Pharmaceutical Technology

MARCH 24, 2023

Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board. Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year.

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Clarivate

JANUARY 23, 2024

The just-published 2023 Factbook indicates an industry that is becoming more nimble and efficient in its R&D over the long haul. Figure 1: Number of NME launches from 2013 to 2022 Analyses from the 2023 R&D Factbook also indicate that the number of late phase terminations has consistently declined in recent years.

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pharmaphorum

AUGUST 31, 2022

The FDA will carry out a speedy review of Sanofi and Sobi’s once-weekly haemophilia A treatment efanesoctocog alfa (BIVV001), with a decision now expected by 28 February next year. An EU filing for efanesoctocog alfa will follow after the results from the ongoing XTEND-Kids paediatric trial, due in 2023.

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pharmaphorum

NOVEMBER 1, 2022

On the plus side, the Mont Blanc trial of the drug showed that it was as effective in treating the eye disease as prostaglandin analogue latanoprost 0.005%, a standard therapy for glaucoma, which bodes well for NCX 470 to meet the criteria for FDA approval – assuming, of course, a second phase 3 study called Denali is also positive.

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Nixon Gwilt Law

SEPTEMBER 7, 2023

A long and expensive path to market The Food & Drug Administration (“FDA”) clearance process for new medical devices for adults, including Software as a Medical Device (“SaMD”) , already requires extensive time and resources to prove to the FDA that the device in question is safe and effective for patients.

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PM360

DECEMBER 20, 2023

At the close of Q3 2023, the SPDR S&P Biotech ETF (XBI), which tracks small and mid-size biotechs, was down 12% compared to the previous year while the S&P 500, an index tracking the stock performance of 500 of the largest companies in the U.S. and 10X Capital Venture Acquisition Corp.

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pharmaphorum

JANUARY 16, 2023

The present article focuses on opportunity, the unmet need which lies at the heart of better healthcare provision, and two areas of growth and opportunity: Point of Care Diagnostics, and the new pharmacotherapy classes which will commercialise for the first time in 2023.

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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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Contrarian Sales Techniques

DECEMBER 14, 2022

This can lead to significant losses for large companies. Other factors such as the generic competition for older drugs and the pricing pressure are also contributing to the industry's decline. J&J's outlook for the business remains positive, as it continues to expect its pharmaceutical business to grow at a high rate in 2023.

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Nixon Gwilt Law

DECEMBER 16, 2021

Click here to find out how to leverage these new codes in an insightful post by RPM Practice Lead Kaitlyn O’Connor. So much so that we’ve recently welcomed 20-year Food and Drug Law veteran and FDA expert Mark Mansour, Esq., serves as the lead of NGL’s busy RPM Practice. Kaitlyn O’Connor, Esq., Don’t wait!

Healthcare 52

Healthcare Healthcare Food and Drug Administration Ethics 52

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. Competition will drive down consumer prices but drive up insurance costs (especially for employers). But she thinks many investors learned lessons from the past three years.

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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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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. SerpinPC causes the inhibition of coagulation factor XIV, which leads to an increase in thrombin production, speeding up the clot formation process.

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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”.

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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

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

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. billion in 2029.

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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.

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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.

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Pharmaceutical Technology

MARCH 29, 2023

AlgoTx remains on track to start enrolling subjects of a Phase II study of its compound ATX01 for the rare condition erythromelalgia in Q2 2023, says CEO Stéphane Thiroloix. While ice baths may help with pain relief, their repeated use may lead to complications.

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Clarivate

DECEMBER 14, 2023

The weight loss drug conundrum PBMs may rethink their coverage policies for GLP-1 receptor agonists after the November 2023 approval of Eli Lilly’s Zepbound whose active ingredient was already available as diabetes drug Mounjaro ® and which joins Novo Nordisk’s Wegovy ® among the latest class of FDA-approved options.

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