MedCity News

JULY 27, 2022

ObsEva’s uterine fibroids drug linzagolix has hit a snag at the FDA, portending a likely delayed regulatory decision. Rather than stick it out and see if its small molecule can match up against commercialized products from AbbVie and Myovant, ObsEva plans to give up rights to the drug as part of a corporate restructuring.

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FDA Leads Biopharma Pharma 118

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 88

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 101

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

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 105

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 109

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 98

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

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 92

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 95

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

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 131

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 91

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

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 106

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 116

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 92

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 89

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 88

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

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 90

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 Biopharma Medicine 110

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 109

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

PM360

JUNE 24, 2024

This fuels an enormous need for effective patient communication and education as new therapies move through the biopharma pipeline. Those of us in the biopharma industry know how fraught drug development can be. Food & Drug Administration (FDA). It’s better to pay a good one than to receive a letter from the FDA.

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Marketing Patients Food and Drug Administration Digital Media 52

PM360

MAY 2, 2023

We are fortunate to work with innovative startup and mid-stage biopharma companies that are developing vaccines and medicines for rare diseases, cancer, specialty therapeutic areas, and other patient needs, as well as partnering with diagnostic and medical device companies.

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Food and Drug Administration Healthcare Healthcare Marketing 52

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

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 104

Clarivate

SEPTEMBER 11, 2024

As dementia becomes more severe, people require greater care, and develop complications such as pressure ulcers, infections, dysphagia, malnutrition and aspiration pneumonia – a leading cause of death among people with Alzheimer’s (Anon., FDA cleared the first CSF diagnostic test based on the detection of Aβ40/Aβ42 (U.S.

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Food and Drug Administration Pharmacology Food FDA 59

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

Legacy MEDSearch

MAY 19, 2023

PaceMate ® announced today its collaboration with AliveCor ® , the global leader in FDA-cleared personal electrocardiogram technology and remote patient management solutions for the cardiovascular industry. The FDA-cleared KardiaMobile device is the most clinically validated personal ECG solution in the world.

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Healthcare Provider Management Healthcare Healthcare 52

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

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 Prescription 52

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

pharmaphorum

SEPTEMBER 13, 2022

Current FDA guidance is that candidate NASH drugs should either improve fibrosis without worsening NASH, or resolve NASH without worsening fibrosis. A second phase 3 trial is due to report in the fourth quarter of this year, and if positive could lead to regulatory filings in the first half of 2023.

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Patients Biopharma FDA Marketing 52

Clarivate

NOVEMBER 8, 2022

RNA therapeutics actually burst onto the scene prior to the COVID-19 pandemic, with the FDA approval of Ionis/Biogen’s SPINRAZA®, for the treatment of spinal muscular atrophy, in 2016. In addition to that drug, Alnylam ® Pharmaceuticals has had four FDA approvals of RNA therapies for rare diseases. Cargene Biopharma Inc.,

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Pharma Biopharma Marketing FDA 52