Elotuzumab Combination Disappoints in Newly Diagnosed Myeloma
(MedPage Today) -- Adding the monoclonal antibody elotuzumab (Empliciti) to lenalidomide (Revlimid) and dexamethasone failed to improve outcomes for patients with newly diagnosed, transplant-ineligible multiple myeloma, a phase III trial showed... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - May 12, 2022 Category: Hematology Source Type: news

CHMP recommends EU conditional approval of Roche ’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma
If approved, mosunetuzumab would be the first CD20xCD3 T-cell engaging bispecific antibody available to treat follicular lymphoma (FL) offering a new, off-the-shelf, fixed-duration treatment optionThe recommendation is based on the GO29781 study where mosunetuzumab induced high complete response rates, with the majority of complete responses lasting for at least 18 months in people with heavily pretreated FLBasel, 22 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval under conditional marketin...
Source: Roche Investor Update - April 22, 2022 Category: Pharmaceuticals Source Type: news

CHMP recommends EU conditional approval of Roche ’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma
If approved, mosunetuzumab would be the first CD20xCD3 T-cell engaging bispecific antibody available to treat follicular lymphoma (FL) offering a new, off-the-shelf, fixed-duration treatment optionThe recommendation is based on the GO29781 study where mosunetuzumab induced high complete response rates, with the majority of complete responses lasting for at least 18 months in people with heavily pretreated FLBasel, 22 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval under conditional marketin...
Source: Roche Media News - April 22, 2022 Category: Pharmaceuticals Source Type: news

Natco Pharma announces launch of first generic of top selling cancer drug Revlimid
Revlimid had annual sales of $2.3 billion as of December 2021, according to IQVIA data. The generic version of Revlimid will be available in 5mg, 10mg, 15mg, and 25mg strengths. The announcement came after market hours. The Shares of Natco Pharma 2.98% to close at Rs 844.30 on BSE on Monday, the benchmark Sensex fell 2.74% to end at 52,842.75 points. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 7, 2022 Category: Pharmaceuticals Source Type: news

New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
The objective responsive rate observed in this study suggests a potential benefit for many patients with triple-class exposed disease with an off-the-shelf therapy.”As of September 2021, 165 patients were treated with teclistamab at the SC 1.5 mg/kg dose across both Phase 1 and Phase 2 of MajesTEC-1.1 The primary objectives of the MajesTEC-1 Phase 1 study (NCT03145181) were to identify the recommended SC RP2D (part 1) and characterize the safety and tolerability of teclistamab at the RP2D (part 2). The primary objective of the MajesTEC-1 Phase 2 study (NCT04557098) was to evaluate the efficacy of teclistamab at the RP2D,...
Source: Johnson and Johnson - December 13, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma
ATLANTA, Ga., December 11, 2021– The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of talquetamab (NCT03399799). Talquetamab is the only investigational off-the-shelf T cell redirecting bispecific antibody in clinical development targeting both GPRC5D, a novel multiple myeloma target, and CD3 on T cells.[1] Results from the study show that no new safety signals were observed with longer follow-up.1 Heavily pretreated patients with multiple myeloma treated with talquetamab at the recommended subcutaneous (SC) Pha...
Source: Johnson and Johnson - December 11, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Clinical and Real-World Data Support Use of DARZALEX ® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma
ATLANTA, Ga., December 11, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new analyses illustrating responses that first-line treatment with DARZALEX® (daratumumab)-based regimens may be able to achieve, including a potential survival benefit for DARZALEX® in combination with lenalidomide and dexamethasone (Rd). Updated data from the randomized Phase 2 GRIFFIN study in transplant-eligible patients and real-world evidence in transplant-ineligible patients were presented at the American Society of Hematology (ASH) 2021 Annual Meeting. Data from the GRIFFIN study will also be featured...
Source: Johnson and Johnson - December 11, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Dr Reddy's gets FDA nod for generic Revlimid; enjoys 180 days exclusivity
​​"We are pleased with the Agency's approval of Lenalidomide Capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity. We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients," Marc Kikuchi, CEO, North America Generics, Dr. Reddy's Laboratories said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 19, 2021 Category: Pharmaceuticals Source Type: news

Thalidomide and Lenalidomide for Refractory SLE/CLE Thalidomide and Lenalidomide for Refractory SLE/CLE
What do we currently know about the safety and efficacy of these drug options for the treatment of refractory systemic/cutaneous lupus erythematosus?Journal of Clinical Rheumatology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 15, 2021 Category: Consumer Health News Tags: Rheumatology Journal Article Source Type: news

Biocon inks patent litigation settlement pact with Celgene
The company along with its subsidiaries has entered into a confidential settlement agreement with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for Revlimid (lenalidomide), the Bengaluru-based company said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 8, 2021 Category: Pharmaceuticals Source Type: news

Dr Reddy's launches cancer drug in Canada
"Our launch of Reddy-Lenalidomide represents our firm commitment to providing access to affordable medicines for Canada's Multiple Myeloma and Myelodysplastic Syndrome (MDS) patient population," Vinod Ramachandran, Vice President and General Manager, Dr. Reddy's Laboratories Canada said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 2, 2021 Category: Pharmaceuticals Source Type: news

Sun Pharma settles patent litigation with Celgene Corporation for cancer drug Revlimid
Drug major Sun Pharma has reached an agreement with Celgene Corporation, to resolve the patent litigation regarding generic version of Revlimid (lenalidomide capsules) in the US. Revlimid is used in the treatment of cancer. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 22, 2021 Category: Pharmaceuticals Source Type: news

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX ® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible
Raritan, N.J., June 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® (daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression.[1] These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing and w...
Source: Johnson and Johnson - June 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 30 company-sponsored studies, including six oral presentations, will be featured during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8. Janssen presentations will include new data and updates for both approved and investigational therapeutics that are being studied for the treatment of various solid tumors and blood cancers. Immediately following ASCO, additional data will be featured during the European Hematology Association (EHA) Virtual Congress, June 9-17. A comp...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news