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.

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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. There’s much more to be done, but it’s generally great news for patients, bringing them hope and choice they didn’t have before.

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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.

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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. Mirati also says its drug penetrates the central nervous system more readily, making it a better option for patients whose disease has metastasised to the brain.

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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.

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World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. We need a 21st-century approach that puts patient safety first. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs). In other words, money over safety.

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Food and Drug Administration Prescription Pharma Manufacturing 187

LEVO Health

OCTOBER 26, 2022

With seemingly countless treatment options on the table, how can your device cut through the clutter and get in front of the right patients at just the right time? You need a marketing strategy that sets your medical device apart from the competition. You need to be a trusted partner for both patients and their providers alike. .

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World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. Drug pricing is done by internal teams who look at what the market will bear and the competitive landscape. Again this is not true.

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Marketing Prescription Side effects Doctors 285

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.

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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 are around 31,000 patients with ALS in the US. The post FDA delays decision on Biogen’s ALS hope tofersen appeared first on.

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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.

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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. The drug industry is driven by profits, not by patient’s needs. The drug industry is driven by profits, not by patient’s needs. billion. .” Big pharma is big business.

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European Pharmaceutical Review

JANUARY 17, 2024

Study findings acoramidis was found to reduce the number of patients who were hospitalised due to a heart-related event” Compared with placebo, acoramidis was found to reduce the number of patients who were hospitalised due to a heart-related event. The drug was also shown to lower cardiac congestion.

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Food and Drug Administration FDA Food Competition 78

pharmaphorum

SEPTEMBER 22, 2022

An analysis of 12-month data from the phase 3 VALOR trial of tofersen in patients with a rare form of ALS caused by a faulty SOD1 gene, plus as an open-label extension (OLE) study, has been published in the New England Journal of Medicine, showing the drug was effective in slowing progression of the disease.

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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.

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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. Cimerli’s biosimilar status is appealing to providers and patients alike in the US.

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Rep-Lite

MAY 10, 2024

From groundbreaking advancements in technology to a growing emphasis on patient-centricity, the industry is constantly evolving. In recent years, shifts in healthcare regulations, including updates in FDA guidelines and compliance standards, have significantly impacted sales representatives and healthcare providers alike.

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Pharmaceutical Technology

JUNE 7, 2023

Mounjaro’s approval for obesity, particularly in the US and EU markets, means the drug is entering a significantly large market where it will have direct competition from Novo Nordisk’s Wegovy (semaglutide), which is currently the leading glucagon-like peptide-1 (GLP-1) therapy approved for obesity by both the FDA and EMA.

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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.

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Food and Drug Administration Competition Safety Pharmacology 98

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. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

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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.

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Pharmaceutical Technology

MARCH 6, 2023

Patients in the US and EU with recurrent or metastatic nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell carcinoma (HNSCC), are mostly treated with a combination of chemotherapy agents in the frontline setting, such as cisplatin + gemcitabine. Tuoyi also enjoys an FDA breakthrough therapy designation.

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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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pharmaphorum

JANUARY 29, 2023

On Friday, Novartis said that the phase 3 STAND trial of Adakveo (crizanlizumab) found no statistically significant difference between the drug and placebo on annualised rates of vaso-occlusive crises (VOCs) – the excruciatingly painful attacks that intermittently affect patients with SCD. compared to 2.98 compared to 2.98

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European Pharmaceutical Review

JANUARY 10, 2023

Treatments identified in the report are predicted to be potential blockbuster drugs by 2027 or have potential to serve unmet patient needs for millions of patients worldwide. They have accounted for over 25 percent of Food and Drug Administration (FDA) approvals for the last seven years, the report found.

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European Pharmaceutical Review

NOVEMBER 8, 2022

There are also several pending bills that seek to lower drug costs by means other than price regulations, including: 1) deterring the delay in FDA approval of drug applications caused by sham ‘Citizen Petitions’. Citizen Petitions before the FDA. 562 would permit the FDA to deny the petition if either of these factors were satisfied.

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pharmaphorum

NOVEMBER 24, 2022

Mirati Therapeutics is the subject of takeover speculation in the biopharma sector once again, as it waits for the FDA’s decision on its KRAS inhibitor adagrasib in non-small cell lung cancer (NSCLC). Response rates above 50% in PD-1 high/intermediate patients with no liver tox surprises could set up for a potential acquisition.”

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pharmaphorum

AUGUST 31, 2022

The FDA will carry out a speedy review of Sanofi and Sobi’s once-weekly haemophilia A treatment efanesoctocog alfa (BIVV001), with a decision now expected by 28 February next year. The drug was one of the primary drivers for Sanofi’s $11.6 billion in the first half of this year.

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Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The FDA’s decision on Leqembi was based on data from a Phase II clinical trial named Athena AD. Leqembi is currently pending approval in the EU and Japan.

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pharmaphorum

JANUARY 19, 2023

Deuroxilitinib (formerly CTP-543) – a JAK 1/2 inhibitor – is coming up against drugs in the class from Eli Lilly and Pfizer in the alopecia areata market, so will face heavyweight competition, although Sun reckons it is a “best in class” therapy.

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Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The FDA’s decision on Leqembi was based on data from a Phase II clinical trial named Athena AD. Leqembi is currently pending approval in the EU and Japan.

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pharmaphorum

AUGUST 2, 2022

The trial involved cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who were getting treatment with Tecentriq second-line after earlier platinum-based chemotherapy failed. For patients however, the promise of greater convenience is a bright spot on the horizon.

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Clarivate

JULY 5, 2023

The month of July could see seven FDA-approved adalimumab biosimilars launch in the United States, an unprecedented situation for a market that has been relatively slow to embrace biosimilars. The Biosimilars Forum has hailed 2022 as a watershed year that could create a more competitive U.S. from 91% in 2023 to 36% by 2031.

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pharmaphorum

SEPTEMBER 11, 2022

The US FDA has cleared the first-in-class tyrosine kinase 2 (Tyk2) inhibitor as Sotyktu , and BMS says it now plans to launch the new drug later this month, aiming to mount a challenge to Amgen’s $2.3 billion oral psoriasis therapy Otezla (apremilast).

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Pharmaceutical Technology

OCTOBER 21, 2022

With Susvimo (ranibizumab sustained release) winning US FDA approval last year, followed by an FDA approval for Vabysmo (faricimab) this year, Roche had all the right assets to take the game to the current market leader, Regeneron and Bayer’s Eylea (aflibercept), at an accelerated pace.

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pharmaphorum

DECEMBER 19, 2022

AbbVie has secured its fourth FDA approval for Vraylar, adding adjunctive therapy of major depressive disorder (MDD) to a list that includes schizophrenia and manic and depressive episodes in bipolar disorder. The FDA’s decision comes despite mixed results in clinical trials of the drug as an adjunctive treatment for depression.

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Pharmaceutical Technology

JUNE 19, 2023

The CCR8 antibody SRF114 is currently being evaluated as a monotherapy in a Phase I/II trial in advanced solid tumour patients. Coherus BioSciences intends to launch its anti-PD-1 antibody, toripalimab, to treat nasopharyngeal carcinoma, after receiving approval from the US Food and Drug Administration (FDA).

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