European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection. US sales of Stelara totalled $6.4 billion in 2022, according to J&J’s financial results.

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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. .

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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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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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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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pharmaphorum

OCTOBER 10, 2022

The FDA has approved use of GlaxoSmithKline’s Boostrix (Tdap) vaccine for use during the third trimester of pregnancy, for prevention of pertussis (whooping cough) in infants younger than two months old. This estimate was supported by updated statistical analyses of data published in observational studies, the FDA said.

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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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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.”. Why is success in pharma sales so hard? Challenge 1: Limited set of marketing and sales tools. The Strategic Importance and Persistence of the Pharma Sales Rep.

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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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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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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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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?

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Pharmaceutical Representative Training

JUNE 22, 2024

The Role of Certified Pharmaceutical Representatives in the Shifting Sales Landscape The US Bureau of Labor Statistics (BLS) projects the number of jobs for pharmaceutical sales representatives will grow by four percent by 2031, adding approximately 170,000 new job openings per year over this decade.

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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 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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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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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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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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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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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.,

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Legacy MEDSearch

JULY 19, 2023

“Currently, prostate cancer patients find themselves in the difficult position of balancing the oncological risks of the disease with the life-altering side effects that can often accompany traditional treatments. ” As the second most common cancer in U.S. market clearance.

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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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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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pharmaphorum

JULY 19, 2022

China’s Simcere Pharmaceutical has been granted approval in its home market for Cosela, a drug designed to limit the side effects of cancer chemotherapy, partnered with US biotech G1 Therapeutics. Sales remain fairly modest given its single approved use, with the biotech reporting that Cosela made $5.5

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Contrarian Sales Techniques

JULY 12, 2024

Generics, while FDA-approved, sometimes carried an invisible question mark. The Internal Struggle Dr. Reyes explained the rigorous testing generics go through to ensure they matched the brand name in effectiveness. What if there were unseen side effects? Reyes understood the concern. Were they truly the same?

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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.

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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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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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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.

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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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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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European Pharmaceutical Review

OCTOBER 24, 2024

The biologic treatment was granted approval as Kisunla (donanemab-azbt) in the US by the Food and Drug Administration (FDA) in July 2024. Nevertheless, both efficiently clear amyloid and have a similar slowing effect on progression of cognitive decline in patients”. billion and $2.0 billion in 2030, respectively.”

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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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Medgadget

FEBRUARY 17, 2023

Human Xtensions chose to proceed with direct sales of its technology in the U.S. Interestingly, due to FDA’s regulatory methodology, surgical robots have to be approved for specific indications by the agency. Because of its tiny domestic market, Israeli firms typically end up joining large conglomerates.

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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%

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Pharma Marketing Network

OCTOBER 1, 2024

These strategies are designed to increase brand awareness, educate the target audience, and ultimately drive sales. Traditional methods like print advertising, conferences, and sales representatives are complemented by digital platforms, social media, and content marketing.

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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.

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