The Pharma Data

SEPTEMBER 1, 2021

Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Results found that 92.5 1 The most common adverse reactions (?5%) Click here to learn more: [link].

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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The Pharma Data

MARCH 30, 2021

2] – The atogepant application demonstrates AbbVie’s longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine. .

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KIF1A

APRIL 25, 2024

Her mother, Megan, has offered to share their experience and journey with everyone to help us understand the process and to share in their hopes, fears, challenges, and successes that come along with ASO treatment. However, we needed to wait for Susannah to finish her trial before we could submit to the FDA for Sloane’s ASO use.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. BASEL, Switzerland, Dec.

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The Pharma Data

DECEMBER 12, 2020

In some disappointing vaccine news, Sanofi and GlaxoSmithKline said Friday that their experimental coronavirus vaccine did not work well in older adults, delaying the start of their late-stage clinical trial that had been set to begin in the United States in December, the Times reported.

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Drug Discovery World

APRIL 14, 2023

Pettit Nassi and Perlmutter will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET. Simon’s award lecture will be held on Sunday April 16 at 3pm ET.

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The Pharma Data

JUNE 18, 2021

June 8, 2021 /PRNewswire/ — Allergan Aesthetics, an AbbVie company (NYSE: ABBV ), is changing the way BOTOX ® Cosmetic, the #1 selling neurotoxin treatment 1 , is connecting with consumers. IRVINE, Calif. Experience the interactive Multimedia News Release here: [link] . Each story is unique. Each story is unique.

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The Pharma Data

APRIL 6, 2022

Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. . Robinson, M.D., ” About Presbyopia.

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The Pharma Data

MARCH 7, 2022

Teva’s Lenalidomide capsules are a prescription medicine used in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone, (2) certain myelodysplastic syndromes, and (3) mantle cell lymphoma following specific prior treatment. Please see the below “What are lenalidomide capsules?”

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The Pharma Data

SEPTEMBER 10, 2021

Long-Term Real-World Effectiveness of Carbidopa/Levodopa Enteral Suspension After 36 Months of Treatment Initiation: Final Results from PROviDE Study. OnabotulinumtoxinA Treatment in Patients with Upper Limb and Lower Limb Spasticity from the ASPIRE Study. BOTOX ® Abstracts.

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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. mL, p=0.002).

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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

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The Pharma Data

APRIL 1, 2021

” Recently, the European Commission (EC) approved RINVOQ (15 mg) for use in adults with active psoriatic arthritis. . ” The safety profile of upadacitinib was generally similar to results reported previously in rheumatoid arthritis trials. The long-term extension of the trial is ongoing. percent), zero, four (0.9

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The Pharma Data

DECEMBER 11, 2020

Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, has already said it plans to begin shipping the vaccine to all 50 states within 24 hours of an FDA approval. Instead, a modified version of the vaccine will be tested in a smaller trial set to begin in February, the newspaper said.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done. Earlier results were published in Nature Medicine.

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Codon

JULY 14, 2024

The transfusion of platelets thus seems like an obvious treatment to stem bleeding. However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial.

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The Pharma Data

SEPTEMBER 8, 2021

–Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine –These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum.

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The Pharma Data

JANUARY 26, 2021

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., INDIANAPOLIS, Jan. Across 1,035 patients, there were 11 events (2.1 have reached record highs.

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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 ).

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Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA.

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Drug Target Review

AUGUST 3, 2023

Precision medicine , with its focus on personalised treatments tailored to an individual’s genetic makeup, has seen remarkable progress in recent years. What preclinical research methods are commonly employed in precision medicine, and how do they contribute to the development of personalised treatments?

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) for the use of XARELTO ® (rivaroxaban) in pediatric patients. If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. for use in pediatric patients. Learn more: [link].

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The Pharma Data

NOVEMBER 4, 2020

REDUCE-IT RENAL results presented in October 2020 showed, through prespecified and post hoc subgroup analyses, that patients in the REDUCE-IT study who had compromised renal function at baseline prior to treatment with VASCEPA or placebo, experienced higher rates of cardiovascular events than the overall population studied in REDUCE-IT.

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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). .

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) for the use of the oral anticoagulant Xarelto (rivaroxaban) in pediatric patients. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. EINSTEIN-Jr. About the EINSTEIN-Jr.

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The Pharma Data

MAY 13, 2021

In this special report, I’m going to show you why researchers at Harvard University and the Massachusetts General Hospital in Boston are now praising a strange new pain treatment originally discovered on the International Space Station. WITHOUT doctors, physical therapists or chiropractors. And then got my Doctor of Pharmacy (Pharm.

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The Pharma Data

OCTOBER 25, 2020

Real-world effectiveness data on Oxbryta ® (voxelotor) in the treatment of sickle cell disease featured as oral presentation. Two abstracts have been accepted for presentation, including real-world effectiveness data of Oxbryta ® (voxelotor) tablets in the treatment of sickle cell disease (SCD). FDA approval. 26-31, 2020.

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The Pharma Data

JUNE 18, 2021

Additionally, new data will be presented during the European Hematology Association (EHA) Virtual Congress from June 9-17 , including findings from the informCLL real-world prospective observational registry assessing how real-world treatment patterns align with National Comprehensive Cancer Network (NCCN ® )-recommended regimens for CLL/SLL.

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The Pharma Data

JANUARY 4, 2021

Food and Drug Administration (FDA) , in combination with Tecentriq ® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. chief medical officer and head of Global Product Development. “We

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The Pharma Data

OCTOBER 24, 2020

Remdesivir gets full FDA approval to treat COVID-19. Remdesivir’s full approval Thursday by the U.S. National Institutes of Health, the FDA announced in a statement. Remdesivir is either approved or has temporary authorization in about 50 countries, Parsey noted. 22 news release.

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The Pharma Data

OCTOBER 23, 2020

Remdesivir gets full FDA approval to treat COVID. Remdesivir’s full approval Thursday by the FDA comes after the agency granted it emergency use authorization last spring. National Institutes of Health, the FDA announced in a statement. Doctors say this reflects India’s younger and leaner population.

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The Pharma Data

AUGUST 9, 2021

as a single-dose 150 mg injection for the treatment of adults with moderate to severe plaque psoriasis. “That’s why we’re proud to provide an updated SKYRIZI treatment experience that allows for fewer injections of the same SKYRIZI that patients and providers have come to know and trust.” ” The U.S.

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PLOS: DNA Science

JANUARY 11, 2024

The physician assistant mentions he’ll need two extra vials of blood for new cancer screening tests, one just FDA-approved, the other available as part of a clinical trial. A treatment begun early is more likely to work. A 52-year-old woman is at her annual physical exam. ” Researchers at Novelna Inc.

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The Pharma Data

OCTOBER 27, 2020

27, 2020 — Testing of Eli Lilly’s antibody drug for hospitalized COVID-19 patients has been halted because the treatment doesn’t help them recover from their infection. Chris Christie said he had received Lilly’s experimental treatment shortly after he was diagnosed with COVID-19, The New York Times reported.

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The Pharma Data

MAY 4, 2021

and developed Europe following the approvals in 2019 for combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma; as well as. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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