pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

FDA

pharmaphorum

APRIL 8, 2021

Gilead’s $21 billion purchase of Immunomedics and its potential blockbuster Trodelvy continues to pay off, as the drug has now been approved by the FDA for triple-negative breast cancer. . months in patients treated with chemotherapy. months in patients treated with chemotherapy. billion in early 2020. .

Chemotherapy

pharmaphorum

SEPTEMBER 21, 2020

But the FDA requires survival data for a full approval, and this is what Immunomedics announced at the European Society for Medical Oncology (ESMO). months in patients treated with chemotherapy. in the chemotherapy arm. months, compared with 6.7 in the Trodelvy arm, compared with 5.4%

Chemotherapy

pharmaphorum

JANUARY 11, 2022

A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. Last year, Biofourmis said its heart failure tool BiovitalsHF was the first DTx to be awarded breakthrough status by the FDA.

FDA

pharmaphorum

MAY 26, 2022

billion takeover of Agios Pharma’s oncology business after getting a key FDA approval for Tibsovo, the main asset in the deal. It can be used in in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Servier is on course to get a return on its $1.8

FDA

pharmaphorum

JANUARY 18, 2021

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder. Until now people with AL amyloidosis have had to rely on chemotherapy, with its accompanying side effects, and other drugs to tackle organ failure once damage gets severe.

Chemotherapy

pharmaphorum

JUNE 11, 2021

Bristol-Myer Squibb has only just won FDA approval for its CAR-T Breyanzi in large B-cell lymphoma (LBCL), but is already eyeing an expansion into earlier-line therapy that could overtake rival therapies from Novartis and Gilead Sciences. The post BMS will file for earlier-line use of Breyanzi in lymphoma after trial win appeared first on.

Chemotherapy

pharmaphorum

NOVEMBER 16, 2020

Phesgo has been recommended by the CHMP for use in combination with chemotherapy in early HER2-positive breast cancer – pre- and post-surgery – as well as for front-line therapy of HER2-positive breast cancer that has already spread in the body. Phesgo is already available in the US, having been approved by the FDA in the summer.

Chemotherapy

pharmaphorum

FEBRUARY 8, 2022

The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday. ” While ODAC could still decide to back the drug at the meeting, the FDA isn’t beholden to follow its experts’ advice.

FDA

pharmaphorum

OCTOBER 4, 2022

AZ and Merck’s drug was also approved as a second-line therapy after Xtandi or Pfizer’s Zytiga (abiraterone) for mCRPC in 2020, but only as a monotherapy in patients with tumours that express homologous recombination repair (HRR) gene mutation – including BRCA1/2 and ATM).

Chemotherapy

Pharmaceutical Technology

FEBRUARY 26, 2023

While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. with placebo.

FDA

pharmaphorum

JANUARY 26, 2021

The European Commission has cleared Bavencio (avelumab) for locally advanced or metastatic urothelial carcinoma (UC) – the most common form of bladder cancer – in cases where cancer hasn’t progressed after platinum-containing chemotherapy. The green light in Europe comes six months after the FDA backed the same use for the drug in the US.

Chemotherapy

European Pharmaceutical Review

MAY 4, 2023

Amivantamab was the first bispecific monoclonal antibody (BsMAb) approved in the EU to treat advanced NSCLC with EGFR exon 20 insertion mutations post chemotherapy. They are not US Food and Drug Administration (FDA)-approved for these patients due to the lack of benefit. 2020; 19(10): 2044–56. Personalized medicine at FDA.

Immunization

pharmaphorum

JANUARY 25, 2023

9,273,135 and 9,320,811, which cover the use of a CTLA4 inhibitor in combination with a PD-1 inhibitor and chemotherapy drug gemcitabine, respectively. Growth for the drug has picked up in the last couple of years, including approval in 2020 as a low-dose add-on to Opdivo in various liver and lung cancer settings. 1:23-cv-00079).

Chemotherapy

pharmaphorum

JULY 15, 2021

Data from the study was published in the New England Journal of Medicine in May 2020, and won tepotinib a breakthrough designation from the FDA. The MHRA said that the standard treatment of non-small cell lung cancer is chemotherapy or immunotherapy with checkpoint inhibitors if there is no targeted therapy available.

Chemotherapy

pharmaphorum

JANUARY 20, 2021

The European approval of Doptelet as a second-line treatment for ITP after therapies such as corticosteroids and immunoglobulin drugs comes after a green light by the FDA in July 2019. According to some analysts it could catapult sales to several hundred million dollars a year, perhaps even broaching the $1 billion threshold.

Chemotherapy

pharmaphorum

JANUARY 26, 2022

The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 billion acquisition of Forty Seven in 2020. The post FDA slaps hold on trials of Gilead’s CD47 drug magrolimab appeared first on.

FDA

pharmaphorum

JULY 19, 2022

China’s Simcere Pharmaceutical has been granted approval in its home market for Cosela, a drug designed to limit the side effects of cancer chemotherapy, partnered with US biotech G1 Therapeutics. Simcere said that the number of new cancer patients requiring chemotherapy in China is expected to reach 4.2

Chemotherapy

Pharmaceutical Technology

JUNE 27, 2022

The transaction is focused on Epizyme’s lead asset, Tazverik (tazemetostat), a chemotherapy-free EZH2 a inhibitor. In 2020, the US Food and Drug Administration (FDA) granted accelerated approval for the drug. The company will begin an all-cash tender offer through its subsidiary to buy Epizyme’s all outstanding shares for $1.45

Chemotherapy

pharmaphorum

MARCH 14, 2022

Prescription digital therapeutics (DTx) company Blue Note is starting a large-scale, decentralised trial of two cancer therapies that it hopes will lead to regulatory approval from the FDA. The study will examine the effects of using two DTx products targeting mental and physical health, as an add-on to standard cancer care.

Chemotherapy

European Pharmaceutical Review

DECEMBER 28, 2023

As a result, when the patient’s lymphoma relapses after treatment with chemotherapy, BV and CPIs, there are no effective treatment alternatives for these patients. We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval.

Immunization

Pharmaceutical Technology

AUGUST 16, 2022

This was followed by a further deal for the global development and commercialisation of another ADC, datopotamab deruxtecan (DS-1062) in 2020, with a deal value of up to $6bn. months compared with patients treated with standard-of-care chemotherapy. overall response rate (ORR), with a median duration of response (DOR) of 8.7

Chemotherapy

pharmaphorum

NOVEMBER 15, 2022

billion in milestone payments to POINT if the two radiotherapeutics get FDA approval and meet commercial objectives, plus royalties on net sales. It is paying $250 million for global rights, with another $250 million forthcoming on FDA approval, plus $1.3 Lantheus is promising up to $1.8 billion in milestone payments.

Chemotherapy

pharmaphorum

FEBRUARY 2, 2021

Incyte has filed its PD-1 inhibitor retifanlimab with the FDA, seeking approval to treat a form of anal cancer associated with human papillomavirus (HPV) and HIV infections. It may get the nod before GlaxoSmithKline’s dostarlimab , also under review at the FDA for endometrial cancer.

Chemotherapy

pharmaphorum

JANUARY 3, 2023

The result is good news for Pfizer, which has exclusive marketing rights to the drug in mainland China under an agreement signed in 2020. Suzhou-based CStone Pharmaceuticals’ checkpoint inhibitor sugemalimab has proved effective in a trial as a first-line therapy for oesophageal cancer, setting up a regulatory filing in China.

Chemotherapy

pharmaphorum

OCTOBER 11, 2020

The phase 3 PENELOPE-B trial was testing the CDK4/6 inhibitor as a potential treatment for early breast cancer patients who have residual invasive disease following neoadjuvant (pre-surgery) chemotherapy, but failed to show an improvement on the main measure of improved disease-free survival (iDFS).

Chemotherapy

The Thyroid Pharmacist

SEPTEMBER 20, 2024

According to a 2020 study, there seems to be a connection between hemorrhoids and Hashimoto’s. [23] Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Published 2020 Oct 8. 23] In this study, patients with hemorrhoids were deemed to be at an increased risk of Hashimoto’s.

Health and Personal Care Stores

The Checkup by Singlecare

DECEMBER 29, 2023

Safety measures while using CoQ10 What are the FDA warnings about CoQ10? The Food and Drug Administration (FDA) has not issued any warnings about CoQ10. It is available over the counter, so the FDA has determined that it’s safe to use without medical supervision. Who should never take CoQ10? Who should use caution with CoQ10?

FDA

The Checkup by Singlecare

MARCH 23, 2023

A small study in 2020 compared the use of hemp CBD, cannabis CBD containing THC, or a placebo in patients with fibromyalgia. The Food and Drug Administration (FDA) approved the drug to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. They are prescribed to increase appetite in patients receiving chemotherapy.

Controlled Substances

The Checkup by Singlecare

DECEMBER 6, 2023

Furosemide, also known by its brand name Lasix, is approved by the United States Food and Drug Administration (FDA) and is available in several forms, including oral tablet, oral solution, and injection. Cisplatin Cisplatin is a chemotherapy drug used to treat certain types of cancers.

Chemotherapy

The Checkup by Singlecare

OCTOBER 27, 2023

Sources Analysis of reports of unintended pregnancies associated with the combined use of non-enzyme-inducing antibiotics and hormonal contraceptives , British Medical Journal (2020) Oral contraceptive efficacy and antibiotic interaction: a myth debunked , Journal of the American Academy of Dermatology (2002) Treatment of pneumococcal meningitis with (..)

Adverse Reactions

pharmaphorum

DECEMBER 23, 2020

2020 also saw some of the first “tumour agnostic” cancer drugs get to market, with Bayer’s Vitravki (larotrectinib) getting funding in the UK for tumours with confirmed neurotrophic tyrosine receptor kinase (NTRK) gene fusions.”. months in patients treated with chemotherapy. billion on buying the US biotech VelosBio in November.

FDA

ISPE

MAY 10, 2023

Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” IEEE Transactions on Signal Processing 68 (2020): 4069-82. SPuMoNI is particularly timely because blockchain has been proposed to become “a new digital service infrastructure” for Europe. link] 6 BBC News. Published 19 January 2017. link] 7 He, J., Cai, and X.

Chemotherapy

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. AML makes up 23.1% of total leukaemia cases globally.

FDA

pharmaphorum

SEPTEMBER 8, 2020

billion USD will be spent in cancer care worldwide this year (2020), compared to 13.8 In England for instance, the introduction of a biosimilar to prevent neutropenia in patients undergoing chemotherapy, resulted in a number of Strategic Health Authorities reassessing their guidance relating to this medicine. Published on 24 June 2020.

Chemotherapy

pharmaphorum

DECEMBER 18, 2020

Amgen has filed its groundbreaking KRAS inhibiting drug sotorasib with the FDA for a group of lung cancer patients with an aggressive form of the disease. The FDA is reviewing sotorasib under its Real-Time Oncology Review (RTOR) programme and could be the first to be approved in this indication, which covers around 13% of NSCLC patients.

FDA

European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

Chemotherapy