A US-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for acute myeloid leukemia (AML). Critical unmet needs are also discussed. Key pipeline assets highlighted include idasanutlin, oral azacitidine, and pevonedistat.
The level of concern surrounding the budget impact of acute myeloid leukemia (AML) has traditionally been low due to the relatively small size of the population in comparison to solid tumors, the high severity of the disease, and a lack of branded treatment options. As a result, few access controls are utilized for AML therapies. […]
Ad26.RSV.preF, in development by Johnson & Johnson, is a replication-deficient vector vaccine that encodes a prefusion form of the RSV F protein.
Adagloxad simolenin (OBI Pharma) is a carbohydrate-based vaccine comprised of Globo-H conjugated to keyhole limpet hemocyanin. Upon exposure to the synthetic Globo-H vaccine and an immunological adjuvant, the immune system mounts IgM and IgG responses against Globo-H hexasaccharide.
Launching after Revatio, Adcirca became the second-to-market PDE5 inhibitor upon its approval in major markets in 2009. Inhibiting the PDE5 enzyme enhances the effect of the endogenous vasodilator, nitric oxide (NO).
Adempas (riociguat; Bayer/Merck & Co) is a first-in-class drug that activates soluble guanylyl cyclase (sGC), a key enzyme in nitric oxide-mediated vasodilation of vascular smooth muscle cells.
Overview We performed a 5-question survey of 25 neurologists in the US to gauge current familiarity with Alzheimer’s Disease (AD) biomarkers and drugs in clinical development for disease modification. Drugs covered include: BIIB037/BART (BIIB), Solanezumab (LLY), Pioglitazone (Takeda), BAN2401 (ESALY/BIIB), MK-8931 (MRK).
Aducanumab (Biogen/Eisai) is an intravenous-infused, fully human recombinant immunoglobulin G1 monoclonal antibody.
Advair ([fluticasone propionate + salmeterol]; GlaxoSmithKline) is a fixed-dose combination of an inhaled corticosteroid (fluticasone propionate) and a long-acting beta 2 agonist (salmeterol). The drug has anti-inflammatory and bronchodilatory effects on patients with asthma.
Product innovation and robust growth have intensified in certain areas of the global advanced wound care products market in recent years, particularly advanced therapies such as negative pressure wound therapy and advanced wound dressings such as foam dressings.
The recombinant factor VIII (rfVIII) therapy Advate was initially developed by Baxter and then marketed by the pharmaceutical spin-off Baxalta, which is now part of Shire. Advate is the first third-generation rfVIII, and is a follow-on product to Shire’s Recombinate.
Adynovate is a long-acting PEGylated recombinant factor VIII (rfVIII) therapy developed by Baxalta and Nektar Therapeutics as a follow-on to Advate (rfVIII; Shire).
Afinitor (everolimus; Novartis) is an orally available analog of the mammalian target of rapamycin (mTOR), which mediates the signal transduction pathways required for cell cycle progression from G1 to S phase.
Afrezza (inhaled human insulin; Sanofi) is a drug-device combination product consisting of an ultra-rapid-acting human insulin for oral inhalation, approved for use in the US for the treatment of type 1 and type 2 diabetes.
Afstyla is a single-chain recombinant factor VIII (rfVIII) product developed by CSL Behring to have a longer duration of action than standard rfVIII. Endogenously produced fVIII consists of a light chain and a heavy chain fused via a metal ion bridge.
Aggrenox (Boehringer Ingelheim/GlaxoSmithKline/Bayer) capsules contain two active ingredients, acetylsalicylic acid and extend-release dipyridamole.
AGS-003 (Argos Therapeutics/Kyowa Hakko Kirin) is a cancer vaccine in development for the first-line treatment of metastatic renal cell cancer (RCC) in combination with Sutent (sunitinib; Pfizer).
lecensa is a second-generation ALK inhibitor developed by Roche and Chugai. In some NSCLC
patients, abnormal ALK configuration leads to the production of proteins that promote and maintain
the malignant behavior of cancer cells (Soda et al., 2008).
Alimta is an antifolate antineoplastic agent that exerts its action by disrupting folate-dependent metabolic processes essential for cell replication.
Aliqopa (copanlisib; Bayer) is a small molecule phosphoinositide 3-kinase (PI3K) inhibitor with high selectivity for the p110-alpha/delta catalytic subunits. The PI3K pathway is crucial for normal B-cell development, and is subverted by follicular lymphoma (FL) to promote survival and growth.
ALKS 3831 is an orally available, fixed-dose combination of samidorphan (ALKS 33) and olanzapine being developed by Alkermes.
ALKS 5461 (Alkermes) is a fixed-dose combination of buprenorphine, a mu opioid receptor partial agonist and kappa opioid receptor antagonist, and samidorphan (ALKS 33), which is a proprietary opioid modulator.
ALKS 8700 is an oral monomethyl fumarate molecule being developed for the treatment of relapsing multiple sclerosis.
PharmaVitae explores Allergan’s prescription pharmaceutical performance and outlook, encompassing corporate strategy, marketed portfolio, pipeline potential, and financial performance over 2017–27.
Alofisel (darvadstrocel; TiGenix/Takeda) is a suspension of allogeneic expanded adipose-derived stem cells via intralesional injection.
Alpelisib is a p110-alpha isoform-specific PI3K inhibitor. PI3K signaling plays a fundamental role in tumorigenesis, governing cell proliferation, survival, and motility, as well as angiogenesis.
Biogen and Swedish Orphan Biovitrum co-developed Alprolix (recombinant factor IX [rfIX] Fc fusion protein) for the treatment of hemophilia B. The therapy is a recombinant protein consisting of a single fIX fused with the dimeric Fc region of immunoglobulin G-1.
Alunbrig (brigatinib; Takeda) is a dual anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) inhibitor.
This interview with a UK key opinion leader (KOL) provides an overview of cost-effectiveness criteria that may be required to bring Alzheimer’s disease products successfully to the clinic in the UK. We also discuss current and potential treatment options, as well as unmet needs in Alzheimer’s disease.
This interview with a US key opinion leader (KOL) provides insight into data from various late-phase Alzheimer’s disease pipeline therapies, as well as a discussion of the design of these trials. Also discussed are treatment trends and current unmet needs.
Alzheimer’s disease is an irreversible, progressive, neurodegenerative, and fatal disease that slowly affects memory, cognition, and function.
KOL is optimistic on amyloid-targeted therapy and believes IV therapy will be tolerated if approved.
Ampyra is a potassium channel blocker, marketed by Acorda Therapeutics and Biogen, which is
approved to improve walking ability in multiple sclerosis patients. Although Ampyra’s active molecule
fampridine (4-aminopyridine) is readily available, by using Elan’s Intestinal Protective Drug Absorption
System, Acorda has developed a sustained-released oral tablet formulation allowing twice-daily
dosing.
AMT-061 is being developed by uniQure as a gene therapy for hemophilia B patients. The product uses an adeno-associated virus as a vector to deliver the highly active Padua factor IX (fIX) variant, which has eightfold to ninefold greater activity than normal, wild-type fIX.
The concept of a drug development partnership between CRO and sponsor is the latest strategic evolution in the search for efficiency and innovation in the biopharmaceutical world.
This interview with a US-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for anemia in chronic kidney disease (CKD). Key topics discussed include current treatments for anemia in CKD, with a focus on ESAs and IV iron, and the future of HIF stabilizers as a potential treatment for the disease.
This interview with a US-based key opinion leader (KOL) provides insights into pricing and reimbursement dynamics and issues concerning anemia in chronic kidney disease, with a focus on the anticipated reimbursement of HIF stabilizers in the US.
Angiomax is a direct thrombin inhibitor which prevents the formation of fibrin from fibrinogen and the activation of coagulation factor XII.
This comprehensive medical market and technology report provides an overview and in-depth market analysis of angioplasty catheters, specifically plain old balloon angioplasty (POBA), drug-coated balloon (DCB), cutting balloon, and scoring balloon catheters, used in the treatment of severe coronary artery disease (CAD) and peripheral artery disease (PAD).
GlaxoSmithKline and Theravance (now Innoviva) developed the once-daily inhaled combination, Anoro, consisting of umeclidinium and vilanterol for the treatment of chronic obstructive pulmonary disease (COPD).
Apalutamide (Johnson & Johnson) is an orally available androgen signaling inhibitor. The drug exhibits high binding affinity to the ligand-binding domain of androgen receptor (AR) and subsequently inhibits its nuclear import, as well as its ability to bind to DNA. Apalutamide has a similar mechanism of action to Xtandi (enzalutamide; Pfizer/Astellas).
APL-130277 (Dainippon Sumitomo/Sunovion) is a sublingual film formulation of apomorphine, a non-ergoline dopamine receptor agonist.
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