Biopharma and Patients - Pharma Rep Focus

Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

MedCity News

NOVEMBER 22, 2024

A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. The post Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose appeared first on MedCity News.

FDA

FDA Patients Biopharma Pharma

Embracing Personalization in Biopharma Patient Support Programs

Fierce Pharma

APRIL 18, 2023

Embracing Personalization in Biopharma Patient Support Programs mteefey Tue, 04/18/2023 - 14:48

Biopharma

Biopharma Patients

Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence

MedCity News

NOVEMBER 10, 2024

The post Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence appeared first on MedCity News.

Patients

Patients Medicine Healthcare Healthcare

Novo Nordisk Launches Lower-Cost Wegovy, Following Eli Lilly Into Direct-to-Patient Sales

MedCity News

MARCH 5, 2025

Wegovy will ship directly to eligible patients through NovoCare, an online pharmacy established by Novo Nordisk. The products price matches a recent price cut for Zepbound offered by Eli Lilly through its own direct-to-patient online platform.

Sales

Sales Patients Biopharma Pharma

Transforming biopharma’s approach to patient engagement with direct-to-patient programs

PharmaVoice

MARCH 3, 2025

Consumers want more from biopharma. Next-generation direct-to-patient programs can deliver.

Patients

Patients Biopharma

Liver Failure-Associated Death Reported in Patient Treated With Sarepta Gene Therapy Elevidys

MedCity News

MARCH 18, 2025

Sarepta Therapeutics said the Duchenne muscular dystrophy patient recently had a cytomegalovirus infection, which can damage the liver and may have contributed to the fatality. Its the first patient death out of more than 800 patients treated with Elevidys, a gene therapy for the rare muscle-wasting disease.

Patients

Patients Biopharma

How Tech Changes to Clinical Trials Help Both Patients and Biopharma Firms

MedCity News

OCTOBER 27, 2023

Technology is transforming how clinical trials are run. A panel during MedCity News’ INVEST Digital Health conference discussed the tech trends shaping the design and execution of drug studies.

Biopharma

Biopharma Patients Pharma

Elevating patient care from the home

MedCity News

JULY 20, 2022

By adding adherence and connectivity capabilities to home-based solutions, clinicians can maintain open lines of communication with patients, helping patients better care for themselves from the comfort of their homes.

Patients

Patients Biopharma

Allying With Patients to Make Every Cure Possible

MedCity News

MAY 22, 2024

To win the battle against rare diseases, drug developers must work hand-in-hand with patients. The post Allying With Patients to Make Every Cure Possible appeared first on MedCity News.

Patients

Patients Biopharma

Top 5 regulatory trends impacting Software as a Medical Device (SaMD)

MedCity News

SEPTEMBER 12, 2022

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to differentiate themselves.

Biopharma

Biopharma Medical Competition Patients

FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

MedCity News

APRIL 23, 2024

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News. The novel immunotherapy works by sparking activity from three types of immune cells.

FDA

FDA Patients Biopharma Pharma

Patient Voice and Patient Choice: Essentials for Successful DCTs

MedCity News

DECEMBER 19, 2022

Historically, clinical trials have not prioritized the experiences of patients, who are required to frequently return on-site and engage with unfamiliar medical technology. They are often left in the dark regarding the data and health outcomes being collected through their participation.

Patients

Patients Medical Biopharma

The PharmaVoice 100: Rare disease warriors

PharmaVoice

OCTOBER 16, 2023

Biopharma leaders pounding away at rare diseases so patients with few other options can have healthier lives.

Biopharma

Biopharma Patients

With Direct-to-Patient Zepbound, Eli Lilly Takes a Stand Against Compounders and PBMs

MedCity News

SEPTEMBER 4, 2024

Eli Lilly now offers vials of obesity medication Zepbound directly to self-pay patients at a nearly 50% discount off the drug’s list price. But more than offering patients a lower-cost alternative, this move represents a strategic stance against certain pharmaceutical industry players.

Patients

Patients Medical Pharmaceutical Biopharma

Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study

MedCity News

JUNE 16, 2024

Investigators say these results indicate telehealth can make palliative care accessible to more cancer patients. The post Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study appeared first on MedCity News.

Patients

Patients Biopharma

How Patient Monitoring Is Poised to Revolutionize Healthcare

MedCity News

FEBRUARY 26, 2023

Wearable patient devices can provide healthcare organizations with more varied data, expand options for clinical trials, and make patients more active participants in their own care.

Healthcare

Healthcare Healthcare Patients Biopharma

What the Radiopharmaceutical Pipeline Means for Patient Care

MedCity News

OCTOBER 16, 2023

With increased access to cutting-edge imaging, improved treatment options, greater personalization of treatment, reduced radiation exposure, and potential for future advances, patients can expect to receive more advanced medical care tailored to their specific needs through radiopharmaceuticals.

Patients

Patients Medical Biopharma

An Attack on Patients’ Right to Informed Consent

MedCity News

MARCH 6, 2024

This case, about the claim that Merck failed to warn patients about the risk of typical femoral fracture, reaches past this suit to potentially change pharmaceutical companies’ relationship with the FDA.

Patients

Patients FDA Pharmaceutical Biopharma

The Key To Faster, More Efficient Clinical Trials? Patient Centricity

MedCity News

DECEMBER 8, 2022

Added complexity to daily life is likely why patient dropout rates remain high, with 19% leaving studies before completion. Truly patient-centric trials will allow for broader participation, allowing patients to decide how and when they want to engage in a study.

Patients

Patients Biopharma

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

MedCity News

APRIL 8, 2024

The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products. The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

FDA

FDA Patients Marketing Biopharma

FDA Approves First Drug for Treating Agitation in Alzheimer’s Patients

MedCity News

MAY 11, 2023

Rexulti, a drug for schizophrenia and depression, now has an additional approval for treating agitation in Alzheimer’s disease patients. The FDA decision makes the Otsuka Pharmaceutical and Lundbeck product the first drug approved for this indication.

FDA

FDA Patients Pharmaceutical Biopharma

Polypharmacy is a Health Killer: Personalized Medication Management is the Answer

MedCity News

NOVEMBER 20, 2024

We cannot change the fact that some patients must take multiple drugs, but we can certainly change how we manage it with careful coordination and communication among healthcare providers, and personalized medicine practices such as pharmacogenomics.

Management

Management Medical Healthcare Provider Medicine

Eli Lilly Moves Closer to Bringing Diabetes Patients a Once-Weekly Insulin Alternative

MedCity News

SEPTEMBER 5, 2024

Positive preliminary results for Eli Lilly’s efsitora alfa continue to build the case for this once-weekly insulin in type 2 diabetes patients. The post Eli Lilly Moves Closer to Bringing Diabetes Patients a Once-Weekly Insulin Alternative appeared first on MedCity News.

Patients

Patients FDA Marketing Biopharma

Video: Battle of the Bulge – Wegovy vs. Zepbound

MedCity News

DECEMBER 4, 2024

The Glp-1 battle heats with new preliminary data from Eli Lilly showing that patients using its weight loss drug Zepbound lost more weight on average in 72 weeks than those on Novo Nordisk’s Wegovy. The post Video: Battle of the Bulge – Wegovy vs. Zepbound appeared first on MedCity News.

Patients

Patients Biopharma

Silver lining: Pandemic learnings propel decentralized trial approaches for patients

MedCity News

OCTOBER 27, 2022

Two decentralized clinical trial methodologies that are “low-hanging fruit” include automating data integration for patient trial selection and establishing standardized, electronic clinical trial templates and procedures.

Electronics

Electronics Patients Biopharma

The Role of Medical Affairs in Bridging Clinical Trial Access for All Patients

MedCity News

JUNE 21, 2024

The post The Role of Medical Affairs in Bridging Clinical Trial Access for All Patients appeared first on MedCity News. Underrepresentation of racial and ethnic groups and other historically disenfranchised populations in clinical trials continues to be a major challenge. Medical Affairs can help identify solutions.

Medical

Medical Patients Biopharma Pharma

Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients

MedCity News

JULY 18, 2024

Expanded FDA approval of Phathom Pharmaceuticals drug Voquezna now includes patients with non-erosive gastroesophageal reflux disease (GERD). The post Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients appeared first on MedCity News. Phathom licensed its flagship product from Takeda Pharmaceutical.

Pharma

Pharma Patients FDA Pharmaceutical

Putting patients at the center of RWD collection processes [Sponsored]

MedCity News

AUGUST 30, 2022

the European Union and other countries amid ongoing efforts to encourage patients who want to share their data. In a recent interview, Jennifer Cubino, COO of BC Platforms, discussed regulatory differences between the U.S.,

Patients

Patients Biopharma Pharma

AstraZeneca Aims to Make Cell Therapy More Accessible With $425M EsoBiotec Acquisition

MedCity News

MARCH 17, 2025

EsoBiotecs allogeneic cell therapies are made by the in vivo reprogramming of a patients immune cells. AstraZenecas EsoBiotec acquisition is the latest in a series of deals struck by the pharma giant to secure a place in the next wave of cell therapies for cancer and immune-mediated diseases.

Pharma

Pharma Patients Biopharma

GSK Wagers $80M on a Tech Platform and Parkinson’s Drug from Flagship-Founded Vesalius

MedCity News

NOVEMBER 17, 2024

Vesalius Therapeutics’ AI-based technology finds novel targets and intervention points for subgroups of patients within a common disease. A small molecule that Vesalius has been developing for a novel Parkinson’s disease target is now headed to GSK, which has licensed global rights.

Patients

Patients Biopharma Pharma

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

MedCity News

NOVEMBER 12, 2024

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

Safety

Safety Patients Biopharma

Alpine stops enrollment in cancer drug study after second patient death this year

MedCity News

OCTOBER 24, 2022

The patient who died in the Phase 1 test of Alpine Immune Sciences drug, davoceticept, reportedly suffered the same cardiovascular complication as the first patient. The biotech company is stopping enrollment in two clinical tests of the drug and assessing all patients in the studies.

Patients

Patients Biopharma Pharma

GSK Multiple Myeloma Drug’s DREAMM Comeback Continues With Phase 3 Data at ASH

MedCity News

DECEMBER 9, 2024

Results from the Phase 3 DREAMM-7 study show GSK drug Blenrep is helping multiple myeloma patients live longer compared to treatment with blockbuster Johnson & Johnson drug Darzalex.

FDA

FDA Leads Marketing Patients

The patient privacy factor in clinical trials

MedCity News

SEPTEMBER 7, 2022

In the first quarter of 2022, my personal life converged with my work life concerning […].

Patients

Patients Biopharma

Streamlining Clinical Research Through Patient Centricity: Addressing Key Challenges Impeding Administrative Operations

MedCity News

NOVEMBER 1, 2023

Investing in comprehensive patient concierge services keeps trial administrators on track by removing the burden of logistical support and improving the overall participant experience, making dropouts and trial delays much less likely.

Patients

Patients Biopharma

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

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

FDA Patients Safety Biopharma

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

MedCity News

AUGUST 5, 2022

Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.

FDA

FDA Patients Biopharma Pharma

Should Patients Have the Right to Own Their Clinical Trial Data?

MedCity News

DECEMBER 28, 2022

It fits in amongst the goal of running nimble and patient-centered studies. Putting data into the hands of participants is an important step in changing the traditional clinical trial paradigm. But, without legislation, it’s doubtful that pharma companies will give up ownership of participant data out of sheer goodwill.

Patients

Patients Pharma Biopharma

New mass spectrometry Chapter could “revolutionise” biopharma quality assurance

European Pharmaceutical Review

DECEMBER 2, 2024

The recognition of mass spectrometry as a complementary method opens the door for us to support biopharmaceutical developers in getting their drugs approved for clinical trials and patient treatment,” Mørtz continued.

Biopharma

Biopharma Manufacturing Consulting Safety

Vertex Pharma’s Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds

MedCity News

JANUARY 31, 2025

Vertex Pharmaceuticals Jounavx is now FDA approved, providing patients a non-opioid option for treating acute pain. The twice-daily pill is the first in a new class of medicines that block a key pathway in the peripheral nervous system.

FDA

FDA Medicine Pharma Pharmaceutical

Amylyx Aims to Help Patients With a Novel GLP-1 Drug, But Not the Way You Think

MedCity News

JULY 10, 2024

The post Amylyx Aims to Help Patients With a Novel GLP-1 Drug, But Not the Way You Think appeared first on MedCity News. Amylyx plans to advance this GLP-1 antagonist into Phase 3 testing for post-bariatric hypoglycemia, a rare condition in which blood sugar levels drop precipitously.

Patients

Patients Pharmaceutical Marketing Biopharma

Acrivon Nets $100M for Protein Tech That Picks Patients for Targeted Cancer Meds

MedCity News

NOVEMBER 20, 2022

While attention is focused on the former Lilly asset, also at stake is Acrivon’s technology platform that relies on proteomics rather than genomics for identifying patients appropriate for targeted therapies.

Patients

Patients Biopharma Pharma

Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition

MedCity News

FEBRUARY 23, 2023

FDA approval of Sanofi hemophilia A drug Altuviiio provides patients with a therapeutic option that lasts longer than most other products available, including one already marketed by the French pharma giant. Altuviiio also gives Sanofi a way to better compete against blockbuster Roche drug Hemlibra.

Competition

Competition FDA Patients Pharma

FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death

MedCity News

JUNE 20, 2023

Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.

Patients

Patients FDA Manufacturing Biopharma

Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

Embracing Personalization in Biopharma Patient Support Programs

Trending Sources

Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence

Novo Nordisk Launches Lower-Cost Wegovy, Following Eli Lilly Into Direct-to-Patient Sales

Transforming biopharma’s approach to patient engagement with direct-to-patient programs

Liver Failure-Associated Death Reported in Patient Treated With Sarepta Gene Therapy Elevidys

How Tech Changes to Clinical Trials Help Both Patients and Biopharma Firms

Elevating patient care from the home

Allying With Patients to Make Every Cure Possible

Top 5 regulatory trends impacting Software as a Medical Device (SaMD)

FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

Patient Voice and Patient Choice: Essentials for Successful DCTs

The PharmaVoice 100: Rare disease warriors

With Direct-to-Patient Zepbound, Eli Lilly Takes a Stand Against Compounders and PBMs

Telehealth Can Broaden Reach of Palliative Care for Lung Cancer Patients, Per MGH Study

How Patient Monitoring Is Poised to Revolutionize Healthcare

What the Radiopharmaceutical Pipeline Means for Patient Care

An Attack on Patients’ Right to Informed Consent

The Key To Faster, More Efficient Clinical Trials? Patient Centricity

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

FDA Approves First Drug for Treating Agitation in Alzheimer’s Patients

Polypharmacy is a Health Killer: Personalized Medication Management is the Answer

Eli Lilly Moves Closer to Bringing Diabetes Patients a Once-Weekly Insulin Alternative

Video: Battle of the Bulge – Wegovy vs. Zepbound

Silver lining: Pandemic learnings propel decentralized trial approaches for patients

The Role of Medical Affairs in Bridging Clinical Trial Access for All Patients

Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients

Putting patients at the center of RWD collection processes [Sponsored]

AstraZeneca Aims to Make Cell Therapy More Accessible With $425M EsoBiotec Acquisition

GSK Wagers $80M on a Tech Platform and Parkinson’s Drug from Flagship-Founded Vesalius

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

Alpine stops enrollment in cancer drug study after second patient death this year

GSK Multiple Myeloma Drug’s DREAMM Comeback Continues With Phase 3 Data at ASH

The patient privacy factor in clinical trials

Streamlining Clinical Research Through Patient Centricity: Addressing Key Challenges Impeding Administrative Operations

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

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

Should Patients Have the Right to Own Their Clinical Trial Data?

New mass spectrometry Chapter could “revolutionise” biopharma quality assurance

Vertex Pharma’s Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds

Amylyx Aims to Help Patients With a Novel GLP-1 Drug, But Not the Way You Think

Acrivon Nets $100M for Protein Tech That Picks Patients for Targeted Cancer Meds

Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition

FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death

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