Pharmaceutical Technology

JUNE 19, 2023

The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. The reason for this review extension was undisclosed in the announcement. In July 2022, GSK acquired the therapy as part of its $1.9bn acquisition of Sierra Oncology.

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European Pharmaceutical Review

JANUARY 5, 2023

Triomphe added: “… it is our intention to make nirsevimab available, if approved in time, for the 2023/2024 season to help alleviate the burden of RSV on families and the healthcare system.”. The safety profile of nirsevimab was similar to placebo. MELODY clinical trials evaluating nirsevimab.

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European Pharmaceutical Review

OCTOBER 17, 2024

However, reports and surveys say that only half of people with an epinephrine needle-injector prescription consistently carry their device, 4 and for patients and caregivers who do carry a needle-injector, more than half either delay or do not administer it in an emergency. Derived from IQVIA Claims Data, 2023. 2023; 152(6):1587-1596.

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Pharmaceutical Technology

MAY 31, 2023

The Phase I/II study assessed the pharmacokinetics, tolerability, safety and anti-tumour activity of repotrectinib in patients with advanced NSCLC. Phase I of the trial has a number of primary and secondary safety and pharmacokinetics endpoints. is the primary endpoint of the Phase II study. “We

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Pharmaceutical Technology

APRIL 19, 2023

The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target action date for the decision on the application. Roflumilast foam had a favourable safety profile and was also found to be well-tolerated. to treat patients aged nine years and above with seborrheic dermatitis.

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Pharmaceutical Technology

JUNE 14, 2023

The placebo-controlled, double-blind, randomised trial assessed the efficacy and safety of Bylvay 120µg/kg/day given for 24 weeks to relieve pruritus in patients with ALGS from 32 sites across the Middle East, Europe, North America and the Asia Pacific. The therapy is being offered immediately through prescription for eligible ALGS patients.

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Pharmaceutical Technology

JANUARY 6, 2023

The regulatory body has assigned a Prescription Drug User Fee Act (PDUFA) date for its decision in the third quarter of this year. If approved, nirsevimab will become the first single-dose preventative against RSV lower respiratory tract disease for the 2023/2024 RSV season in the US. Nirsevimab showed a 74.5%

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Pharmaceutical Technology

FEBRUARY 8, 2023

The regulator has assigned 23 November 2023 as the Prescription Drug User Fee Act (PDUFAs) date for its decision. Aldeyra stated that the investigational drug candidate had been studied in over 2,000 patients, and no clinically significant safety concerns were observed.

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European Pharmaceutical Review

DECEMBER 6, 2022

“Through our clinical development programme, we have seen that tofersen has the potential to slow the progression of this relentless and ultimately fatal disease,” commented Priya Singhal, Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc.

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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. million in the third quarter, with predictions that it will make between $14 million and $16 million from its prescription DTx range for the full year.

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World of DTC Marketing

MAY 19, 2021

According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S. 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.

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Pharmaceutical Technology

JUNE 1, 2023

For context, in January 2023, the FDA accepted Intercept’s resubmission of its NDA for OCA as a Class 2 resubmission (which has a six-month review period in NASH) and set a Prescription Drug User Fee Act (PDUFA) date of 22 June 2023. risk reduction compared with placebo).

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Clarivate

OCTOBER 25, 2023

While more expensive than type 2 diabetes drugs, blood thinners follow a similar pattern of high prescription volumes. Humira, the long-running blockbuster autoimmune drug, was not eligible for negotiations since it will have nine biosimilars on the market by the end of 2023. With 27.5%

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PM360

AUGUST 9, 2022

The combined solution enables health plans and self-insured employers to realize immediate pharmacy cost savings and near-term medical cost reductions by integrating Levrx’s plan-specific and real-time prescription insights into the Adhere Platform medication optimization offerings. The Andaman7 Platform Solution. Vincent Keunen.

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PM360

JULY 13, 2023

Launched in April 2023, BrightInsight’s PSP+ Companion App, built on the compliant BrightInsight Platform, connects patients to the resources they need to complete prior authorization, register for financial assistance, understand and track their therapies, and much more. But outdated manual processes are complex and leave many patients out.

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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. 1435 (“Affordable Prescriptions for Patients Act of 2021”), [link] gov/bill/117th-congress/senate-bill/1435/text; H.R. Actavis, 570 U.S. 136 (2013), [link] opinions/12pdf/12-416_m5n0.pdf.

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Clarivate

MAY 13, 2024

following the end of the COVID-19 public health emergency, which lapsed in May 2023. Many insurers use similar networks for Medicaid and exchange plans, so shifting to an exchange plan is less likely to cause a lapse in coverage or abandonment of prescription drugs or maintenance medications that control chronic conditions. to about 2.5

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pharmaphorum

SEPTEMBER 30, 2022

” However, it added that the limited efficacy of the two approved therapies for ALS – Radicava and oral riluzole – plus the apparent safety of Relyvrio means that “this level of uncertainty is acceptable in this instance and consideration of these results in the context of regulatory flexibility is appropriate.”

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pharmaphorum

OCTOBER 27, 2022

Additionally, SeresTx’s BLA has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) target date of 26 th April 2023. The BLA is supported by results from a completed phase 3 development programme, including ECOSPOR III (NCT03183128) and ECOSPOR IV (NCT03183141).

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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.), in the top five European Union markets and 7.1% in the U.S.

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pharmaphorum

AUGUST 17, 2022

GSK – which originally developed the drug in the early 1980s and sold it as a prescription and over-the-counter (OTC) product for indications like heartburn and acid indigestion – has been named as a defendant in approximately 3,000 filed personal injury cases in federal and state court.

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Clarify Health

MARCH 1, 2023

There was a significant decrease in pills per prescription both for peer comparison feedback and for the combination of peer comparison and individual audit feedback. pills per prescription than non-discordant clinicians. 2023), A Site-of-Service Intervention to Change Physician Behavior and Generate Net Savings.

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PM360

OCTOBER 13, 2023

Casey Cronin Life sciences marketers have a unique opportunity to connect with target audiences on an individual level and foster brand safety through AI advancement. Edith Hodkinson Our industry is well versed in how to use insights rooted in clinical behavior data—prescriptions, diagnoses, lab results, etc.—to

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Referral MD

JULY 5, 2022

With its array of benefits and growing popularity, the Global Electronic Health Records (EHR) Market is expected to reach $33,294 million by 2023. Needless to explain, patient safety is indirectly improved by digital records. It helps take a load off the administration department and better track appointments and prescriptions.

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Clarivate

MAY 11, 2023

Mainland China has streamlined regulatory protocols for testing and approving prescription drugs in recent years, making dozens of urgently needed treatments, from domestic and international manufacturers alike, available to patients in the process. CDE also released guidelines on Clinical trial requirements for overseas drugs.

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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. I love this conference!”

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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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Nixon Gwilt Law

NOVEMBER 5, 2021

Overview The Centers for Medicare and Medicaid Services (CMS) issued its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (IFR) on November 4, 2021, the same day the Department of Labor’s Occupational Safety and Health Administration (OSHA) issued its COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS).

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Pharmaceutical Technology

MAY 4, 2023

The approval comes after an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted in support of Arexvy’s effectiveness and safety. Furthermore, in April 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion in support of the vaccine’s approval.

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Pharmaceutical Technology

MAY 1, 2023

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased. Even in LICs, they do yearly checks or catch up campaigns.

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