pharmaphorum

OCTOBER 27, 2022

Santhera should hear from the FDA whether the speedy review has been granted within the next 60 days, and if so the review time will be cut from 10 to six months. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

FDA 86

FDA Side effects Biopharma Marketing 86

World of DTC Marketing

MAY 3, 2022

In trying to save the product, Biogen’s reputation was trashed by FDA advisors, HCPs, and the healthcare media. 2wo: The competition’s MS drugs were better – The MS market is lucrative, and competitors launched products that were better than Biogen’s with fewer side effects discussed by the MS community online.

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Side effects FDA Media Pharma 207

Rep-Lite

MARCH 14, 2024

Medical sales representatives are the medium through which medical companies sell their healthcare products to providers like hospitals and clinics. Medical sales rep requirements include technical knowledge of medical equipment and technologies, sales skills, and interpersonal abilities. Why Pursue a Career in Medical Sales?

Medical sales reps 52

Medical sales reps Medical sales Medical Sales 52

Legacy MEDSearch

JULY 19, 2023

VAPOR 2 is a prospective, multicenter, single-arm study that will treat 235 patients with intermediate-risk, localized prostate cancer at up to 30 U.S. “I am excited to be participating in the VAPOR 2 study and it is a great privilege to treat the first patient,” said Dr. Kella. Francis Medical, Inc., clinical sites.

Medical 52

Medical Side effects Patients Recruitment 52

Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

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Patients Recruitment Pharmacology Side effects 98

pharmaphorum

SEPTEMBER 7, 2022

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug early next year. GSK said it is “committed to working closely with the US FDA to bring daprodustat to appropriate patients with anaemia of CKD.”

FDA 52

FDA Safety Side effects Marketing 52

pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. Mirati also says its drug penetrates the central nervous system more readily, making it a better option for patients whose disease has metastasised to the brain.

FDA 52

FDA Side effects Competition Patients 52

pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The post FDA slaps partial hold on Biogen, InnoCare MS drug appeared first on.

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FDA Side effects Biopharma Prospecting 68

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 .

FDA 52

FDA Side effects Prospecting Patients 52

Legacy MEDSearch

DECEMBER 12, 2022

Under the new program, Highmark members prescribed by providers participating in the program will receive access to Nerivio ®, the first FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals aged 12 and older.

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Side effects Insurance FDA Pharmacology 98

Quantified

APRIL 18, 2022

A global head of sales at a pharma company recently told me that “only 15% of our sales calls end in a positive outcome.”. In the context of a new medical innovation where there is a high unmet patient need, this means patients are not getting rapid access to medicines that can positively impact or even extend their lives.

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Sales Pharma Pharma sales reps Medicine 52

pharmaphorum

OCTOBER 27, 2022

The phase 3 clinical programme, named ContRAst, was the first in RA to include head-to-head comparisons of otilimab with current treatments, hoping to build a niche for otilimab among hard-to-treat patients who have an inadequate response to or cannot tolerate available drugs.

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Side effects FDA Patients Sales 76

Contrarian Sales Techniques

FEBRUARY 25, 2023

A point of view from a Medical Sales Rep I strongly believe that the most effective insurance policy is not to get sick. During my pharmacology class, I learned that there are no safe drugs, only safe patients. This includes potential side effects or adverse reactions to medications.

Side effects 52

Side effects Medical sales reps Insurance Pharmacology 52

pharmaphorum

AUGUST 31, 2022

As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicron subvariants BA.5 The FDA said in a statement that the BA.4 The post FDA clears bivalent Omicron shots from Pfizer, Moderna appeared first on.

FDA 57

FDA Side effects Manufacturing Insurance 57

Legacy MEDSearch

JUNE 28, 2023

2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 ”, states board-certified cosmetic dermatologist, Roy G.

Medical 52

Medical FDA Recruitment Side effects 52

PM360

OCTOBER 24, 2022

received FDA approval for once-daily GEMTESA—the first new oral OAB medication approved by the FDA since 2012. While Urovant realized this, launching a new company, a new sales team, and a new therapy for OAB amidst the pandemic in early 2021 would be challenging.

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Side effects Doctors FDA Patients 40

Pharmaceutical Technology

APRIL 24, 2023

The British institute that oversees a therapy’s cost-effectiveness opted for the recommendation based on clinical data from the Phase II CAPTIVATE and the Phase III GLOW studies. The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance.

Food and Drug Administration 52

Food and Drug Administration Side effects Sales Food 52

Silver Line CRM

MARCH 22, 2021

Reading time: 4 minutes Patient centricity. Patient-focused medicine. Patient-centric approaches. These words have become so overused in the pharmaceutical industry that it’s hard to remember what they really mean: leading with empathy when it comes to serving patients. . What side effects are they talking about? .

Pharma 52

Pharma Patients Medical Medicine 52

Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. In its announcement, the FDA advised individuals to keep their electronic or printed health records from the past year ready while seeking treatment.

Food and Drug Administration 111

Food and Drug Administration Physicians Prescription Medical 111

pharmaphorum

OCTOBER 13, 2022

Top-line results from phase ALPINE pitted the two drugs against each other in patients with previously treated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), and showed that Brukinsa (zanubrutinib) achieved better progression-free survival (PFS) compared to Imbruvica (ibrutinib), which made $10 billion in sales last year.

Side effects 52

Side effects Sales Marketing Competition 52

pharmaphorum

DECEMBER 12, 2022

Updated results from the ADVANCE IV study of Vyvgart (efgartigimod alfa) showed that more than half of patients with ITP treated with Argenx’ drug showed an improvement in platelet counts, which are dramatically reduced in the disorder. After 24 weeks, 21.8%

Side effects 52

Side effects Sales Competition Patients 52

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. month mPFS with Keytruda plus chemo, with fewer side effects.

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Side effects Sales Marketing FDA 57

Legacy MEDSearch

OCTOBER 25, 2023

She emphasized the significance of these findings stating, “When assessing the clinical benefits of therapies for chronic neurological disorders such as migraine, it’s important to evaluate patient adherence and clinical efficacy over a long period of time, in order to eliminate possible tachyphylaxis or waning over time.

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Side effects Recruitment Networking Management 52

pharmaphorum

SEPTEMBER 12, 2022

The full data will be presented as a late-breaker later today, so may be subject to change, and for now shows a solid reduction in disease progression or death in patients with the KRAS inhibitor in KRAS G12C-mutated non-small cell lung cancer (NSCLC) compared to docetaxel, but no improvement in overall survival.

Side effects 52

Side effects FDA Patients Safety 52

pharmaphorum

JANUARY 13, 2023

Everyone agrees that cell and gene therapies are poised for an explosion, with far more drugs in the pipeline than are currently approved, and the FDA predicts it will clear 10 to 20 per year by 2025. These therapies have incredible potential to fight cancer and other diseases using the patient’s own immune system.

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FDA Side effects Pharma Manufacturing 95

pharmaphorum

AUGUST 5, 2022

Sanofi is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring two new cancer therapies as quickly as possible to patients in the world’s second-largest pharma market. It is being tested in a wide range of solid tumours and lymphoma, alone and in combination with other drugs.

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Side effects Marketing Pharma Medicine 84

pharmaphorum

DECEMBER 14, 2022

. “These results suggest iptacopan […] could essentially allow patients to live a normal life with just one pill each morning and night,” he added. Almost all patients treated with Novartis’ drug had no need for blood transfusions over the course of the study. g/dL, compared with an average decrease of 0.04

Side effects 52

Side effects Patients Sales Safety 52

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. Increased reluctance to authorise innovative and unproven drugs for use, stemming from the FDA’s experience with Aduhelm, reduced the overall novel approvals in 2022. months longer on the treatment.

Manufacturing 52

Manufacturing FDA Side effects Marketing 52

pharmaphorum

NOVEMBER 4, 2022

Top of the list of three new pillars of the strategy is a switch from Galapagos’ previous drug discovery approach focused on novel drug targets – which attracted a big alliance with Gilead Sciences but has so far failed to deliver as hoped – to one focused more on patient-centricity and medical need. Jyseleca has made €60.5

Side effects 52

Side effects Safety FDA Sales 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. Updated results from the phase 3 XTEND-1 trial were presented at ISTH, once again comparing the therapy to patients’ previous treatment with clotting factor replacement.

Engineering 52

Engineering Side effects Competition Sales 52

Silver Line CRM

NOVEMBER 11, 2020

But today, the need to satisfy patients, providers, payers, regulatory agencies, and shareholders alike — while staying ahead of the competition — takes the right technologies at the right time. . Internally, this means updating legacy systems and combining multiple data sources like ERP and marketing/sales systems needed to be effective.

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Marketing Pharmaceutical Side effects Insurance 52

pharmaphorum

SEPTEMBER 30, 2022

of patients, while for ARIAH-H the rates were 17% and 0.7%, respectively. He pointed out that services to administer the injections frequently, and the required radiology and clinical monitoring for patients, “will all need to be factored in on top of the simple cost of the drug.” In Clarity AD, the rate of ARIA-E was 12.5%

Doctors 52

Doctors Side effects Safety Sales 52

pharmaphorum

SEPTEMBER 8, 2022

The problem with this form of treatment is that it is not targeted and, as a result, there are a number of short- and long-term side effects which can impact patients’ lives. billion acquisition of Endocyte in 2018 , with estimations that sales could reach $600 million in this first indication alone.

Manufacturing 93

Manufacturing Pharma Side effects Patients 93

Contrarian Sales Techniques

FEBRUARY 10, 2023

They are designed to be safe and comfortable for patients, and typically have minimal side effects. Check for certifications and accreditations, such as FDA approval, and read customer reviews to get a sense of the supplier's reputation.

Healthcare 52

Healthcare Healthcare Manufacturing Medical 52

Medgadget

FEBRUARY 17, 2023

All of these systems operate under the “master-slave” concept, which involves a surgeon sitting behind a console, away from the patient, who manipulates the mechanical arms of the robot via some kind of joystick-like device. Human Xtensions chose to proceed with direct sales of its technology in the U.S.

Physicians 80

Physicians Engineering Side effects Leads 80

pharmaphorum

DECEMBER 15, 2022

Back in 2015, the influencer-of-influencers, Kim Kardashian, was slammed for failing to mention the potential side effects of an anti-nausea drug, leading to the US FDA getting involved. Despite the slap on the wrist, the campaign was highly effective and there is no sign of this approach going away. Connecting peers.

Media 81

Media Healthcare Healthcare Education 81

pharmaphorum

JULY 6, 2022

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. Now, in addition to doctors and providers, the FDA announced pharmacists with your medical information can prescribe Paxlovid to patients.

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FDA Doctors Side effects Patients 99