Fierce Pharma

DECEMBER 9, 2023

A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions. BCMA-targeted therapies are transforming care for multiple myeloma patients. But these immunotherapies also come with various potentially dangerous side effects. |

Side effects 264

Side effects FDA Safety Doctors 264

World of DTC Marketing

DECEMBER 29, 2020

All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. Let’s also remember that pharma is going to make a LOT of money on these vaccines. That’s a hell of an incentive.

Pharma 307

Pharma Food and Drug Administration Media Food 307

Fierce Pharma

NOVEMBER 29, 2023

The revelation of an FDA investigation< | As industry watchers deliberate the implications from the FDA's investigation into secondary cancer risks from CAR-T medicines, an upcoming expert meeting could offer precious clarity from drug regulators.

FDA 226

FDA Safety Medicine 226

Fierce Pharma

JANUARY 25, 2024

But questions remained unanswered.

Safety 256

Safety FDA Medicine Patients 256

Fierce Pharma

SEPTEMBER 11, 2024

Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva. For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming.

FDA 222

FDA Safety Pharmaceutical Marketing 222

Fierce Pharma

JUNE 27, 2023

Despite Regeneron’s impressive high-dose Eylea data, its high-stakes launch is delayed thanks to an unexpected FDA rejection. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter. But the company said it has nothing to do with the drug's efficacy or safety.

FDA 215

FDA Manufacturing Safety 215

World of DTC Marketing

JUNE 24, 2021

Pharma TV ads drive people online to search for more information. Safety pages on Pharma product websites continue to have high utility. As we have seen over the past few years, Pharma companies are a business, a regulated business, but still a business. This is normal, and the FDA should take note.

FDA 165

FDA Doctors Prescription Pharma 165

World of DTC Marketing

FEBRUARY 9, 2021

6ix: Safety information needs context. They understand that patient content could be edited to meet FDA requirements, but they like reading others’ experiences managing their health issues. 9ine: “Why aren’t pharma websites updated?” First impressions are 94% design-related. 7even: Real patient stories.

Pharma 180

Pharma Medical Side effects FDA 180

MedCity News

APRIL 15, 2024

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

Safety 95

Safety FDA Leads Biopharma 95

World of DTC Marketing

FEBRUARY 4, 2021

The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S. COVID Dashboards.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

Fierce Pharma

MARCH 4, 2024

. | After a preliminary analysis found a potentially higher risk of Guillain-Barré syndrome following RSV vaccination in older adults, GSK and Pfizer said they will conduct further safety studies.

Safety 239

Safety FDA 239

Fierce Pharma

AUGUST 15, 2024

So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels. | So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels.

Side effects 225

Side effects Safety FDA 225

Fierce Pharma

SEPTEMBER 19, 2023

Gaining FDA approval last month for its geographic atro | Astellas reported results of a phase 3 trial that assessed Izervay’s effectiveness and safety over a 24-month period.

Safety 247

Safety FDA 247

World of DTC Marketing

OCTOBER 29, 2020

It’s time to admit that the FDA is completely out of touch regarding DTC advertising. I just finished an analysis of a pharma clients website using their analytics. Who could blame them when the safety information sounds like a medical journal? For some reason, the FDA still requires fair balance on website home pages.

Side effects 181

Side effects Safety FDA Pharma 181

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

FDA 207

FDA Food and Drug Administration Patients Biopharma 207

MedCity News

JANUARY 23, 2024

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

Safety 88

Safety FDA Patients Biopharma 88

World of DTC Marketing

JANUARY 8, 2021

Pharma companies will make an estimated $40 billion on the global COVID-19 vaccine market this year, which will be split between Johnson & Johnson, AstraZeneca, Novavax, and others. Wall Street has been speculating for a long time on which pharma company is going to make the most from the development of a Covid-19 vaccine.

Government 266

Government Safety FDA Pharma 266

Pharmaceutical Commerce

MAY 29, 2024

The latest news for pharma industry insiders.

Pharma 109

Pharma Safety FDA 109

Fierce Pharma

JULY 13, 2023

After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still trying to work out the logistics of testing and reimbursement. After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still working out the logistics of testing and reimbursement.

Doctors 206

Doctors Safety FDA 206

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Hedley Rees has written a book on pharma supply chains that is eye-opening and downright scary. We need a 21st-century approach that puts patient safety first. In other words, money over safety. Patients should be scared.

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

MedCity News

SEPTEMBER 27, 2024

Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety. The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics.

FDA 102

FDA Safety Pharma Biopharma 102

MedCity News

JULY 29, 2024

As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.

FDA 110

FDA Safety Healthcare Healthcare 110

World of DTC Marketing

NOVEMBER 10, 2020

Pharma CEOs still are more concerned about their company’s stock price than patents. Biogen shot up when an initial review of their Alzheimer’s drug was positive, but then analysts torpedoed the company when another FDA panel said there wasn’t enough data. It’s a never-ending cycle. It’s sad, really.

Media 286

Media Retail FDA Safety 286

MedCity News

JULY 6, 2023

Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.

Safety 79

Safety FDA Biopharma Pharma 79

pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? They found that the FDA approved 85 (95%) of the drugs before the EMA, with the latter clocking up a median delay of 241 (150-370) days.

Safety 89

Safety FDA Medicine Patients 89

MedCity News

MARCH 31, 2024

Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020. The FDA rejected the drug two years ago due to concerns about cardiovascular safety.

FDA 100

FDA Safety Marketing Biopharma 100

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. Clinical trials of the FDA approved Rykindo ®. “Rykindo ® is our first new drug developed in-house and approved for marketing in the US,” declared Yang Rongbing, President of Luye Pharma Group.

Food and Drug Administration 122

Food and Drug Administration FDA Competition Pharma 122

MedCity News

NOVEMBER 10, 2024

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

FDA 95

FDA Engineering Safety Biopharma 95

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

FDA 107

FDA Food and Drug Administration Patients Food 107

MedCity News

JULY 7, 2022

Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.

Safety 96

Safety Pharma FDA Pharmaceutical 96

MedCity News

FEBRUARY 20, 2024

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

FDA 91

FDA Patients Safety Biopharma 91

World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. 3hree: DTC marketing minimizes the side effects of prescription drugs – One of the top pages within prescription drug websites continues to be “safety information.” SUMMARY: DTC marketing is not the reason why prescription drugs cost so much.

Marketing 285

Marketing Prescription Side effects Doctors 285

pharmaphorum

NOVEMBER 23, 2022

The Japanese pharma said it has filed for approval of TAK-003 with the FDA for the prevention of dengue disease caused by any dengue virus serotype in individuals aged four through 60. The post FDA starts speedy review of Takeda’s dengue vaccine appeared first on. billion in peak sales.

FDA 119

FDA Marketing Leads Safety 119

PM360

OCTOBER 28, 2022

Promising AI Use Cases in Pharma. Although we’re still at the beginning of the AI revolution in pharma, promising use-cases have already been identified: Drug discovery: In drug discovery , AI models are predicting the 3D structure of target proteins at an unprecedented scale.

Pharma 105

Pharma Food and Drug Administration Medicine Government 105

World of DTC Marketing

DECEMBER 23, 2020

While pharma product websites stop the train for online health seekers, the vast majority fail to provide the information needed to convince people to ask for an advertised product. The FDA can be myopic when researching how consumers view and react to DTC. What are the side effects? Is it covered by my insurance?

Prescription 249

Prescription Doctors Side effects Marketing 249

Pharma Marketing Network

MARCH 25, 2022

5 While the CDC gathers information on these topics for public health planning, there are immediate needs that pharma can address. . What Can Pharma Do? The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Findings note that caregivers are a vital source of information.

Pharma 98

Pharma Education Training Transportation 98