Safety - Pharma Rep Focus

Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Fierce Pharma

JUNE 18, 2024

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

Safety

Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

Fierce Pharma

JUNE 22, 2023

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

Safety

AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

NOVEMBER 20, 2024

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

Safety

Safety FDA

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

Fierce Pharma

MAY 17, 2023

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29

Safety

Safety FDA

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Revvity Signals provides a centralized analytics platform built to support today’s clinical study requirements and increase trial efficiency, glean actionable analytic insights, automate data collection and harmonization, support safety and efficacy decision-making, and enable a singular view across a company’s entire candidate portfolio.

Safety

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

Fierce Pharma

JANUARY 17, 2023

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. Tue, 01/17/2023 - 11:49.

Safety

After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs

Fierce Pharma

MAY 17, 2024

A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns. Following a controversy over Covis’ preterm birth drug Makena in the U.S.

Safety

Safety Medicine

Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Fierce Pharma

JANUARY 24, 2024

Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. . | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Instead, it's adjusted the wording of a proposed boxed warning.

Safety

Safety FDA

New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

AUGUST 20, 2024

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

Safety

How Machine Learning Drives Clinical Trial Efficiency

Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Safety

FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

Fierce Pharma

JANUARY 22, 2024

As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. |

FDA

FDA Safety Leads

Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe

Fierce Pharma

JANUARY 6, 2024

A group of cell therapy experts, including CAR-T pioneers Drs. Bruce Levine and Carl June, wrote in support of continued use of CAR-T therapy.

Safety

Safety Medicine FDA

Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Fierce Pharma

JANUARY 25, 2024

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more (..)

Safety

Safety FDA Medicine Patients

Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?

Fierce Pharma

OCTOBER 26, 2023

With concerns growing over the burden Leqembi could impose on healthcare infrastructure, Eisai and Biogen have trotted out data for an under-the-skin version of the Alzheimer’s disease drug that ma | Eisai and Biogen have trotted out data for a subcutaneous version of the Alzheimer’s disease drug Leqembi.

Safety

Safety Healthcare Healthcare

Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.

Medical

CSL Vifor proposes campaign to undo messaging about safety profile of rival product

Fierce Pharma

APRIL 19, 2024

CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safe | CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safety of a rival product, the European Commission (EC) said.

Safety

Safety Signal in Phase 2 Deals a Setback to BioAge Labs’ Muscle-Preserving Obesity Drug

MedCity News

DECEMBER 8, 2024

BioAge Labs said the potential safety problem was observed in some who received experimental drug azelaprag, which is being tested as a monotherapy and in combination with Eli Lilly obesity medication Zepbound. No safety signals were observed in those who received Zepbound alone.

Safety

Safety Medical Biopharma Pharma

Organon's prolific asthma med Singulair needs new safety labeling, NY attorney general argues

Fierce Pharma

FEBRUARY 27, 2024

Organon’s inherited asthma med Singulair is back in the spotlight for the wrong reasons after New York Attorney General Letitia James raised fresh concerns about the drug’s neuropsychiatric side ef | Organon’s inherited asthma med Singulair is back in the spotlight for the wrong reasons after New York Attorney General Letitia James raised fresh concerns (..)

Side effects

Side effects Safety

Staff Safety is Key to Sustaining Home Health Growth

MedCity News

OCTOBER 1, 2024

Innovative approaches to home care will only be successful if organizations can ensure the safety of the professionals who enter patient homes. The post Staff Safety is Key to Sustaining Home Health Growth appeared first on MedCity News.

Safety

Safety Patients Healthcare Healthcare

Right-to-Repair Laws Could Threaten Healthcare Safety

MedCity News

MAY 14, 2024

The post Right-to-Repair Laws Could Threaten Healthcare Safety appeared first on MedCity News. Healthcare devices must be exempted from general right to repair legislation.

Safety

Safety Healthcare Healthcare

As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost

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

FDA Safety Medicine

Safety Stands Out in Arcellx Cell Therapy’s ASH Data, But Don’t Overlook Manufacturing Advantages

MedCity News

DECEMBER 10, 2024

The post Safety Stands Out in Arcellx Cell Therapys ASH Data, But Dont Overlook Manufacturing Advantages appeared first on MedCity News. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.

Safety

Safety Manufacturing Biopharma Pharma

Patient Safety Structural Measure Marks Progress Towards Safer and Compassionate Care

MedCity News

OCTOBER 1, 2024

CMS recently finalized the Patient Safety Structural Measure, which sets forth a broad roadmap for the implementation of a culture of safety, learning, transparency and accountability within hospitals and health systems nationwide — enabling and encouraging significant progress towards safer care and improved support for healthcare workers.

Safety

Safety Patients Healthcare Healthcare

As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

Fierce Pharma

DECEMBER 9, 2023

BCMA-targeted therapies are transforming care for multiple myeloma patients. But these immunotherapies also come with various potentially dangerous side effects. | 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.

Side effects

Side effects FDA Safety Doctors

From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

MedCity News

JUNE 14, 2024

The post From Recalls to Reliability: Tools to Ensure Software Safety in MedTech appeared first on MedCity News. Cutting-edge technology empowers developers to proactively detect and mitigate issues before they cause problems, reducing recalls and fostering trust in the industry.

Safety

Safety Patients Medical

The Value-based Care Throughline to Healthcare Quality and Safety

MedCity News

MAY 27, 2024

The post The Value-based Care Throughline to Healthcare Quality and Safety appeared first on MedCity News. By prioritizing continuous patient engagement and strategic communication across the entire care journey, healthcare organizations can drive real progress toward value-based care.

Safety

Safety Healthcare Healthcare Patients

J&J, Legend’s Carvykti slapped with FDA black-box warning over secondary cancer risk

Fierce Pharma

DECEMBER 22, 2023

As the FDA investigates a safety signal for approved CAR-T therapies, the agency has upgraded a warning about secondary cancers resulting from use of Johnson & Johnson and Legend Biotech’s Carv | As the FDA investigates a safety signal for approved CAR-T therapies, the agency has elevated a warning about secondary cancers resulting from use of (..)

FDA

FDA Safety

Incyte's Opzelura clears skin in children with atopic dermatitis, but safety remains a question

Fierce Pharma

JULY 12, 2023

Fighting for a place in the competitive atopic dermatitis market, Incyte hopes to reach younger patients with its JAK inhibitor cream Opzelura. Fighting for a place in the competitive atopic dermatitis market, Incyte hopes to reach young patients with its JAK inhibitor cream Opzelura.

Safety

Safety Competition Marketing Patients

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

NOVEMBER 1, 2024

Now, less than a year later, the FDA is reconsidering those serious safety warnings with plans to potentially change them, CBER Director Peter Marks, M.D., . | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.

FDA

FDA Safety Pharma Patients

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

MedCity News

APRIL 15, 2024

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

Safety

Safety FDA Leads Biopharma

Jacobio plans bid for China’s KRAS market with safety edge

pharmaphorum

MAY 1, 2024

China's Jacobio Pharma is preparing to file its KRAS inhibitor glecirasib for approval, saying it could offer a safety advantage over current drugs in the class

Safety

Safety Marketing Pharma

Apellis attempts to clear the air around Syfovre safety as eye drug launch gains steam

Fierce Pharma

JULY 31, 2023

For Apellis Pharmaceuticals, the emergence of rare but serious side effects has cast a pall over the launch of the company’s geographic atrophy med Syfovre. While touting the “strong commercial execution” of Syfovre’s launch, Apellis’ CEO Cedric Francois, M.D.,

Side effects

Side effects Safety Pharmaceutical

Medication Management Technology Puts Patient Safety at the Center of Care

MedCity News

FEBRUARY 21, 2024

In the same way that airbags were a natural evolution of vehicle safety technology, seamless, RFID-based systems are the next evolution of medication management technology.

Safety

Safety Management Medical Patients

EMA Committee’s Negative Opinion for Eisai Alzheimer’s Drug Focuses on Safety Risks

MedCity News

JULY 26, 2024

The post EMA Committee’s Negative Opinion for Eisai Alzheimer’s Drug Focuses on Safety Risks appeared first on MedCity News. The EMA’s Committee for Medicinal Products for Human Use expressed concern about brain complications associated with the Eisai Alzheimer’s drug, Leqembi.

Safety

Safety Medicine Biopharma Pharma

Safety Plans are Effective at Reducing Suicidal Behavior. So Why Aren’t More People Getting Them?

MedCity News

JULY 7, 2024

In addition to making suicide screening more accessible and widespread, successful implementation of safety plans is critical — here are 3 recommendations that care teams can implement. The post Safety Plans are Effective at Reducing Suicidal Behavior. So Why Aren’t More People Getting Them? appeared first on MedCity News.

Safety

Uzedy partners Teva and MedinCell's latest long-acting schizophrenia candidate notches phase 3 win

Fierce Pharma

MAY 8, 2024

The companies second go at a long-acting schizophrenia med uses popular antipsychotic olanzapine, which Eli Lilly first marketed in the 90s but found safety issues with its own long-acting version.

Safety

Safety Marketing

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

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

Safety FDA Patients Biopharma

RSV vaccines may raise risk of Guillain-Barré syndrome, FDA preliminary analysis finds

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

Safety FDA

Fierce Pharma Asia—AZ, Daiichi's ADC scare; Moderna's China investment; Takeda's F-Star deal

Fierce Pharma

JULY 7, 2023

AstraZeneca and Daiichi Sankyo's TROP2 antibody-drug conjugate returned a concerning safety message. AstraZeneca and Daiichi Sankyo delivered a concerning safety message for their TROP2 antibody-drug conjugate. Moderna reportedly plans to invest up to $1 billion in China.

Safety

Safety Pharma

Eli Lilly flags bacteria, impurity concerns in fake and compounded versions of popular GLP-1 meds

Fierce Pharma

MARCH 7, 2024

With the swelling popularity of Eli Lilly’s diabetes med Mounjaro and its weight loss counterpart Zepbound, unauthorized copycats continue to emerge, posing a growing safety risk. |

Safety

Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc

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

FDA Safety Pharmaceutical Marketing

AbelsonTaylor Group Receives the Healthcare Businesswomen’s Association ACE Aspire Award for its Employee Psychological Safety Initiative

PM360

NOVEMBER 9, 2023

Award-winning health and wellness advertising agency AbelsonTaylor Group received the inaugural ACE Aspire Award for its employee Psychological Safety Initiative from the Healthcare Businesswomen’s Association (HBA). In 2022, AbelsonTaylor developed and implemented a large-scale, ongoing Psychological Safety initiative for its 300 employees.

Safety

Safety Healthcare Healthcare Recruitment

Astellas touts 2-year trial of geographic atrophy drug Izervay but shares few details

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

Safety FDA

With phase 3 miss, Pfizer's DMD candidate is no threat to Sarepta's Elevidys ahead of key label expansion: analysts

Fierce Pharma

JUNE 13, 2024

With a phase 3 miss following a fatality in a related study and marking what analysts are calling the “final nail” in Pfizer’s Duchenne muscular dystrophy (DMD) gene therapy coffin, Sarepta Therape | With a phase 3 miss and severe safety signals, Pfizer's Duchenne muscular dystrophy gene therapy candidate is no competition to Sarepta's established (..)

Competition

Competition Safety

Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

Trending Sources

AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs

Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

How Machine Learning Drives Clinical Trial Efficiency

FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe

Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?

Commercial Drug Sourcing for Clinical Trials

CSL Vifor proposes campaign to undo messaging about safety profile of rival product

Safety Signal in Phase 2 Deals a Setback to BioAge Labs’ Muscle-Preserving Obesity Drug

Organon's prolific asthma med Singulair needs new safety labeling, NY attorney general argues

Staff Safety is Key to Sustaining Home Health Growth

Right-to-Repair Laws Could Threaten Healthcare Safety

As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost

Safety Stands Out in Arcellx Cell Therapy’s ASH Data, But Don’t Overlook Manufacturing Advantages

Patient Safety Structural Measure Marks Progress Towards Safer and Compassionate Care

As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

From Recalls to Reliability: Tools to Ensure Software Safety in MedTech

The Value-based Care Throughline to Healthcare Quality and Safety

J&J, Legend’s Carvykti slapped with FDA black-box warning over secondary cancer risk

Incyte's Opzelura clears skin in children with atopic dermatitis, but safety remains a question

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

Jacobio plans bid for China’s KRAS market with safety edge

Apellis attempts to clear the air around Syfovre safety as eye drug launch gains steam

Medication Management Technology Puts Patient Safety at the Center of Care

EMA Committee’s Negative Opinion for Eisai Alzheimer’s Drug Focuses on Safety Risks

Safety Plans are Effective at Reducing Suicidal Behavior. So Why Aren’t More People Getting Them?

Uzedy partners Teva and MedinCell's latest long-acting schizophrenia candidate notches phase 3 win

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

RSV vaccines may raise risk of Guillain-Barré syndrome, FDA preliminary analysis finds

Fierce Pharma Asia—AZ, Daiichi's ADC scare; Moderna's China investment; Takeda's F-Star deal

Eli Lilly flags bacteria, impurity concerns in fake and compounded versions of popular GLP-1 meds

Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc

AbelsonTaylor Group Receives the Healthcare Businesswomen’s Association ACE Aspire Award for its Employee Psychological Safety Initiative

Astellas touts 2-year trial of geographic atrophy drug Izervay but shares few details

With phase 3 miss, Pfizer's DMD candidate is no threat to Sarepta's Elevidys ahead of key label expansion: analysts

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