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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FDA Leads Patients Biopharma 91

MedCity News

APRIL 15, 2024

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder.

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Safety FDA Leads Biopharma 104

MedCity News

JUNE 30, 2022

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

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FDA Leads Safety Patients 98

European Pharmaceutical Review

MAY 12, 2023

Swedish Orphan Biovitrum AB (Sobi ® ) has agreed to acquire CTI BioPharma for $1.7 The biopharma companies anticipate the transaction will help to change the treatment landscape for patients with rare diseases through new, innovative and effective medicines and therapies.

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Food and Drug Administration Biopharma Medicine Food 105

MedCity News

SEPTEMBER 30, 2022

An Amylyx Pharmaceuticals drug developed to slow the progression of amyotrophic lateral sclerosis is now approved, making it just the third FDA-approved treatment for the disease. Amylyx will market its new product under the name “Relyvrio.”.

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FDA Leads Pharmaceutical Marketing 79

MedCity News

FEBRUARY 7, 2024

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

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Safety Leads FDA Biopharma 101

MedCity News

FEBRUARY 21, 2023

Travere Therapeutics drug Filspari won accelerated FDA approval to treat a rare disorder that can lead to kidney failure. The small molecule is also in late-stage testing for another rare kidney disease; analysts say each indication represents a blockbuster opportunity.

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FDA Leads Biopharma Pharma 94

MedCity News

DECEMBER 26, 2022

By easing regulatory requirements for animal testing, the Act allows scientists to use innovative, leading-edge technologies more fully in future drug development strategies. .

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FDA Leads Biopharma 134

MedCity News

DECEMBER 9, 2024

The data, presented Monday during the annual meeting of the American Society of Hematology, are part of a submission now under FDA review that could lead to Blenreps return to the market. The post GSK Multiple Myeloma Drugs DREAMM Comeback Continues With Phase 3 Data at ASH appeared first on MedCity News.

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FDA Leads Marketing Patients 108

MedCity News

JANUARY 21, 2024

The FDA said Amgen’s Prolia may lead to low levels of calcium, or hypocalcemia.

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FDA Medicine Leads Biopharma 102

MedCity News

JUNE 14, 2023

The FDA has been notified and an investigation is underway. 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.

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Leads Patients FDA Biopharma 89

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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FDA Side effects Biopharma Marketing 80

MedCity News

FEBRUARY 17, 2023

The FDA approved Apellis Pharmaceuticals’ Syfovre as a treatment for geographic atrophy, a retinal disorder that is a leading cause of blindness. The drug, administered as an injection into the eye, will launch in March at the price of $2,190 per vial.

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FDA Pharmaceutical Leads Biopharma 110

MedCity News

OCTOBER 21, 2022

based biotech’s lead program is an antibody drug in preclinical development for idiopathic pulmonary fibrosis, a chronic lung disorder with few FDA-approved treatments. AbbVie acquired DJS Antibodies for $255 million up front.

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FDA Leads Biopharma Pharma 115

pharmaphorum

DECEMBER 16, 2022

The FDA has already granted a fast-track designation to zolbetuximab for the treatment of gastric and GEJ adenocarcinoma. I-Mab Biopharma, meanwhile, has a bispecific antibody called TJ-CD4B – which binds to both claudin 18.2 The post Second phase 3 trial extends Astellas’ lead in claudin 18.2 Claudin 18.2

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Leads Biopharma Prospecting Patients 59

MedCity News

NOVEMBER 4, 2024

The Novo Nordisk/Ascendis partnership’s lead program is once-monthly injectable semaglutide for type 2 diabetes and obesity. This product candidate will be developed with Ascendis Pharma technology that has already yielded two FDA-approved products with longer dosing intervals.

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Pharma FDA Leads Biopharma 108

MedCity News

AUGUST 1, 2024

Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU). Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical.

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Pharmaceutical Medicine FDA Leads 86

pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease.

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Sales Patients Medicine Biopharma 104

PM360

DECEMBER 20, 2024

Courier Health Powered by machine learning AI, Avalere Courier Health was founded in 2021 with the goal of revolutionizing the biopharma landscape with its groundbreaking patient-focused customer relationship management (CRM) platform. It simplifies complex workflows (e.g., In July 2024, Courier Health secured $16.5

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Customer Relationship Management CRM Biopharma Relationship management 52

MedCity News

JULY 18, 2023

Novartis’s acquisition of DTx Pharma brings a lead program for a rare disease with no FDA-approved therapies. But the deal could also help the pharma giant bring new RNA therapies to new places in the body, a top Novartis executive explained.

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Pharma FDA Leads Biopharma 84

pharmaphorum

JANUARY 6, 2023

With an early view of market viability, leading companies will be able to monetise new products quickly and at scale across Europe.”. This will enable biopharmas to create a more streamlined drug development process rooted in lean process execution and higher-quality data.”.

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Safety Management Patients Training 101

Pharmaceutical Technology

SEPTEMBER 5, 2022

On 23 August, at a Reuters Newsmakers online forum, Soriot announced his interest in increasing AstraZeneca’s portfolio of bolt-on acquisitions leading up to 2025. The FDA has granted the drug an orphan drug designation, and Phase III trials with eplontersen were completed In June. In 2019, AstraZeneca entered a $6.9

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FDA Pharmaceutical Biopharma Pharma 114

pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

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Side effects Safety Biopharma Recruitment 76

pharmaphorum

SEPTEMBER 6, 2022

Pleco Therapeutics has closed a first-round financing, raising just over €17 million that it says will fund the development of its lead therapy for acute myeloid leukaemia (AML) through to regulatory filings in the US and EU. million in equity and R&D funding from Belgian biopharma company Hyloris, which was first announced last year.

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Leads Biopharma Government Patients 76

Pharmaceutical Technology

MAY 15, 2023

The US FDA database has 95 approved pyridine derivatives, including isoniazid and ethionamide (tuberculosis), delavirdine (HIV/AIDS), abiraterone acetate (prostate cancer), and tacrine (Alzheimer’s).

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Pharmaceutical Leads Pharmacology Medicine 52

pharmaphorum

JANUARY 9, 2023

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. Supported by voting agreements from leading Amryt shareholders and directors, and unanimously approved and recommended by the boards of both companies, the total transaction is worth up to $1.48 is to acquire the 2015-established Amryt Pharma Plc. on 6 th January.

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Pharma Biopharma Management Medicine 78

European Pharmaceutical Review

AUGUST 31, 2023

Compared to the aforementioned copper‑based radionuclides, Cu-64 has a longer production and decay time, which leads to a more expensive production process and a higher radiation burden for the patient. During her career, she held positions of increasing responsibility to lead companies in the field, including AREVA/Framatome.

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Food and Drug Administration Manufacturing Safety Transportation 97

European Pharmaceutical Review

APRIL 30, 2024

What are the top three trends that you are seeing in the biopharma manufacturing space? Let’s talk about continuous biopharma manufacturing. Speaking of your biopharma clients, what are you hearing about their main priorities? I believe this is going to be an emerging trend in the market.

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Manufacturing Food and Drug Administration Biopharma Marketing 97

pharmaphorum

SEPTEMBER 12, 2022

Dr Prasanth Reddy, head of oncology at LabCorp, tells us how the company works with cancer care teams, biopharma partners, and patients as an integral part of the patient journey from testing to treatment. They offer the only diagnostic kit cleared by the US FDA for pan-solid cancer comprehensive tumour profiling using a 500+ gene panel.

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Patients Medicine FDA Healthcare 96

European Pharmaceutical Review

OCTOBER 19, 2023

billion deal, in which Eli Lilly agreed to acquire two of POINT Biopharma Global’s late-stage radioligand therapies for oncological indications. Can you share an update on the clinical trial for your lead candidate? Hoppin served as lead director of Noria as the two organisations were sold to Bayer Healthcare in June of 2021.

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Food and Drug Administration Manufacturing Side effects Doctors 105

Pharmaceutical Technology

MAY 24, 2023

Every major pharma company is now involved in CGT development which has resulted in the approval of 28 therapies by the FDA thereby making CGT no longer a niche category of therapies. This major difference leads to very different requirements and processes for the clinical trial supply chain, which are summarized below.

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Manufacturing Transportation Specialization Patients 98

Medgadget

MARCH 2, 2023

This leads to substantial damage to healthy tissues and too often results in poor outcomes. The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S. We hope to see Alpha TAU presenting its technology at Biomed Israel , the leading international Life Science and HealthTech conference in Israel.

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Manufacturing Leads Patients Medicine 82

European Pharmaceutical Review

SEPTEMBER 2, 2024

The oral treatment GMRx2 is biopharma George Medicines’ lead drug candidate. George Medicines submitted GMRx2 as a treatment for hypertension for review earlier this month to the US Food and Drug Administration (FDA). The results are based on the ‘deliVERy of Optimal blood pressure coNtrol in afrICA (VERONICA)-Nigeria’ trial.

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Food and Drug Administration Medicine Biopharma Food 59

Clarify Health

MAY 19, 2020

After FDA-approval comes the last critical mile of this journey: bringing the product to market. There is also a looming, time-sensitive reality that biopharma companies face once their products hit the market: they need to recoup the costs of development as quickly as possible before drug patents expire and generics threaten sales.

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Biopharma Physicians Marketing Patients 52

PM360

NOVEMBER 21, 2024

is a leading neuroscience-focused, biopharmaceutical company headquartered in San Diego, CA, with a single purpose: to relieve suffering for people with great needs but few options. Neurocrine Biosciences, Inc. Neurocrine Biosciences was founded in 1992 and has grown today to 1,436 U.S.-based

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Pharma Training Biopharma Manufacturing 52

PM360

JULY 13, 2023

Our lead indications are HER2-positive metastatic breast cancer (mBC) and metastatic castration-resistant prostate cancer (mCRPC). The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023.

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Patients Engineering Side effects Leads 98

Medgadget

FEBRUARY 17, 2023

Thanks to kind support from Biomed Israel , the leading international Life Science and HealthTech conference in Israel (see more below), we met with Ronan Castro, the CEO of Human Xtensions at the company’s offices in Netanya, Israel.

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Physicians Engineering Leads Side effects 80