Biopharma, FDA and Patients - Pharma Rep Focus

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.

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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.

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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

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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

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.

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Reducing real world data lag time for improved patient outcomes

Clarivate

MARCH 8, 2023

In recent years, there has been an increased focus on real world evidence to advance medical science and improve patient quality of life. Biopharma companies are investing in the use of real world data (RWD) to accelerate innovation. The treatment of patients experiencing acute disease is quite dynamic.

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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

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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.

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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.

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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.

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Bristol Myers Squibb Wins FDA Approval for Lung Cancer Drug From $4B Deal

MedCity News

NOVEMBER 16, 2023

FDA approval of Bristol Myers Squibb’s Augtyro covers treatment of patients whose non-small cell lung cancer is driven by the rare ROS1 mutation. The molecule comes from BMS’s 2022 acquisition of Turning Point Therapeutics.

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FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death

MedCity News

JUNE 20, 2023

Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.

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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.

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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.

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$1.7b acquisition to develop rare haematology therapy

European Pharmaceutical Review

MAY 12, 2023

Swedish Orphan Biovitrum AB (Sobi ® ) has agreed to acquire CTI BioPharma for $1.7 There is a large unmet medical need within myelofibrosis, in particular for patients suffering from thrombocytopenia who are inadequately treated by existing medicines. This treatment inhibits JAK2, IRAK1 and ACRV1, while sparing JAK1.

Food and Drug Administration

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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.

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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.

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US FDA accepts Accord BioPharma’s BLA for HLX02 to treat cancer

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals. Biosimilars are key to making healthcare more affordable and accessible.

Food and Drug Administration

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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.

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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

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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.

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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.

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US FDA accepts BLA for Henlius’ biosimilar HLX02

Pharmaceutical Technology

FEBRUARY 16, 2023

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) for Shanghai Henlius Biotech ’s proposed biosimilar HLX02 (trastuzumab for injection). Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA.

Food and Drug Administration

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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.

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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.

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InflaRx Covid-19 Drug Welcomes an FDA Win; Pardes Bio Throws In the Towel

MedCity News

APRIL 5, 2023

The FDA granted emergency use authorization to an InflaRx antibody drug that treats hospitalized Covid-19 patients. But Pardes Bioscience’s coronavirus journey is ending following the Phase 2 failure of an antiviral that was expected to compete with Pfizer’s Paxlovid.

FDA

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UCB Muscle Disease Drug Wins FDA Nod on Heels of Rival’s Regulatory Approval

MedCity News

JUNE 27, 2023

The FDA approved UCB’s Rystiggo for treating generalized myasthenia gravis. Drugs are already available for the rare neuromuscular disorder, but Rystiggo’s approval includes treatment of a subset of patients not addressed by other products.

FDA

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Kinnate Biopharma’s CCA therapy KIN-3248 receives FDA Fast Track status

Pharmaceutical Technology

FEBRUARY 15, 2023

Kinnate Biopharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its pan-FGFR inhibitor, KIN-3248, to treat unresectable, locally advanced or metastatic cholangiocarcinoma (CCA). Kinnate Biopharma expects to receive initial dose escalation data in the second half of this year.

Food and Drug Administration

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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

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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.

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Solution to Clinical Trial Enrollment Lies Hidden in FDA Guidance

MedCity News

MARCH 16, 2023

The FDA is apparently open to new technologies that enable patients to easily participate in clinical research, whether it be from their homes, a nearby clinic, or a provider’s office.

FDA

FDA Patients Recruitment Biopharma

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.

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Patient Death Leads to Pause in Test of 2seventy Bio Cell Therapy for Leukemia

MedCity News

JUNE 14, 2023

2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study. The FDA has been notified and an investigation is underway.

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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

Trending Sources

Patient Death Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

FDA Approves First Drug for Treating Agitation in Alzheimer’s Patients

Pfizer acquires biopharma firm Biohaven for $11.6bn

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

An Attack on Patients’ Right to Informed Consent

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

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

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

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

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

Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

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

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

Ipsen beefs up in oncology, buying US biopharma Epizyme

Reducing real world data lag time for improved patient outcomes

FDA approves first gene therapy for Haemophilia B

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

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

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

Bristol Myers Squibb Wins FDA Approval for Lung Cancer Drug From $4B Deal

FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death

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

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

$1.7b acquisition to develop rare haematology therapy

GSK gets June 2023 FDA decision date for momelotinib

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

US FDA accepts Accord BioPharma’s BLA for HLX02 to treat cancer

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

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

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

Santhera seeks speedy FDA review of Duchenne drug vamorolone

US FDA accepts BLA for Henlius’ biosimilar HLX02

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

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

InflaRx Covid-19 Drug Welcomes an FDA Win; Pardes Bio Throws In the Towel

UCB Muscle Disease Drug Wins FDA Nod on Heels of Rival’s Regulatory Approval

Kinnate Biopharma’s CCA therapy KIN-3248 receives FDA Fast Track status

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

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

Solution to Clinical Trial Enrollment Lies Hidden in FDA Guidance

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

Patient Death Leads to Pause in Test of 2seventy Bio Cell Therapy for Leukemia

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