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.

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Drugs.com

FEBRUARY 15, 2024

Food and Drug Administration (FDA) on Wednesday approved the first treatment for severe frostbite. THURSDAY, Feb. 15, 2024 -- The U.S. Known as Aurlumyn (iloprost), the injected medication lowers the risk of finger or toe amputation in cases of.

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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.

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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.

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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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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.

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BioPharma Drive: Drug Pricing

SEPTEMBER 5, 2023

The FDA-approved therapy, called Palforzia, was little used, leading Nestle to abandon a business it had secured in a $2.6 billion deal three years ago.

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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.

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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.

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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.

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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.

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BioPharma Drive: Drug Pricing

JUNE 7, 2024

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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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.

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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.

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BioPharma Drive: Drug Pricing

JANUARY 4, 2024

The agency could soon clear important new drugs from Eli Lilly and Merck, as well as the first treatment for a common liver disease.

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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.

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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.

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PLOS: DNA Science

OCTOBER 19, 2023

Also recently, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committe turned down a stem cell treatment for amyotrophic lateral sclerosis, aka ALS, Lou Gehrig’s disease, or motor neuron disease. The only treatment for ALS is a drug, Riluzole , taken as a tablet or a film. The pace though varies quite a lot.

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Drugs.com

JANUARY 24, 2024

Food and Drug Administration has told drugmakers to add a boxed warning to a type of cancer treatment called CAR-T therapy, saying the treatment itself may sometimes cause a secondary. WEDNESDAY, Jan. 24, 2024 (Healthday News) -- The U.S.

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Drug Discovery Today

NOVEMBER 7, 2023

Kinnov Therapeutics expects to have clear guidance from the FDA in early 2024 on the phase III trial

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BioPharma Drive: Drug Pricing

MARCH 15, 2024

The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.

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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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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.

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BioPharma Drive: Drug Pricing

JUNE 9, 2023

The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

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BioPharma Drive: Drug Pricing

JUNE 11, 2024

The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.

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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.

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Drugs.com

AUGUST 12, 2024

Food and Drug Administration declined to approve it as treatment for. MONDAY, Aug. 12, 2024 -- Advocates for the use of the psychedelic drug MDMA (midomafetamine) to treat mental health conditions were delivered a setback on Friday after the U.S.

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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.

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BioPharma Drive: Drug Pricing

NOVEMBER 28, 2023

The agency said the benefit of approved treatments like Gilead’s Yescarta still outweighs any such risk, but the alert could slow drugmaker efforts to develop the treatments for wider use.

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BioPharma Drive: Drug Pricing

APRIL 19, 2024

The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.

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Drug Target Review

JUNE 5, 2023

It also supports the argument for developing ZW171 for the treatment of other MLSN-expressing solid tumours. What is the significance of ZW191 demonstrating strong responses in FRα-low expressing PDX models for the treatment of oncology indications with lower levels of FRα?

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Conversations in Drug Development Trends

AUGUST 23, 2023

However, patients also play a vital role in engaging directly with the FDA. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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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.

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Drugs.com

DECEMBER 8, 2023

Food and Drug Administration on Friday approved two milestone gene therapies for sickle cell disease, including the first treatment ever approved that uses gene-editing technology. FRIDAY, Dec. 8, 2023 -- The U.S. Casgevy, developed by Vertex.

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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.

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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.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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