Multiple Myeloma

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Pharma News for Nexcella, Janssen, Alentis
FDA Approves BMS’s Reblozyl for MDS; FDA Awards Orphan Drug Designation to NXC-201; Janssen Submits Supplemental NDA for Full Approval of BALVERSA; FDA Grants Fast Track Status to ALE.C04; FDA Orphan Drug Designation to Faron’s Bexmarilimab; FDA Clears IND Application for AHB-137

FDA Approves Bristol Myers Squibb’s Reblozyl as First-Line Treatment of Anemia in Adults with Lower-Risk MDS Who May Require Transfusions Bristol Myers Squibb announced that the Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt) for the treatment of anemia in adult patients with very l...

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A New Era for Multiple Myeloma Treatment: Bispecific Antibodies Enter the Fray

Step aside, CAR-Ts; with three FDA approvals, the class of bispecific antibodies has begun to take on the relapsed/refractory multiple myeloma treatment segment. Currently, the US Food and Drug Administration (FDA) has authorized 10 bispecific antibodies and one bispecific molecule, the majority of which are a...

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Pharma News for Janssen, Galera, Genprex
J&J’s 2-in-1 Tablet for Prostate Cancer; FDA Approves TALVEY for Heavily Pretreated Multiple Myeloma; PDS Biotech Updated on VERSATILE-003 Trial; FDA Issues CRL to NDA for Avasopasem in Radiotherapy-Induced Severe Oral Mucositis in HNC; FDA Orphan Drug Designation to Genprex’s REQORSA; FDA Orphan Drug Designation to Bloomsbury’s BGT-OTCD

FDA Clears J&J’s 2-in-1 Tablet for Prostate Cancer Johnson & Johnson's Janssen Pharmaceutical Companies stated that the US Food and Drug Administration (FDA) had approved AKEEGA (niraparib and abiraterone acetate), the first-and-only dual-action tablet combining a PARP inhibitor including abiraterone ace...

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Transforming Multiple Myeloma Treatment: The Promise of Novel Drug Classes

Multiple myeloma is the second most prevalent blood cancer diagnosis in the United States, after non-Hodgkin lymphoma. Males are significantly more likely than females to have multiple myeloma. Myeloma incidence is highly tied to age, with older adults having the highest incidence rates and being diagnosed most fre...

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CELMoDs – A Worthy Successor to REVLIMID?

Over the years, REVLIMID has become an integral weapon in the cancer therapeutics’ armory. This odyssey of REVLIMID in the multiple myeloma segment began in 2005, when it was approved by the US FDA for the treatment of adult patients with multiple myeloma, in combination with dexamethasone.  As the wise say...

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Minimal Residual Disease (MRD) Testing: A Path to Cure Cancer?

Measurable or Minimal Residual Disease (MRD) is a term often used when treating patients with blood cancers. MRD is a small number of cancer cells left in the body after cancer treatment, and these cells can potentially cause relapse in these patients. The number of remaining cells is often too small to cause any s...

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Pharma News and Updates for Leo Pharma, GSK, Roche, Aldeyra, IASO Bio
Leo Pharma’s Hand Eczema Clinical Trial Updates; GSK’s PD-1 inhibitor Jemperli Approval; Roche Announces Phase III Result of Vabysmo; FDA Accepts NDA for Aldeyra’s reproxalap; RMAT and Fast Track Designations to IASO Bio’s CT103A; Orphan Drug Designation to Jubilant Therapeutics’s JBI-778

Leo Pharma Announces Positive Results of Phase III Hand Eczema Clinical Trial LEO Pharma A/S, a global leader in medical dermatology, announced that the DELTA 2 trial yielded positive results. DELTA 2 is the second of two pivotal phase III clinical trials involving delgocitinib cream, an investigational topical ...

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Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval

FDA Approves Eli Lilly’s Jaypirca for Relapsed Mantle Cell Lymphoma Eli Lilly has received FDA approval for Jaypirca, a non-covalent BTK inhibitor, in relapsed mantle cell lymphoma (MCL) patients who have relapsed after treatment with other drugs in the class. Adult MCL patients who have previously received at l...

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Pharma News for Amgen, AstraZeneca, Sanofi, Anavex, Sensorion, GSK
Amgen’s Olpasiran Candidate; GSK’s Novel Antibiotic for Urinary Tract Infections; AstraZeneca and Sanofi’s Beyfortus Approval; FDA Orphan Designation to Anavex’s Anavex2-73; FDA Rare Pediatric Disease Designation to Sensorion’s OTOF-GT; GSK’s Blenrep Fails in Phase III Trial in R/R Multiple Myeloma

Amgen Reports Promising Mid-stage Results for its Olpasiran Candidate  Amgen has reported encouraging mid-stage results for its olpasiran candidate for lowering lipoprotein(a) - a risk factor for atherosclerotic cardiovascular disease - and now plans to move forward with a phase III program as soon as possi...

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Pharma News for Actinium, Santhera, Gilead, Seres, BMS, Boehringer
Actinium Announces SIERRA Trial Results; Santhera Seeks FDA Review for Vamorolone; Seres Announces BLA Submission for SER-109; BMS Announces Results of COMMANDS Trial; Boehringer’s PDE4B Moves Late-stage Clinical Testing; FDA Rejects Gilead’s Hepcludex; Approval to J&J’s BCMAxCD3 Bispecific Antibody for Multiple Myeloma; Syncona to Acquire AGTC

Actinium Announces Positive Top-line Results from Pivotal Phase III SIERRA Trial of Iomab-B Actinium Pharma is on track to submit its targeted radiotherapy for AML patients requiring a bone marrow transplant in the United States, boosted by top-line data from a pivotal trial. The SIERRA trial of Iomab-B, an anti...

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