Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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World of DTC Marketing

JANUARY 1, 2022

More and more patients demand a level of service they want with the increased costs of health insurance premiums. 1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections.

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World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. ” So, are we supposed to believe that better images in DTC ads lead to patients asking for an Rx? ” Uh…no.

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Food and Drug Administration Side effects FDA Prescription 185

pharmaphorum

NOVEMBER 25, 2022

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

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World of DTC Marketing

OCTOBER 29, 2020

It’s time to admit that the FDA is completely out of touch regarding DTC advertising. For some reason, the FDA still requires fair balance on website home pages. Fair balance needs to be scraped and the FDA needs to start by asking “what are people looking for when they come to a drug company product website?

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Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. Some 48% of patients on Briumvi also suffered with infusion reactions.

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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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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

DECEMBER 1, 2020

Walk into any corporate pharma HQ, and you’re likely to see a mission statement that’s pure b t about how patients come first. We all know that Wall Street and sales come well before patients. In the past, pharma product websites had a huge effect on whether a patient asks for an Rx. 8ight: Challenge the FDA.

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World of DTC Marketing

DECEMBER 23, 2020

DTC marketers who believe that DTC is essentially the same as before the pandemic are failing to recognize significant shifts in patient behavior regarding prescription drugs. Any discussion around DTC should acknowledge the following: 1ne: DTC is more effective for some health categories than others. What are the side effects?

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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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Food and Drug Administration FDA Side effects Recruitment 98

Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. when the market closed on 20 September, compared to the previous day.

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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 post FDA clears Incyte’s Opzelura as first vitiligo therapy appeared first on.

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pharmaphorum

JANUARY 20, 2023

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer’s disease therapy donanemab based on mid-stage clinical results, but says it remains on track to file a traditional submission around the middle of this year. Final results from CLARITY-AD are also due in the first half of this year.

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FDA Safety Side effects Marketing 62

European Pharmaceutical Review

DECEMBER 7, 2022

The common, expected side effects were within expectations for a vaccine in this age group. In November 2021, the US Food and Drug Administration (FDA) authorised the emergency use of COVID-19 vaccine Comirnaty ® in children aged five to 11 years. Data that facilitated the line extension of Comirnaty ® for Covid-19.

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Food and Drug Administration Patients Side effects Medicine 85

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.”

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FDA Safety Side effects Marketing 52

Pharma Leaders

JUNE 14, 2023

Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. It offers dual advantage of providing a longer duration of pain relief, with less systemic side effects, stated the company.

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Food and Drug Administration FDA Side effects Food 52

World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Since that time, Biogen’s MS drugs have faced intense competition as MS patients continue to vent on social media that the Biogen drug has nasty side effects. Washington Post.

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Side effects FDA Patients Doctors 187

World of DTC Marketing

DECEMBER 29, 2021

The demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. Wegovy can indeed help patients lose weight, but it requires that users adhere to a diet and exercise. Some were happy for any product that would help patients lose weight others were worried about the long-term use of the drug.

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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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World of DTC Marketing

NOVEMBER 5, 2021

Patients want quick fixes, and the idea of losing some weight because of a new drug is enticing to them. In response, the company has been providing six-month waivers to some insured patients that will cap the drug’s out-of-pocket costs at $25 a month, though the long-term picture of coverage is still in flux. Click to Tweet.

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pharmaphorum

DECEMBER 14, 2022

An FDA advisory committee has voted against approval of Cytokinetics’ cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough. Trading in Cytokinetics shares was halted in advance of the adcomm, but had weakened more than 6% pre-market. with omecamtiv mecarbil from 39.1%

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Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment. Health technology assessment (HTA) bodies also have some appetite for this information.

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Food and Drug Administration Patients Side effects Medicine 52

World of DTC Marketing

JULY 15, 2021

Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. This approval was NOT about patients; it was about the profits of a pharma company in quicksand and sinking fast. That meeting was reportedly followed by a formal meeting between Biogen and FDA in June 2019.

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Food and Drug Administration FDA Side effects Ethics 202

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. There are only two marketed treatments for ALS in the US. The FDA’s action plan.

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FDA Food and Drug Administration Physicians Side effects 98

pharmaphorum

OCTOBER 26, 2022

The US FDA has cleared Tecvayli (teclistamab) for the treatment of adults with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.

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Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. The trial reported a statistically significant reduction of clinical decline in the patients.

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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.

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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. The post Aldeyra spies FDA filing ahead for dry eye drug reproxalap appeared first on. billion respectively last year.

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Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

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Side effects Food and Drug Administration Safety Physicians 64

PM360

OCTOBER 13, 2023

Doctor Docs: Targeting Trust Between Pharma and HCPs A new study shows the crucial link in pharma marketers’ digital engagement strategy with HCPs is in jeopardy—trust. HCPs need pharma, and pharma needs HCPs—so let’s make sure that this next chapter of engagement is one of partnership, in pursuit of the interest of patients.”

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Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. million people in the UK and 2.7

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Silver Line CRM

NOVEMBER 20, 2020

Reading time: 4 minutes Bringing new treatments to patients in dire need of additional options is why those of us who work in life sciences do what we do. A successful vaccine, treatment, or new medical device brings forth both new opportunities as well as challenges given a new group of patients with unique needs to be met.

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pharmaphorum

JUNE 28, 2022

Basilea Pharmaceutica may finally be able to bring its antibiotic ceftobiprole to the US market – 13 years after its first attempt was turned down – thanks to a new phase 3 clinical trial. Ceftobiprole was turned down by the FDA in 2009 for ABSSSI, when the drug was partnered with Johnson & Johnson’s Janssen Cilag unit.

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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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World of DTC Marketing

FEBRUARY 9, 2021

Consistently we heard that they like images of real patients or a REAL doctor with one key message communicated. In clinical trials, how many people experienced a listed side effect? 7even: Real patient stories. They wanted to know why pharma didn’t communicate that their websites had to meet FDA guidelines?

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