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GlobalData

Pharma

BMS mezigdomide and iberdomide poised to transform multiple myeloma treatment landscape, predicts GlobalData

The latest results from a Phase II study highlight the potential of an all-oral combination therapy, featuring Bristol Myers Squibb’s (BMS) cereblon E3 ubiquitin ligase modulator (CELMoD) mezigdomide and dexamethasone in treating patients with triple-class-refractory multiple myeloma (MM). Consequently, the sales of mezigdomide and iberdomide are expected to increase significantly, amid the shifting dynamics within […]
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Crohn’s disease treatment market sees major shift with emergence of biosimilars and next-gen therapies, says GlobalData

There is a transformative shift taking place in the Crohn’s disease (CD) treatment market, challenging AbbVie’s Humira’s long-standing dominance. Adalimumab biosimilars are reshaping the landscape, impacting Humira and competitors like Janssen’s Stelara and Takeda’s Entyvio. With a focus on biologic-exposed CD patients, novel therapies for TNF-refractory individuals are gaining prominence. Advancements in biologics and oral […]
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Humira biosimilar to see $832mn in sales by 2029, forecasts GlobalData

Samsung Bioepis and Organon recently announced positive topline results from a Phase IV clinical trial of SB5, a biosimilar to the reference tumor necrosis factor (TNF) blocker Humira (adalimumab), in patients with moderate-to-severe chronic plaque psoriasis (PsO). The study met its primary endpoint of comparable pharmacokinetic profiles between SB5 and Humira, and showed comparable efficacy, […]
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Commercial impact for some of first drugs released for Medicare price negotiation to be minimal, says GlobalData

The Biden Administration has released its highly anticipated list of 10 drugs selected for Medicare drug price negotiation under the Inflation Reduction Act. The list contains several drugs that may face generic/biosimilar competition before, or very soon after, the negotiated prices start. Therefore, the commercial impact could likely be minimal for some of the drugs, […]
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J&J’s Akeega FDA approval to heat up PARP battle with dual-action treatment for prostate cancer, says GlobalData

The FDA recently granted approval for Johnson & Johnson’s (J&J) Akeega, a novel first-in-class combination tablet treatment for adults with breast cancer gene (BRCA)-positive, metastatic castration-resistant prostate cancer (mCRPC). Akeega’s current predicted sales will experience only a slight increase as a result of its narrow label and fierce competition with other recently approved poly(ADP-ribose) polymerase […]
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Opportunity for first indigenous South Korea SGLT-2 and metformin combination therapy to go global, says GlobalData

Daewoong Pharmaceutical recently obtained approvals for its indigenous therapies—sodium–glucose linked transporter-2 (SGLT-2) inhibitor Envlo (enavogliflozin) and its metformin combination drug Envlomet—in South Korea. As prescription trends tilt in favor of SGLT-2 combination therapies globally, the domestic innovator has an opportunity to compete with the established SGLT-2 combination therapies from multinational companies, says GlobalData, a leading […]
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National Immunization Awareness Month provides opportunities to increase influenza vaccination rates, says GlobalData

August is observed as National Immunization Awareness Month (NIAM) in the US to highlight the importance of vaccines in preventing serious illness, complications, and death from infectious diseases. The intention is to educate individuals on the importance of staying up-to-date with routine vaccinations*. During the 2022-2023 influenza season, vaccination was responsible for averting 36.25% of […]
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Prospects to win concessions on EU pharmaceutical legislation overhaul strengthened, says GlobalData

The potential for German Chancellor Olaf Scholz’s government to secure pro-pharmaceutical industry concessions related to the proposed overhaul of EU pharmaceutical legislation may have received a significant boost. A recent report from the German Federal Ministry of Health has raised substantial concerns regarding critical elements of the reform strategy, further underscoring the need for careful […]
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More pricing pain for pharma as new legislation expands scope of Inflation Reduction Act, says GlobalData

The global pharma industry is bracing itself for more headaches in its most profitable market as US House Democratic health leaders introduce new legislation, which would expand the Inflation Reduction Act and further lower prescription drug prices. House Democrats Frank Pallone Jr., Richard Neal, and Robert Scott unveiled the Lowering Drug Costs for American Families […]
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Shanghai Junshi renal cell carcinoma drug toripalimab to get first-mover advantage in China PD-1 market, says GlobalData

Shanghai Junshi Biosciences supplemental new drug application (sNDA) for toripalimab, the company’s anti-PD-1 monoclonal antibody, in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (RCC), has been accepted by the National Medical Products Administration (NMPA). Following the approval, the drug is expected to get a first-mover advantage […]
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Zurzuvae provides breakthrough for postpartum depression but misses out on larger MDD patient population, says GlobalData

Following the news that the FDA granted approval for Sage Therapeutics and Biogen’s novel antidepressant Zurzuvae (zuranolone) for the treatment of postpartum depression (PPD) but rejected the drug for the treatment of major depressive disorder (MDD), issuing a complete response letter (CRL); Philippa Salter, Senior Neurology Analyst at GlobalData, offers her view: “Zurzuvae is a […]
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NASH market holds enormous untapped potential, says GlobalData

The prevalence of nonalcoholic steatohepatitis (NASH), a more advanced stage of nonalcoholic fatty liver disease (NAFLD), continues to increase. Following the receipt of a complete response letter (CRL) from the FDA for its farnesoid X receptor (FXR) agonist, obeticholic acid (OCA), in NASH, Intercept Pharmaceuticals has joined the list of companies who have failed to […]
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