Fierce Pharma

JUNE 6, 2023

But first the partners will need to pass several regulatory milestones, including an FDA advisory committee discussion set for later this week.

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Prospecting FDA Marketing 205

Fierce Pharma

OCTOBER 30, 2023

As an FDA decision draws closer on bluebird bio’s sickle cell disease gene therapy, the company has lined up a potential sale of a priority review voucher (PRV). | The company entered an advance agreement for a priority review voucher ahead of the FDA's decision on the sickle cell disease gene therapy prospect.

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FDA Prospecting Sales 212

Fierce Pharma

OCTOBER 30, 2023

After Sarepta overcame several regulatory hurdles to finally win | After Sarepta overcame several regulatory hurdles to finally win FDA approval for its DMD gene therapy Elevidys, the company now faces the prospect of more FDA scrutiny because a pivotal study on the drug has failed on the primary endpoint.

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Prospecting FDA 254

MedCity News

SEPTEMBER 21, 2023

Seven months after Travere Therapeutics’ flagship drug received accelerated FDA approval in a rare kidney disease, the molecule has fallen short of the key goal of its confirmatory test. It’s the small molecule’s second Phase 3 failure this year.

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Prospecting FDA Biopharma Pharma 97

Fierce Pharma

JULY 24, 2023

The pair will also add two more biosimilar prospects to their deal.

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Manufacturing Prospecting FDA 194

pharmaphorum

AUGUST 3, 2022

Immunotherapies and combination therapies have dramatically improved the prospects for newly-diagnosed SCLC patients, but despite these advances, many rapidly relapse due to the aggressive nature of the disease. The post Phase 3 lung cancer fail dents prospects of Ipsen, Servier’s Onivyde appeared first on.

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Prospecting FDA Sales Patients 52

Medgadget

JUNE 8, 2023

The iLet Bionic Pancreas for use by type 1 diabetes patients has been cleared by the FDA and is now available commercially. It’s a very scary prospect that blood sugars could go low at night. It’s what put this project on a high-speed rail. When you’re sleeping, you’re checked out—you don’t want to check out permanently.”

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FDA Medicine Prospecting Patients 102

pharmaphorum

AUGUST 15, 2022

Gilead has also confirmed that it has now filed with the FDA for approval to extend the label for Trodelvy on the strength of the TROPICS-02 data, and intends to share the data with regulators outside the US as well. The post Survival data firms up Trodelvy prospects in new breast cancer use appeared first on.

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Prospecting Sales Medical Patients 61

Tribeca Knowledge

NOVEMBER 28, 2023

T he drug-approval slump in major markets that clouded innovation prospects during 2022 seems to be over.

Food and Drug Administration 52

Food and Drug Administration Marketing FDA Prospecting 52

Legacy MEDSearch

JANUARY 3, 2023

Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

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FDA Food and Drug Administration Recruitment Prospecting 95

pharmaphorum

SEPTEMBER 28, 2022

The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm. Trial sponsors are still left with the challenge of including children in an ethical , safe, and secure way, and the new guidance is the FDA’s attempt to make that easier to achieve.

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FDA Ethics Prospecting Safety 57

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Prospecting 52

European Pharmaceutical Review

AUGUST 14, 2023

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study.

FDA 52

FDA Food and Drug Administration Medicine Prospecting 52

Legacy MEDSearch

MAY 24, 2023

iHealthScreen conducted a prospective trial in the general population to prospectively assess the product’s accuracy, sensitivity and specificity. These prospective study results were initially presented at the Annual Meeting of the American Academy of Ophthalmology (AAO) and selected for Panel Discussion as outstanding work.

FDA 52

FDA Prospecting Recruitment Healthcare 52

pharmaphorum

SEPTEMBER 13, 2022

The FDA has started a priority review of Chiesi ‘s velmanase alfa, an enzyme replacement therapy for lysosomal storage disease (LSD) alpha-mannosidosis, with a decision expected in the first half of 2023. The post FDA starts review of first drug for alpha-mannosidosis, from Chiesi appeared first on.

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FDA Distribution Prospecting Patients 94

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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FDA Side effects Pharmacology Patients 115

pharmaphorum

NOVEMBER 9, 2022

ADC Therapeutics has said it will not seek accelerated approval of its Hodgkin lymphoma drug camidanlumab tesirine (cami) based on phase 2 results, as the FDA will not review it unless a confirmatory trial is already “well underway and fully enrolled.”.

FDA 57

FDA Prospecting Marketing Safety 57

pharmaphorum

SEPTEMBER 30, 2022

Sarepta’s chief executive Doug Ingram has been increasingly positive on the prospects for the therapy, and said today that the FDA filing “is a significant milestone in our quest to intervene with urgency on behalf of the children we serve.” Photo by Markus Spiske on Unsplash.

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FDA Prospecting Patients Safety 90

MedCity News

MARCH 19, 2023

Prospective buyers can pick up Pear’s FDA-cleared products for substance use disorder, opioid use disorder, and insomnia. Pear Therapeutics isn’t meeting the commercialization goals for its prescription digital therapeutics, so it’s now seeking strategic alternatives for the business.

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Prescription Prospecting FDA Biopharma 90

Pharmaceutical Technology

FEBRUARY 26, 2024

The Phase II prospective, randomised trial will evaluate three doses of PKM-01 to select the optimal dosage for a Phase III study.

Prospecting 52

Prospecting FDA 52

Legacy MEDSearch

OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). It additionally signals that the FDA is already thinking about future pandemic preparedness, something we are keen to partner on with them and the medical community.” “I RAC & Chief Regulatory Officer for ExThera. Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 52

pharmaphorum

OCTOBER 17, 2022

The FDA is planning to take an additional three months to review Biogen’s experimental therapy for amyotrophic lateral sclerosis (ALS), setting back its decision date from January to April. A few weeks ago the delay would have been a big deal for Biogen, as tofersen was among its most important near-term launch prospects.

FDA 52

FDA Prospecting Competition Safety 52

World of DTC Marketing

SEPTEMBER 1, 2020

With trust in government so low we can’t afford, as a nation, to allow the FDA to become a political pawn. Here’s what you didn’t say: There are no data or evidence from prospective, randomized trials for convalescent plasma to support any survival benefit. This is unnerving to say the least.

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FDA Government Prospecting Patients 278

pharmaphorum

DECEMBER 14, 2022

An FDA advisory committee has voted against approval of Cytokinetics’ cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough. The post FDA adcomm votes down Cytokinetics heart failure drug appeared first on. with omecamtiv mecarbil from 39.1%

FDA 52

FDA Side effects Prospecting Patients 52

Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years.

Food and Drug Administration 52

Food and Drug Administration FDA Prospecting Food 52

pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The post FDA slaps partial hold on Biogen, InnoCare MS drug appeared first on.

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FDA Side effects Biopharma Prospecting 63

PharmaTech

APRIL 24, 2023

The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.

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Prospecting FDA 52

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date.

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FDA Safety Pharmaceutical Patients 126

Pharmacy Times

JUNE 6, 2023

The proposed indications for milvexian include stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack; recent acute coronary syndrome; and atrial fibrillation.

Prospecting 26

Prospecting FDA 26

Legacy MEDSearch

DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The device previously received the FDA’s Breakthrough Designation for its potential to provide significant advantages over currently approved spinal stabilization technologies. Empirical Spine, Inc., About LimiFlex.

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FDA Food and Drug Administration Recruitment Patients 94

World of DTC Marketing

NOVEMBER 12, 2020

That, however, didn’t stop a conspiracy loving imbecile from blaming the FDA and Pfizer. According to JAMA , “between January 2010 and June 2020, the FDA approved 21 vaccines, most commonly for influenza (5 [23.8%]) and meningococcus (5 [23.8%]). Of these, 4 (19.0%) received Accelerated Approval.

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Food and Drug Administration FDA Distribution Government 187

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry.

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Manufacturing FDA Food and Drug Administration Pharmaceutical 98

pharmaphorum

JULY 6, 2022

The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that keep them ahead of closest rival Eli Lilly. ” The post Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan appeared first on.

FDA 52

FDA Prospecting Marketing Patients 52

pharmaphorum

SEPTEMBER 15, 2022

The Massachusetts-based biotech said it a meeting with the FDA to discuss the programme has given it the confidence to press ahead with filing for approval of the RASP modulator in the US later this year. The post Aldeyra spies FDA filing ahead for dry eye drug reproxalap appeared first on. Image by StockSnap from Pixabay .

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FDA Side effects Prospecting Patients 52

World of DTC Marketing

OCTOBER 23, 2020

The Food and Drug Administration’s (FDA) panel of experts questioned the safety and efficacy of its own rules around emergency COVID-19 vaccine approval at an advisory meeting Thursday. A senior administration official told Vanity Fair, “No one has pressured the FDA to rush through an approval. Yeah, right.

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Food and Drug Administration FDA Safety Prospecting 181

Legacy MEDSearch

APRIL 21, 2023

a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval (PMA) of its Lava® Liquid Embolic System (Lava® LES) for treatment of peripheral arterial hemorrhage. Bay Area-based BlackSwan Vascular, Inc., Are you hiring?

FDA 52

FDA Safety Recruitment Prospecting 52

Pharmaceutical Technology

OCTOBER 7, 2022

The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk. Simultaneously, the companies have signed a securities purchase agreement under which Sanofi will procure $35m of Provention’s common stock on teplizumab, obtaining FDA approval. .

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Food and Drug Administration FDA Healthcare Provider Prospecting 119