FDA

The US FDA Grants Priority Review to Takeda’s Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

  • by

Shots: The US FDA has granted PR for mobocertinib’s NDA to treat adult patients with EGFR Exon20 insertion+ mNSCLC, as detected by an FDA-approved test, who have received prior Pt-based CT. The anticipated PDUFA date is Oct 26, 2021 The NDA is based on a… Read More »The US FDA Grants Priority Review to Takeda’s Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Approval for dMMR Endometrial Cancer

  • by

Shots: The US FDA has approved the BLA filing for Jemperli for adult patients with dMMR recurrent or advanced solid tumors endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a Pt.-containing regimen AnaptysBio has received $20M… Read More »GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Approval for dMMR Endometrial Cancer

Medtronic Receives the US FDA’s Approval for Pipeline Flex Embolization Device with Shield Technology

  • by

Shots: The US FDA has approved Pipeline Flex Embolization Device with a Shield Technology to advance flow diversion therapy that demonstrates a reduction in material thrombogenicity or a reduction in the tendency of the surface treatment material to create clots The first patient receives new… Read More »Medtronic Receives the US FDA’s Approval for Pipeline Flex Embolization Device with Shield Technology

LEXEO Therapeutics Receives the US FDA’s Fast Track Designation for LX1001 to Treat APOE4 Associated Alzheimer Disease

  • by

Shots: The US FDA has granted FT Designation to LX1001 for the treatment of APOE4 associated AD. The designation evaluates to facilitate the development and expedite the review of drug The company has initiated P-I trial to assess the safety and toxicity of LX1001 as… Read More »LEXEO Therapeutics Receives the US FDA’s Fast Track Designation for LX1001 to Treat APOE4 Associated Alzheimer Disease

Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

  • by

Shots: The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated with PD-1/L1 inhibitor and platinum-based therapy. The first sBLA seeks to convert PADCEV’s accelerated approval to regular approval The second… Read More »Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

A Year Into Pandemic, Federal Officials Design New Mask Guidelines to Better Protect More Workers

  • by

Federal officials announced new measures to help get fresh, new N95 masks to health care workers and expand their use in other industries after scientists argued that the highly protective masks are essential to keep workers safe from covid-19. Use Our Content It can be… Read More »A Year Into Pandemic, Federal Officials Design New Mask Guidelines to Better Protect More Workers

AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

  • by

Shots: The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated for three years or until disease recurrence Results:… Read More »AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Novartis’s Xolair (omalizumab) Prefilled Syringe for Self-Injection Receives the US FDA’s Approval Across All Indications

  • by

Shots: The US FDA has approved the sBLA for a new self-administration option for Xolair in patients across all approved indications in the US The use of the therapy across multiple indications is based on the efficacy and safety profile of Xolair in allergic asthma,… Read More »Novartis’s Xolair (omalizumab) Prefilled Syringe for Self-Injection Receives the US FDA’s Approval Across All Indications

FDA warns of infection risk from reusable urological endoscopes

  • by

The agency said it had received more than 450 reports of infections or other issues in the last four years from reprocessed urological endoscopes, which are used to view or access the urinary tract. Three patient deaths were associated with these infections. 

Exelixis Reports the US FDA’s Acceptance of IND for XB002 in Patients with Advanced Solid Tumors

  • by

Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. The P-I trial is expected to initiate in Q2’21 The preclinical data demonstrated that XB002 binds to tissue factors without… Read More »Exelixis Reports the US FDA’s Acceptance of IND for XB002 in Patients with Advanced Solid Tumors

Taiho Oncology’s Futibatinib (TAS-120) Receives the US FDA’s Breakthrough Therapy Designation for Advanced Cholangiocarcinoma

  • by

Shots: The designation is based on efficacy & safety results from the P-II FOENIX-CCA2 study involves assessing futibatinib (TAS-120) in patients with advanced cholangiocarcinoma. The findings will be presented at AACR 2021 The preliminary clinical evidence showed improvement on at least one clinical EPs over… Read More »Taiho Oncology’s Futibatinib (TAS-120) Receives the US FDA’s Breakthrough Therapy Designation for Advanced Cholangiocarcinoma

FDA greenlights two more over-the-counter Covid-19 tests

  • by

The Food and Drug Administration gave an emergency use authorization to two more over-the-counter Covid-19 tests that can be used without a prescription. They include Abbott’s BinaxNow test and an at-home test developed by Quidel Corp. 

Kite Reports Submission of sBLA to the US FDA for Tecartus in Adult Patients with R/R Acute Lymphoblastic Leukemia

  • by

Shots: The sBLA is based on data from the P- I/II ZUMA-3 trial in adult patients age ≥18 years old for the treatment of adult patients with r/r B-cell ALL The focus of the study is to evaluate the safety and efficacy in adult patients… Read More »Kite Reports Submission of sBLA to the US FDA for Tecartus in Adult Patients with R/R Acute Lymphoblastic Leukemia

BeyondSpring Submits NDA to the US FDA and China NMPA for Plinabulin to Prevent CT-Induced Neutropenia

  • by

Shots: The NDA submission is based on data from P-III PROTECTIVE-2 study evaluating Plinabulin + Neulasta vs Neulasta alone for the prevention of CIN The study met its 1EPs and 2EPs with an improvement in the rate of prevention of grade 4 neutropenia from 13.6%… Read More »BeyondSpring Submits NDA to the US FDA and China NMPA for Plinabulin to Prevent CT-Induced Neutropenia

Sanofi’s Sarclisa (isatuximab-irfc) + Carfilzomib and Dexamethasone Receives the US FDA’s Approval for the Treatment of R/R Multiple Myeloma

  • by

Shots: The approval is based on P-III IKEMA study involves assessing of Sarclisa + carfilzomib and dexamethasone(kd) vs SOC in 302 patients with RRMM who had received 1 to 3 prior lines of treatment The result demonstrated a reduction in the risk of disease progression… Read More »Sanofi’s Sarclisa (isatuximab-irfc) + Carfilzomib and Dexamethasone Receives the US FDA’s Approval for the Treatment of R/R Multiple Myeloma

Qiagen’s NeuMoDx Multiplex Test Receives the US FDA’s EUA and Expands its COVID-19 Portfolio

  • by

Shots: The US FDA has granted EUA for Qiagen’s NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay that will help in identifying and differentiate individuals suspected of respiratory viral infection consistent with COVID-19 Qiagen launched the multiplex test in the EU in Nov’2020 and will now begin commercialization… Read More »Qiagen’s NeuMoDx Multiplex Test Receives the US FDA’s EUA and Expands its COVID-19 Portfolio

Helius Medical’s PoNS Receives the US FDA’s Approval to Improve Gait in Multiple Sclerosis Patients

  • by

Shots: The approval is based on two clinical studies and a retrospective analysis of RWD. The device is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program in patients aged ⥸22yrs. The approval will help in improving the… Read More »Helius Medical’s PoNS Receives the US FDA’s Approval to Improve Gait in Multiple Sclerosis Patients

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

  • by

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… 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

Zealand’s Zegalogue (dasiglucagon) Receives the US FDA’s Approval for the Treatment of Severe Hypoglycemia

  • by

Shots: The approval is based on efficacy results from P-III studies involve assessing Zegalogue vs PBO in children aged 6-17yrs. and in adults with T1D The study met its 1EPs showed an increase in blood glucose of ≥20 mg/dL within 45 minutes, the median time… Read More »Zealand’s Zegalogue (dasiglucagon) Receives the US FDA’s Approval for the Treatment of Severe Hypoglycemia

Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis

  • by

Shots: The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children aged ≥12yrs. in a ratio (1:1) with recurrent pericarditis The result showed a 96% reduction in the risk, with pain-… Read More »Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis

Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis

  • by

Shots: The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children aged ≥12yrs. in a ratio (1:1) with recurrent pericarditis The result showed a 96% reduction in the risk, with pain-… Read More »Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis

Merck Reports the US FDA’s Acceptance of NDA for Priority Review of Belzutifan (MK-6482) to Treat Patients with Von Hippel-Lindau Disease Associated RCC

  • by

Shots: The NDA is based on P-II study-004 trial involves assessing Belzutifan (120 mg, PO, qd) in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney and did not require immediate surgery Results: It showed ORR of… Read More »Merck Reports the US FDA’s Acceptance of NDA for Priority Review of Belzutifan (MK-6482) to Treat Patients with Von Hippel-Lindau Disease Associated RCC

BioXcel’s BXCL501 Receives the US FDA’s Breakthrough Therapy Designation for Acute Treatment of Agitation Associated with Dementia

  • by

Shots: The BTD is based on a P-Ib/II TRANQUILITY study assessing BXCL501 in patients with acute treatment of agitation associated with dementia, including AD The results demonstrated significant reductions in agitation measures @2hrs. post-dose with both 30 and 60 mcg doses as measured by multiple… Read More »BioXcel’s BXCL501 Receives the US FDA’s Breakthrough Therapy Designation for Acute Treatment of Agitation Associated with Dementia

Roche’s Ventana ALK (D5F3) CDx Assay Receives the US FDA’s Approval for the Treatment of ALK-Positive NSCLC

  • by

Shots: The US FDA has granted approval of Ventana ALK (D5F3) as a CDx assay to identify ALK+ NSCLC patients eligible for treatment with Pfizer’s drug Lorbrena (lorlatinib) The label expansion approval strengthens Roche’s commitment to personalized healthcare by providing lung cancer patients with access… Read More »Roche’s Ventana ALK (D5F3) CDx Assay Receives the US FDA’s Approval for the Treatment of ALK-Positive NSCLC

 FDA OKs another over-the-counter Covid-19 test

  • by

As the Biden Administration pushes to offer more over-the-counter Covid-19 tests, the Food and Drug Administration authorized the first molecular Covid-19 test for over-the counter use. The test was developed by San Diego-based startup Cue Health.

BioIntelliSense Partners with Leukemia & Lymphoma Society for Continuous Monitoring in Clinical Trials

  • by

What You Should Know: –BioIntelliSense announced it has entered into a strategic partnership with The Leukemia & Lymphoma Society (LLS) to incorporate the BioSticker™ platform in clinical trials of hematological cancer patients. – The LLS clinical trials will include use of the BioSticker medical device… Read More »BioIntelliSense Partners with Leukemia & Lymphoma Society for Continuous Monitoring in Clinical Trials

Innovative, Non-Invasive Technologies Advanced Earlier Detection & Monitoring of Liver Disease

  • by

Jon Gingrich, CEO, Echosens North America Leveraging technological advances to facilitate new ways of engaging patients and integrating non-invasive technology into a liver disease program not only serves to improve individual outcomes and reduce costs but also strengthens the financial performance of health systems and… Read More »Innovative, Non-Invasive Technologies Advanced Earlier Detection & Monitoring of Liver Disease

Roche’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s Approval as the First Biologic for Systemic Sclerosis-Associated Interstitial Lung Disease

  • by

Shots: The approval is based on P-III focuSSced trial assessing Actemra (SC, 162mg) vs PBO in a ratio (1:1) in 212 adults with SSc. The data from P-I/II fascinate study also supported the approval The P-III study did not meet its 1EPs i.e. change from… Read More »Roche’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s Approval as the First Biologic for Systemic Sclerosis-Associated Interstitial Lung Disease

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

  • by

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… 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

Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

  • by

Shots: The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated advanced ALK-positive NSCLC The P-III study resulted in a 72% reduction in risk of progression or death as assessed by… Read More »Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

G1 Therapeutics and Boehringer Ingelheim Launch Cosela (trilaciclib) in the US

  • by

Shots: On Feb 12, 2021, the US FDA has approved Cosela to decrease the incidence of CT induced myelosuppression in adult patients when administered before a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC The launch is supported by the “One Patient Support Program” which is… Read More »G1 Therapeutics and Boehringer Ingelheim Launch Cosela (trilaciclib) in the US

Veru to Advance VERU-111 in P-III Study for COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

  • by

Shots: The US FDA agreed to advance VERU-111 into a P-III study which will evaluate VERU-111 vs PBO in ~400 hospitalized patients in a ratio (2:1) with COVID-19 and are at high risk for ARDS. The study is anticipated to begin in Apr’2021 with clinical… Read More »Veru to Advance VERU-111 in P-III Study for COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

Merck Reports the US FDA’s Acceptance of NDA for Review of Gefapixant to Treat Refractory or Unexplained Chronic Cough

  • by

Shots: The NDA submission is based on two P-III studies (COUGH-1 & -2) involves assessing gefapixant (45/15mg, bid) vs PBO in 2,044 patients with RCC & UCC In both the studies, gefapixant resulted in the reduction of in 24hrs.-cough frequency @12 & 24wks respectively. Data… Read More »Merck Reports the US FDA’s Acceptance of NDA for Review of Gefapixant to Treat Refractory or Unexplained Chronic Cough

BridgeBio and Origin’s Nulibry (fosdenopterin) Receives the US FDA’s Approval as the First Therapy to Reduce the Risk of Mortality in Patients with MoCD Type A

  • by

Shots: The FDA has approved Nulibry based on three clinical trials compared to data from a natural history study in patients with MoCD Type A The results from three clinical trials showed improvement in overall survival and an 82% reduction in the risk of death,… Read More »BridgeBio and Origin’s Nulibry (fosdenopterin) Receives the US FDA’s Approval as the First Therapy to Reduce the Risk of Mortality in Patients with MoCD Type A

Why AstraZeneca and J&J’s Vaccines, In Use the World Over, Are Still on Hold in America

  • by

This story also ran on Fortune. It can be republished for free. The World Health Organization greenlighted emergency use of AstraZeneca and Oxford’s covid-19 vaccine this month, following in the steps of the United Kingdom, the European Union and others, who are already injecting it… Read More »Why AstraZeneca and J&J’s Vaccines, In Use the World Over, Are Still on Hold in America

AbbVie’s Humira (adalimumab) Receives the US FDA’s Approval to Treat Pediatric Patients with Ulcerative Colitis

  • by

Shots: The approval is based on P-III ENVISION I study that involves assessing Humira (SC) vs PBO in pediatric patients aged 4-17yrs. with mod. to sev. UC The study demonstrated that 60% of patients taking the higher dosage achieved clinical remission per PMS @8wks induction… Read More »AbbVie’s Humira (adalimumab) Receives the US FDA’s Approval to Treat Pediatric Patients with Ulcerative Colitis

Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)

  • by

Shots: The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in Aug 2021. If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas The… Read More »Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

  • by

Shots: The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e,… Read More »Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Incyte Reports the US FDA’s Acceptance of sNDA for Priority Review of Jakafi (ruxolitinib) to Treat Chronic Graft Versus Host Disease

  • by

Shots: The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory chronic GVHD. The findings were recently presented at the 62nd ASH Annual Meeting & Exposition The study showed greater ORR… Read More »Incyte Reports the US FDA’s Acceptance of sNDA for Priority Review of Jakafi (ruxolitinib) to Treat Chronic Graft Versus Host Disease

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

  • by

Shots: The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the 1L treatment with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or… Read More »Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

Incyte Reports the US FDA’s Acceptance of NDA for Priority Review of Ruxolitinib Cream to Treat Atopic Dermatitis

  • by

Shots: The NDA is based on two P-III TRuE-AD 1 & 2 assessing ruxolitinib cream (0.75%/1.5%, bid) vs vehicle (non-medicated cream) in 600 patients aged ≥12yrs. in a ratio (2:2:1) diagnosed with AD for at least 2yrs. and who were candidates for topical therapy Patients… Read More »Incyte Reports the US FDA’s Acceptance of NDA for Priority Review of Ruxolitinib Cream to Treat Atopic Dermatitis

Immunocore’s Tebentafusp Receives the US FDA’s Breakthrough Therapy Designation for Unresectable or Metastatic Uveal Melanoma

  • by

Shots: The US FDA has granted BTD to the tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable/ mUM The pre-planned interim analysis of a P-III study (IMCgp100-202) in prior untreated muM demonstrated superior OS as monothx. Immunocore will be working with the… Read More »Immunocore’s Tebentafusp Receives the US FDA’s Breakthrough Therapy Designation for Unresectable or Metastatic Uveal Melanoma

FDA issues warning on pulse oximeter limitations, but says little about racial disparities

  • by

In an alert on Friday, the Food and Drug Administration warmed that pulse oximeters might be inaccurate in some circumstances. The agency listed skin color among other factors that may affect the accuracy of a reading, but didn’t mention research that has demonstrated the devices… Read More »FDA issues warning on pulse oximeter limitations, but says little about racial disparities

Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

  • by

Shots: The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based CT and a PD-1/L1 inhibitor. The 1EP of the study was… Read More »Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

BeiGene Reports the US FDA’s Acceptance of sNDA for Brukinsa (zanubrutinib) in Waldenström’s Macroglobulinemia

  • by

Shots: The sDNA submission is based on a P-III APSEN study assessing Brukinsa vs ibrutinib in 351 patients with WM and includes a pivotal P-II trial of zanubrutinib in r/r WM conducted in China and P- I/II trial in patients with B-cell malignancies Additionally, safety… Read More »BeiGene Reports the US FDA’s Acceptance of sNDA for Brukinsa (zanubrutinib) in Waldenström’s Macroglobulinemia

Novartis’s Entresto Receives US FDA’s Approval for Chronic Heart Failure

  • by

Shots: The approval is based on P-III PARAGON-HF study involves assessing of Entresto (sacubitril/valsartan) in the treatment of patients with preserved ejection fraction HFpEF The expanded indication enables potential treatment of adults with left ventricular ejection fraction (LVEF) below normal, benefits are most clearly evident… Read More »Novartis’s Entresto Receives US FDA’s Approval for Chronic Heart Failure

Targovax Receives US FDA’s Fast Track Designation for ONCOS-102 for Malignant Pleural Mesothelioma

  • by

Shots: The US FDA has granted FT designation for ONCOS-102 based on pre/clinical efficacy associated with broad immune activation observed to date The designation is granted to therapies with the potential to address unmet medical needs in serious diseases and allows for more frequent interactions… Read More »Targovax Receives US FDA’s Fast Track Designation for ONCOS-102 for Malignant Pleural Mesothelioma

Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

  • by

Shots: The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one maintenance dosing option while the efficacy, safety, and tolerability were observed during 7 maintenance infusions @3wks. intervals over a 6mos.… Read More »Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

G1 Therapeutics’ Cosela (trilaciclib) Receives US FDA’s Approval as the First Myeloprotection Therapy for Extensive-Stage Small Cell Lung Cancer

  • by

Shots: The approval is based on three clinical trials involves assessing Trilaciclib +carboplatin/etoposide (+/- atezolizumab) and topotecan CT regimens in patients with ES-SCLC. 90% of all patients with ES-SCLC will receive at least one of these regimens The result show reductions in the incidence and… Read More »G1 Therapeutics’ Cosela (trilaciclib) Receives US FDA’s Approval as the First Myeloprotection Therapy for Extensive-Stage Small Cell Lung Cancer

Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia

  • by

Shots: The approval is based on P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg, IV, q4w) + vs PBO in 65 patients aged ≥12yrs. with HoFH for 24wks. The study met 1EPs i.e. 49% reduction in LDL-C (47% vs 2%), patients also experienced a… Read More »Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia

Eli Lilly and AbCellera’s Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Receive the US FDA’s EUA for COVID-19

  • by

Shots: The FDA authorized EUA for bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild to mod. COVID-19 patients aged ≥12yrs. who are at high risk for progressing to severe COVID-19 and/or hospitalization The EUA is based on P-III BLAZE-1 trial in… Read More »Eli Lilly and AbCellera’s Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Receive the US FDA’s EUA for COVID-19

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma

  • by

Shots: The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or distant) Results: median follow-up (9.5 & 15.1mos.); ORR (21% & 29%); PR (21% & 23%); D0R @≥6mos. (100% & 79%);… Read More »Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma

Signifier’s eXciteOSA Receives US FDA’s Approval for the Treatment of Mild Obstructive Sleep Apnea and Snoring

  • by

Shots: The FDA has approved eXciteOSA to treat mild obstructive sleep apnea and snoring by using for only 20 min./day for a period of 6 wks. and then twice per week In a study of 65 mild obstructive sleep apnea patients, 79% responded to therapy… Read More »Signifier’s eXciteOSA Receives US FDA’s Approval for the Treatment of Mild Obstructive Sleep Apnea and Snoring

Roche’s Elecsys GDF-15 Assay Receives the US FDA’s Breakthrough Device Designation as a CDX in Cancer Treatment

  • by

Shots: The US FDA grants the BDD for Elecsys GDF-15 assay that is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients aged≥18yrs. with solid tumors for treatment with Pfizer’s PF-06946860 GDF-15 assay helps to identify patients suitable for innovative treatment addressing unintentional… Read More »Roche’s Elecsys GDF-15 Assay Receives the US FDA’s Breakthrough Device Designation as a CDX in Cancer Treatment

BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for Adults With R/R Large-B-Cell Lymphoma

  • by

Shots: The approval is based on pivotal TRANSCEND NHL 001 (017001) study assessing Breyanzi in 268 patients with 3L+R/R LBCL including patients with a broad range of histologies and high-risk disease. Breyanzi was administered in the inpatient & outpatient settings Results: ORR (73%); CR (54%);… Read More »BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for Adults With R/R Large-B-Cell Lymphoma

Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate

  • by

Shots: The EUA submission is based on P-III ENSEMBLE trial assessing the safety and efficacy of the COVID-19 vaccine in protecting adults aged ≥18yrs. against both mod. and sev. COVID-19 disease with assessment of efficacy as of day 14 and as of day 28 as… Read More »Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate

Merck KGaA’s Tepmetko (tepotinib) Receives the US FDA’s Approval for Patients with Metastatic NSCLC with METex14 Skipping Alterations

  • by

Shots: The approval is based on pivotal P- II VISION study that involves assessing of Tepmetko (450mg, qd) as monothx. in 152 patients with a median age of 73 years with advanced/ m-NSCLC with METex14 skipping alterations Results: treatment-naïve patients & previously treated patients, ORR… Read More »Merck KGaA’s Tepmetko (tepotinib) Receives the US FDA’s Approval for Patients with Metastatic NSCLC with METex14 Skipping Alterations

Highmark BCBS Expands Access to Freespira’s Digital Therapeutic to Help Treat Pain, PTSD, Panic Attacks

  • by

What You Should Know: – Health insurer Highmark expands access to FDA-cleared digital therapeutic Freespira proven to reduce the symptoms of panic disorder and PTSD for members in Pennsylvania, Delaware and Virginia. – The announcement follows a pilot study finding that nearly 9 out of… Read More »Highmark BCBS Expands Access to Freespira’s Digital Therapeutic to Help Treat Pain, PTSD, Panic Attacks

ViewPoints Interview: BoneHealth Technologies’ Laura Yecies Shares Insights on OsteoBoost Vibration Belt

  • by

In a recent interview with PharmaShots, Laura Yecies, CEO of BoneHealth Technologies shared her views on OsteoBoost Vibration Belt that has been granted “Breakthrough Device” designation by the US FDA Shots: OsteoBoost receives the US FDA’s BDD to reduce the risk of osteoporosis. It uses vibration… Read More »ViewPoints Interview: BoneHealth Technologies’ Laura Yecies Shares Insights on OsteoBoost Vibration Belt

Medtronic Receives the US FDA’s Approval for DiamondTemp Ablation System to Treat Atrial Fibrillation

  • by

Shots: The approval is based on DIAMOND-AF trial assessing the safety and efficacy of the DTA system vs contact force-sensing ablation system in 482 patients with recurrent, symptomatic, PAF whose condition is unresponsive to drug therapy Results: patient complication rate (96.7% vs 93.4%); primary effectiveness… Read More »Medtronic Receives the US FDA’s Approval for DiamondTemp Ablation System to Treat Atrial Fibrillation

Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma

  • by

Shots: The US FDA has granted FTD for GLR2007 for the treatment of patients with glioblastoma and application is eligible for Rolling Review and for Accelerated Approval and Priority Review The Designation evaluate to facilitate the development and expedite the review of drugs to treat… Read More »Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma

Bio-Thera Solutions Reports the US FDA’s Acceptance of BLA for BAT1706 (Proposed Biosimilar to Avastin)

  • by

Shots: The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated BsUFA date is Nov 27, 2021 The BLA seeks approval of BAT1706 for mCC in… Read More »Bio-Thera Solutions Reports the US FDA’s Acceptance of BLA for BAT1706 (Proposed Biosimilar to Avastin)

Remdesivir, Given to Half of Hospitalized Covid Patients in U.S., Is Big Win for Gilead — Boosted by Taxpayers

  • by

It was the end of April — just as the U.S. confirmed its millionth covid-19 case and 50,000 deaths — when White House adviser Dr. Anthony Fauci announced “highly significant” news about a drug called remdesivir. That was surprising because the antiviral drug, owned by… Read More »Remdesivir, Given to Half of Hospitalized Covid Patients in U.S., Is Big Win for Gilead — Boosted by Taxpayers

Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

  • by

Shots: The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all… Read More »Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

  • by

Shots: The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously untreated advanced or metastatic RCC. Results: @ median follow-up of 18.1 mos. patients treated with the combination achieved PFS of… Read More »Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

  • by

Shots: The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen in those who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen Prior to initiating treatment… Read More »ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D

  • by

Shots: The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification Result: 2.0 mg dose achieved significant and superior reduction in HbA1c, both doses are safe and well-tolerated profiles Ozempic… Read More »Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

  • by

Shots: The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for 24wks. The anticipated PDUFA date is May’2021 Results: Over 24wks. predicted median change in FVC measured by home spirometry (-87.7… Read More »Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

  • by

Shots: The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event The study met the primary efficacy objective based… Read More »Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

  • by

Shots: The US FDA has accepted the BLA and granted the PR with an anticipated PDUFA date as Jul 17, 2021 The BLA filing marks the milestone on the path to commercialization of narsoplimab Narsoplimab is an investigational mAb targeting MASP-2 has received the US… Read More »Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

  • by

Shots: The approval is based on P-III ANDROMEDA (AMY3001) study involves assessing of Darzalex Faspro + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in 388 patients with newly diagnosed AL amyloidosis Genmab to receive $30M as milestones with the first commercial sale of Darzales… Read More »Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer

  • by

Shots: The approval is based on pivotal P-II DESTINY-Gastric01 trial involves assessing of Enhertu (6.4 mg/kg, q3w) vs CT in a ratio (2:1) in adult patients with LA or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen In a… Read More »Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

  • by

Shots: The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment The therapy is currently being evaluated in ongoing P-III program including PEARL 1 & -2 that assess Ligelizumab vs Xolair (omalizumab) in… Read More »Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

  • by

Shots: The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL prior treated with at least one systemic treatment The study showed 88% ORR. Among 23 patients, who achieved a response,… Read More »Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

New CMS rule to enable immediate coverage for FDA-designated ‘breakthrough’ devices

  • by

The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed “breakthrough devices.” The new coverage process would enable seniors to get access to these devices more quickly, but some provider and payer groups are concerned… Read More »New CMS rule to enable immediate coverage for FDA-designated ‘breakthrough’ devices

ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

  • by

In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his views on the approval of Xolair in the US. Shots: The approval is based on P-III POLYP 1 & 2… Read More »ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D

  • by

Shots: The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has also granted Provention’s request for Priority Review and assigned anticipated PDUFA date as Jul 02, 2021 The company is actively… Read More »Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D

Arsenic in Infant Rice Cereal

  • by

When it comes to rice and rice-based products, pediatric nutrition authorities have recommended that arsenic intake should be as low as possible. “The US Food and Drug Administration (FDA) has been monitoring the arsenic content in foods” for decades, yet despite the “well-established science describing… Read More »Arsenic in Infant Rice Cereal

AMA Adds 3 Additional CPT Codes for AstraZeneca’s COVID-19 Vaccine

  • by

What You Should Know: – The American Medical Association (AMA) announced the addition of three Current Procedural Terminology (CPT) codes for AstraZeneca’s COVID-19 vaccine. The American Medical Association (AMA) today announced that the Current Procedural Terminology (CPT®) code set is being updated by the CPT Editorial Panel… Read More »AMA Adds 3 Additional CPT Codes for AstraZeneca’s COVID-19 Vaccine

Amazon, CVS Health, Thermo Fisher Scientific Form Alliance for Employer-based COVID-19 Testing

  • by

What You Should Know: – Amazon, CVS Health, Thermo Fisher Scientific join forces to promote employer-based testing As part of a comprehensive COVID-19 testing strategy. – The coalition, named Workplace Employers Alliance for COVID-19 Testing (WE ACT), believes that employer-based testing programs are essential to… Read More »Amazon, CVS Health, Thermo Fisher Scientific Form Alliance for Employer-based COVID-19 Testing

DoD Awards $2.8M to Philips & BioIntelliSense to Validate Wearable for Early COVID-19 Detection

  • by

What You Should Know: – Philips and BioIntelliSense has been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly $2.8M from the U.S. Department of Defense (DoD) to validate BioIntelliSense’s FDA-cleared BioSticker device for the early detection of COVID-19 symptoms.… Read More »DoD Awards $2.8M to Philips & BioIntelliSense to Validate Wearable for Early COVID-19 Detection

12 Recently Launched COVID-19 Vaccine Management Solutions to Know

  • by

An in-depth look at twelve recently released COVID-19 vaccine management solutions as COVID-19 vaccines are being distributed nationwide. 1. Microsoft Microsoft launches a COVID-19 vaccine management platform with partners Accenture and Avanade, EY, and Mazik Global to help government and healthcare customers provide fair and… Read More »12 Recently Launched COVID-19 Vaccine Management Solutions to Know

Medical Device Design: 4 Ways Designers Can Create Medical Devices That Work for Everyone

  • by

Stuart Karten, Founder/President, Karten Design Medical device design has been going through sweeping changes over the last decade.  Ten years ago, medical device companies weren’t concerned with delivering consumer-level design: Devices that are both attractive and intuitively easy to use by a wide variety of… Read More »Medical Device Design: 4 Ways Designers Can Create Medical Devices That Work for Everyone

FDA gives emergency OK to Pfizer and BioNTech vaccine

  • by

The vaccine was developed in record time, a big scientific accomplishment, even though the agency’s move follows an unusual level of pressure from President Trump’s White House, renewing concerns that politics drove the vaccine process even as the first doses are shipped.

Freespira Secures $10M for FDA-Cleared Digital Therapeutic to Eliminate Panic Attacks, PTSD Symptoms

  • by

What You Should Know: – Lightspeed Venture Partners, the VC behind Nest and GrubHub, is leading a $10 million round for Freespira, an FDA-cleared digital therapeutic proven to significantly reduce or eliminate panic attacks and PTSD symptoms by training users to normalize respiratory irregularities. –… Read More »Freespira Secures $10M for FDA-Cleared Digital Therapeutic to Eliminate Panic Attacks, PTSD Symptoms

Recent Executive Hires: CVS Health New President, Cleveland Clinic/Amwell Joint Venture Leadership, Others

  • by

Neela Montgomery, EVP & President at CVS Pharmacy/Retail CVS Health Corporation names Neela Montgomery Executive Vice President and President of CVS Pharmacy/Retail, effective November 30, 2020. Montgomery will oversee the company’s 10,000 pharmacies across the United States. Montgomery, currently a Board Partner at venture capital… Read More »Recent Executive Hires: CVS Health New President, Cleveland Clinic/Amwell Joint Venture Leadership, Others

KHN on the Air This Week

  • by

KHN Editor-in-Chief Elisabeth Rosenthal discussed how to manage unexpected health care costs with CBSN on Wednesday. Click here to watch Rosenthal on CBSN KHN chief Washington correspondent Julie Rovner discussed the Affordable Care Act case before the Supreme Court with WBEZ’s “Reset” and WDET’s “Detroit… Read More »KHN on the Air This Week

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

  • by

Shots: The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20, 2021. The US FDA is not planning to hold an advisory committee meeting to discuss the application Additionally, the company is expecting… Read More »Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Fern Health Taps 10M Mass General De-Identified Patient Records for Pain Management

  • by

What You Should Know: – Fern Health will reveal a first-of-its-kind collaboration with Mass General Hospital where it will inform existing and future digitally-delivered pain management programs through the marriage of AI + predictive analytics with 10 million de-identified Mass General patient records. – MGH… Read More »Fern Health Taps 10M Mass General De-Identified Patient Records for Pain Management

To avoid crisis, pharma must address costs

  • by

Scrutiny of drug prices will continue whether Trump or Biden wins. But pharma can take steps to address critics and cut costs before they reach a crisis point, according to a panel of industry experts.

Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds

  • by

What You Should Know: – Northwestern Memorial Hospital is the first in the nation to deploy FDA-cleared AI-guided ultrasound by Caption Health, including measurement of ejection fraction – the most widely used measurement to assess cardiac function. – Caption Health’s AI-guided cardiac ultrasound enables clinicians… Read More »Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds

FDA Clears First-in-World Hematology App, Unlocking Potential of Diagnosis

  • by

What You Should Know: – Scopio Labs announced FDA clearance of its AI-powered X100 microscope and decision support system with Full Field Peripheral Blood Smear (Full Field PBS) application.  – Using advanced computational photography imaging and tailored AI tools, Full Field PBS gives clinical laboratories an… Read More »FDA Clears First-in-World Hematology App, Unlocking Potential of Diagnosis

FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

  • by

What You Should Know: – FDA awards AppliedVR Breakthrough Device designation for treating treatment-resistant fibromyalgia and chronic intractable lower back pain – AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods. AppliedVR, a pioneer advancing… Read More »FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment