Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Recruitment 98

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

World of DTC Marketing

APRIL 22, 2021

Product websites are stagnant, and online health seekers are going elsewhere to learn about your medication’s side effects and cost. A website and TV commercials are not enough to get patients to ask for a prescription medication especially when fair balance lists side effects like cancer.

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Marketing Side effects Prescription Media 265

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.

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FDA Side effects Biopharma Marketing 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 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 75

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. The FDA approval is conditional on a positive outcome from a phase 3 confirmatory trial – KRYSTAL-12 – which is scheduled to complete next year. and 10 months, respectively.

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FDA Side effects Competition Patients 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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FDA Side effects Prospecting Patients 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.

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FDA Side effects Manufacturing Insurance 57

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

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. This includes potential side effects or adverse reactions to medications. The results of these studies are carefully analyzed and scrutinized by regulatory bodies, such as the FDA in the United States.

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Side effects Medical sales reps Insurance Pharmacology 52

pharmaphorum

OCTOBER 27, 2022

It’s a disappointing outcome for a programme that GSK said in 2021 could potentially generate £1 to £2 billion in peak sales because of the serious unmet need in RA patients. The non-dialysis segment is, however, a key part of GSK’s hopes of £500 million to £1 billion in peak sales for the drug.

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Side effects FDA Patients Sales 95

Legacy MEDSearch

JUNE 28, 2023

3,6 It stops hemangioma growth, reduces the lesion, and accelerates hemangioma regression, especially in the superficial IH, without serious side effects. Port wine stains affect 1 in every 300 infants, and over time usually get darker and thicker, making early onset treatment critical for optimal results. Geronemus, M.D.,

Medical 52

Medical FDA Recruitment Side effects 52

pharmaphorum

AUGUST 4, 2022

Ten months after ChemoCentryx scored an unexpected FDA approval for autoimmune disease therapy Tavneos, Amgen has swooped in with a $3.7 Currently, ANCA vasculitis is treated with rituximab combined with corticosteroids, which can have serious side effects when administered over prolonged periods.

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Side effects Pharma Sales Competition 97

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

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.

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Side effects Sales Marketing Competition 52

Pharmaceutical Technology

APRIL 24, 2023

The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. While Imbruvica sales were $3.78 billion in the same year. billion in 2029.

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Food and Drug Administration Side effects Sales Food 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

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. This could mean avoiding the side effects associated with radiation therapies, even targeted ones.

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FDA Side effects Pharma Manufacturing 98

pharmaphorum

DECEMBER 12, 2022

Adverse events such as bruising, headaches, and blood in urine occurred at roughly the same frequency in both groups of patients in ADVANCE IV, and while serious side effects were seen in 8% of the Vyvgart group, that was lower than the 16% reported with placebo.

Side effects 52

Side effects Sales Competition Patients 52

pharmaphorum

AUGUST 5, 2022

Innovent is responsible for developing the drug in China, picking up exclusive marketing rights there, with Sanofi in line for up to €80 million in milestone payments as well as royalties on sales if it gets approved. 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 101

pharmaphorum

JULY 26, 2022

There was also continued decline for Tecfidera, which have not been offset by follow-up Vumerity (diroximel fumarate), which has fewer side effects. The company is in the process of considering a possible sale of Sandoz, although it has stressed it may opt to retain the business or spin it out.

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Competition Side effects Marketing Sales 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 12, 2022

CodeBreak-200 will nevertheless likely serve as a confirmatory study for the approval of Lumakras (sotorasib) in this heavily pretreated patient population, which was granted by the FDA in May 2021.

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Side effects FDA Patients Safety 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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Management Manufacturing Sales Competition 105

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.

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Food and Drug Administration Physicians Prescription Medical 111

Legacy MEDSearch

OCTOBER 25, 2023

. “Whether you are a high school student, a police officer, or a musician, if you live with migraine, you want a trustworthy treatment that combines persistent high efficacy, minimal side effects and ease of use. We designed Nerivio with exactly these requirements in mind.”

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Side effects Recruitment Networking Management 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

Galapagos is in the roll-out phase for its first commercial products – JAK1 inhibitor Jyseleca (filgotinib) for rheumatoid arthritis – which has been approved in Europe and Japan but fell foul of FDA concerns about the class’s safety and was rejected in the US. 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. Sanofi acquired the drug when it bought Bioverativ in 2018 for $11.6

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Engineering Side effects Competition Sales 52

pharmaphorum

DECEMBER 14, 2022

Researchers cautioned that these are early results, and more follow-up is needed to determine the long-term safety and efficacy, but the data could spell trouble for AZ and Alexion’s C5 franchise, which brought in more than $4 billion in sales in the first nine months of this year.

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Side effects Patients Sales Safety 52

Silver Line CRM

NOVEMBER 11, 2020

In order to advance the effective delivery of healthcare for individuals, health information systems must work together within and across organizational boundaries. 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

GlobalData notes that the side effect could be a barrier for lecanemab use as it will require patient monitoring, but points out that the rates are a “significant improvement” on Aduhelm, which had an ARIA-E rate of 35% of patients taking the approved dose in clinical trials. In Clarity AD, the rate of ARIA-E was 12.5%

Doctors 52

Doctors Side effects Safety Sales 52

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

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.

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Manufacturing Pharma Side effects Patients 104

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.

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Media Healthcare Healthcare Education 100

Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA). In this case, the woman had taken apetamin in the form of cyproheptadine, lysine, and vitamin syrup.

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Food and Drug Administration FDA Side effects Food 52