Biopharma, FDA and Patients - Pharma Rep Focus

A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? Nowhere to be seen.

FDA

FDA Food and Drug Administration Patients Biopharma

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. But Neurogene is able to avoid a lengthy clinical trial pause largely because of its participation in an FDA pilot program intended to speed up the development of therapies for rare diseases.

FDA

FDA Patients Biopharma Pharma

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.

FDA

FDA Patients Biopharma Pharma

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

Pfizer acquires biopharma firm Biohaven for $11.6bn

Pharmaceutical Technology

OCTOBER 4, 2022

Treatments to enhance the lives of debilitating neurological and neuropsychiatric disease patients are part of Biohaven’s portfolio. Zavegepant, another CGRP receptor antagonist, is expected to receive approval as an intranasal spray from the FDA for the acute treatment of migraine in the first quarter of next year.

Biopharma

Biopharma Food and Drug Administration Medicine FDA

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

Ipsen beefs up in oncology, buying US biopharma Epizyme

pharmaphorum

JUNE 27, 2022

Tazverik is a first-in-class EZH2a inhibitor that was cleared by the FDA in 2020 as a third-line or later treatment for adults with relapsed or refractory follicular lymphoma (FL) whose tumours have an EZH2 mutation. The post Ipsen beefs up in oncology, buying US biopharma Epizyme appeared first on.

Biopharma

Biopharma Sales Prescription FDA

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

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

Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

MedCity News

JULY 2, 2024

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy.

Competition

Competition FDA Patients Biopharma

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

MedCity News

MARCH 22, 2024

FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease. Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects.

Side effects

Side effects FDA Patients Biopharma

FDA approves first gene therapy for Haemophilia B

European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

FDA

FDA Food and Drug Administration Biopharma Food

Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

MedCity News

SEPTEMBER 6, 2024

The FDA decision for Travere Therapeutics’ Filspari also expands its addressable patient population. The post Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas appeared first on MedCity News.

Competition

Competition FDA Patients Biopharma

Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency

MedCity News

AUGUST 12, 2024

FDA approval of Ascendis Pharma’s Yorvipath is just in time for patients with hypoparathyroidism as Takeda Pharmaceutical will soon stop making the only drug therapy for the rare disorder. The post Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency appeared first on MedCity News.

FDA

FDA Pharma Competition Pharmaceutical

Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

Pharmaceutical Technology

AUGUST 5, 2022

An orally administered selective inhibitor of complement component 5a receptor, Tavneos received approval from the US Food and Drug Administration (FDA) in October last year. The post Amgen to acquire biopharma firm ChemoCentryx for $3.7bn appeared first on Pharmaceutical Technology.

Biopharma

Biopharma Food and Drug Administration Food Marketing

FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

MedCity News

AUGUST 21, 2024

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. The post FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma appeared first on MedCity News.

FDA

FDA Manufacturing Pharmaceutical Marketing

FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

MedCity News

OCTOBER 15, 2023

The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.

FDA

FDA Patients Biopharma

FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

MedCity News

JULY 12, 2024

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news.

FDA

FDA Manufacturing Patients Biopharma

FDA Probes New Cases of Cancer That May Stem From Cancer Cell Therapies

MedCity News

NOVEMBER 28, 2023

CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.

FDA

FDA Patients Biopharma Pharma

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

MedCity News

FEBRUARY 12, 2024

FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.

FDA

FDA Leads Pharmaceutical Patients

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.

Pharma

Pharma Patients FDA Pharmaceutical

Novo Nordisk’s Diabetes Pill Rybelsus Gets FDA O.K. as First-Line Therapy

MedCity News

JANUARY 13, 2023

The FDA approved a change in Rybelsus’s label, allowing the drug to be used as an initial therapy for type 2 diabetes patients. The once-daily pill has already become a blockbuster product for Novo Nordisk.

FDA

FDA Patients Biopharma Pharma

FDA Mulls Policy Switch on Switching Study Requirement for Biosimilars

MedCity News

JUNE 20, 2024

FDA draft guidance eliminates the requirement that biosimilars produce clinical data to show they are interchangeable with their reference drugs. Some lawmakers have said these so-called switching studies add time and expense to the development of biosimilars, delaying them from reaching patients.

FDA

FDA Patients Biopharma Pharma

Pfizer Meningococcal Vaccine Nabs FDA Nod, Offering More Convenient Dosing

MedCity News

OCTOBER 22, 2023

The FDA approved Pfizer’s Penbraya for vaccinating against five bacterial groups that can cause meningococcal disease. Pfizer already has vaccines covering those groups, but Penbraya addresses all of them in a single vaccine, making dosing easier for patients.

FDA

FDA Patients Biopharma Pharma

J&J multiple myeloma drug gets FDA nod, bringing patients an easier dosing option

MedCity News

OCTOBER 26, 2022

FDA approval of Tecvayli, from Johnson & Johnson subsidiary Janssen Biotech, makes it the newest therapy that treats multiple myeloma by targeting the cancer protein BCMA.

FDA

FDA Patients Biopharma Pharma

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

MedCity News

APRIL 24, 2024

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.

FDA

FDA Patients Biopharma Pharma

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

Provention Wins FDA Approval for First Drug to Delay Type 1 Diabetes Progression

MedCity News

NOVEMBER 18, 2022

Type 1 diabetes patients now have a new therapeutic option for the autoimmune disorder. Provention Bio drug Tzeild has received FDA approval for delaying the onset of the most severe stage of this chronic disease.

FDA

FDA Patients Biopharma Pharma

Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

MedCity News

JUNE 27, 2024

Verona Pharma’s COPD drug Ohtuvayre is a single small molecule that blocks two targets to bring patients both bronchodilation and anti-inflammatory effects. The post Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD appeared first on MedCity News.

Pharma

Pharma FDA Medical Patients

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. Lilly is trying to catch up to Novo Nordisk’s once weekly insulin icodec, which is commercially available in several markets around the world but is not yet approved by the FDA.

Patients

Patients FDA Marketing Biopharma

GSK gets June 2023 FDA decision date for momelotinib

pharmaphorum

AUGUST 17, 2022

The clock is now ticking on the FDA’s review of GSK’s momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 The post GSK gets June 2023 FDA decision date for momelotinib appeared first on. billion acquisition of Sierra Oncology which completed last month.

FDA

FDA Biopharma Patients Marketing

Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod

MedCity News

SEPTEMBER 28, 2023

The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products. Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency.

FDA

FDA Marketing Patients Biopharma

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

Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

MedCity News

FEBRUARY 17, 2023

Chiesi drug Lamzede is an engineered version of an enzyme that’s lacking in patients with the rare disease alpha-mannosidosis. FDA approval of the Chiesi drug comes about five years after European regulators authorized the product.

FDA

FDA Engineering Patients Biopharma

FDA Approval of Eisai Alzheimer’s Drug Bears Imprint of Aduhelm Review

MedCity News

JANUARY 8, 2023

Eisai Alzheimer’s disease drug Leqembi is now approved for the treatment of patients with an early form of the memory-robbing disease. In granting the antibody accelerated approval, the FDA employed reasoning that was the also basis for the controversial speedy regulatory nod for Biogen’s drug, Aduhelm.

FDA

FDA Patients Biopharma Pharma

FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

MedCity News

AUGUST 7, 2022

Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.

FDA

FDA Pharma Pharmaceutical Patients

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

MedCity News

JANUARY 23, 2024

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

Safety

Safety FDA Patients Biopharma

New Hemophilia Data Lead FDA to Delay Decision for BioMarin Gene Therapy

MedCity News

MARCH 7, 2023

BioMarin Pharmaceutical’s submission of additional data for patients treated with its hemophilia A gene therapy, Roctavian, mean that the FDA will push out a regulatory decision to early summer. But it could be worth the wait as analysts anticipate FDA approval and project Roctavian becoming one of BioMarin’s biggest products.

FDA

FDA Leads Pharmaceutical Patients

Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

MedCity News

OCTOBER 31, 2023

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to all patients who have the muscle-wasting disease.

Prospecting

Prospecting FDA Patients Biopharma

Santhera seeks speedy FDA review of Duchenne drug vamorolone

pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

FDA

FDA Side effects Biopharma Marketing

FDA Rejects Eli Lilly Alzheimer’s Drug, Asks for More Data From Ongoing Study

MedCity News

JANUARY 19, 2023

The company said the FDA is asking for data from more patients—results that must come from a larger study that’s underway but won’t report data until later this year. Eli Lilly’s accelerated approval application for its Alzheimer’s disease drug has fallen short.

FDA

FDA Patients Biopharma Pharma

Cardiac Complication Leads FDA to Place Foghorn Cancer Drug Under Partial Hold

MedCity News

APRIL 24, 2023

A clinical trial for a Foghorn Therapeutics cancer drug is under a partial FDA hold after a patient in the early-stage study developed a cardiovascular complication. It’s the biotech’s second partial hold in the past year.

FDA

FDA Leads Patients Biopharma

A sad day for us all as the FDA continues to lose credibility

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

Trending Sources

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

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

Pfizer acquires biopharma firm Biohaven for $11.6bn

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

Ipsen beefs up in oncology, buying US biopharma Epizyme

An Attack on Patients’ Right to Informed Consent

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

Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

FDA approves first gene therapy for Haemophilia B

Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency

Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

FDA Probes New Cases of Cancer That May Stem From Cancer Cell Therapies

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

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

Novo Nordisk’s Diabetes Pill Rybelsus Gets FDA O.K. as First-Line Therapy

FDA Mulls Policy Switch on Switching Study Requirement for Biosimilars

Pfizer Meningococcal Vaccine Nabs FDA Nod, Offering More Convenient Dosing

J&J multiple myeloma drug gets FDA nod, bringing patients an easier dosing option

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

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

Provention Wins FDA Approval for First Drug to Delay Type 1 Diabetes Progression

Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

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

GSK gets June 2023 FDA decision date for momelotinib

Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod

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

Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

FDA Approval of Eisai Alzheimer’s Drug Bears Imprint of Aduhelm Review

FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

New Hemophilia Data Lead FDA to Delay Decision for BioMarin Gene Therapy

Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

Santhera seeks speedy FDA review of Duchenne drug vamorolone

FDA Rejects Eli Lilly Alzheimer’s Drug, Asks for More Data From Ongoing Study

Cardiac Complication Leads FDA to Place Foghorn Cancer Drug Under Partial Hold

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