

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The Pharma Data

JUNE 26, 2021

The EC also approved Libtayo in advanced basal cell carcinoma, the first treatment to be indicated for those patients who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

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The Pharma Data

FEBRUARY 24, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. For more than 170 years, we have worked to make a difference for all who rely on us.

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