Zymewire

FEBRUARY 8, 2024

Over t his period , Axonis has brought together and become world leaders in KCC2 biology , which has further separated us from our competition. To what extent has the prospect of a looming recession influenced your research & development strategy? It was a “Technology in Space” grant put together by the ISS NL , NASA, and Boeing.

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Rep-Lite

NOVEMBER 30, 2023

The Unique Challenges of B2B Medical Sales B2B medical sales come with their own set of challenges, including: Regulatory Compliance: The healthcare industry is highly regulated, and medical sales professionals must navigate complex compliance requirements, such as HIPAA and FDA regulations. We’ll find you high-quality talent quickly.

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Contrarian Sales Techniques

DECEMBER 14, 2022

Other factors such as the generic competition for older drugs and the pricing pressure are also contributing to the industry's decline. Bright Prospects Indicates by Zacks Industry Rank The large-cap pharmaceutical industry, which is a part of the Medical sector, has a favorable Industry rank of A.

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Evolve Your Success

APRIL 11, 2023

We have launched into the US marketplace and got the product design through FDA. My company standpoint is, “Online is the new prospecting tool.” Online is the new prospecting tool. I’ve got an FDA issue.” It’s very competitive. We are launching it here in the US. I embrace it too.

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Clarivate

OCTOBER 7, 2021

Based on the KEYNOTE-716 data, it is anticipated that Keytruda will gain a label expansion in this patient setting, with FDA priority review status and a PDUFA date set for December 2021. This novel antibody-drug conjugate (ADC)ADC faces much competition, should it be approved. Abstract LBA52. Abstract 944P.

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Pharmaceutical Technology

APRIL 20, 2023

This is one of several patent infringement cases Amgen has pursued in recent years to stave competition. Despite this legal win, Amgen still faces a competitive psoriasis market as other drugs enter the landscape. The FDA first approved Otezla in March 2014 for the treatment of psoriatic arthritis. Patent No.

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Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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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). GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry.

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Pharmaceutical Technology

MAY 12, 2023

As the next step in the FDA’s efforts to reduce prescription drug deaths , the agency is requiring updates to the boxed warning and other information for attention deficit hyperactivity disorder (ADHD) prescription stimulants. Prescription stimulants are used to treat ADHD, narcolepsy, and binge-eating disorder.

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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. While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date.

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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).

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Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. In its 2022 annual report on generics, the US FDA stated it had approved 106 first generics, which it claimed would offer significant cost savings for patients. from 2001 to 2022.”

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The guidance also touched upon clinical trial design elements that must be explained, described, or rationalised to the FDA.

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Pharmaceutical Technology

MAY 11, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. The FDA has no obligations to follow the recommendation of AdComs, though the vote will likely be weighed in the agency’s final decision.

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

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Pharmaceutical Technology

MAY 4, 2023

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. These recommendations and the FDA approval were based on positive AReSVi-006 Phase III trial data.

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Pharmaceutical Technology

JUNE 21, 2023

This is the first time the FDA has approved an oral diabetes drug for paediatric patients since its approval of metformin in 2000. The FDA first approved Jardiance to help control blood sugar in adults with T2D in 2014. The drugs are approved for use along with changes in diet and exercise.

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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. The FDA’s fast track designation is designed to speed up the regulatory process to allow faster drug development and review to fill unmet needs.

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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. The gene therapy consists of a gene coding for micro-dystrophin carried through a recombinant adeno-associated virus vector.

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Pharmaceutical Technology

MARCH 6, 2023

Currently, most drugs being investigated for their healthy aging or anti-aging properties are being repurposed from readily accessible FDA-approved drugs. Barzilai hopes that the well-established profile of the drug may allow the FDA to accept the trial more easily and then other aging-related studies can follow.

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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. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.

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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. The FDA approved Biogen’s Aduhelm (aducanumab) for treating Alzheimer’s disease in June 2021.

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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. The FDA approved Biogen’s Aduhelm (aducanumab) for treating Alzheimer’s disease in June 2021.

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Pharmaceutical Technology

JUNE 2, 2023

Before that, the US Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee will debate Leqembi’s traditional approval on 9 June, based on results from the Phase III Clarity AD study (NCT03887455). Clinical investigators commonly use registries to gather information on patient outcomes.

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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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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

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. We have worked hard to make Daybue available as quickly as possible following FDA approval.”

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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). However, the French company will not be required to run a further efficacy study.

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Pharmaceutical Technology

MAY 2, 2023

Memo Therapeutics has announced that the FDA has awarded a fast track designation for its BK polyomavirus (BKV) drug AntiBKV (MTX-005). This FDA decision was based on data from the Phase I Safe Kidney I clinical study (NCT05358106). Memo expects to potentially launch AntiBKV in 2025.

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Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Several CRISPR-based gene therapies are in development , with one for sickle cell disease and transfusion-dependent beta thalassemia (TDT), being examined by the FDA for an approval.

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Pharmaceutical Technology

MAY 31, 2023

Following a rocky and somewhat controversial road to securing a US Food and Drug Administration (FDA) approval, Amylyx’s amyotrophic lateral sclerosis (ALS) drug is likely to hit another regulatory snag in Europe. However, the FDA prefers a joint-assessment of both function and survival that requires time-consuming data collection.

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Pharmaceutical Technology

JANUARY 6, 2023

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

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Pharmaceutical Technology

JUNE 16, 2023

In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum.

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Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. Data from the analyses will be used for a potential end-of-Phase II study meeting with the FDA.

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Pharmaceutical Technology

APRIL 17, 2023

In December 2021, the US Food and Drug Administration (FDA) approved argenx’s Vyvgart for the treatment of myasthenia gravis in December 2021, marking the company’s first approval. Vyvgart is also the first FDA-approved neonatal Fc receptor (FcRN) antagonist.

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Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. The ABPI points to the FDA in the US as an example. The FDA’s Modernization Act 2.0 In 2021, they accounted for 0.2%

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Pharmaceutical Technology

MARCH 22, 2023

In December 2022, the US passed its ‘ominous spending bill’ directing the US Food and Drug Administration (US FDA) to establish an advanced manufacturing Centre for excellence and an advanced manufacturing technologies designation programme. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry.

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