The Pharma Data

OCTOBER 26, 2020

Kala Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. Roughly 16.4 million U.S. INVELTYS launched in the U.S.

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The Pharma Data

JUNE 17, 2022

“By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fueling pharmaceutical innovation.”. The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL.

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New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

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New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA).

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New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] The FDA granted the application for palopegteriparatide orphan drug and priority review designations. [5] Food and Drug Administration (FDA) (Press release). 14 August 2024.

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Drug Target Review

JULY 5, 2024

Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. Pharmaceutics. Pharmaceutics. 15(9):700-706 (2018) [link] Deshmukh V, et al. Nature Neuroscience. 22:669-679 (2019).

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

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New Drug Approvals

AUGUST 26, 2023

Zuranolone CAS 1632051-40-1 Zurzuvae FDA APPROVED 8/4/2023, To treat postpartum depression Press Release WeightAverage: 409.574 Monoisotopic: 409.272927379Chemical FormulaC 25 H 35 N 3 O 2 SAGE 217 SAGE-217 SAGE217 Zuranolone , sold under the brand name Zurzuvae , is a medication used for the treatment of postpartum depression. [1]

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Drug Target Review

AUGUST 3, 2023

An analysis of all terminated trials within the Clinical Trials Database by GlobalData in 2018 found the single highest reason for trial termination – at 55 percent of total trials – was a low enrolment rate. And precision medicine studies suffer from challenges common to all clinical trials, such as poor enrolment and retention rates.

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The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

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Practical Cheminformatics

AUGUST 3, 2023

Most pharmaceutical compounds tend to have solubilities somewhere between 1 and 500 µM. I wrote more about the problems with this dataset in a Practical Cheminformatics post in 2018. Over the last 40 years, the pharmaceutical industry has developed a wide range of invitro and invivo assays for assessing the safety of drug candidates.

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Agency IQ

JUNE 7, 2024

However, this means that substances that were already available as dietary ingredients prior to their sponsors submitting an IND or obtaining FDA approval may still be marketed as such. L-glutamine offers an example of a more recently approved drug product. FDA’s problems with supplement oversight go well beyond just NDIs.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

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Eye on FDA

AUGUST 4, 2021

The blue represents the number of AdComms, Orange the number of new molecular entities and the gray the number of BT designations (Note that 2021 figures are through June 30): What we can see here is that there is a significant body growing of BT designated compounds and a growing number, generally speaking, of new molecular entities being approved.

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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. medRxiv; 2023.

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Metabolite Tales Blog

MAY 12, 2023

Now >20% of all commercialised medicines in the pharmaceutical industry contain a fluorine atom [2]. In 2021, almost one third of FDA approved drugs contained at least one fluorine. References [1] Metabolic and Pharmaceutical Aspects of Fluorinated Compounds. Benjamin M. Bourgeois, James A. Perkins, Arsany A.

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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). Venclexta, an oral B-cell lymphoma-2 (BCL-2) inhibitor, was previously granted provisional approval in Nov.

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The Pharma Data

SEPTEMBER 9, 2020

ENSPRYNG is the first and only FDA-approved subcutaneous, self-administered medicine for NMOSD and the first medicine for NMOSD that is designed to target the interleukin-6 receptor, which is believed to play a key role in the inflammation associated with this disorder.”. ENSPRYNG has been designated as an orphan drug in the U.S.,

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The Pharma Data

SEPTEMBER 28, 2021

Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Evrysdi for the treatment of SMA in adults and youngsters 2 months aged and older. Evrysdi was granted PRIME designation by the EMA in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively.

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The Pharma Data

DECEMBER 30, 2020

based company made waves in December when it acquired Alexion Pharmaceuticals and its rare diseases platform in a $39 billion deal. Soliris has been approved for paroxysmal hemoglobinuria (PNH), atypical hemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder. But the U.K.-based

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Dark Matter Blog

AUGUST 27, 2020

In addition to the early work of Matt Disney at the Scripps Research Institute and others in the academic community showing that this was even possible, a number of pharmaceutical companies have made important advances towards drugging RNA structures to discover new therapeutics.

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Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Toronto, Ontario–(Newsfile Corp. – January 25, 2021) – PharmaDrug Inc. About PharmaDrug Inc. PharmaDrug Inc.

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The Pharma Data

APRIL 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the availability of an additional tablet strength of ERLEADA ® (apalutamide) in the United States. Food and Administration (FDA) approval for nmCRPC in February 2018, and received U.S. FDA approval for mCSPC in September 2019.To

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The Pharma Data

JUNE 26, 2021

Application seeks two pediatric indications, including an age-appropriate new weight-based oral suspension formulation to help minimize dosing errors If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. Food and Drug Administration (FDA) for the use of XARELTO ® (rivaroxaban) in pediatric patients.

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The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Tecentriq’s indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018.

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Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

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Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. Two medicines approved by the EMA in 2023 received FDA approval more than a year earlier, but only as a result of application dates.

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Codon

JUNE 18, 2024

A major breakthrough came in January 2018, when a paper in Nature indicated, for the first time, that gas vesicles could be expressed in E. Credit: Mikhail Shapiro Just consider a pharmaceutical company that wants to test whether an engineered immune cell, such as those used for CAR-T therapy , can detect and destroy cancer cells.

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The Pharma Data

AUGUST 31, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today multiple company-sponsored presentations in prostate and bladder cancers will be highlighted at the virtual 2021 American Urological Association Annual Meeting (AUA 2021), September 10-13. 2] ERLEADA ® received U.S.

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Agency IQ

OCTOBER 6, 2023

While stimulant use disorder is increasing, there are currently no FDA-approved medications. This opener sets the context for a guidance document that addresses drug development in the new space of treatment for stimulant use disorder which, as yet, has no approved medications. What’s next? reported using cocaine, 0.4%

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The Pharma Data

NOVEMBER 4, 2020

As with much of the pharmaceutical industry, VASCEPA revenue and prescription growth have been adversely impacted by the COVID-19 pandemic. Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health.

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The Pharma Data

APRIL 27, 2021

Pharmaceuticals. First-quarter 2021 Pharmaceutical sales increased 3.8% At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Pharmaceuticals business operating income. Sarclisa ® is already approved in the U.S

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Agency IQ

NOVEMBER 3, 2023

In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP. As with dietary supplements, cosmetic products do not need to have FDA approval before they go on the market; they are regulated after the fact.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

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The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Ono Pharmaceutical Co. In the U.S.,

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