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This week (18-22 September) marks Fungal Disease Awareness Week (FDAW) in the US, an annual event in which the Centers for Disease Control and Prevention (CDC) and partners promote activities and outreach that encourage everyone to “Think Fungus”. This often-underestimated health burden is the focus of webinars and interactive events designed to encourage awareness and […]
CureVac highlights shift to mRNA technology in seasonal influenza vaccine development, says GlobalData
CureVac, in collaboration with GSK, recently announced the advancement of its multivalent, modified mRNA seasonal influenza vaccine candidate into Phase II clinical trials. The interim Phase I results reported positive safety and immunogenicity data, citing observed humoral responses in support of the selection of a vaccine candidate to proceed into Phase II testing. CureVac’s utilization […]
Major unmet needs plague classification and treatment of myasthenia gravis, says GlobalData
Myasthenia gravis (MG) is an autoimmune and neuromuscular disease characterized by muscle weakness and fatigue. Currently, most of the first-line treatment options are off-label symptomatic therapies, mainly due to their affordability and accessibility, while disease modifying therapies (DMTs) are typically reserved for refractory patients diagnosed with class II-V MG. As a result, major unmet needs […]
World Sepsis Day 2023: GlobalData highlights promise of new treatments
World Sepsis Day is commemorated on the 13th of September every year to raise awareness about this life-threatening condition, resulting in at least 11 million deaths occurring globally each year. Over 7,000 facilities and organizations around the world are expected to take part in World Sepsis Day, hosting events such as provision of medical education, […]
HepaStem seems most promising pipeline agent for decompensated cirrhosis due to NASH, says GlobalData
While there are no marketed drugs for nonalcoholic steatohepatitis (NASH) in the EU or US, most NASH therapies in development primarily focus on treating patients with F2 (moderate fibrosis) or F3 (advanced fibrosis). Of the 33 late-stage pipeline assets in development for NASH, only three focus on decompensated cirrhosis (DC) due to NASH. A further […]
Redx will become one of key upcoming players in IPF treatment with FDA’s ODD for zelasudil, says GlobalData
The FDA granted an orphan drug designation (ODD) to Redx’s zelasudil (RXC007) in August 2023. Zelasudil is an oral, selective rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor for the potential treatment of idiopathic pulmonary fibrosis (IPF). The FDA move will put RedX on the map as one of the key upcoming players in the […]
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 […]
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 […]
Amgen olpasiran may fill critical treatment gap in lowering Lp(a), opines GlobalData
Amgen’s olpasiran, a small interfering RNA (siRNA), is making strides in reducing Lp(a) levels significantly in patients with cardiovascular disease. This is noteworthy as elevated Lp(a) is considered a potent risk factor for heart disease and stroke. It also underscores olpasiran’s potential to address a vital treatment gap, representing a pivotal advancement in the realm […]
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, […]
BioNTech to lead $2 billion mRNA-based oncology therapy market despite challenges, says GlobalData
With the rise of mRNA-based treatments, the field of oncology is about to go through a big change. The global market for mRNA-based oncology therapies is expected to reach a record-breaking $2 billion by 2029. BioNTech, a German pharmaceutical company, is expected to lead the market with projected sales of $885 million and a 44.6% […]
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, […]
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 […]
Novo Nordisk, Eli Lilly record growth in Q2 driven by obesity, diabetes drug sales, reveals GlobalData
Novo Nordisk and Eli Lilly achieved the highest year-on-year (YoY) revenue growth when compared to the top 20 pharmaceutical firms by sales during the second quarter (Q2) of 2023. Unlike their competitors in the same period, the notable revenue surge was driven by their obesity and type 2 diabetes (T2D) medications. Both Lilly and Novo […]
Diabetic macular edema market across 7MM set to reach $9.6 billion in 2031, forecasts GlobalData
The diabetic macular edema (DME) market in the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) is set to grow from $5.4 billion in 2021 to $9.6 billion in 2031, driven by the launch of longer-acting anti-vascular endothelial growth factor (VEGF) therapies to treat patients with DME, an increase […]
Abrysvo and Beyfortus hold game-changing potential for pediatric RSV sector, says GlobalData
Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo (RSVpreF) recently received FDA approval for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32-36 weeks gestation.* A few weeks ago, AstraZeneca and Sanofi’s monoclonal […]
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 […]
Industry backlash may reshape EU compulsory pharma licensing reform, says GlobalData
There was a substantial backlash from major pharmaceutical trade associations and companies to the European Commission’s (EC) feedback initiative on the introduction of a pan-European compulsory license, which would allow for the invalidation of existing drug patents across the European Union (EU) in emergency situations. This could lead to further revision of the proposal, says […]
Teva trial postponement improves chances of summary judgement, observes GlobalData
A US District Court’s decision to postpone the trial of Teva Pharmaceuticals for Medicare fraud, which was originally planned to take place in September, suggests Teva may yet be able to achieve summary judgement in this case. This decision represents an initial positive outcome for Teva in one of the key ongoing legal battles surrounding […]
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 […]