European Pharmaceutical Review

NOVEMBER 25, 2022

According to the pre-IND meeting with the US Food and Drug Administration (FDA), Luye Pharma plans to submit the New Drug Application (NDA) for LY03010 to the FDA through the 505(b)(2) pathway. The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.

Competition 93

Competition Food and Drug Administration Pharma Food 93

Fierce Pharma

OCTOBER 2, 2023

Even as Biogen weighs strategic options for its biosimilars unit, the group is celebrating an industry first. | The exact launch timing of the biosimilar remains unclear, but Roche said it expects competition to kick off in the second half of 2023.

Competition 304

Competition FDA 304

MedCity News

DECEMBER 13, 2022

Amgen’s Lumakras became the first FDA-approved drug that addresses the elusive KRAS mutation, but Mirati believes its newly approved therapy, Krazati, could be better. The small molecule’s features include the ability to penetrate into the brain, where it can address cancer that has spread to the central nervous system.

Competition 98

Competition FDA Biopharma Pharma 98

Fierce Pharma

AUGUST 15, 2023

With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. With its blockbuster eye drug Eylea, Regeneron is already juggling between a recent FDA rejection and new competition. Meanwhile, biosimilar players are also eying a piece of the pie.

Competition 225

Competition FDA 225

European Pharmaceutical Review

OCTOBER 14, 2022

Amgen’s 2022 market report has detailed how competition has driven savings across healthcare, estimating that a considerable number of biologics will be in competition with biosimilars in five to 10 years. A rise in savings per quarter was recognised in this year’s data. Seven more are expected to be launched in 2023.

Competition 74

Competition Healthcare Healthcare Food and Drug Administration 74

pharmaphorum

OCTOBER 7, 2022

It’s often stated – mostly without reference to data – that the environment for innovative launches is more competitive now than it ever has been. Continued competitive intensity. The first in class launches barely have time to establish before they face competition, and then the competition keeps on coming.

Competition 72

Competition Marketing Medicine Pharmaceutical 72

MedCity News

JUNE 26, 2023

Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.

Competition 103

Competition FDA Biopharma Pharma 103

MedCity News

MAY 10, 2023

A drug developed by Protalix BioTherapeutics and Chiesi Group is now FDA approved for treating Fabry disease, a rare inherited metabolic disorder. The drug, Elfabrio, is an enzyme replacement therapy.

Competition 98

Competition FDA Biopharma Pharma 98

Pharmaceutical Technology

OCTOBER 2, 2023

Biogen’s Tofidence scores the US FDA approval for all arthritis indications similar to Roche’s Actemra (tocilizumab).

Competition 52

Competition FDA 52

MedCity News

JANUARY 23, 2023

The FDA approved TheracosBio’s Brenzavvy as a treatment for type 2 diabetes. But before it won a regulatory nod for controlling blood glucose in adults, it was approved at a different dose (with flavor) as a veterinary product.

Competition 98

Competition FDA Biopharma Pharma 98

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Sustainable biosimilar competition in Europe: can it be achieved? The post FDA approves first Stelara biosimilar, Wezlana appeared first on European Pharmaceutical Review.

Food and Drug Administration 83

Food and Drug Administration FDA Side effects Safety 83

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. We look forward to working with the FDA to bring this potential first-in-class AKT inhibitor to patients as quickly as possible.”

Food and Drug Administration 98

Food and Drug Administration FDA Food Competition 98

MedCity News

NOVEMBER 7, 2023

The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.

Biopharma 133

Biopharma Competition FDA Pharma 133

Fierce Pharma

JULY 11, 2023

That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel. . | With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely.

Manufacturing 168

Manufacturing Competition Pharma FDA 168

MedCity News

AUGUST 3, 2022

Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help the much larger group of patients suffering heart problems from the rare protein disease.

FDA 94

FDA Competition Pharmaceutical Patients 94

Eversana Intouch

MARCH 31, 2023

It’s an exciting era in oncology: many new drugs with increasing benefits and more tolerable profiles are being developed and released, and that means that nearly all tumor type spaces are becoming more competitive.

Competition 52

Competition Marketing Healthcare Healthcare 52

Pharmaceutical Technology

FEBRUARY 10, 2023

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).

FDA 105

FDA Competition Leads Marketing 105

Legacy MEDSearch

MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. The company aims to offer the device at a competitive price point, but further pricing details will be shared closer to the product’s release date. Are you hiring?

Food and Drug Administration 52

Food and Drug Administration FDA Food Management 52

Pharmaceutical Technology

JUNE 14, 2023

The US Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) and fast track designations for Eagle Pharmaceuticals’ CAL02. It acts as a competitive decoy for bacterial virulence factors that contribute to complications, sepsis, septic shock and death following infection.

Food and Drug Administration 52

Food and Drug Administration FDA Engineering Food 52

pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. The FDA approval is conditional on a positive outcome from a phase 3 confirmatory trial – KRYSTAL-12 – which is scheduled to complete next year.

FDA 52

FDA Side effects Competition Patients 52

PharmaTech

AUGUST 2, 2022

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

FDA 52

FDA Competition 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. There was no update from Biogen on whether the FDA will require an advisory committee meeting to review the data with the drug.

FDA 52

FDA Prospecting Competition Safety 52

pharmaphorum

JULY 6, 2022

The FDA has granted a priority review to Roche’s T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the drug by 29 December. The post FDA to decide on Roche’s lymphoma drug Lunsumio before year-end appeared first on.

FDA 81

FDA Competition Patients Manufacturing 81

World of DTC Marketing

MAY 3, 2022

In trying to save the product, Biogen’s reputation was trashed by FDA advisors, HCPs, and the healthcare media. 2wo: The competition’s MS drugs were better – The MS market is lucrative, and competitors launched products that were better than Biogen’s with fewer side effects discussed by the MS community online.

Side effects 207

Side effects FDA Media Pharma 207

World of DTC Marketing

APRIL 12, 2021

The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. Ironically, in later times, the intense competition for out-of-patent drugs has subsided, which has led to spiraling rises in generic drug prices and shortages.

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

pharmaphorum

JANUARY 16, 2023

China’s Luye Pharma has claimed its first FDA approval, getting a green light for Rykindo, an injectable formulation of the antipsychotic risperidone given every two weeks. ” The post Luye claims its first FDA approval, for bi-weekly schizophrenia drug appeared first on.

FDA 52

FDA Pharma Marketing Competition 52

World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Since that time, Biogen’s MS drugs have faced intense competition as MS patients continue to vent on social media that the Biogen drug has nasty side effects. Washington Post.

Side effects 187

Side effects FDA Patients Doctors 187

World of DTC Marketing

JULY 9, 2021

SUMMARY: Pfizer asks for accelerated approval for a COVID booster shot even though the FDA says it’s unnecessary. Hours after Pfizer issued its statement, the FDA and Centers for Disease and Control issued a joint statement saying Americans do not need booster shots yet” So who to believe? Big pharma is big business.

Pharma 292

Pharma FDA Leads Competition 292

pharmaphorum

SEPTEMBER 22, 2022

The FDA granted the drug an accelerated review with a verdict expected by 25 January. ” The new data will no doubt be debated extensively at a yet-to-be-scheduled FDA advisory committee meeting, and Biogen will be hoping for a better outcome than at the Aduhelm meeting, which resulted in a vote against approval of the drug.

FDA 52

FDA Sales Prospecting Patients 52

Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Insurance 52

PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA). Challenges in Working with Label Data.

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

European Pharmaceutical Review

JANUARY 17, 2024

Regulatory developments for heart failure drug acoramidis Last month, BridgeBio Pharma confirmed that it had that submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for acoramidis to treat transthyretin amyloid cardiomyopathy, based on data from the Phase III trial. “We

Food and Drug Administration 74

Food and Drug Administration FDA Food Competition 74

World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. Drug pricing is done by internal teams who look at what the market will bear and the competitive landscape. The FDA, in its wisdom, has never studied what patients actually do when they see a DTC TV ad. DTC ads raise awareness around health conditions.

Marketing 285

Marketing Prescription Side effects Doctors 285

Pharmaceutical Technology

MARCH 24, 2023

Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board. Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year.

Competition 59

Competition Marketing FDA Physicians 59

European Pharmaceutical Review

DECEMBER 6, 2022

According to a market report by GlobalData, expanding generic drug competition and a drop in demand for COVID-19 vaccines and therapies have lowered the aggregate market capitalisation of the global top 20 biopharmaceutical companies by 9.1 percent from $3.45 trillion in Q2 2022 to $3.14 trillion in Q3 2022. percent and 24.2 percent and 24.2

Biopharma 70

Biopharma Marketing Food and Drug Administration Sales 70

Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Overall, Aurinia’s Lupkynis is expected to face tough competition from Benlysta in LN, which received FDA approval in December 2020 and EMA approval in May 2021.

Food and Drug Administration 59

Food and Drug Administration Physicians Competition FDA 59

Pharmaceutical Technology

DECEMBER 20, 2022

The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. The FDA also awarded priority review for Eli Lilly’s donanemab, a monoclonal antibody for Alzheimer’s disease, in August 2022, and the company expects approval by February 2023. trillion in Q2 2022 to $3.14

Biopharma 52

Biopharma Marketing Competition Sales 52