MedCity News

FEBRUARY 23, 2023

FDA approval of Sanofi hemophilia A drug Altuviiio provides patients with a therapeutic option that lasts longer than most other products available, including one already marketed by the French pharma giant. Altuviiio also gives Sanofi a way to better compete against blockbuster Roche drug Hemlibra.

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MedCity News

DECEMBER 13, 2022

Amgen’s Lumakras became the first FDA-approved drug that addresses the elusive KRAS mutation, but Mirati believes its newly approved therapy, Krazati, could be better. The small molecule’s features include the ability to penetrate into the brain, where it can address cancer that has spread to the central nervous system.

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MedCity News

AUGUST 12, 2024

FDA approval of Ascendis Pharma’s Yorvipath is just in time for patients with hypoparathyroidism as Takeda Pharmaceutical will soon stop making the only drug therapy for the rare disorder. But competition could come from others, including an AstraZeneca peptide in late-stage development.

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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

JULY 30, 2024

Shield could also face new competition from other liquid biopsy companies. The post With FDA Nod for Colorectal Cancer Screening, How Much Market Share Can Guardant’s Blood Test Get? appeared first on MedCity News.

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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

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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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

JULY 22, 2024

Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year.

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European Pharmaceutical Review

AUGUST 21, 2023

Q2 2023 biopharma market capitalisation results Eli Lilly “Eli Lilly witnessed the largest market capitalisation growth of 36.1 Lilly completes biopharma acquisitions GlobalData highlighted that Eli Lilly reported its synthetic peptide Mounjaro had $980 million in global sales in Q2. trillion in the Q1 of 2023 to $3.56

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European Pharmaceutical Review

DECEMBER 6, 2022

According to a market report by GlobalData, expanding generic drug competition and a drop in demand for COVID-19 vaccines and therapies have lowered the aggregate market capitalisation of the global top 20 biopharmaceutical companies by 9.1 percent from $3.45 trillion in Q2 2022 to $3.14 trillion in Q3 2022. percent and 24.2 percent and 24.2

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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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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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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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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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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

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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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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Pharmaceutical Representative Training

JANUARY 29, 2025

These high prices are the result of multiple factors: theyre derived from living organisms making them sensitive and complex for both manufacturers and patients, research requires advanced technology to test for safety and effectiveness, and theyre in high demand without much competition. The Cost-Saving Alternative: What are Biosimilars?

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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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PM360

JANUARY 24, 2025

Compliant: Validated to comply with FDA regulations. Based on this, the AI assistant could also suggest next steps, like sharing clinical evidence aligned with Dr. Smiths patients, a comparative study related to competitive products Dr. Smith has prescribed, or follow-up material to a webinar Dr. Smith attended.

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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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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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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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MedCity News

MARCH 21, 2025

Amvuttra, an Alnylam drug approved to treat nerve pain from transthyretin amyloidosis, is now FDA-approved for treating cardiomyopathy caused by this disease. The post Alnylam Drug Approval Brings Cardiomyopathy Competition to Pfizer, BridgeBio Pharma appeared first on MedCity News.

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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

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

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

AUGUST 20, 2024

drugs more recently approved by the FDA, those with an orphan drug designation for a single indication, or those facing current or looming biosimilar threat) can escape negotiations. In highly competitive categories like diabetes, net price could be half of the list price.

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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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Clarivate

OCTOBER 17, 2024

As California Attorney General from 2011 to 2017, Harris was a forceful opponent of healthcare industry consolidation, both vertical and horizontal, believing that mergers of hospitals, physician groups and insurers would damage competition and raise prices for care.

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