PM360

OCTOBER 13, 2023

HCPs need pharma, and pharma needs HCPs—so let’s make sure that this next chapter of engagement is one of partnership, in pursuit of the interest of patients.” Only 15% of prescribers think the drugs come at reasonable cost to patients or have decent insurance coverage eligibility. Three quarters of U.S.

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Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.

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Pharmaceutical Technology

APRIL 14, 2023

Alvotech has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for AVT02, a biosimilar to Humira (adalimumab). The FDA performed an inspection of the Reykjavik site in March 2022 and found deficiencies there.

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. Repotrectinib is a tyrosine kinase inhibitor (TKI) intended to treat patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

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Nixon Gwilt Law

FEBRUARY 27, 2023

Late Friday (February 24, 2023), the US Drug Enforcement Agency (DEA) released a proposed rule to make permanent some of the flexibilities allowed during the Public Health Emergency (PHE) for telemedicine companies whose providers prescribe controlled substances.

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Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). More than 90% of patients who received treatment with odevixibat were pruritus responders.

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Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has accepted GSK’s supplemental biologics licence application (sBLA) for its Jemperli (dostarlimab) plus chemotherapy for priority review. The regulatory body aims to take a decision on the application by 23 September 2023 under the Prescription Drug User Fee Act.

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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year. Bad news for Biohaven.

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Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics ’ new drug application (NDA) for roflumilast foam 0.3% to treat patients aged nine years and above with seborrheic dermatitis. in patients with seborrheic dermatitis. in patients with seborrheic dermatitis.

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Food and Drug Administration FDA Safety Prescription 52

World of DTC Marketing

MARCH 10, 2022

The cost of Humira, which is injected via syringe, was more than $72,000 a year on prescription drug websites this week and is not expected to come down until at least 2023. AbbVie significantly inflated prices over the past two decades for patients in the U.S. The executives at AbbVie make over $300 million.

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Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

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Pharmaceutical Technology

FEBRUARY 8, 2023

The US Food and Drug Administration (FDA) has accepted Aldeyra Therapeutics’ new drug application (NDA) for topical ocular reproxalap to treat signs and symptoms of dry eye disease. The regulator has assigned 23 November 2023 as the Prescription Drug User Fee Act (PDUFAs) date for its decision.

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Pharmacy Times

AUGUST 18, 2023

Based on results from a trial of repotrectinib in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer, the FDA accepted the New Drug Application and set a Prescription Drug User Fee Act goal date of November 27, 2023.

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Pharmaceutical Technology

JUNE 20, 2023

The US Food and Drug Administration (FDA) has now granted fast-track and rare paediatric disease designations, and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has also granted promising innovative medicine status to vamorolone for DMD.

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MedReps

JANUARY 30, 2023

Medical Sales Trends to Watch Out For in 2023 If you want to know what the future holds and create some forward-thinking sales goals, then check out these medical sales trends to watch out for in 2023. Along with an increase in elderly people, there’s also more healthcare spending taking place. Some are located throughout the world.

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pharmaphorum

NOVEMBER 2, 2022

Lilly’s head of diabetes, Mike Mason, said on the company’s results call that the rollout of Mounjaro (tirzepatide) was “really unprecedented” for a new diabetes therapy in the US, and had been driven by “tremendous patient satisfaction and the visible results that people experience.”

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pharmaphorum

JANUARY 5, 2023

Addiction treatment specialist Spero Health has expanded an agreement to use Pear Therapeutics’ prescription digital therapeutics (DTx) in its network of US clinics. We believe having access to patient-reported data via Pear’s clinician dashboard gives us better insight into patient behaviours.”.

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. Citizen Petitions before the FDA. 2 Submission of a Citizen Petition to the FDA obligates the regulator to address the arguments raised. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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PM360

AUGUST 9, 2022

How can we help ensure patients continue to take their medications as prescribed? The reasons why a patient may not take their medication are plentiful, and as a result so are the solutions now available to attempt to solve this issue. But it is not a simple answer. Furthermore, it is estimated to reach $6.5 Vincent Keunen.

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Pharmaceutical Technology

APRIL 18, 2023

Three regulators in different jurisdictions have accepted Bristol Myers Squibb’s applications for Abecma (idecabtagene vicleucel) for earlier use to treat triple-class exposed relapsed and/or refractory multiple myeloma in adult patients. Abecma treatment showed improvement in progression-free survival and overall response rate.

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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. biologics market and reduce prescription drug costs. biologics market and reduce prescription drug costs.

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Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. In fact, 73% were White, 14% were Asian, 6% were Hispanic, and 5% were African American. However, another study found that 0.1% 2] Figure 1.

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PM360

DECEMBER 20, 2023

market (source: IQVIA MIDAS, May 2023). billion people in 2023). Medicines that are not listed in either Category 1 or 2, such as over the counter (OTC) and other prescription therapies (pembrolizumab, CAR-T therapy, etc.), The GBA gives patients access to innovative drugs (e.g., in the U.S.

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pharmaphorum

JANUARY 9, 2023

This Nine for 2023 three-part series will argue that, this year, the future-facing Janus prediction of unprecedented and transformative change is true. However, the pandemic is only one of the often deep-rooted forces that will come together in 2023 to exert transformative pressure on healthcare.

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pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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Pharmaceutical Technology

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved Braeburn’s Brixadi (buprenorphine) – a subcutaneous extended-release injection available in weekly or monthly treatments. The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US. Buprenorphine is an important treatment option for opioid use disorder.

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MedCity News

JUNE 12, 2023

The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities. Combined, DTx and DCTs improve patient recruitment, retention, and access, allowing researchers to pull from underserved communities, including rural populations.

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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. In contrast, non-prescription digital therapeutics do not need clinical data to enter the market, says Wasden, adding that evidence from observational studies suffices.

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Nixon Gwilt Law

JANUARY 16, 2024

Companies will also need to understand whether the FDA will consider their model to be software as a medical device (SaMD) that is subject to the FD&C Act. What started as a drug to help patients with Type 2 diabetes is now the preferred weight loss aid of many celebrities, influencers, and everyday people.

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Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. RSV poses a particular threat to older and younger patients , and it is the single most common reason for most children being admitted to most US hospitals.

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Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds.

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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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Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

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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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Nixon Gwilt Law

NOVEMBER 5, 2021

The IFR and ETS complement each other, with both aimed at furthering the Biden Administration’s goal of vaccinating the entire United States healthcare workforce to ensure capacity to serve local and national healthcare needs, the safety of the workforce and patients, and to reduce the risk of continued COVID-19 transmission. What’s Next?

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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 spray can be used for diagnostic procedures and conditions where short-term pupil dilation is necessary, such as cataract surgery or corrective prescriptions.

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