Pharmaceutical Commerce

JANUARY 19, 2024

Today's approval amends the accelerated approval granted by the FDA in April 2019 to Balversa (erdafitinib) for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy.

FDA

pharmaphorum

FEBRUARY 11, 2022

The subject from the initial study of RGX-111 that led to FDA approval of the phase 1/2 trial also showed better-tan-expected improvements on those skills over a follow-up period of around 20 months.

Chemotherapy

pharmaphorum

JUNE 6, 2022

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

Chemotherapy

pharmaphorum

OCTOBER 19, 2020

MCL is generally treated first with chemotherapy, and patients whose disease progresses despite that can then receive stem cell transplantation or BTK inhibitor drugs like Johnson & Johnson/AbbVie’s Imbruvica (ibrutinib) and AstraZeneca’s Calquence (acalabrutinib).

Chemotherapy

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

FEBRUARY 15, 2021

To recap, Padcev (enfortumab vedotin) was quickly okayed by the FDA in December 2019 in advanced urothelial cancer on the basis of phase 2 response data that made it a rising star at that year’s American Society of Clinical Oncology (ASCO) conference. months in the chemotherapy group. of patients in the chemotherapy arm.

Chemotherapy

pharmaphorum

APRIL 28, 2021

Roche’s Tecentriq can stay on the US market as a therapy for triple negative breast cancer, advisers to the FDA have said as part of a review of several quickly-approved cancer drugs. While the ODAC’s vote is non-binding the FDA rarely goes against the advice of its expert advisers.

FDA

pharmaphorum

MARCH 30, 2022

The SKYSCRAPER-02 showed that the combination of the two drugs given on top of chemotherapy was unable to improve progression-free survival versus Tecentriq (atezolizumab) plus chemo in extensive-stage SCLC – a notoriously hard-to-treat form of lung cancer.

Chemotherapy

European Pharmaceutical Review

OCTOBER 19, 2023

How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy? This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

Chemotherapy

Pharmaceutical Technology

MARCH 30, 2023

On March 27, MSD announced that the combined use of Keytruda with chemotherapy significantly improved progression-free survival versus the chemotherapy alone, as a first-line therapy for advanced or recurrent endometrial carcinoma. This announcement is not the only recent development for Keytruda.

Chemotherapy

pharmaphorum

JANUARY 20, 2021

Sobi acquired Doptelet via its $915 million takeover of Dova Pharmaceuticals in 2019, adding to its haematology and rare disease franchise. 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.

Chemotherapy

pharmaphorum

DECEMBER 21, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

Chemotherapy

pharmaphorum

APRIL 6, 2022

The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July. FDA clears Vijoice for rare overgrowths.

FDA

Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. months compared with patients treated with standard-of-care chemotherapy.

Chemotherapy

pharmaphorum

OCTOBER 4, 2021

Xencor has previously partnered with MorphoSys and Incyte to test plamotamab in combination with their CD19-targeted antibody Monjuvi (tafasitamab) – plus Bristol-Myers Squibb’s Revlimid (lenalidomide) – as a chemotherapy-free strategy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), an aggressive type of NHL.

Chemotherapy

pharmaphorum

NOVEMBER 11, 2021

Antibody-drug conjugate Trodelvy (sacituzumab govitecan) is already approved in the US for TNBC, and was licensed for development in China and other Asian territories by Everest in 2019 ahead of Gilead’s $21 billion takeover of its original develop Immunomedics. months in patients treated with chemotherapy. Learn more.

Chemotherapy

The Checkup by Singlecare

MARCH 23, 2023

A 2019 study used hemp-derived CBD in patients taking opioids to manage their chronic pain. 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 Thyroid Pharmacist

SEPTEMBER 20, 2024

Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. [45] As the intestines are made of smooth muscles, a reduction in the action of these muscles can slow down digestion and cause constipation.

Health and Personal Care Stores

ISPE

MAY 10, 2023

1 May 2023 Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI) 1 harnesses the potential of state-of-the-art technologies for the pharmaceutical industry. Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” Juan Miguel García-Gómez, Ph.D. Chis, Ph.D. 30 June 2016.

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. The median OS in patients on quizartinib was 31.9

FDA

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. months for the chemotherapy arm. months compared with 5.1 months compared with 16.8

FDA

pharmaphorum

JANUARY 18, 2021

This latest indication adds to Enhertu first approval at the end of 2019 for advanced HER2-positive breast cancer after two or more HER2-targeted regimens. The FDA approved the new use based on positive results from the randomised DESTINY-Gastric01 phase 2 trial conducted in Japan and South Korea. months on chemotherapy.

Chemotherapy

STAT

SEPTEMBER 13, 2023

plummeted nearly 45% between 2011 and 2019, new federal data show, even as fatal overdoses rose to record levels as users increasingly used heroin, and then illegal fentanyl, The Washington Post reports. Once again, we hope you have a successful day and, of course, keep in touch. We enjoy hearing your tips and tidbits.

FDA

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

pharmaphorum

OCTOBER 25, 2021

The European Commission has cleared Keytruda (pembrolizumab) in combination with chemotherapy as a first-line treatment for locally recurrent, unresectable or metastatic TNBC involving tumours with a PD-L1 expression score of 10 or more. months to 23 months, according to data reported at this year’s ESMO cancer conference.

Chemotherapy

pharmaphorum

SEPTEMBER 13, 2021

Novartis has filed for FDA approval of tislelizumab – a PD-1 inhibitor licensed from Chinese biotech BeiGene earlier this year – as a second-line treatment for oesophageal cancer. The FDA review has an action date of 12 July next year. The post First FDA filing for Novartis’ latecomer PD-1 drug tislelizumab appeared first on.

FDA

pharmaphorum

JULY 28, 2021

Merck & Co’s Keytruda has just picked up its 30th approval from the FDA, and it is a good one – early-stage triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. It’s the latest in a string of positive developments for Keytruda in breast cancer.

Chemotherapy

pharmaphorum

SEPTEMBER 8, 2020

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 8 March 2019. Published 25 November 2019. Unpleasant truth: let’s embrace it and take action.

Chemotherapy

pharmaphorum

DECEMBER 18, 2020

MacroGenics’ HER2-targeted breast cancer drug Margenza has been approved by the FDA, challenging several recently approved drugs with a narrow efficacy edge over Roche’s Herceptin in data gathered so far in advanced disease. The median progression-free survival (PFS) of patients treated with Margenza and chemotherapy was 5.8

Chemotherapy

pharmaphorum

APRIL 20, 2021

The next milestone in Seagen and Astellas’ bid to build their antibody-drug conjugate (ADC) Padcev into a blockbuster will come in August, when the FDA concludes an accelerated review of two bladder cancer filings. . Both have been granted an FDA priority review with an action date of 17 August.

Chemotherapy

pharmaphorum

NOVEMBER 10, 2022

Sales were around $140 million in 2019, and climbed to $165 million the following year, despite the impact of the pandemic. Sales of Rubraca fell further to $30 million in the third quarter of this year from $37 million a year earlier, while Clovis posted a net loss of $55 million.

Chemotherapy

pharmaphorum

JULY 1, 2025

billion, Amgen has promising phase 3 results with a drug for gastric cancer that was the focal point for the deal. billion, Amgen has promising phase 3 results with a drug for gastric cancer that was the focal point for the deal. billion, Amgen has promising phase 3 results with a drug for gastric cancer that was the focal point for the deal.

Pharmaceutical Companies

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.

FDA

Pharmaceutical Technology

MARCH 2, 2023

Keytruda is indicated in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. It is also indicated for the treatment of metastatic transitional (urothelial) tract cancer and gastric cancer.

Chemotherapy

pharmaphorum

APRIL 20, 2021

At the moment, the only option for patients in this category is chemotherapy. “There is currently a lack of clinical trial data directly comparing trastuzumab deruxtecan with chemotherapy,” said NICE in a statement. AZ licensed rights to Enhertu in 2019 for a hefty $1.35

Chemotherapy

pharmaphorum

MARCH 18, 2021

AstraZeneca’s BTK inhibitor Calquence has become the first targeted oral therapy to be backed by NICE for NHS England patients with chronic lymphocytic leukaemia (CLL) who can’t be treated with first-line chemotherapy. Daiichi Sankyo gets okay for cholesterol drugs.

Hospitals

pharmaphorum

AUGUST 10, 2021

The FDA has given the drug a breakthrough designation in the latter indication, and Seagen is eyeing additional studies of the drug in a range of cancer types including tumours that express HER2 at high and low levels. While the licensing deal with Seagen tops up its finances, the scale well below the $6.9 billion bundle – including $1.3

Chemotherapy