BioPharma Drive: Drug Pricing

JUNE 9, 2023

In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

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BioPharma Drive: Drug Pricing

JANUARY 30, 2024

The company plans to soon ask the FDA for approval of the drug, which it has pitched as a safer alternative to addictive opioid painkillers.

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BioPharma Drive: Drug Pricing

SEPTEMBER 17, 2024

The FDA previously rejected patritumab deruxtecan over manufacturing issues. Tuesday's study data should boost the companies' case, however.

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Trials FDA 294

Drugs.com

JULY 2, 2024

In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early. TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday.

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BioPharma Drive: Drug Pricing

JUNE 22, 2023

The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, and raises the stakes of an ongoing trial that could prove how well it works.

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Therapies FDA Trials Disease 319

Science Daily: Pharmacology News

APRIL 15, 2024

Researchers have discovered that an FDA-approved epilepsy drug can prevent or slow the growth of NF1-linked optic gliomas in mice, laying the groundwork for a clinical trial.

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BioPharma Drive: Drug Pricing

MAY 10, 2024

The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.

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Vaccine FDA Regulations Trials 265

BioPharma Drive: Drug Pricing

MARCH 24, 2025

The company expects next quarter to read out initial data from its Heart-2 trial, which is testing a one-time treatment for people with genetically elevated cholesterol.

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Drugs.com

JULY 2, 2024

clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early. TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday.In

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BioPharma Drive: Drug Pricing

SEPTEMBER 27, 2023

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.

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Therapies Clinical Trials FDA Trials 273

Drugs.com

FEBRUARY 5, 2025

The approval was based on the results of three phase 3 trials of. Food and Drug Administration has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.

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FDA Approval Treatment FDA Trials 261

BioPharma Drive: Drug Pricing

MARCH 25, 2024

The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.

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BioPharma Drive: Drug Pricing

SEPTEMBER 27, 2023

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.

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Therapies Clinical Trials FDA Trials 265

BioPharma Drive: Drug Pricing

OCTOBER 16, 2024

Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.

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FDA Approval FDA Trials 250

ProRelix Research

AUGUST 3, 2023

Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has […] The post FDA Guidance on Advancement of Decentralized Clinical Trials appeared first on ProRelix Research.

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Clinical Trials FDA Trials Research 97

BioPharma Drive: Drug Pricing

AUGUST 8, 2024

Analysts at Evercore ISI called pegcetacoplan’s data in two kidney conditions a “left-field hit” that compare favorably to results for a Novartis treatment.

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Trials FDA Treatment Drugs 177

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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BioPharma Drive: Drug Pricing

JUNE 20, 2024

The decision makes Elevidys available to Duchenne patients at least 4 years of age, despite mixed trial results that have led to skepticism about its effectiveness.

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Therapies FDA Trials 202

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. Her fellow panelists represented a diverse group of stakeholders across clinical research, including patient advocates, sponsors, sites, and the FDA itself.

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Antidote

SEPTEMBER 25, 2023

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed.

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Clinical Trials Trials FDA Treatment 128

BioPharma Drive: Drug Pricing

MARCH 15, 2024

A majority of experts believed that the factors that may have led to an increased risk of early death in testing of Carvykti and Abecma aren’t as likely to occur outside of a clinical trial.

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BioPharma Drive: Drug Pricing

MARCH 6, 2025

Elsewhere, Novo started up an online pharmacy and the FDA cleared testing of a base editing therapy for Duchenne. Phase 3 studies for Amgen’s closely watched obesity drug were posted on a federal database.

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Online Pharmacies Pharmacy Trials FDA 139

Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy. local standards of care).

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Eye on FDA

AUGUST 4, 2021

As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product approvals. There are 31 advisory committees on matters ranging from food to medical devices to pediatric care.

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BioPharma Drive: Drug Pricing

SEPTEMBER 13, 2024

Roche has now beat Merck and Bristol Myers to market with its under-the-skin immunotherapy. Elsewhere, Sanofi bought into radiopharmaceuticals and Mene Pangalos joined Biogen's board.

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Drug Patent Watch

DECEMBER 9, 2024

Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product. This involves the use of statistical techniques such as equivalence and non-inferiority testing, as well as adaptive design approaches to reduce sample size and trial duration.

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BioPharma Drive: Drug Pricing

APRIL 29, 2024

The company will soon start a Phase 1/2 study of its treatment for chronic granulomatous disease, a milestone for the search-and-replace gene editing technology.

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Trials FDA Treatment Disease 148

BioPharma Drive: Drug Pricing

FEBRUARY 20, 2024

Rapt reported one case of liver failure in a study participant who received the biotech’s drug, which is seen by analysts as a possible competitor to Dupixent.

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Trials FDA Drugs 148

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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Therapies Trials FDA Clinical Trials 98

FDA Law Blog: Drug Discovery

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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BioPharma Drive: Drug Pricing

NOVEMBER 22, 2024

Elsewhere, Argenx has another blockbuster target in sight and an FDA veteran plans retirement. Evotec appears to have rebuffed Halozyme’s $2.1 billion acquisition attempt.

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Trials FDA 139

BioPharma Drive: Drug Pricing

FEBRUARY 20, 2024

The FDA approved the targeted therapy together with chemo for first-line metastatic lung cancer, while fresh trial results supported earlier use.

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Trials FDA Approval FDA Therapies 114

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.

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BioPharma Drive: Drug Pricing

AUGUST 26, 2024

Regulators in Europe granted approval based on remission rates, while the FDA sought more progress in confirmatory trials when it rejected Ordspono.

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Regulations FDA Trials Drugs 171

Eye on FDA

JULY 29, 2021

The scope of the story and the revelations underlying indicate that FDA is experiencing a crisis. At least judging from the reporting, the FDA narrative has not always been consistent. The agency’s response so far does not. This is an abbreviated list. Moreover, the narrative must be consistent.

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PPD

AUGUST 16, 2023

The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs.

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Clinical Trials Trials Clinical Research FDA 98

BioPharma Drive: Drug Pricing

OCTOBER 12, 2023

Earlier this year Pfizer removed thousands of participants from a study of its Lyme disease shot over concerns the group, Care Access, wasn't meeting clinical practice standards.

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