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AstraZeneca and MSD’s Selumetinib Receive EU’s CHMP Positive Opinion as the First Therapy for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

Shots: EMA’s CHMP has recommended conditional marketing authorization of Selumetinib in the EU. The recommendation is based on the results from the P-I/II SPRINT Stratum 1 trial evaluating selumetinib as a monothx (PO, bid) in pediatric patients aged ≥3yrs. with NF1 and symptomatic, inoperable PNs The trial showed 66% ORR which is defined as the …

AstraZeneca and MSD’s Selumetinib Receive EU’s CHMP Positive Opinion as the First Therapy for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas Read More »

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML

Shots: The CHMP has recommended the approval of Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L treatment for unresectable MPM and is based P-III CheckMate -743 trial that met its 1EPs of OS The opinion for Onureg is based P-III QUAZAR AML-001 study assessing Onureg (300mg, qd) vs PBO in 472 patients in a ratio (1:1) …

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Read More »

Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer

Shots: The CHMP’s recommendation is based on Phase III IMpower110 study assessing Tecentriq vs CT  in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with stage IV non-squamous or squamous NSCLC Results: OS in people with high PD-L1 expression (7.1 vs 3.1mos.); safety profile is consistent with the current profile & no new safety signals …

Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer Read More »

BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma

Shots: The approval is based on the P-II  KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab Results: ORR (72%); sCR (28%); mDoR (11mos.); responses were rapid and durable, with a median time to response of …

BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma Read More »

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children

Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were generally consistent with the known safety profile of Dupixent. Dupixent …

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA for Review of Dupixent to Treat Moderate-to-Severe Asthma in Children Read More »

AstraZeneca and Serum Institute of India’s COVID-19 Vaccine Receive WHO’s EUA to Prevent COVID-19

Shots: WHO has granted EUL to AZ’s vaccine for active immunization to prevent COVID-19 in individuals aged ≥18yrs., including those over 65yrs. EUL granted AZ and SII enabling global access to the vaccine The WHO’s SAGE recommended a dosing interval of 8-12wks. and also recommended the use of the vaccine in countries where new variants, …

AstraZeneca and Serum Institute of India’s COVID-19 Vaccine Receive WHO’s EUA to Prevent COVID-19 Read More »

Biocon Biologics and Viatris Receive EC’s Approval for Kixelle (biosimilar, insulin aspart) for Diabetes Mellitus

Shots: The EC approval follows CHMP’s positive recommendation for Kixelle to treat DM in adults, adolescents, and children aged ≥1yr. The biosimilar has been approved as a 100 units/ml solution for injection in vial & pre-filled pen presentations The EC’s CMA is valid in all EU Member States as well as in the EEA countries …

Biocon Biologics and Viatris Receive EC’s Approval for Kixelle (biosimilar, insulin aspart) for Diabetes Mellitus Read More »

Incyte Receive Positive CHMP’s Opinion for Pemigatinib

Shots: The EMA’s CHMP has adopted a positive opinion of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status, after at least one line of ST The CHMP opinion is based on P-II FIGHT-202 and patients enrolled into one of three cohorts – cohort a (FGFR2 fusions …

Incyte Receive Positive CHMP’s Opinion for Pemigatinib Read More »

Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China

Shots: Henlius reported that NMPA has approved the IND application of HLX15 for the treatment of multiple myeloma The company has compared HLX15 in a head to head study with reference daratumumab via analytical & preclinical studies. The results demostrated that HLX15 is highly similar to reference daratumumab The company has developed the HLX15 in …

Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China Read More »

Innovent’s Sulinno (Adalimumab biosimilar) Receives China’s NMPA Approval for Pediatric Plaque Psoriasis and Non-infectious Uveitis

Shots: The approval is granted in pediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis in adults, who do not respond adequately to corticosteroids. These are fifth and sixth approved indications of Sulinno in China and it was first approved by NMPA on Sep 2, 2020 Sulinno is an adalimumab biosimilar which is …

Innovent’s Sulinno (Adalimumab biosimilar) Receives China’s NMPA Approval for Pediatric Plaque Psoriasis and Non-infectious Uveitis Read More »

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein

Shots: The US FDA’s EUA follows the launch of the Elecsys Anti-SARS-CoV-2 S Ab test for markets accepting the CE Mark. The serology test can be used to measure the level of Abs in people who have been exposed to the SARS-CoV-2 virus The test has both a high NPA of 99.98% and PPA of …

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein Read More »

Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

Shots: Onvision needle tip tracking technology will be exclusively available on the latest version of the B. Braun and Philips’ Xperius ultrasound system together with the Stimuplex Onvision needle, empowering anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia. It allows anesthesiologists the confidence to accurately position the needle tip …

Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia Read More »

Vertex’s Kaftrio + Ivacaftor Receive the EC’s Approval to Treat Cystic Fibrosis in People Aged 12 Years and Older

Shots: The EC has granted MAA to Kaftrio (ivacaftor/tezacaftor/lumacaftor) + ivacaftor (150mg) to treat people with CF aged ≥12yrs. with one F508del mutation and one minimal function mutation (F/MF), or two F508del mutations (F/F) in the CFTR gene The MAA is based on two P-III studies i.e. a 24wks. study in 403 people with one …

Vertex’s Kaftrio + Ivacaftor Receive the EC’s Approval to Treat Cystic Fibrosis in People Aged 12 Years and Older Read More »

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Shots: The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies Results: 42% reduction in risk of death (OS); 41% reduction the risk of disease …

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma Read More »

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology The study met its 1EPs & …

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer Read More »

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Shots: The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine The US government has an option to supply an additional 500M dose and helps the government’s Operation …

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine Read More »

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

Shots: Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs  In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage …

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis Read More »

Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

Shots: The NDA is based on P-III VICTORIA study assessing vericiguat (qd, (titrated up to 10mg) vs PBO when given in combination with available HF therapies in ~5,050 patients with worsening CHF, reduced left VEF of <45% within 12mos. prior to randomization following a decompensation event The 1EPs is the composite of time to the …

Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF Read More »

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks …

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer Read More »