FDA and Medicine - Pharma Rep Focus

Orexo, leveraging drug delivery tech, seeks FDA approval of nasal high-dose opioid rescue medicine

Fierce Pharma

FEBRUARY 7, 2023

Orexo, leveraging drug delivery tech, seeks FDA approval of nasal high-dose opioid rescue medicine ntaylor Tue, 02/07/2023 - 08:18

Medicine

Medicine FDA

'Most' cancer meds approved under FDA's accelerated pathway couldn't prove survival benefit after 5 years: study

Fierce Pharma

APRIL 8, 2024

One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials.

FDA

FDA Medicine

FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

Fierce Pharma

FEBRUARY 16, 2024

The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods. . | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades.

Food

Food FDA Medicine Marketing

FDA signs off on new uses for Astellas and Pfizer's Xtandi, Merck's Keytruda

Fierce Pharma

NOVEMBER 17, 2023

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. | The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi.

FDA

FDA Medicine

Johnson & Johnson's Aurlumyn scores first FDA approval to treat severe frostbite

Fierce Pharma

FEBRUARY 14, 2024

The FDA has approved the first medicine for severe frostbite. Over the last month, for those watching HBO’s macabre “True Detective Night Country”—a TV series set in a harsh, sunless winter in a fictional Alaskan town—a continual theme is frostbite. |

FDA

FDA Medicine

As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost

Fierce Pharma

NOVEMBER 29, 2023

The revelation of an FDA investigation< | As industry watchers deliberate the implications from the FDA's investigation into secondary cancer risks from CAR-T medicines, an upcoming expert meeting could offer precious clarity from drug regulators.

FDA

FDA Safety Medicine

Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

Fierce Pharma

DECEMBER 8, 2023

| Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. The transformational treatment is a potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black.

FDA

FDA Medicine Pharmaceutical

UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay

Fierce Pharma

SEPTEMBER 20, 2023

UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. After a manufacturing-related complete response letter held up the U.S. | But now the company warned a decision will likely be delayed past the third quarter.

Manufacturing

Manufacturing FDA Medicine

J&J, Legend's Carvykti bid for earlier multiple myeloma use will face FDA adcomm

Fierce Pharma

JANUARY 23, 2024

Early evidence showing Carvykti’s potential to prolong patients’ lives in an earlier multiple myeloma setting didn’t save Johnson & Johnson and Legend Biotech’s CAR-T medicine from a public int | Early evidence showing the drug's potential to prolong patients' lives didn't save Johnson & Johnson and Legend Biotech's Carvykti (..)

FDA

FDA Medicine Patients

US FDA approves Blueprint Medicines’ indolent systemic mastocytosis therapy

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients.

Medicine

Medicine Food and Drug Administration FDA Healthcare Provider

Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe

Fierce Pharma

JANUARY 6, 2024

A group of cell therapy experts, including CAR-T pioneers Drs. Bruce Levine and Carl June, wrote in support of continued use of CAR-T therapy.

Safety

Safety Medicine FDA

KRAS crisis? FDA will gather advisers to weigh full approval for Amgen's Lumakras

Fierce Pharma

AUGUST 21, 2023

The FDA will hold an advisory committee meeting to discuss confirmatory trial data for Amgen's Lumakras in KRAS-mutated lung cancer. This comes after a bumpy stretch for the medicine since its debut in 2021. First came doubts about the combinability of Amgen’s Lumakras with a standard PD-1 inhibitor. |

FDA

FDA Medicine

FDA allows Florida to import medicines from Canada

Pharmaceutical Technology

JANUARY 8, 2024

The US FDA has granted authorisation for Florida's drug importation programme under section 804 of the FD&C Act.

FDA

FDA Medicine

Study finds no link between Novo Nordisk’s GLP-1 drugs and suicidal ideation

Fierce Pharma

JANUARY 5, 2024

Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medi | Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one (..)

Side effects

Side effects Medicine FDA Medical

Prime editing comes of age as FDA clears human trials

pharmaphorum

APRIL 30, 2024

Prime Medicine has been given the go-ahead by the FDA for the first human trial of its prime editing technology, which promises to deliver one-shot therapies for a range of severe genetic diseases.

FDA

FDA Medicine

Regeneron wins FDA approval for rare immune disease med Veopoz, expects high-dose Eylea decision in the coming weeks

Fierce Pharma

AUGUST 18, 2023

Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited im | Alongside a Friday approval for its ultra-rare disease medicine Veopoz, Regeneron now expects a high-dose Eyelea nod in the next few weeks after resolving (..)

FDA

FDA Medicine

Eosinophilic esophagitis medicine approval expanded

European Pharmaceutical Review

JANUARY 26, 2024

The US Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) as a treatment for children patients aged one to 11 years, weighing at least 15kg with eosinophilic esophagitis (EoE). This new authorisation by the FDA’s expands its initial approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40kg.

Medicine

Medicine Food and Drug Administration FDA Food

Pfizer, FDA ease shortage concerns as tornado relief efforts pick up at massive NC injectables plant

Fierce Pharma

JULY 24, 2023

FDA are picking up the pieces after a violent tornado devastated the drugmaker’s massive North Carolina injectables plant last week. It noted crews are working around the clock to restore power, assess the structural integrity of the building and to relocate finished medicines to nearby sites for storage. Pfizer and the U.S.

FDA

FDA Manufacturing Medicine

MindMed gets FDA breakthrough tag for LSD in anxiety

pharmaphorum

MARCH 8, 2024

In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.

FDA

FDA Medicine

The FDA might yank cold medicines from shelves — and that could be just the beginning

PharmaVoice

OCTOBER 17, 2023

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

FDA

FDA Medicine

New FDA head needs to examine the accelerated approval program

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

FDA

FDA Insurance Prescription Medicine

FDA Approves Blueprint Medicines’ Rare Blood Disorder Treatment

PharmaTech

MAY 24, 2023

Blueprint Medicines’ avapritinib has been approved by FDA for the treatment of indolent systemic mastocytosis.

Medicine

Medicine FDA

CHMP issues positive option for first gene-editing medicine

European Pharmaceutical Review

DECEMBER 15, 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of Vertex’s gene-editing therapy Casgevy for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia.

Medicine

Medicine Food and Drug Administration Food Patients

'Unprecedented' demand for Eli Lilly's Zepbound sparks US supply constraints

Fierce Pharma

MARCH 29, 2024

Once again, a medicine in the popular GLP-1 class of diabetes and weight loss therapies is facing supply hurdles. While the drug is not listed on the FDA's shortage list, some pharmacies are facing supply issues. Amazon Pharmacy, for instance, notes that several dosage strengths are "unavailable."

Medicine

Medicine FDA

First oral medicine for postpartum depression approved

European Pharmaceutical Review

AUGUST 7, 2023

The US Food and Drug Administration ( FDA ) has approved Zurzuvae ( zuranolone ), the first oral medicine to treat postpartum depression (PPD) in adults. FDA approval of Zurzuvae for postpartum depression was granted to Sage Therapeutics, Inc. Historically, treatment for PPD has been only available as an IV injection.

Medicine

Medicine Food and Drug Administration FDA Food

Drug companies know how to play the FDA drug approval process

World of DTC Marketing

JULY 13, 2021

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. Drug companies know how to play the system. Can we make sense of this? Maybe they should.

FDA

FDA Medicine Healthcare Healthcare

FDA approves Amgen T-cell engager for small cell lung cancer

European Pharmaceutical Review

MAY 17, 2024

The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle), a bispecific T-cell engager, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The post FDA approves Amgen T-cell engager for small cell lung cancer appeared first on European Pharmaceutical Review.

Food and Drug Administration

Food and Drug Administration FDA Food Patients

Generic manufacturers sign sublicences to produce long-acting HIV medicine

European Pharmaceutical Review

MARCH 31, 2023

The Medicines Patent Pool (MPP) has signed sublicence agreements with three generics manufacturers to produce generic versions of cabotegravir long-acting (LA) injectable for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). The pharma companies who will manufacture the generic versions are Viatris, Aurobindo and Cipla.

Medicine

Medicine Manufacturing Food and Drug Administration Food

Novartis delays Pluvicto filing as CEO spots industry 'conundrum' with FDA

Fierce Pharma

OCTOBER 24, 2023

As the pure-play innovative medicines company reports strong growth from the business it’s now built on, one product faces a delay. Novartis entered a new era after spinning off Sandoz earlier in October. Novartis entered a new era after spinning off Sandoz earlier in October.

FDA

FDA Medicine

Psychedelic medicines: are they gaining traction in Europe?

European Pharmaceutical Review

APRIL 13, 2023

6 Therefore, the quality of data provided to regulators will be key in obtaining MAs and subsequently marketing of psychedelic medicines. 6 Therefore, the quality of data provided to regulators will be key in obtaining MAs and subsequently marketing of psychedelic medicines.

Medicine

Medicine Food and Drug Administration Doctors Government

GSK Gets FDA Nod for Drug Treating Anemia From Chronic Kidney Disease

MedCity News

FEBRUARY 2, 2023

The FDA approved GSK drug Jesduvroq for treating anemia in patients with chronic kidney disease. The once-daily pill is the first oral medicine to pass FDA muster in this indication, giving patients a more convenient alternative to injectable anemia therapies.

FDA

FDA Medicine Patients Biopharma

FDA Warns of Rare but Serious Drug Reaction to Antiseizure Medicines

PharmaTech

DECEMBER 4, 2023

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.

Medicine

Medicine FDA Patients

New FDA Draft Guidance Made Available for Materials Used in Manufacturing CGTs and Tissue-Engineered Therapeutics

PharmaTech

MAY 4, 2024

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Manufacturing

Manufacturing FDA Engineering Medicine

Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Fierce Pharma

JANUARY 25, 2024

But questions remained unanswered.

Safety

Safety FDA Medicine Patients

Biogen bolsters case for ALS drug under FDA review with new published data

MedCity News

SEPTEMBER 22, 2022

A Biogen drug designed for a genetically defined form of amyotrophic lateral sclerosis led to patient improvement at a 12- month analysis, according to data now published in the New England Journal of Medicine.

FDA

FDA Medicine Patients Biopharma

Shorter timelines, evolving strategies: Four key trends in regulatory approvals of new medicines

Clarivate

AUGUST 2, 2022

Four major trends came to light from CIRS’ most recent analysis of new active substance (NAS) approvals for the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).

Medicine

Medicine Food and Drug Administration FDA Healthcare

Bristol Myers Squibb's Reblozyl, chasing $4B sales target, wins key FDA label expansion

Fierce Pharma

AUGUST 29, 2023

As Bristol lays off staffers and works through the painful loss of exclusivity for | The first-line anemia use in MDS represents a key milestone as Bristol Myers targets $4 billion in peak sales for the new medicine.

Sales

Sales Medicine FDA

After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure

MedCity News

MAY 30, 2023

Lexicon Pharmaceuticals drug Inpefa is now FDA-approved for heart failure. Inpefa is third in its class, but the biotech says its pill can reach a specific subset of patients, enabling it to stand apart from rival medicines from AstraZeneca and partners Eli Lilly and Boehringer Ingelheim.

FDA

FDA Medicine Pharmaceutical Patients

FDA Publishes Guidance on Regenerative Medicine Therapies

PharmaTech

JUNE 16, 2022

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

Medicine

Medicine FDA

Canadian and US developers to trial psychedelic medicines in UK

European Pharmaceutical Review

DECEMBER 13, 2022

The regulators are the Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) respectively. The post Canadian and US developers to trial psychedelic medicines in UK appeared first on European Pharmaceutical Review.

Medicine

Medicine Food and Drug Administration Ethics Government

Finding Balance: A Decentralized Trial Strategy to Help Sponsors Address the New FDA Draft Guidance

PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. The FDA has made a purposeful choice to write in broad strokes, stopping short of detailing ways to execute DCTs.

FDA

FDA Food and Drug Administration Safety Medicine

Synlogic’s SYNB1934 receives orphan drug status from US FDA

Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. SYNB1934 has also gained rare paediatric disease designation (RPDD) from the FDA and orphan drug designation from the European Medicines Agency (EMA).

Food and Drug Administration

Food and Drug Administration FDA Engineering Medicine

FDA Gets Its Arms Around Advanced Therapy Medicinal Products Early

PharmaTech

OCTOBER 2, 2023

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

Medicine

Medicine Government FDA

FDA approves first-in-class antidepressant

European Pharmaceutical Review

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). According to the company’s website, the medicine offers the first truly novel mechanism for MDD in over 30 years.

FDA

FDA Food and Drug Administration Medicine Food

Orexo, leveraging drug delivery tech, seeks FDA approval of nasal high-dose opioid rescue medicine

'Most' cancer meds approved under FDA's accelerated pathway couldn't prove survival benefit after 5 years: study

Trending Sources

FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

FDA signs off on new uses for Astellas and Pfizer's Xtandi, Merck's Keytruda

Johnson & Johnson's Aurlumyn scores first FDA approval to treat severe frostbite

As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost

Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay

J&J, Legend's Carvykti bid for earlier multiple myeloma use will face FDA adcomm

US FDA approves Blueprint Medicines’ indolent systemic mastocytosis therapy

Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe

KRAS crisis? FDA will gather advisers to weigh full approval for Amgen's Lumakras

FDA allows Florida to import medicines from Canada

Study finds no link between Novo Nordisk’s GLP-1 drugs and suicidal ideation

Prime editing comes of age as FDA clears human trials

Regeneron wins FDA approval for rare immune disease med Veopoz, expects high-dose Eylea decision in the coming weeks

Eosinophilic esophagitis medicine approval expanded

Pfizer, FDA ease shortage concerns as tornado relief efforts pick up at massive NC injectables plant

MindMed gets FDA breakthrough tag for LSD in anxiety

The FDA might yank cold medicines from shelves — and that could be just the beginning

New FDA head needs to examine the accelerated approval program

FDA Approves Blueprint Medicines’ Rare Blood Disorder Treatment

CHMP issues positive option for first gene-editing medicine

'Unprecedented' demand for Eli Lilly's Zepbound sparks US supply constraints

First oral medicine for postpartum depression approved

Drug companies know how to play the FDA drug approval process

FDA approves Amgen T-cell engager for small cell lung cancer

Generic manufacturers sign sublicences to produce long-acting HIV medicine

Novartis delays Pluvicto filing as CEO spots industry 'conundrum' with FDA

Psychedelic medicines: are they gaining traction in Europe?

GSK Gets FDA Nod for Drug Treating Anemia From Chronic Kidney Disease

FDA Warns of Rare but Serious Drug Reaction to Antiseizure Medicines

New FDA Draft Guidance Made Available for Materials Used in Manufacturing CGTs and Tissue-Engineered Therapeutics

Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Biogen bolsters case for ALS drug under FDA review with new published data

Shorter timelines, evolving strategies: Four key trends in regulatory approvals of new medicines

Bristol Myers Squibb's Reblozyl, chasing $4B sales target, wins key FDA label expansion

After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure

FDA Publishes Guidance on Regenerative Medicine Therapies

Canadian and US developers to trial psychedelic medicines in UK

Finding Balance: A Decentralized Trial Strategy to Help Sponsors Address the New FDA Draft Guidance

Synlogic’s SYNB1934 receives orphan drug status from US FDA

FDA Gets Its Arms Around Advanced Therapy Medicinal Products Early

FDA approves first-in-class antidepressant

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