BioPharma Drive: Drug Pricing

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

FDA 130

FDA FDA Approval Clinical Trials Therapies 130

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. In June 2023, the U.S.

Treatment 75

Treatment FDA Clinical Trials Therapies 75

ProRelix Research

NOVEMBER 5, 2024

Clinical trials are necessary in advancing medical research and health care options by allowing new treatments to be introduced in the market through safety and efficacy testing in humans. Successful […] The post Clinical Trials and Human Subject Protection as per US FDA appeared first on ProRelix Research.

Clinical Trials 52

Clinical Trials FDA Trials Treatment 52

Drugs.com

FEBRUARY 19, 2024

Food and Drug Administration has approved a novel treatment for advanced melanoma, the most deadly form of skin cancer. MONDAY, Feb. 19, 2024 -- The U.S. Amtagvi, made by Iovance Biotherapeutics Inc., becomes the first cellular therapy approved to.

FDA Approval 72

FDA Approval Treatment FDA Therapies 72

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).

FDA 105

FDA Disease Clinical Pharmacology Science 105

SCIENMAG: Medicine & Health

DECEMBER 14, 2023

In the fatal world of opioid use disorder (OUD), pharmacotherapy, or using a prescribed medication to treat drug dependence, has emerged as the gold standard of treatment. Among the trio of FDA-approved medications to treat OUD, buprenorphine is the newest highly effective drug that can suppress and reduce cravings for opioids.

Treatment 85

Treatment FDA Approval FDA Drugs 85

BioPharma Drive: Drug Pricing

DECEMBER 8, 2023

In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.

FDA 139

FDA Therapies Pharmaceuticals Treatment 139

SCIENMAG: Medicine & Health

FEBRUARY 9, 2024

CLEVELAND—University Hospitals (UH) Brain Health & Memory Center is now treating patients with LEQEMBI® (lecanemab), a Food and Drug Administration-approved medication for the treatment of Alzheimer’s disease.

Hospitals 79

Hospitals FDA Approval Treatment Disease 79

BioPharma Drive: Drug Pricing

OCTOBER 31, 2023

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

FDA 133

FDA Therapies Treatment 133

Drugs.com

FEBRUARY 19, 2024

Food and Drug Administration has approved a novel treatment for advanced melanoma, the most deadly form of skin cancer.Amtagvi, made by Iovance Biotherapeutics Inc., MONDAY, Feb. 19, 2024 -- The U.S. becomes the first cellular therapy approved to.

FDA Approval 59

FDA Approval Treatment FDA Therapies 59

BioPharma Drive: Drug Pricing

OCTOBER 23, 2023

since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease. The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S.

FDA 136

FDA Trials Treatment Disease 136

BioPharma Drive: Drug Pricing

JULY 11, 2024

The FDA’s decision to turn back the drugmaker’s new insulin product narrows Novo’s lead in the U.S. over Eli Lilly, which has a similar diabetes treatment in late-stage testing.

FDA 70

FDA Treatment Production 70

Agency IQ

OCTOBER 6, 2023

In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders. While stimulant use disorder is increasing, there are currently no FDA-approved medications.

FDA 40

FDA Treatment Production Trials 40

BioPharma Drive: Drug Pricing

SEPTEMBER 25, 2023

Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.

FDA 120

FDA Therapies Treatment 120

Drugs.com

SEPTEMBER 28, 2023

Food and Drug Administration on Wednesday voted resoundingly against recommending, NurOwn, a stem cell-based experimental treatment for ALS. Although the FDA isn't bound by the votes of. THURSDAY, Sept. 28, 2023 – An advisory panel to the U.S.

FDA 111

FDA Drugs Treatment 111

Drugs.com

DECEMBER 13, 2023

Food and Drug Administration to approve MDMA, the active ingredient in party drugs like molly and ecstasy, as a treatment for post-traumatic stress disorder (PTSD).When WEDNESDAY, Dec. 13, 2023 -- A California company has asked the U.S. When announcing.

Treatment 85

Treatment FDA Drugs 85

BioPharma Drive: Drug Pricing

SEPTEMBER 12, 2024

based F2G complete late testing of a treatment that the FDA rejected one year ago. The funding, from AMR Action Fund and others, will help U.K.

FDA 60

FDA Treatment Drugs 60

The Pharma Data

APRIL 26, 2022

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D.,

FDA Approval 52

FDA Approval FDA Treatment Vaccine 52

Drugs.com

SEPTEMBER 28, 2023

Food and Drug Administration on Wednesday voted resoundingly against recommending a stem cell-based experimental treatment for ALS. Although the FDA isn't bound by the votes of its advisory. THURSDAY, Sept. 28, 2023 – An advisory panel to the U.S.

FDA 98

FDA Drugs Treatment 98

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.

FDA 122

FDA Clinical Pharmacology FDA Approval Therapies 122

The Pharma Data

AUGUST 9, 2021

deputy director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. The FDA will continue to work with stakeholders to advance the development of additional new, effective and safe therapies for rare diseases, including Pompe disease.”

FDA Approval 52

FDA Approval FDA Disease Treatment 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. 53,688 (Aug. 53,767 (Aug.

FDA 67

FDA FDA Approval Treatment Drugs 67

Eye on FDA

AUGUST 27, 2023

There are still many decisions and publicly available PDUFA dates with many novel treatments among them, including investigative treatments for sickle cell disease and ALS. During the first half of 2022, FDA issued only six press releases about drug approvals compared to 13 during the first half of this year.

FDA 78

FDA Drugs Treatment Therapies 78

BioPharma Drive: Drug Pricing

AUGUST 13, 2024

Nemluvio is now cleared for adults with the chronic itching condition prurigo nodularis, making it a competitor to Sanofi and Regeneron’s Dupixent.

FDA Approval 67

FDA Approval Treatment FDA 67

Drugs.com

SEPTEMBER 20, 2023

Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. WEDNESDAY, Sept. 20, 2023 -- In a surprising move, the U.S. Approval of the Neffy nasal spray.

FDA 116

FDA Treatment Drugs 116

Drugs.com

SEPTEMBER 18, 2024

Food and Drug Administration's expanded approval of the treatment, drug maker Novartis. WEDNESDAY, Sept. 18, 2024 -- Women with early stage breast cancer may now take Kisquali, a medication already approved for advanced disease, following the U.S.

FDA 116

FDA Drugs Treatment Disease 116

Eye on FDA

MARCH 7, 2024

Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). GeMDAC at this time does not have any members appointed.

FDA 78

FDA Disease Government Drugs 78

BioPharma Drive: Drug Pricing

JUNE 20, 2023

The company said limitations on "bridging treatment" used to hold cancer in check could be to blame, and is working with the FDA to change the study's protocol.

FDA 107

FDA Therapies Treatment 107

Drugs.com

JULY 24, 2023

Food and Drug Administration has approved the topical solution Ycanth (cantharidin) for the treatment of molluscum contagiosum (molluscum) in adult and pediatric patients (aged 2 years and older). MONDAY, July 24, 2023 -- The U.S. Ycanth uses a.

FDA Approval 52

FDA Approval Treatment FDA Drugs 52

BioPharma Drive: Drug Pricing

JULY 27, 2023

While the FDA doesn’t think the brain disease treatment merits an evaluation, Biohaven is still pushing for one and has requested a further meeting.

FDA 94

FDA Treatment Disease Drugs 94

Eye on FDA

JULY 29, 2021

Perhaps no other decision by the Food and Drug Administration has garnered as much controversy, as the recent one to authorize the accelerated approval a new treatment for Alzheimer’s. The scope of the story and the revelations underlying indicate that FDA is experiencing a crisis. The agency’s response so far does not.

FDA 105

FDA Vaccine Clinical Trials Treatment 105

The Pharma Data

MAY 16, 2022

Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). (Nasdaq: GILD) today announced the U.S. There is no cure for HIV or AIDS. About Lenacapavir.

FDA 52

FDA Treatment Science Therapies 52

The Pharma Data

OCTOBER 8, 2021

Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. “Today’s action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children,” said Peter Marks, M.D., Dosing is patient?customized,

FDA Approval 52

FDA Approval FDA Treatment Disease 52

SCIENMAG: Medicine & Health

OCTOBER 31, 2023

. — A new drug developed by professors from the School of Pharmacy and Pharmaceutical Sciences at Binghamton University has received Food and Drug Administration (FDA) approval for the treatment of patients with Duchenne muscular dystrophy (DMD), a common genetic disease that mostly affects young boys.

FDA Approval 83

FDA Approval FDA Disease Pharmacy 83

The Pharma Data

FEBRUARY 24, 2022

Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, M.D., The FDA, an agency within the U.S.

FDA Approval 52

FDA Approval FDA Treatment Hospitals 52

Drug Target Review

FEBRUARY 21, 2024

This is a time when several promising treatments – including mRNA vaccines, BiTE therapies and CAR-T cell therapy, are essentially in competition with each other – they all have a common goal of treating the same disease, but they are approaching the objective from different angles.

Therapies 64

Therapies Treatment Vaccine FDA Approval 64

Agency IQ

OCTOBER 20, 2023

FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developing therapies to treat diabetic foot infections, focusing on Phase 3 efficacy trials.

FDA 40

FDA Treatment Trials Therapies 40