Biopharma and Safety - Pharma Rep Focus

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

Safety Risk Sinks Cargo Therapeutics’ Cancer Cell Therapy Prospect, Leading to 50% Staff Cut

MedCity News

JANUARY 30, 2025

The post Safety Risk Sinks Cargo Therapeutics Cancer Cell Therapy Prospect, Leading to 50% Staff Cut appeared first on MedCity News. Phase 2 data for Cargo Therapeutics CD22-targeting cell therapy show low durability and cases of a severe immune response, some that were classified as grade 4 or 5 serious adverse events.

Prospecting

Prospecting Safety Leads Biopharma

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

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

‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

MedCity News

NOVEMBER 10, 2024

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. Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia.

FDA

FDA Engineering Safety Biopharma

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

Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors

MedCity News

NOVEMBER 12, 2024

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

Safety

Safety Patients Biopharma

Novartis Tries Again in Huntington’s, Putting Up $1B to Partner on a PTC Therapeutics Drug

MedCity News

DECEMBER 2, 2024

Last year, Novartis discontinued its Huntington’s program after safety issues emerged in Phase 2 testing. Novartis is securing global rights to a PTC Therapeutics Huntington’s disease drug candidate that has encouraging Phase 2 data that will be discussed with the FDA to plan a pivotal study.

Safety

Safety FDA Biopharma Pharma

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

Eisai Alzheimer’s Drug Wins Full FDA Approval, But With Sterner Safety Alert

MedCity News

JULY 6, 2023

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

Safety

Safety FDA Biopharma Pharma

Viking Therapeutics’ Early Clinical Data Continue to Build Case for Its Oral Obesity Drug

MedCity News

NOVEMBER 4, 2024

Higher doses of a Viking Therapeutics pill that targets two receptors led to greater weight loss without worsening safety or tolerability, according to Phase 1 results presented during the ObesityWeek conference. Meanwhile, an injectable version of this Viking drug is on track to Phase 3 testing.

Safety

Safety Biopharma

Better Predicting Drug Safety Calms Quarrels Between Medical Needs & Regulatory Process

MedCity News

JUNE 11, 2023

Human tissues, coupled with AI that can deal with terabytes of data will blow mice models out of the water. With animal testing requirements finally removed, the pharma industry and its constituents can hope for faster innovation.

Safety

Safety Medical Pharma Biopharma

New mass spectrometry Chapter could “revolutionise” biopharma quality assurance

European Pharmaceutical Review

DECEMBER 2, 2024

It is an industry-wide challenge to control [host cell proteins] HCPs to ensure the safety and quality of biopharmaceutical products” stated Derrick Zhang , Senior Scientist, US Pharmacopeia. This follows an announcement by USP about its intent to revise General Chapter <1132.1>

Biopharma

Biopharma Manufacturing Consulting Safety

Safety Risks and FDA Hold Lead Gilead to Stop Work on Drug in Blood Cancers

MedCity News

FEBRUARY 7, 2024

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

Safety

Safety Leads FDA Biopharma

How Risk-Based Quality Management Improves Data Quality, Patient Safety, Accelerating Drug Development

MedCity News

APRIL 11, 2023

Risk-based quality management, or RBQM, is the process by which pharmaceutical organizations monitor and manage quality throughout clinical trials.

Management

Management Safety Patients Pharmaceutical

Eisai Alzheimer’s Drug Data Show Slowing of Decline But Safety Questions Linger

MedCity News

NOVEMBER 30, 2022

Eisai has presented and published full data from the Phase 3 clinical trial for its Alzheimer’s disease drug lecanemab, with results showing a statistically significant slowing decline associated with the neurodegenerative disorder.

Safety

Safety FDA Biopharma Pharma

Making the Most of Real-World Data in Clinical Trials

MedCity News

JANUARY 1, 2024

Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies.

Electronics

Electronics Media Safety Biopharma

Nvidia’s AI Tech Designs Proteins Never Seen in Nature, Pointing Way to New Therapies

MedCity News

JANUARY 22, 2023

A collaboration between Nvidia and startup Evozyne was able to produce novel versions of a human protein never before seen in nature but with enhanced function and the same safety as native protein. The research lays the groundwork for potential new therapies for a rare inherited disorder.

Safety

Safety Biopharma

Automation to accelerate biopharma in next decade

European Pharmaceutical Review

APRIL 17, 2023

A report on automation in the biopharma industr y has shown that the market is projected to grow at a compound annual growth rate (CAGR) of 5.7 Factors impacting the automation in the biopharma industry market The report found that 75 percent of pharmaceutical organisations want to use automated solutions more frequently.

Biopharma

Biopharma Manufacturing Pharmaceutical products Marketing

Enabling Clinical Trial Innovation Through AI Regulation at FDA

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

FDA Safety Healthcare Healthcare

J.P. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer

MedCity News

APRIL 30, 2024

With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. Enlaza Therapeutics’ drugs form covalent bonds that lock the therapy onto its target. The post J.P.

Leads

Leads Safety Biopharma Pharma

Akebia Recovers From Rejection to Win FDA Approval for Anemia Drug

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

FDA Safety Marketing Biopharma

Machine learning: An essential tool in the shift to risk-based quality management

MedCity News

NOVEMBER 16, 2022

Risk-based quality management is a data monitoring approach that accelerates the drug development pathway without compromising on safety – and one that is enhanced by the use of technologies such as artificial intelligence.

Management

Management Safety Biopharma

FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

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

FDA Safety Pharma Biopharma

Longboard Pharma Trial Data Show How It Could Stand Out in the Epilepsy Field

MedCity News

JANUARY 2, 2024

Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%.

Safety

Safety Pharma Pharmaceutical Biopharma

On Heels of Positive Parkinson’s Gene Therapy Data, MeiraGTx Looks Ahead to Pivotal Test

MedCity News

OCTOBER 15, 2024

In addition to meeting the main safety and tolerability goal, MieraGTx Holdings’ gene therapy for Parkinson’s disease also showed signs of efficacy. The one-time treatment is intended to reprogram dysfunctional brain circuits.

Safety

Safety Biopharma Pharma

Structure Raises $300M as Oral GLP-1 Drug’s Data Keep Up With Pfizer, Eli Lilly

MedCity News

SEPTEMBER 29, 2023

Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies.

Competition

Competition Safety Pharma Biopharma

FDA Pauses Verve’s Trial Plan for Gene-Editing Therapy for High Cholesterol

MedCity News

NOVEMBER 7, 2022

No details about the FDA’s questions or concerns were disclosed; so far, no serious safety problems have been reported in the U.K. The FDA placed a clinical hold on Verve Therapeutics’ application to begin human testing of its gene-editing therapy for an inherited form of high cholesterol.

FDA

FDA Safety Biopharma Pharma

Bio Startup Scorpion Partners With Pierre Fabre for Trials of Targeted Lung Cancer Drugs

MedCity News

APRIL 4, 2023

The Scorpion drugs could have safety advantages over approved Johnson & Johnson and Takeda therapies that address the same rare genetic signature.

Safety

Safety Biopharma Pharma

With new gene therapy data in hand, Sarepta talks with FDA about approval pathways

MedCity News

JULY 6, 2022

Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.

Safety

Safety FDA Biopharma Pharma

Gene therapy is saving lives; There are still key challenges to realize its full potential

MedCity News

OCTOBER 20, 2022

Gene therapy can offer hope to patients with previously untreatable diseases, but there’s more work to be done to improve both the safety and efficacy of this therapeutic modality.

Safety

Safety Patients Biopharma

Patient Death Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

MedCity News

FEBRUARY 20, 2024

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. The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug.

FDA

FDA Patients Safety Biopharma

CMS Will Cover Approved Alzheimer’s Drugs, But It Still Wants More Evidence

MedCity News

JUNE 1, 2023

But the decision keeps the spirit of an earlier coverage determination, which called for the gathering of more evidence about the safety and efficacy of these therapies. Medicare will cover Alzheimer’s disease drugs granted traditional FDA approval, CMS announced.

Safety

Safety FDA Biopharma Pharma

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

MedCity News

JUNE 30, 2022

tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring. The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury.

FDA

FDA Leads Safety Patients

After initial failure, Intercept Pharma feels new data can get NASH drug approval

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

Safety Pharma FDA Pharmaceutical

Gilead pays $60M to strike up another cancer drug alliance with MacroGenics

MedCity News

OCTOBER 17, 2022

Gilead Sciences is betting that a MacroGenics antibody drug for blood cancers can offer a safety edge over others that address the same target. It’s the second partnership between the two companies; an alliance that began in 2013 expired without Gilead licensing any molecules from the deal.

Safety

Safety Biopharma Pharma

NASH Drug Biotech 89bio Nails Phase 2 Goals; Next Up Is a Pivotal Clinical Trial

MedCity News

MARCH 22, 2023

In addition to demonstrating efficacy and safety according to measures the FDA says are needed to support a regulatory submission, 89bio says the results also show its drug could offer a dosing edge over potential rivals. 89bio reported its NASH drug candidate met the main endpoints of a mid-stage clinical trial.

Safety

Safety FDA Biopharma Pharma

Sanofi Puts Up $125M to Partner on Oral Drug That Could Be Dupixent’s Successor

MedCity News

JULY 20, 2023

If it works, the drug could have safety and dosing advantages over currently available biologic drugs, including blockbuster Sanofi drug Dupixent. Sanofi is interested in Recludix Pharma’s approach to treating inflammation with an oral small molecule that targets a protein thought to be undruggable.

Safety

Safety Biopharma Pharma

Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder

MedCity News

AUGUST 7, 2023

The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product. Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy.

Pharmaceutical products

Pharmaceutical products Safety FDA Pharma

BioNTech Puts Up $200M to Partner With OncoC4 in Cancer Immunotherapy

MedCity News

MARCH 20, 2023

The antibody was designed to offer a safety edge over other CTLA-4-blocking drugs it’s on track for a Phase 3 test in non-small cell lung cancer. BioNTech is expanding its cancer immunotherapy scope by partnering with OncoC4 on clinical testing of its lead drug.

Safety

Safety Leads Biopharma Pharma

China grants EUA to Covid-19 vaccine against XBB descendent lineages

Pharmaceutical Technology

JUNE 9, 2023

WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University. recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) 5 subvariants.

Biopharma

Biopharma Safety Medical

Prioritizing Safety and Pharmacovigilance in the Age of Innovation

Veeva

APRIL 22, 2024

A robust pharmacovigilance and safety strategy is crucial, regardless of a company’s scale. Solutions like Veeva Vault Safety enable life sciences companies to bring management of safety processes in-house, with global end-to-end adverse event management on a unified platform, enabling access to real-time information.

Safety

Safety Management Biopharma Patients

Pepper Bio’s ‘Google Maps for Drug Discovery’ Finds Way to Potential New Liver Cancer Drug

MedCity News

MAY 1, 2024

Pepper Bio has licensed rights to lerociclib, a molecule that G1 Therapeutics designed to offer dosing and safety advantages over approved therapies in the same drug class. EQRx previously held rights to the drug, but returned them after the company was acquired last year.

Safety

Safety Biopharma Pharma

6 research and development life sciences predictions for 2023

pharmaphorum

JANUARY 6, 2023

Veeva’s industry experts share their predictions about how breaking down silos across clinical, regulatory, safety, and quality teams will benefit patients. This will enable biopharmas to create a more streamlined drug development process rooted in lean process execution and higher-quality data.”.

Safety

Safety Management Patients Training

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

Safety Risk Sinks Cargo Therapeutics’ Cancer Cell Therapy Prospect, Leading to 50% Staff Cut

Trending Sources

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

Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

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

Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors

Novartis Tries Again in Huntington’s, Putting Up $1B to Partner on a PTC Therapeutics Drug

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

Eisai Alzheimer’s Drug Wins Full FDA Approval, But With Sterner Safety Alert

Viking Therapeutics’ Early Clinical Data Continue to Build Case for Its Oral Obesity Drug

Better Predicting Drug Safety Calms Quarrels Between Medical Needs & Regulatory Process

New mass spectrometry Chapter could “revolutionise” biopharma quality assurance

Safety Risks and FDA Hold Lead Gilead to Stop Work on Drug in Blood Cancers

How Risk-Based Quality Management Improves Data Quality, Patient Safety, Accelerating Drug Development

Eisai Alzheimer’s Drug Data Show Slowing of Decline But Safety Questions Linger

Making the Most of Real-World Data in Clinical Trials

Nvidia’s AI Tech Designs Proteins Never Seen in Nature, Pointing Way to New Therapies

Automation to accelerate biopharma in next decade

Enabling Clinical Trial Innovation Through AI Regulation at FDA

J.P. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer

Akebia Recovers From Rejection to Win FDA Approval for Anemia Drug

Machine learning: An essential tool in the shift to risk-based quality management

FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

Longboard Pharma Trial Data Show How It Could Stand Out in the Epilepsy Field

On Heels of Positive Parkinson’s Gene Therapy Data, MeiraGTx Looks Ahead to Pivotal Test

Structure Raises $300M as Oral GLP-1 Drug’s Data Keep Up With Pfizer, Eli Lilly

FDA Pauses Verve’s Trial Plan for Gene-Editing Therapy for High Cholesterol

Bio Startup Scorpion Partners With Pierre Fabre for Trials of Targeted Lung Cancer Drugs

With new gene therapy data in hand, Sarepta talks with FDA about approval pathways

Gene therapy is saving lives; There are still key challenges to realize its full potential

Patient Death Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

CMS Will Cover Approved Alzheimer’s Drugs, But It Still Wants More Evidence

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

After initial failure, Intercept Pharma feels new data can get NASH drug approval

Gilead pays $60M to strike up another cancer drug alliance with MacroGenics

NASH Drug Biotech 89bio Nails Phase 2 Goals; Next Up Is a Pivotal Clinical Trial

Sanofi Puts Up $125M to Partner on Oral Drug That Could Be Dupixent’s Successor

Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder

BioNTech Puts Up $200M to Partner With OncoC4 in Cancer Immunotherapy

China grants EUA to Covid-19 vaccine against XBB descendent lineages

Prioritizing Safety and Pharmacovigilance in the Age of Innovation

Pepper Bio’s ‘Google Maps for Drug Discovery’ Finds Way to Potential New Liver Cancer Drug

6 research and development life sciences predictions for 2023

Stay Connected