MedCity News

MAY 10, 2023

A drug developed by Protalix BioTherapeutics and Chiesi Group is now FDA approved for treating Fabry disease, a rare inherited metabolic disorder. The drug, Elfabrio, is an enzyme replacement therapy.

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MedCity News

JUNE 26, 2023

Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.

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MedCity News

JANUARY 23, 2023

The FDA approved TheracosBio’s Brenzavvy as a treatment for type 2 diabetes. But before it won a regulatory nod for controlling blood glucose in adults, it was approved at a different dose (with flavor) as a veterinary product.

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MedCity News

AUGUST 3, 2022

Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help the much larger group of patients suffering heart problems from the rare protein disease.

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Pharmaceutical Technology

DECEMBER 20, 2022

The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. The FDA also awarded priority review for Eli Lilly’s donanemab, a monoclonal antibody for Alzheimer’s disease, in August 2022, and the company expects approval by February 2023. trillion in Q2 2022 to $3.14

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pharmaphorum

NOVEMBER 24, 2022

Mirati Therapeutics is the subject of takeover speculation in the biopharma sector once again, as it waits for the FDA’s decision on its KRAS inhibitor adagrasib in non-small cell lung cancer (NSCLC).

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Pharmaceutical Technology

FEBRUARY 8, 2023

The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 Roche’s market capitalization fell with a decline in sales of their Regeneron-partnered COVID-19 therapy, Ronapreve, and increasing competition from biosimilars for their oncology drugs Avastin, Herceptin, and Rituxan. to $365.84.

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pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

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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. The Biosimilars Forum has hailed 2022 as a watershed year that could create a more competitive U.S. from 91% in 2023 to 36% by 2031.

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pharmaphorum

DECEMBER 28, 2022

M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009.

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Zymewire

FEBRUARY 8, 2024

Skip to a topic Axonis' journey and purpose The impact of the economic client on emerging biopharma The place of Artificial Intelligence in drug development & discovery Working with NASA Relationships with CROs, CDMOs, and other service providers What made you want to start Axonis? sending neurons to space.

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Clarivate

JANUARY 23, 2024

While some industry observers read this drop as a clear decline in productivity, others take a more optimistic view, attributing the decline to FDA submission calendar fluctuations and noting that 2022 numbers were not very different from the ten-year average. In fact, the number of NMEs has grown by 65% between 2013 and 2022.

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Pharmaceutical Technology

DECEMBER 20, 2022

A regulatory success story from the SA25 user group came when one participating company achieved an industry first — the FDA approved commercial production of their biologic drug without requiring routine viable EM, but rather requiring viable EM only during process simulations. You wouldn’t talk to competitive companies.

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Clarivate

OCTOBER 19, 2023

the FDA offers a period of 3 years of data exclusivity for a new application of a previously approved drug. “However, drug repurposing faces multiple challenges in the regulatory area,” points out Martí Bernardo-Faura, Senior Bioinformatics Consultant at DTS Consulting Services in Clarivate. For example, in the U.S.,

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Clarivate

OCTOBER 10, 2022

Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Fruquintinib will face fierce competition should it be approved in the third- and later-line setting.

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Clarivate

MAY 24, 2023

A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market.

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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.

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Pharmaceutical Technology

MARCH 21, 2023

FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. Regulatory decisions by the FDA and EMA for select therapies from late January to late February and the CMOs contracted to manufacture the therapies.

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Pharmaceutical Technology

JANUARY 15, 2023

FDA expands approval labels. The FDA passed several positive supplementary approval decisions involving younger patients. Baxter Biopharma Solutions, Fareva SA, BSP Pharmaceuticals SpA, and Takeda Pharmaceuticals are manufacturing the parenteral portion of the ADC. Source: GlobalData Pharmaceutical Intelligence Center.

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Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study.

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Pharmaceutical Technology

FEBRUARY 27, 2023

Baxter Biopharma Solutions has been contracted for the ADC’s parenteral manufacture and packaging. FDA decisions In December 2022, the FDA expanded the label for Novo Nordisk’s Wegovy (semaglutide), to include its use as an anti-obesity drug in adolescents with an initial body mass index over a certain threshold.

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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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