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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PM360

SEPTEMBER 21, 2023

Jeff Casberg, MS, RPh, Senior Vice President of Clinical Pharmacy at IPD Analytics, a managed care and pharmaceutical consultancy, highlighted a wide range of 2023 key events that will affect managed care professionals by the end of the year. This product is expected to have three generic launches in 2023.

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PM360

OCTOBER 13, 2023

Of the eight FDA-approved weight loss drugs on the market, these two are making waves for doctors who believe they represent “a new era for weight loss medications,” and “changing options and giving hope.” Arcutis received FDA approval for its Zoryve (roflumilast) cream 0.3% Three quarters of U.S.

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Pharmacy Times

DECEMBER 21, 2022

The FDA granted Priority Review to both applications and set a Prescription Drug User Fee Act goal date for each application of April 21, 2023.

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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

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

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

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. The FDA has assigned a prescription drug user fee act action date of 27 November 2023 for the NDA.

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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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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). The therapy is being offered immediately through prescription for eligible ALGS patients.

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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. The drug was also filed for approval in Europe in February, with a decision due in early 2023.

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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. Now let’s get to it.

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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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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% The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target action date for the decision on the application. in patients with seborrheic dermatitis.

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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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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 filed 55% of Imbruvica’s patent applications after FDA approval, the report said”. The executives at AbbVie make over $300 million.

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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.

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Pharmacy Times

MAY 23, 2023

The FDA’s final decision is expected by a Prescription Drug User Fee Act goal date in August 2023.

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pharmaphorum

AUGUST 31, 2022

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. ” The post Futura eyes FDA filing as topical ED drug passes phase 3 test appeared first on.

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pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic. Now at $6.79

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Pharmaceutical Technology

MAY 16, 2023

In January 2023, the US Food and Drug Administration (FDA) approved lecanemab under the accelerated approval pathway to treat AD. Eisai stated that the Clarity AD study met its primary endpoint as well as all its important secondary endpoints with highly statistically significant results.

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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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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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pharmaphorum

NOVEMBER 2, 2022

” Mounjaro was approved by the FDA in May, becoming the first combined GLP-1/GIP agonist to reach the market, but has also benefitted from supply constraints from Novo Nordisk’s GLP-1 agonist Ozempic (semaglutide), a key competitor.

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European Pharmaceutical Review

DECEMBER 6, 2022

Tofersen is under priority review with the US Food and Drug Administration (FDA) and has a Prescription Drug User Fee Act action date of 25 April 2023. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc. under a collaborative development and license agreement.

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Pharmaceutical Technology

APRIL 18, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics licence application for Abecma. The regulator has set 16 December 2023 as the prescription drug user fee act date, which is the deadline for the review of new drugs.

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European Pharmaceutical Review

APRIL 13, 2023

Psychedelic research: evaluating the fast-evolving regulatory roadmap Psychedelics: the position in Europe The EMA’s recent letter confirms that as of 17 February 2023 in the EU, 6 there were: 11 ongoing clinical trials in EU with psilocybin for a range of central nervous system conditions four ongoing trials with MDMA one trial with LSD.

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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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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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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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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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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. To advance equity in clinical research, the U.S. In fact, 73% were White, 14% were Asian, 6% were Hispanic, and 5% were African American.

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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. I love this conference!”

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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

Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & Drug Administration (FDA) clearance, and provided solid clinical study evidence. Photo: Bulat Silvia, Getty Images

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