Medico Reach

MARCH 24, 2023

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. Even for cancers that are difficult to treat, new treatments and technologies improve patient survival rates. To address the shortcomings of existing treatments, routine utilization of patient data becomes crucial. billion by 2028.

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Medico Reach

MARCH 24, 2023

The American Cancer Society estimates 1,958,310 new cases of cancer in the United States in 2023. Even for cancers that are difficult to treat, new treatments and technologies improve patient survival rates. To address the shortcomings of existing treatments, routine utilization of patient data becomes crucial. billion by 2028.

Marketing 52

Marketing Medicine Healthcare Healthcare 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.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. More therapies to meet unmet needs GlobalData predicts that at least 35 US regulatory decisions on drugs for rare diseases are on the horizon for 2023. GlobalData is the parent company of Pharmaceutical Technology.

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PM360

SEPTEMBER 21, 2023

The recent wave of Alzheimer’s Disease (AD) drug approvals and promising pivotal trial data from various drug manufacturers has been celebrated by physicians, patients, caregivers, and advocacy groups across the U.S. When used in CMS-approved prospective comparative studies, the data for which may be collected in a registry.

Manufacturing 99

Manufacturing FDA Recruitment Prospecting 99

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. .

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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., LamaMed is based in Hayward, California.

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FDA Safety Recruitment Prospecting 52

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). Ferring plans to begin Adstiladrin production in the H2 2023, as part of an initial rollout in the US.

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Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Indeed, Amgen’s biosimilar was approved in September 2016, but the company was not able to launch it until January 2023 in the US. At the same time, Cross says that this is not up to clinicians or the patients, but the payers.

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Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. ” This latest FDA clearance for the EyeArt v2.2.0 sensitivity and 91.1%

FDA 52

FDA Food and Drug Administration Recruitment Marketing 52

pharmaphorum

AUGUST 1, 2022

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023.

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FDA Safety Patients Doctors 93

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

FDA 52

FDA Food and Drug Administration Patients Prospecting 52

pharmaphorum

DECEMBER 16, 2022

The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

Medicine 105

Medicine Prospecting Networking Marketing 105

Pharmaceutical Technology

MAY 22, 2023

Intercept Pharmaceuticals faced a setback after a US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) meeting on the prospective use of its drug Ocaliva in pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) did not go in its favour.

Medicine 59

Medicine FDA Prospecting Food 59

European Pharmaceutical Review

DECEMBER 28, 2023

Finally, Andreas looks at the prospects for antibodies that target the innate immune system in treating both haematological malignancies and solid tumours. Following their introduction, these therapies have moved to early lines of treatment, but unfortunately, a significant number of patients are not cured with these approaches.

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Food and Drug Administration Patients Safety Medical science 84

Pharmaceutical Technology

MARCH 21, 2023

FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. Regulatory decisions by the FDA and EMA for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.

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Manufacturing Pharmaceutical Biopharma FDA 59

European Pharmaceutical Review

JUNE 27, 2023

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023.

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Food and Drug Administration Manufacturing Medicine Pharma 95

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. However, patients require regular treatments to manage the condition. However, patients require regular treatments to manage the condition.

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FDA Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

MAY 15, 2023

If approved, the therapy could become the first FDA-approved gene transfer therapy for the condition. The FDA will assess the drug’s approval before its Prescription Drug User Fee Act (PDUFA) date on 29 May 2023. She said, “I wish the data were more persuasive”. Free Report How is the Biopharmaceutical industry evolving?

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FDA Food and Drug Administration Prescription Prospecting 52

Pharmaceutical Technology

MAY 9, 2023

After the FDA rejected an accelerated approval bid in January, Eli Lilly has returned with topline data proving that donanemab may be an effective alternative to Eisai’s Leqembi (lecanemab) in treating Alzheimer’s disease. On May 3, Eli Lilly announced that donanemab slowed Alzheimer’s progression by 35% in patients compared to placebo.

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FDA Prospecting Patients Marketing 52

Pharmaceutical Technology

MAY 9, 2023

After the FDA rejected an accelerated approval bid in January, Eli Lilly has returned with topline data proving that donanemab may be an effective alternative to Eisai’s Leqembi (lecanemab) in treating Alzheimer’s disease. On May 3, Eli Lilly announced that donanemab slowed Alzheimer’s progression by 35% in patients compared to placebo.

FDA 52

FDA Prospecting Patients Marketing 52

pharmaphorum

NOVEMBER 21, 2022

With top-line results from the KALAHARI trial not due until the second half of 2023 – and cash reserves dwindling – the Belgian biotech hopes to look at the data after at least 25% of patients in the phase 2b portion of the study is completed. That dose – three monthly injections into the eye of 0.13 mg THR-149 – achieved a 6.1-point

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Prospecting Competition Patients FDA 57

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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Pharma Food and Drug Administration Manufacturing Medicine 122

Pharmaceutical Technology

MAY 9, 2023

New York-based Eyenovia has announced an FDA approval for Mydcombi (tropicamide and phenylephrine hydrochloride), the first ophthalmic spray for mydriasis or pupil dilation. The company will provide further updates on Mydcombi and its ongoing development programs and partnerships during its scheduled Q1 2023 update conference call on May 11.

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FDA Prescription Prospecting Medical 52

pharmaphorum

JANUARY 29, 2023

One of the Johnson & Johnson’s top clinical trial readouts for 2023 just generated results, which bode very well for the future prospects of multiple myeloma CAR-T Carvykti.

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Sales Prospecting Patients Manufacturing 62

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. More recently, the FDA granted approval of Roctavian in June 2023.

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Pharmaceutical Technology

APRIL 19, 2023

The company is in discussions with industry experts and the National Institutes of Health (NIH) about the prospects of moving into Parkinson’s disease, said Kelleher-Andersson. The potential Phase II trial in Parkinson’s disease will recruit between 75 and 100 patients, said Kelleher-Andersson.

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Food and Drug Administration Recruitment Prospecting Food 52

Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.

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Food and Drug Administration FDA Patients Prospecting 97

Pharmaceutical Technology

MAY 9, 2023

Revenue prospects for Novo Nordisk’s blockbuster diabetes and weight-loss drug semaglutide in Brazil have been dealt a major blow after a federal court denied a request by the Danish firm for two patent extensions. The average patient lost 15.7% of body weight over the course of the trial, surpassing the 9.6%

Marketing 59

Marketing Manufacturing Prospecting Physicians 59

Pharmaceutical Technology

JUNE 2, 2023

While Leqembi was awarded an accelerated approval in January 2023, a decision on a traditional approval is expected by 6 July. The FDA will then consider the results of the committee for an approval decision in the following weeks. Clinical investigators commonly use registries to gather information on patient outcomes.

Food and Drug Administration 52

Food and Drug Administration FDA Prospecting Food 52

pharmaphorum

NOVEMBER 16, 2022

Having presented the data from the 24-month phase 3 trial at the American Academy of Ophthalmology (AAO) annual meeting, Dr Wykoff set aside some time to go into further detail with pharmaphorum about how the results were received, and what glimmer of hope this might hold for patients with GA. Bleak prospects, indeed.

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Safety Patients Consulting Prospecting 91

Pharmaceutical Technology

MARCH 17, 2023

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. But while appealing, the prospects of developing a merged approach that combines both digital and pharmacological therapeutics remain challenging.

Prescription 111

Prescription Pharmacology Pharma Medical 111

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). In March 2023, the company announced the screening of the trial’s first patient.

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Food and Drug Administration FDA Safety Prospecting 52

Pharmaceutical Technology

FEBRUARY 6, 2023

In the midst of tough predictions for 2023 due to inflation and a difficult funding environment, Pliant Therapeutics closed an oversubscribed $287.5 Leading up to 2023, experts have said a company’s financial wellbeing may depend on its economic position when the market shifted. The FDA approved both drugs in 2014.

Marketing 59

Marketing Pharmaceutical FDA Prospecting 59

Legacy MEDSearch

JUNE 16, 2023

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

Food and Drug Administration 52

Food and Drug Administration Recruitment Safety Medical 52

Pharmaceutical Technology

APRIL 18, 2023

This news follows the treatment’s FDA approval on 10 March, making it the first-approved Rett Syndrome treatment in the US. The FDA approved the drug based on positive Phase III data from the Lavender trial. The FDA approved the drug based on positive Phase III data from the Lavender trial.

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FDA Pharmaceutical Prospecting Patients 102

Pharmaceutical Technology

JANUARY 15, 2023

In the first 2023 edition of the CMO Moves monthly series , Pharmaceutical Technology explores recent news stories on regulatory and reimbursement decisions in different countries, and the companies linked to their success and failures. FDA expands approval labels. Source: GlobalData Pharmaceutical Intelligence Center.

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