XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. billion in Q4 2022.

Sales 52

Sales Insulin FDA Approval Drugs 52

pharmaphorum

SEPTEMBER 16, 2021

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval appeared first on.

FDA Approval 105

FDA Approval Sales Clinical Trials Clinical Trials 105

XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events. billion in 2032.

FDA Approval 81

FDA Approval Clinical Trials Clinical Trials Trials 81

pharmaphorum

AUGUST 4, 2021

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. The post Failed trial nixes another FDA approval, this time for BMS’ Istodax appeared first on.

FDA Approval 98

FDA Approval Trials Sales Marketing 98

pharmaphorum

JANUARY 16, 2023

China’s Luye Pharma has claimed its first FDA approval, getting a green light for Rykindo, an injectable formulation of the antipsychotic risperidone given every two weeks. Analysts at GlobalData said last year that they expect LY03010 to launch in 2024 and bring in sales of around $64 million in 2030.

FDA Approval 52

FDA Approval Drugs Bioavailability Marketing 52

XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

FDA Approval 101

FDA Approval Drugs Sales Development 101

pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.

FDA Approval 52

FDA Approval Marketing Branding Generic Drugs 52

pharmaphorum

MAY 5, 2022

Three years after it was formed as a spinout of Japanese drugmaker Takeda, Phathom Pharmaceuticals has racked up its first FDA approvals, and claimed a sizeable $260 million in new financing to help with the rollout. The post Takeda spinout Phathom claims its first FDA approvals appeared first on.

FDA Approval 52

FDA Approval Sales Production Regulation 52

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. BTK plays an important role in the immune system by regulating B cell receptor signaling through its effects on the development and maturation of B cells.

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

Sales 52

Sales FDA Approval Pharmacy Production 52

XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species.

FDA Approval 52

FDA Approval Drugs Life Science Cosmetics 52

XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. The GLP-1 drug market is on its way to becoming one of the most lucrative pharmaceutical markets.

Pharmacy 104

Pharmacy Drugs Sales Production 104

XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. While Eylea’s sales have been on the decline, Vabysmo has been picking up steam.

FDA Approval 104

FDA Approval Clinical Trials Clinical Trials Sales 104

XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

AUGUST 19, 2021

With the FDA green light, Xywav has become the first drug approved for IH. This, despite the drug having strict regulations and safety concerns. GHB has now become a strictly regulated medication for treating narcolepsy, which is also associated with excessive daytime sleepiness. billion in sales.

FDA Approval 64

FDA Approval Drugs Regulation Sales 64

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

FDA Approval 52

FDA Approval Production Clinical Trials Clinical Trials 52

XTalks

MAY 15, 2024

These bans reflect concerns from traditional meat industries about market competition and consumer acceptance. In the US, cultivated meat has received approval from the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). Following suit, lab-grown meat was recently banned in Florida and Alabama.

Production 98

Production Regulation Marketing Manufacturing 98

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. Servier refiled the drug in Europe in March, thanks to the results of the AGILE trial which form the basis of the latest FDA approval. Servier is on course to get a return on its $1.8

FDA Approval 52

FDA Approval Sales Drugs Regulation 52

Delveinsight

OCTOBER 1, 2021

There are several therapies in the market to address the Myasthenia Gravis burden, and many companies are still working on their drug candidates to cope with Myasthenia Gravis. Myasthenia Gravis Approved Therapies. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis.

Marketing 85

Marketing Antibody Drugs Sales 85

pharmaphorum

JUNE 22, 2021

AstraZeneca’s SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly’s rival therapy Jardiance. . billion respectively, assuming they also get approved for the HFpEF indication.

Sales 98

Sales Marketing FDA Approval Regulation 98

Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. Benlysta Sales and Annual cost of therapy (ACOT). million respectively.

Marketing 52

Marketing Sales FDA Approval Antibody 52

pharmaphorum

JULY 20, 2021

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. Ardelyx was gunning for approval in dialysis patients. “Despite….advantageous

Drugs 98

Drugs FDA Approval Marketing Branding 98

XTalks

NOVEMBER 9, 2022

Glucagon-like peptide-1 (GLP-1) receptor agonists are a newer class of diabetes drugs that have the potential to double as weight loss drugs, widening their lucrative market potentials. Novo’s obesity version of semaglutide (at a higher dose) is marketed as Wegovy and was approved in 2021. billion in 2021 to $61.6

Insulin 98

Insulin Hormones FDA Approval Sales 98

pharmaphorum

AUGUST 9, 2021

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. Myozyme was first to market in 2006 for infantile-onset Pompe, with Lumizyme reaching the market four years later to treat late-onset Pompe in children aged over eight.

FDA Approval 98

FDA Approval Production Marketing Drugs 98

pharmaphorum

FEBRUARY 28, 2022

Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB). Read Faith’s story and more personal stories at [link] & share them on your social media to help raise awareness!

Drugs 98

Drugs Marketing Regulation FDA Approval 98

pharmaphorum

JANUARY 12, 2021

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million.

Sales 71

Sales FDA Approval Trials Marketing 71

XTalks

JULY 27, 2022

Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. FDA-Approved?

FDA Approval 98

FDA Approval Packaging Packaging Production 98

pharmaphorum

OCTOBER 25, 2021

The US and Japanese regulators approved the Keytruda plus chemo regimen for first-line TNBC treatment earlier this year. The new approval is the first breast cancer indication for Keytruda in Europe, although elsewhere Merck has already started to expand the label for its cancer immunotherapy in TNBC.

FDA Approval 87

FDA Approval Marketing Trials Sales 87

pharmaphorum

AUGUST 8, 2022

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 Last week, Bayer reported sales of Nubeqa doubled in the second quarter of this year to €105 million.

Sales 59

Sales Hormones FDA Approval Marketing 59

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis resubmitted its marketing application in the US earlier this year, after swapping fill-and-finish production to one of its own facilities in Schaftenau, Austria.

Drugs 105

Drugs Sales Antibody FDA Approval 105

pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The company is gunning for sales in atopic dermatitis alone of $1.5 million people in the US.

Sales 98

Sales FDA Approval Regulation Drugs 98

pharmaphorum

AUGUST 24, 2021

One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved treatment. It’s also in line for up to $240 million in US sales-based milestones.

Drugs 105

Drugs Sales FDA Approval Licensing 105

pharmaphorum

MAY 4, 2021

AstraZeneca is already seeing sales rocket for its SGLT2 inhibitor Farxiga in heart failure, and is expected to gather even more momentum after claiming FDA approval in chronic kidney disease (CKD). . There are around 37 million people in the US alone with CKD.

Sales 98

Sales FDA Approval Marketing Trials 98

pharmaphorum

DECEMBER 22, 2021

Amgen has won FDA approval for a stronger label for its oral plaque psoriasis therapy Otezla, as it prepares for competition from Bristol-Myers Squibb’s much-touted rival deucravacitinib, which could make its debut next year. Otezla was acquired by Amgen for $13.4 Otezla was acquired by Amgen for $13.4 versus 4.1%. .

FDA Approval 59

FDA Approval Marketing Sales Clinical Trials 59

pharmaphorum

AUGUST 20, 2021

The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. Astellas also has rights to the drug in Japan – where it also approved and on sale – as well as Turkey, Russia, the Middle East, and South Africa.

Sales 59

Sales Regulation FDA Approval Drugs 59

pharmaphorum

JUNE 6, 2021

Novo Nordisk is celebrating the FDA approval of its GLP-1 agonist semaglutide as a treatment for obesity, which it believes has the potential to redefine the market for weight-loss medicines. . Already approved at a lower dose as Ozempic for treating diabetes, the new 2.4 Photo by i yunmai on Unsplash.

Drugs 91

Drugs Sales Marketing Trials 91

XTalks

OCTOBER 27, 2021

It received FDA approval in 2018. Related: Why Mask-Associated Dry Eye Won’t Necessarily Boost Restasis Sales. With its drug and delivery system combo, Roche is attempting to rival Regeneron’s Eylea, which is administered every two months; the company is now vying for approval for a 16-week dosing schedule.

Drug Delivery Systems 104

Drug Delivery Systems Drug Delivery FDA Approval Drugs 104