The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. In that case, the NDA sponsor applied for two PTEs based on these approvals—one for either U.S.

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The Pharma Data

DECEMBER 29, 2020

an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. galactosidase-A product candidate under development for the treatment of Fabry disease.

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The Pharma Data

DECEMBER 18, 2020

Roxadustat is approved in China, Japan (under the name Evrenzo), and Chile for the treatment of anemia in CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. J Am Soc Nephrol (2012); 23:1631-1634. Related Articles: Roxadustat FDA Approval History. Available from: URL: [link] 2.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. That PTE application was submitted to the PTO on July 26, 2012.

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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.

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Codon

AUGUST 26, 2024

In 2012, a research group at MIT isolated the major components of mucus from pig stomachs (“porcine gastric mucins”) and tested its ability to inhibit infections caused by human papillomavirus, influenza virus, and Merkel cell polyomavirus. One solution is to use broad-spectrum antiviral prophylactics rather than treatments.

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The Pharma Data

DECEMBER 30, 2020

The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Posted: December 2020.

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Drug Target Review

JUNE 21, 2023

4 For the treatment of rare genetic disorders especially, drugs with genetically supported targets are more than twice as likely to be approved 5 , thereby indicating genetics and genomics can empower companies to develop better drugs. Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Specifically, after 2 to 4 weeks of treatment with this combination of two correctors and a potentiator, such patients experienced about a 10 percentage point improvement in forced expiratory volume in 1 second (FEV1), which is a key measure of lung capacity. About 30,000 Americans have CF.

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The Pharma Data

FEBRUARY 8, 2021

No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the control arm.

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The Pharma Data

AUGUST 3, 2021

“As we look to the balance of the year, we are excited to be launching LUMAKRAS , a first-in-class lung cancer treatment, and advancing a robust pipeline of potential new medicines to meet the demands of patients around the world.” LUMAKRAS received accelerated approval based on overall response rate and duration of response.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. Novo Nordisk.

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Agency IQ

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended. Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

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The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

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Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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The Pharma Data

OCTOBER 9, 2021

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). There are currently no approved treatments for eosinophilic esophagitis in the US. Currently there are no FDA-approved treatments for EoE.

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The Pharma Data

OCTOBER 21, 2020

It’s reassuring to know that even in the midst of a global pandemic that has led to restricted access to some clinics and providers, there were few injection visit interruptions and those that occurred were effectively managed by providing participants with oral treatment. Shionogi joined in October 2012. Kimberly Smith, M.D.,

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The Pharma Data

AUGUST 22, 2021

today that the European Commission (EC) has approved XELJANZ ® (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc.

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PLOS: DNA Science

DECEMBER 21, 2023

Martin’s Press was about to publish my book about gene therapy in 2012, my agent urged me to start blogging. It’s a history of gene therapy told through the voices of the patients, families, researchers, and clinicians behind the first FDA approvals, which didn’t come until 2017.

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The Pharma Data

OCTOBER 30, 2020

Gilead’s Veklury (remdesivir) is First Approved Treatment for COVID-19 . In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). FDA Approves Opdivo + Yervoy for Malignant Pleural Mesothelioma. .

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Drug & Device Law

MAY 11, 2023

Its staff has a broad view tied to public health considerations, available drug and non-drug treatment options, data that may not be publically available, and decades of experience with the subject matter. That all matters because judges lack that expertise, broad view, and experience. This also includes “ology” confusion. Sebelius , 671 F.3d

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Drug & Device Law

JULY 24, 2023

The drug is still on the market, and it has other risks that the FDA has found significantly more serious – requiring a boxed warning – than a three-one hundredths-of one-percent (0.0003) increase in absolute incidence of bladder cancer. But the FDA has concluded just the opposite. PATDC82 I , 943 F.3d 3d at 1251.

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Drug & Device Law

JANUARY 4, 2024

2012), we hailed it as the best decision of 2012. The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. Hamilton , 372 S.W.3d

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Drug & Device Law

FEBRUARY 2, 2023

2012 WL 956192, at *5 (S.D. March 19, 2012); Holland v. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. . . . 2012) (applying Texas law). Centocor, Inc. Hamilton , 372 S.W.3d 3d 140, 165 (Tex. 448 F.Supp.3d

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