PM360

FEBRUARY 8, 2024

SYLVANT Can Open the Door SYLVANT is the only FDA-approved therapy for idiopathic multicentric Castleman disease (iMCD) that targets the underlying cytokine storm and can help deliver sustained symptomatic relief and durable tumor response. Silver Winner – Elevate Healthcare and Recordati Rare Diseases Inc.

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Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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Food and Drug Administration FDA Food Safety 52

Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. Dagi Ben-Noon , CEO of Inspira, stated that, “We are preparing for global deployments of our INSPIRA ART100 systems once FDA clearance is achieved. Are you hiring?

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Legacy MEDSearch

MARCH 1, 2024

Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. The FDA’s approval was largely based on data from the AGENT IDE trial, which compared treatment with the AGENT DCB to traditional balloon angioplasty. Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Legacy MEDSearch

OCTOBER 10, 2023

Our product development and sales teams are looking forward to being a part of this market transformation that will make a major impact for surgeons and their patients for many years to come. ” Intelivation will be exhibiting this exciting product and others at the annual ACFAS Meeting, being held February 1-4, 2024 in Tampa, Florida.

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Food and Drug Administration FDA Recruitment Marketing 52

Pharmaceutical Technology

APRIL 21, 2023

On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). According to GlobalData’s patient-based forecast model, Stelara is anticipated to have US sales of $525.5m

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Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This enhanced functionality will be made available commercially in 2024.

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FDA Food and Drug Administration Recruitment Management 52

pharmaphorum

NOVEMBER 2, 2022

One of the highlights of Eli Lilly’s third-quarter results was the rapid uptake of new type 2 diabetes therapy Mounjaro, which added more than $97 million in US sales alone in what has been described as “viral” take-up by the drugmaker.

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Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

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Distribution FDA Specialization Sales 52

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.

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Legacy MEDSearch

AUGUST 21, 2023

Global expansion will begin in 2024. See Full Press Release at the Source: Exactech Announces FDA 510(k) Clearance for Advanced Activit-E Knee Replacement Polyethylene Press Release by: Exactech Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Marketing 52

pharmaphorum

SEPTEMBER 15, 2022

The Massachusetts-based biotech said it a meeting with the FDA to discuss the programme has given it the confidence to press ahead with filing for approval of the RASP modulator in the US later this year. Sales were nevertheless solid at $468 million and $1.29 billion respectively last year. Image by StockSnap from Pixabay .

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Legacy MEDSearch

JUNE 14, 2023

Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Surmodics expects to initiate limited market evaluation (LME) for the Pounce LP Thrombectomy System by the end of the first quarter of its fiscal 2024 (ending December 2023), with commercialization planned following completion of the LME.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

AUGUST 30, 2023

Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg ; its robotic prosthetic knee. This registration marks a significant milestone in the company’s commitment to deliver its robotic prosthetic knee to the USA market in 2024 with Japanese-proven technologies. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

NOVEMBER 25, 2022

GlobalData’s report showed LY03010 is expected to launch in the US in 2024. If successful, the drug is forecasted to reach sales of $63.5 According to the pre-IND meeting with the US Food and Drug Administration (FDA), Luye Pharma plans to submit the New Drug Application (NDA) for LY03010 to the FDA through the 505(b)(2) pathway.

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Competition Food and Drug Administration Pharma Food 100

pharmaphorum

OCTOBER 10, 2022

Australian biotech Immutep’s LAG-3 checkpoint inhibitor eftilagimod alpha (efti) may not be the first drug in the class to reach the market, but is a strong contender and, according to at least one analyst, is on course for multibillion-dollar peak sales. Also in its favour is that LAG-3 is now a tried and tested target.

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Side effects Sales Marketing FDA 57

Legacy MEDSearch

NOVEMBER 6, 2023

Histotripsy has been shown to be safe and effective in destroying targeted liver tumors, including unresectable liver tumors, recently gaining clearance from the FDA to market the Edison System for the non-invasive destruction of liver tumors, using a non-thermal, mechanical process of focused ultrasound.

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Recruitment Physicians Medical Patients 52

pharmaphorum

JANUARY 9, 2023

Additionally, its top-selling drug, Myalept or Myalepta, had third-quarter sales of $37.9m. The development is for expansion of the company’s in-house drug development of biologicals and rare disease targeting and the site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025.

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Pharmaceutical Technology

APRIL 4, 2023

The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024. According to GlobalData’s Pharma Intelligence Centre, Tagrisso is forecasted to have global sales of $8.19

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Food and Drug Administration Biopharma FDA Pharmaceutical 52

Pharmaceutical Technology

MAY 16, 2023

This comes with an upfront cash payment of $375 million, with a potential additional $25 million if Hemgenix net sales reach a certain milestone in 2024, based on a May 15 announcement. Additionally, UniQure was set to get tiered royalties of up to “a low-twenties percentage” of net product sales related to Hemgenix. million.

Food and Drug Administration 52

Food and Drug Administration Healthcare Healthcare Sales 52

pharmaphorum

JANUARY 9, 2023

Albireo secured approval in the US and Europe for the ileal bile acid transport inhibitor (IBATi) drug in 2021 for the treatment of pruritus (itching) in patients with rare disorder progressive familial intrahepatic cholestasis (PFIC), and has said sales should reach $24 million this year. billion deal.

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Transportation Sales Leads FDA 52

PM360

SEPTEMBER 21, 2023

Generic Drug Launches This year could see up to 50 generic drug approvals on brand pharmaceuticals worth more than $20 billion in sales, Casberg noted. billion in sales. The product had sales of roughly $800 million per year. The drug generated $2 billion in sales last year. “We’re

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Legacy MEDSearch

MAY 9, 2023

Company executives anticipate regulatory submission in 2024, pursuant of FDA approval for sale in the United States. This device has not yet been approved by the FDA and is not for sale in the United States. physicians,” Robert J.

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Pharmaceutical Technology

OCTOBER 28, 2022

In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. Merck, known outside of the US and Canada as MSD, is developing its portfolio of pneumococcal vaccines , and has secured an FDA approval for the paediatric use of its 15-serotype vaccine Vaxneuvance in June.

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Training Marketing Competition FDA 64

Pharmaceutical Technology

MAY 30, 2023

Maselli also cited non-manufacturing factors in Catalent’s poor performance and incorrect forecasting, especially a revenue cliff as the pandemic recedes: Catalent’s Covid-related sales will decline by more than 50% compared with last year, he said, and will be even lower in 2024.

Manufacturing 52

Manufacturing FDA Sales Leads 52

pharmaphorum

DECEMBER 22, 2022

Regulators in the US and EU have started a review of Pfizer’s S1P receptor modulator etrasimod for people living with moderately-to-severely active ulcerative colitis (UC), with decisions expected in the first halves of 2023 and 2024, respectively.

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Pharmacology Safety Patients Marketing 52

pharmaphorum

JULY 11, 2022

One issue dogging the programmes has been cases of blood clots in late-stage trials, which prompted the FDA to place the drug under a clinical hold a few years ago. Sanofi acquired the drug when it bought Bioverativ in 2018 for $11.6

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Pharmaceutical Technology

JANUARY 20, 2023

billion in Covid-19 vaccine sales. In a January business update , the company predicted it will make a minimum of $5 billion in new vaccine sales. The CEO illustrated his point, by discussing that in June, the Center for Biologics Evaluation and Research (CBER), at the FDA, requested new vaccines for the BA.5 5 Omicron variant.

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Evolve Your Success

APRIL 11, 2023

Building your brand in medical device sales requires experience, strategic insights, and a relentless pursuit of excellence. With 40 years of medical device sales experience, Pat discusses how to build a successful medical device sales business. He also touches on the sales funnel, the art of hiring, and more.

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Pharmaceutical Technology

JANUARY 10, 2023

billion in sales in 2019, increasing to $136.2 billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%. Mounjaro is forecast to compete for significant market share with semaglutide and also Lilly’s Trulicity (dulaglutide), reaching peak sales of $10.2

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Marketing Physicians Leads Sales 52

MedTechVets

JULY 20, 2023

After my stint at Humana, I joined Abbott Laboratories in a sales role serving in their Diagnostics Division. Over the next few months, we are wrapping up manufacturing and testing in preparation for the submission of our FDA 510(k) to bring this life saving device to the world. Anything else you’d like to share?

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Legacy MEDSearch

SEPTEMBER 29, 2023

The HYDRAFIL-D Study will enroll approximately 225 patients in up to fifteen centers across North America and is expected to start in early 2024 after the company completes its next round of financing. “I Vapotherm (NYSE:VAPO), and National Sleep Technologies. ABOUT REGELTEC, INC: ReGelTec, Inc. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

pharmaphorum

SEPTEMBER 22, 2022

The company said this morning that US sales growth is its main priority, and that it will be led in the near-term by “high-value” new drugs Kisqali (ribociclib), iptacopan, Pluvicto (lutetium Lu 177 vipivotide tetraxetan), remibrutinib, and Scemblix (asciminib). billion by 2024.

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Management Sales Patients Medicine 52

pharmaphorum

OCTOBER 6, 2022

On the plus side, the time that tirzepatide will stay under review at the FDA has just got shorter, as the FDA has granted the drug fast-track review that means it should make a decision within six months of the filing being completed. billion in 2025 sales.

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Sales Marketing FDA Leads 52

Legacy MEDSearch

DECEMBER 19, 2022

Both the EU and FDA clinical trials will be initiated in Q2 2023 for the purpose of obtaining European and US regulatory approvals respectively in Q1 2024. .” Sonorous NV received its initial seed funding in Q1 of 2022 and quickly developed their product to achieve first clinical use in less than 1 year.

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pharmaphorum

SEPTEMBER 14, 2022

It has, however, been cleared by Health Canada under the Albrioza brand name, and the FDA is due to decide on the US marketing application later this month. .” AMX0035 (phenylbutyrate/ursodoxicoltaurine), meanwhile, isn’t yet approved in the US, so its price there hasn’t been set.

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Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. In a press release, the company said a generic launch would damage sales in FY 2023 by $300,000.

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