Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN). The Swedish biotech says the IUS regulator has set an action date… Read More »FDA sets September review date for Calliditas’ rare kidney disease drug
The US FDA Grants Priority Review to Takeda’s Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer
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
Dosing can start once again in uniQure’s phase 3 trial of its haemophilia B gene therapy, after the FDA concluded that a case of liver cancer seen in the study was unlikely to be caused by the treatment. The biotech said that the FDA had… Read More »FDA lifts hold on uniQure gene therapy after cancer case review
FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck &… Read More »FDA looks at pulling speedy approvals for three cancer drugs
A uniQure gene therapy for hemophilia B that has been under a clinical hold for four months can now resume testing. The hold was lifted after uniQure answered the FDA’s questions about whether the gene therapy caused the liver cancer diagnosed in one patient who… Read More »FDA lifts clinical hold, clearing uniQure to resume hemophilia gene therapy trial
With FDA approval of Zynlonta, ADC Therapeutics can offer patients who have diffuse large B-cell lymphoma an option if CAR-T therapy doesn’t work. Additional clinical trials are underway that could expand use of the antibody drug conjugate to more cancer patients.
The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 billion acquisition of Tesaro, for certain patients with endometrial cancer. With Jemperli, a PD-1 class drug, GSK is a latecomer to the immunotherapy party with a host of other competitors already… Read More »FDA approves under-pressure GSK’s Jemperli for endometrial cancer
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
The FDA approved GlaxoSmithKlie drug dostarlimab (Jemperli) for endometrial cancer that carries a particular genetic signature. The immunotherapy now joins Merck’s Keytruda as the checkpoint inhibitors approved for treating endometrial cancer.
Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johnson’s COVID-19 vaccine. The US regulator says it completed an inspection of the Bayview… Read More »FDA pens stinging report on Emergent COVID vaccine plant
Medtronic Receives the US FDA’s Approval for Pipeline Flex Embolization Device with Shield Technology
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
In the final days of the Trump Administration, the Department of Health and Human Services sought to deregulate 83 different types of medical devices, citing a lack of reported adverse events. But the Food and Drug Administration put an end to the sudden reversal, saying… Read More »HHS reverses previous administration’s push to deregulate more than 80 medical devices
LEXEO Therapeutics Receives the US FDA’s Fast Track Designation for LX1001 to Treat APOE4 Associated Alzheimer Disease
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
The FDA placed a clinical hold on a KalVista Pharmaceuticals drug being readied for mid-stage studies in a rare, inherited disorder. Meanwhile, the FDA has some questions about the historical data Y-mAbs used as the control in a clinical trial for its antibody cancer drug.
Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer
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
Can’t see the audio player? Click here to listen on SoundCloud. The effort to vaccinate Americans against covid-19 took a hit this week. The Centers for Disease Control and Prevention and the Food and Drug Administration jointly called for a pause in use of the vaccine… Read More »KHN’s ‘What the Health?’: Pause and Effect on Covid Vaccines
Chuck Peterson of Omaha, Nebraska, recently experienced a swollen, painful knuckle caused by arthritis. He got a prescription for colchicine. Doctors have used the drug for treating gout and other rheumatic conditions for well over two centuries. When Peterson went to the pharmacy, he was… Read More »The FDA Seeks a New Way to Review Old Drugs Without Causing Prices to Soar
Amylyx’s ALS drug met the goals of a mid-stage study, paving the way for regulatory submissions in Europe and Canada. But the FDA is requiring data from a larger Phase 3 clinical trial and that study is slated to begin later this year.
A phase 3 trial of Romark’s antiviral drug NT-300 has missed the main objective in a phase 3 trial in mild to moderate COVID-19 patients, but could still have a shot at emergency use authorisation (EUA), according to the US company. The Florida-based firm has… Read More »Romark eyes FDA okay for COVID antiviral despite mixed trial results
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
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
In a review of 130 FDA-cleared AI tools, researchers found that the vast majority of them relied on retrospective studies. Most of the developers also didn’t share information on how many sites the algorithms had been tested in, or how they performed in different patient… Read More »FDA-cleared AI devices lack critical information on performance, equity
Blood clots found in six people given Johnson & Johnson’s Covid-19 vaccine have led federal health officials to recommend a pause on dosing with that shot. A CDC advisory committee on vaccine practices is meeting Wednesday to review the cases, which so appear similar cases… Read More »FDA & CDC “pause” J&J Covid-19 vaccine to launch inquiry into rare blood clot cases
US health authorities have recommended pausing dosing with Johnson & Johnson’s COVID-19 vaccine as they investigate cases of blood clots also observed in some people taking the AstraZeneca shot. The FDA said there had been reports of six cases of cerebral venous sinus thrombosis (CVST)… Read More »US seeks halt on J&J COVID vaccine rollout as clot concerns spread
Novartis’s Xolair (omalizumab) Prefilled Syringe for Self-Injection Receives the US FDA’s Approval Across All Indications
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
A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug developer, along with partner Roche, plan to ask regulators to expand the drug’s authorization to include disease prevention.
The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The issues are holding up discussions between the agency and company about labeling and post-marketing… Read More »Provention faces delay in FDA review of diabetes prevention antibody
Shots: Lilly and Incyte reported that the US FDA has extended the review period of sNDA for baricitinib to treat adults with mod. to sev. atopic AD The FDA has extended the action date, allowing the time to review additional data analyses submitted by Lilly… Read More »The US FDA Extends Review Period of Olumiant’s sNDA to Treat Moderate to Severe Atopic Dermatitis
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.
UK digital health company Oxehealth has claimed FDA approval for software that can be used to remotely measure vital signs like heart and breathing rates from a camera feed. Oxehealth Vital Signs – which has been approved as a class IIa medical device in Europe… Read More »FDA green lights Oxehealth vital signs monitoring software
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
Acadia Pharmaceuticals is butting heads with US regulators again, this time over the FDA’s decision to reject its Nuplazid (pimavanserin) for use in dementia-related psychosis (DRP) – with the company bemused by the agency’s apparent pivot on an agreed trial design. The FDA has rejected… Read More »Acadia puts blame on FDA as Nuplazid rejected for dementia
FDA approval of Supernus Pharmaceuticals drug Qelbree gives attention-deficit hyperactivity disorder patients another treatment option that is not classified as a Schedule II substance. It’s a different formulation of a drug that was first approved in Europe decades ago.
The FDA’s rejection of Nuplazid cited clinical trial results in subgroups of patients. Acadia Pharmaceuticals said the FDA’s decision goes against all feedback the company previously received and amounts to an incorrect way of evaluating dementia patients.
Taiho Oncology’s Futibatinib (TAS-120) Receives the US FDA’s Breakthrough Therapy Designation for Advanced Cholangiocarcinoma
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
A Helius Medical Technologies medical device that stimulates the brain by sending electrical stimulation to the tongue has received FDA clearance for multiple sclerosis patients. The company says its approach could also have applications in other disorders.
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.
The FDA increased the maximum number of doses permitted for each vial of Moderna’s Covid-19 vaccine, a change intended to make more doses available. The regulator also authorized storage changes for the vaccines at vaccination sites.
Kite Reports Submission of sBLA to the US FDA for Tecartus in Adult Patients with R/R Acute Lymphoblastic Leukemia
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
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
The FDA decision for Tyvaso as a treatment for pulmonary arterial hypertension in patients who have interstitial lung disease is the second approval for the United Therapeutics drug. The additional indication gives the company another way to grow revenue for the drug, which faces generic… Read More »United Therapeutics notches another FDA approval for lung drug
Sanofi’s Sarclisa (isatuximab-irfc) + Carfilzomib and Dexamethasone Receives the US FDA’s Approval for the Treatment of R/R Multiple Myeloma
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
¿Podría un antidepresivo que se usa desde hace décadas ser un arma secreta contra covid? Algunos científicos creen que sí, después de que dos pequeños estudios demostraran que la fluvoxamina, que se suele recetar para el trastorno obsesivo compulsivo (TOC), evitara que los participantes desarrollaran… Read More »Medicamentos ya conocidos, y baratos, podrían ser clave para tratar covid
The FDA has approved a Bristol Myers Squibb cell therapy made by engineering a patient’s immune cells to target a cancer protein called BCMA. The regulatory decision for Abecma in multiple myeloma gives BMS its second approved CAR-T therapy.
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
Shots: The EUA submission is based on an interim analysis of the P-III COMET-ICE study assessing VIR-7831 vs PBO for the early treatment of COVID-19 in 583 adults at high risk of hospitalization The study demonstrated an 85% reduction in hospitalization. Due to evidence of… Read More »GSK and VIR Report EUA Submission to the US FDA for VIR-7831 to Treat COVID-19
Could a decades-old antidepressant be a secret weapon against covid? A few scientists think so, after two small studies showed that fluvoxamine, typically prescribed for obsessive-compulsive disorder, prevented serious illness in all participants who took the pills soon after developing symptoms. This story also ran… Read More »Scientists Seek Covid Treatment Answers in Cheap, Older Drugs
This story also ran on Los Angeles Times. It can be republished for free. Here’s one big takeaway from our country’s disastrous 2020 covid response: For 20 years, we’ve lavished attention and money on fighting human terrorism and forgot that the terrorism of nature is… Read More »Analysis: How the US Invested in the War on Terrorism at the Cost of Public Health
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
One of the frustrations of our Big Data era is that, despite the existence of an ever-growing wealth of valuable data, this data is often stuck in different silos. This lack of accessibility makes it hard to get the most out of data that has… Read More »FDA Introduces Data Modernization Action Plan
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… 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
Earlier this year, AppliedVR shared results of a pivotal study that it plans to submit to the FDA. It received a breakthrough device designation last year to use its VR platform to treat fibromyalgia and lower back pain.
Dr. Miller, Medical Director of CancerLinQ LLC Despite decades of scientific progress against cancer, access to treatment remains highly unequal. Some of the reasons — like institutional racism and poverty — are a reflection of our broader society. Other inequities may go unrecognized but are… Read More »To Advance Health Equity, Put Real-World Cancer Data to Work
Can’t see the audio player? Click here to listen on SoundCloud. As questions swirl about the covid vaccine made by AstraZeneca, public health experts are worried the confusion could create more doubts among people already hesitant to get a vaccine. Meanwhile, the first Senate-confirmed officials are… Read More »KHN’s ‘What the Health?’: Getting Down to Work at HHS
The former top White House coronavirus adviser under President Donald Trump, Dr. Deborah Birx, has joined an air-cleaning company that built its business, in part, on technology that is now banned in California due to health hazards. This story also ran on NBC News. It… Read More »Birx Joins Air-Cleaning Industry Amid Land Grab for Billions in Federal Covid Relief
Zealand’s Zegalogue (dasiglucagon) Receives the US FDA’s Approval for the Treatment of Severe Hypoglycemia
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
What You Should Know: – AppliedVR, a Los Angeles, CA-based company advancing the next generation of digital medicine, today announced $29 million in Series A funding, bringing its total funds raised to date to $35 million. The round, which includes key investors F-Prime Capital, JAZZ… Read More »AppliedVR Lands $29M for VR Platform to Treat Chronic Pain
Six months after it was controversially hailed by Trump administration officials as a “breakthrough” therapy to fight the worst effects of covid-19, convalescent plasma appears to be on the ropes. This story also ran on NBC News. It can be republished for free. The treatment… Read More »The Hype Has Faded, but Don’t Count Out Convalescent Plasma in Covid Battle
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
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
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel… Read More »The US FDA New Drug Approvals in February 2021
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel… Read More »The US FDA New Drug Approvals in February 2021
Lisa Romano, MSN, RN, Chief Nursing Officer at CipherHealth The New Year brings hope and promises that an end to the COVID-19 pandemic is in sight. With two vaccines authorized by the FDA for emergency use, and close to 3 million healthcare workers already vaccinated,… Read More »3 Ways Providers Can Navigate COVID-19 Vaccination Rollout Successfully
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
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
Melinta Therapeutics already sells an antibiotic for serious skin infections. But FDA approval of Kimyrsa gives clinicians another option to offer patients, one with more convenient dosing.
BioXcel’s BXCL501 Receives the US FDA’s Breakthrough Therapy Designation for Acute Treatment of Agitation Associated with Dementia
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
President Joe Biden has promised enough covid vaccine to immunize every willing adult by June 1. But right now, the gap between supply and demand is so dramatic that vaccinators are discovering ways to suck the final drops out of each vaccine vial — if… Read More »To Extract More Doses per Vial, Vaccinators Put Squeeze on FDA to Relax Vaccine Handling Advice
In two pivotal studies years apart, Aveo Oncology’s drug tivozanib did not help kidney cancer patients live longer overall compared to the standard of care. The FDA approved still approved it, the latest development in a long saga that includes several regulatory stumbles.
The positive data for the antibody drug from Vir Biotechnology and GlaxoSmithKline give a clearer picture of how and when these treatments could help. Last week, a different pivotal study testing the same drug in hospitalized patients yielded murkier results.
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious… Read More »Insights+: Breakthrough Therapy Designation by the US FDA in 2020
Shots: The US FDA has granted FTD for VX-880 to treat T1D. The designation is designed to facilitate the development and expedite the review of treatments for serious condition and fill an unmet medical need Additionally, the company has initiated P-I/II trial for VX-880 in… Read More »Vertex’s VX-880 Receives the US FDA’s Fast Track Designation for T1D
Shots: The US FDA provide feedback on the pivotal trial protocol and statistical analysis plan (SAP) for the development program of biosimilar insulin glargine candidate, which the company plan to launch in 2023 The US FDA has requested Lannett to submit a protocol for the… Read More »Lannett Receives the US FDA’s Feedback for Development of Biosimilar Insulin Glargine
Vertex Pharma has made its name with treatment for cystic fibrosis, but has big plans in cell and genetic therapies – and has just chalked up fast-track status from the FDA for a cell-based therapy for diabetes. VX-880 (formerly known as STx-02) derives from Vertex’… Read More »FDA fast tracks type 1 diabetes cell therapy from Vertex
Eli Lilly reported data from a second group in a Phase 3 study testing its combination antibody drug for Covid-19 showing that the treatment reduced the risk of hospitalization and death by 87%. That’s better than the data that supported the emergency authorization that the… Read More »Eli Lilly’s authorized Covid-19 antibody racks up more positive Phase 3 data
Bluebird bio said independent analyses found that the gene therapy inserted its payload at a site not known to cause cancer. Based on the results, the company has asked the FDA for permission to resume all of the clinical trials that were placed on hold… Read More »Bluebird analysis finds gene therapy ‘very unlikely’ to be cause of patient’s cancer
Pfizer’s management knew last year there was “a mold issue” at the Kansas facility now slated to produce the drugmaker’s urgently needed covid-19 vaccine, according to a Food and Drug Administration inspection report. This story also ran on The Daily Beast. It can be republished… Read More »Pfizer’s Newest Vaccine Plant Has Persistent Mold Issues, History of Recalls
Roche’s Ventana ALK (D5F3) CDx Assay Receives the US FDA’s Approval for the Treatment of ALK-Positive NSCLC
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
Each night it’s the same. Story after story on the TV news is about the covid vaccination effort, and they are all illustrated with footage of needles sinking into exposed upper arms. Could those visuals, ostensibly making this all seem routine, backfire? More than causing… Read More »Ouch! Needle-Phobic People Scarred by So Many Images of Covid Shots
Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on the market. The voluntary withdrawal comes amid an industry-wide FDA review of drugs that were awarded accelerated approval but later… Read More »Roche withdraws Tecentriq for bladder cancer, pullback comes amid FDA review
FDA approval for Yescarta in follicular lymphoma makes it the first approved CAR-T treatment for this type of cancer. It also marks Gilead Sciences’ third approved indication for a CAR-T cell therapy.
Shots: The approval is based on a P-II ZUMA-5 study assessing Yescarta (axicabtagene ciloleucel) in 146 patients aged ≥18rs. with r/r iNHL, prior treated with at least 2L of systemic therapy The P-II ZUMA-5 study showed 91% of patients responded to a single infusion of… Read More »Kite’s Yescarta Receives the US FDA’s Approval for R/R Follicular Lymphoma
Satsuma Pharmaceuticals executives say they now understand why their intranasal migraine treatment failed a pivotal test. But even with a new Phase 3 plan, the company is behind a competitor that could launch its intranasal migraine treatment later this year.
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
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
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
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
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
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
A Brainstorm Cell Therapeutics therapy for Lou Gehrig’s disease failed a pivotal study, but the company points to better results in a subgroup. The FDA took the unusual step of publicly stating that study’s results do not show the stem cell therapy helps patients.
Joan Kapusnik-Uner PharmD, FCSHP, FASHP, VP of Clinical Content for First Databank (FDB) As the Biden administration ramps up its efforts to increase the access of COVID-19 vaccines to more Americans, there are a large number of Americans who are skeptical about of the COVID-19 vaccine.… Read More »First Databank Clinician Addresses COVID-19 Vaccine Skepticism – Q/A
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
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 & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing data. Keytruda had been granted accelerated approval in metastatic small cell lung cancer (SCLC) with… Read More »Merck & Co axes Keytruda lung cancer niche amid FDA crackdown
Merck Reports the US FDA’s Acceptance of NDA for Review of Gefapixant to Treat Refractory or Unexplained Chronic Cough
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
Athenex’s bid to offer an oral version of an intravenous chemotherapy has stalled after the FDA rejected the drug. Among the remedies proposed by the regulator is another Phase 3 study.
The FDA decision makes Nulibry the first drug approved to treat MoCD type A, a rare metabolic disease. It’s also the first FDA-approved product for rare disease drug developer BridgeBio Pharma.
Shots: The FDA has issued a EUA for a single-shot COVID-19 vaccine to prevent COVID-19 in individuals aged ≥18yrs. The company plans to file BLA to the US FDA in 2021 The EUA is based on a P-III ENSEMBLE study that demonstrated 85% efficacy in… Read More »Johnson & Johnson Receives the US FDA’s EUA for COVID-19 Vaccine
The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Janssen’s Ad26.COV2.S vaccine has been authorised for use in people aged 18 or over after… Read More »FDA clears third emergency COVID-19 vaccine from J&J
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
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
Johnson & Johsnon’s Covid-19 vaccine is now the third one granted FDA emergency authorization. The company expects to deliver enough vials to for vaccinating more than 200 million people in the U.S. by the middle of this year.
The committee voted 22-0 on the question of whether the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh its risks. FDA emergency use authorization would bring the public a third vaccine for the novel coronavirus.
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
The FDA decision gives Sarepta Therapeutics its third approved drug for Duchenne muscular dystrophy. The accelerated approval requires the biotech to conduct additional clinical testing to confirm the drug’s benefit.
Diversity in clinical trials Recently, the FDA’s Center for Drug Evaluation and Research’s (CDER’s) released its 2020 Drug Trials Snapshots Summary Report. Part of the report examines the demographics of participants in clinical trials for the 53 drugs that FDA approved in 2020 either as… Read More »How representative are clinical trials of the US population?
AbbVie’s Humira (adalimumab) Receives the US FDA’s Approval to Treat Pediatric Patients with Ulcerative Colitis
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
This story also ran on NBC News. It can be republished for free. Covid-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by… Read More »Have a Case of a Covid Variant? No One Is Going to Tell You
Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use authorisation. In a briefing document published ahead of the Vaccines and Related Biological Products Advisory Committee… Read More »FDA reviewer backs J&J COVID jab for emergency OK
Pfizer Reports the US FDA’s Acceptance and Priority Review of BLA for Ticovac (Tick-Borne Encephalitis Vaccine)
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
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
Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients. The approval in first-line lung cancer, in non-small cell lung cancer patients whose tumours have high PD-L1 expression brings the drug into competition with… Read More »Sanofi’s immunotherapy Libtayo gets FDA not in first line lung cancer
Incyte Reports the US FDA’s Acceptance of sNDA for Priority Review of Jakafi (ruxolitinib) to Treat Chronic Graft Versus Host Disease
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
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
AstraZeneca is withdrawing U.S. marketing of Imfinzi in bladder cancer after the drug failed a study required as a condition of its 2017 accelerated approval. The drug’s other approvals in lung cancer are not affected.
Incyte Reports the US FDA’s Acceptance of NDA for Priority Review of Ruxolitinib Cream to Treat Atopic Dermatitis
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
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
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
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
After Everlywell received an emergency use authorization last year from the FDA for its at-home collection kit, the agency gave Everlywell the green light to sell its test kits without requiring a prescription.
The US FDA has approved 4 NDAs in Jan 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 4 novel products in 2021.… Read More »The US FDA New Drug Approvals in January 2021
BeiGene Reports the US FDA’s Acceptance of sNDA for Brukinsa (zanubrutinib) in Waldenström’s Macroglobulinemia
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
Kroger Health Partners with Gauss to Provide Smartphone-Enabled COVID-19 Rapid Antigen Home Tests What You Should Know: – Kroger Health, the healthcare division of The Kroger Co. announced plans to offer the first smartphone-enabled, at-home Gauss COVID-19 Rapid Antigen Test Kit to patients nationwide, expanding… Read More »Kroger Health to Offer Smartphone-Enabled COVID-19 Tests Nationwide
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
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
What You Should Know: – ECRI Institute identified the complexity of managing medical devices with COVID-19 emergency use authorization as the number one technology hazard in its Top 10 Health Technology Hazards for 2021 report. ECRI Institute’s Top 10 Health Technology Hazards, now in its 14th year, identifies… Read More »ECRI Institute: Top 10 Health Technology Hazards to Watch in 2021
Shots: The US FDA 510K clearance for stabilized urine samples to be used with the cobas BKV test on the cobas 6800/8800 systems. It is also approved for use in CE markets with EDTA plasma and urine stabilized in cobas PCR media as sample types… Read More »Roche’s Receives the US FDA’s Clearance for Urine Sample Type for BK Virus Quantitative Test
Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy
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
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
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
Can’t see the audio player? Click here to listen on SoundCloud. President Joe Biden has said he still wants a bipartisan bill to provide the next round of covid relief. But in case that doesn’t happen, House committees this week got down to work on a… Read More »KHN’s ‘What the Health?’: All About Budget Reconciliation
Seagen and Genmab have announced they have filed their antibody-drug conjugate tisotumab vedotin with the FDA for patients with recurrent or metastatic cervical cancer. The companies are asking for an accelerated approval based on phase 2 data, which will have to be confirmed by data… Read More »Seagen and Genmab file ‘trojan horse’ drug with FDA for cervical cancer
The EUA for Eli Lilly brings to patients a second antibody cocktail, following the FDA’s fall authorization of an antibody combination from Regeneron Pharmaceuticals. Lilly is working with Amgen to ramp up manufacturing of its newly authorized therapy.
Eli Lilly and AbCellera’s Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Receive the US FDA’s EUA for COVID-19
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
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
Given the lead contamination found in candies containing chili imported from Mexico, 25 hot sauces were tested for heavy metals. “Lead toxicity is prevalent and a major concern of public health,” especially for babies. “One of the important sources of lead exposure for the fetus… Read More »Lead Contamination in Hot Sauces
Signifier’s eXciteOSA Receives US FDA’s Approval for the Treatment of Mild Obstructive Sleep Apnea and Snoring
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
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
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’s Covid-19 vaccine offers storage and distribution advantages compared to mRNA vaccines, and is the only single-shot vaccine to reach late-stage testing. The next stop is a Feb. 26 FDA advisory panel meeting.
The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. The post-marketing ORAL Surveillance safety study showed that JAK inhibitor Xeljanz (tofacitinib) was… Read More »FDA holds back from action over Xeljanz safety study
The change of administration in the US has also seen a new leader at the FDA, with Dr Janet Woodcock appointed as interim commissioner by president Joe Biden’s new team. But there are doubts about her suitability for the permanent job because of her handling… Read More »Dilemma for Biden as Woodcock’s audition for FDA chief stumbles
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
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
EMD Serono’s Tepmetko is one of a number of targeted cancer therapies that have passed FDA muster in the past year. The decision sets up the German company’s pill for head-to-head competition with a Novartis drug targeting the same genetic signature.
The Neurocrine decision follows a clinical hold placed on the Parkinson’s program in December. It’s Voyager’s second loss of an R&D partner in the past year; AbbVie previously ended an alliance aiming to develop gene therapies for Parkinson’s and Alzheimer’s.
Highmark BCBS Expands Access to Freespira’s Digital Therapeutic to Help Treat Pain, PTSD, Panic Attacks
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
What You Should Know: – Casana raises $14M in Series A funding to pursue FDA clearance for its an IoT heart health toilet seat that captures clinically relevant measurements, including heart rate, blood pressure, blood oxygenation, and cardiac output. Casana, previously known as Heart Health… Read More »Casana Raises $14M to Expand IoT Heart Health Toilet Seat
What You Should Know: – Syapse raises 68M in equity investment led by Ally Bridge Group (ABG), with Northpond Ventures to expand delivery of real-world evidence through Syapse’s Learning Health Network. – The Syapse Learning Health Network is a global precision oncology data sharing network,… Read More »Syapse Lands $68M to Expand Global Precision Oncology Data Sharing Network
ViewPoints Interview: BoneHealth Technologies’ Laura Yecies Shares Insights on OsteoBoost Vibration Belt
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
Incyte has filed its PD-1 inhibitor retifanlimab with the FDA, seeking approval to treat a form of anal cancer associated with human papillomavirus (HPV) and HIV infections. The application covers the use of the intravenous PD-1 inhibitor for adults with advanced squamous cell carcinoma of… Read More »Incyte makes bid to join the checkpoint inhibitor club
Medtronic Receives the US FDA’s Approval for DiamondTemp Ablation System to Treat Atrial Fibrillation
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
Bristol-Myers Squibb’s commercial hopes for new multiple sclerosis drug Zeposia have yet to bear fruit thanks to the pandemic, but it’s already cued up a second indication for the would-be blockbuster. Orally-active S1P agonist Zeposia (ozanimod) has been submitted to the FDA as a treatment… Read More »BMS eyes May FDA verdict for MS drug Zeposia in ulcerative colitis
What You Should Know: – SWORD Health raises $25 million in Series B to accelerate growth of its best-in-class virtual musculoskeletal care solution led by Todd Cozzens, Managing Partner at Transformation Capital and former healthcare investor at Sequoia Capital. Existing investors Khosla Ventures, Founders Fund,… Read More »SWORD Health Nabs $25M for Virtual Musculoskeletal Care Solution
The FDA has delayed its decision on aducanumab, the troubled Alzheimer’s drug from Biogen and Eisai by three months, raising hopes that it could be approved after all. Biogen’s share price jumped considerably after the news broke at the back end of last week, as… Read More »Biogen shares soar as FDA delays decision on aducanumab
Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma
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)
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
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
A new report from the U.S. Food and Drug Administration (FDA) notes that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year. These figures are in addition to innovative medicines that are approved through FDA’s Center for Biologics Evaluation and… Read More »2020 FDA approvals show innovation despite COVID-19 pandemic challenges
Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis
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
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
President Joe Biden looks likely to ditch the previous administration’s move to create a quicker route to market for digital health products and other devices following the pandemic emergency. After he took office on Wednesday, Biden quickly moved to freeze a raft of Trump policies,… Read More »Biden likely to ditch Trump’s plans to relax digital health regulations
ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment
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
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
The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”
Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. Verquvo has been approved to reduce risk of cardiovascular death and heart failure hospitalisation in adults with symptomatic chronic heart… Read More »FDA approves Bayer/Merck & Co heart failure drug
Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD
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
Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden to replace outgoing Trump appointee Stephen Hahn. Woodcock has most recently been working with the Operation Warp Speed coronavirus vaccine and drug project started by the Trump administration. While… Read More »Biden appoints veteran Woodcock as interim FDA commissioner
Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure
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
What You Should Know: – Tyto Care announces the launch of its fingertip Pulse Oximeter device, allowing users to measure their own blood oxygen saturation level and heart rate from the comfort and safety of home. – Expanding its clinic-quality remote capabilities, TytoCare users will… Read More »Tyto Care Launches FDA-Cleared Fingertip Pulse Oximeter Medical Device
Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA
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
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
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
Developers of digital health tools have benefited from a truncated route to market during the COVID-19 crisis, and that could be made permanent if new FDA guidance is adopted. Pandemic emergency provisions were put in place in March last year to allow certain medical devices… Read More »US eyes permanent change to digital health regulatory path
Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria
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
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
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
AI tools increasingly occupy a regulatory gray area in healthcare. For clinicians to assess whether they are trustworthy, they need transparency on how they work, said panelists at CES.
What are some strategies to reduce arsenic exposure from rice? Those who are exposed to the most arsenic in rice are those who are exposed to the most rice, like people who are eating plant-based, gluten-free, or dairy-free. So, at-risk populations are not just infants… Read More »How Much Arsenic in Rice Is Too Much?
Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. The US regulator is looking at data from the EMPEROR-Reduced trial of… Read More »Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label
The new tests can open a window into the duration of immunity and to the antibody levels needed to sustain it. But first, a universal standard is needed to ensure results are comparable between tests.
Getting rice down to the so-called safe water limit for arsenic would still allow for roughly 500 times greater cancer risk than is normally considered acceptable. Given the level of arsenic in rice, how could we figure out how much rice is too much? There… Read More »How Risky Is the Arsenic in Rice?
Shots: The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28, 2021 The NDA & sNDA is based… Read More »Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy
ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps
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
What You Should Know: – TigerConnect has announced an expansion in their suite through the acquisition of Critical Alert, a leading provider of enterprise-grade middleware for hospitals and health systems. – For the hundreds of thousands of nurses that currently use TigerConnect, these new capabilities… Read More »M&A: TigerConnect Acquires Hospital Middleware Solution Critical Alert
Shots: The US FDA has granted EUA to Nirmidas’ COVID-19 rapid antibody IgG/IgM test for use in POC settings, delivering results in 15-20min Using a fingerstick serology test, the MidaSpot COVID-19 Ab combo detection kit checks for Ab against the RBD antigen and showed 100%… Read More »Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test
Elsevier, the data analytics business specialized in science and health, and Heel, a pharmaceutical company specialized in developing and manufacturing medicines made from natural ingredients, have recently completed a series of research projects with a focus on improving exploratory preclinical studies. “We at Heel are… Read More »Elsevier to Work with Heel for Mechanism-based Drug Action Discovery
In an unusual move, the Food and Drug Administration issued an alert about false negatives in startup Curative’s Covid-19 test. The test was being used by the County of Los Angeles, as well as Congress.
Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots. The regulator made its comments after the UK announced… Read More »FDA and doctors warn against extending COVID-19 vaccine dose gap
Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D
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
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
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
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
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
Use Our Content It can be republished for free. The recent rollout of two newly authorized COVID-19 vaccines is a bright ray of hope at the pandemic’s darkest hour. We now have a path that can lead us to happier times — even as we… Read More »COVID Vaccines Appear Safe and Effective, but Key Questions Remain
One tray of COVID-19 vaccine from pharmaceutical giant Pfizer contains 975 doses — way too many for a rural hospital in Arkansas. But with the logistical gymnastics required to safely get the Pfizer vaccine to rural health care workers, splitting the trays into smaller shipments… Read More »Inside the First Chaotic Days of the Effort to Vaccinate America
Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to be inspected. Matters appear to have been complicated by the pandemic and the travel disruption that it has caused, which… Read More »FDA rejects Novartis’ cholesterol drug after factory inspection issue
As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee. The authorisation means that around six million more vaccine doses can now be rolled out in the US coronavirus immunisation programme,… Read More »Moderna’s COVID-19 vaccine is second for US after FDA green light
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
The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Yesterday’s advisory panel meeting voted 20-0 in favour of approving Moderna’s vaccine and although the vote is non-binding, you could probably bet your house on… Read More »FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote
GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta… Read More »GSK’s Benlysta claims first FDA okay for lupus kidney damage
Pawel Czech, Founder of Nex.D While countries around the world continue to flounder with regards to COVID-19 testing, everyone is wondering how national governments could get things so horribly wrong. It’s true that governments have acted incompetently, leaders can make poor judgment calls, and optimistic… Read More »Why Some COVID-19 Testing Protocols Aren’t What You Think
With the US and other major countries poised to begin national distribution of multiple FDA-approved COVID-19 vaccines, the cybersecurity threats to secure COVID19 vaccine distribution is imminent. Earlier this month, IBM released a report on malicious cyber actors targeting the COVID-19 cold chain—an integral part… Read More »How Hackers Are Targeting COVID-19 Vaccine Distribution Chain – Q/A
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
Novartis’ Entresto is on course to become the first drug to be approved in the US for a form of heart failure that is notoriously hard to treat effectively, despite missing the mark in a phase 3 trial. An FDA advisory committee 12 to 1… Read More »Entresto set for big sales hike after FDA panel endorsement
Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. The document has been published just after the US started the rollout… Read More »FDA backs Moderna COVID-19 shot ahead of emergency use vote
The FDA authorized an at-home antigen test for Covid-19 developed by Ellume. It does not require a prescription.
Brown rice contains more arsenic than white rice, but the arsenic in brown rice is less absorbable, so how does it wash out when you compare the urine arsenic levels of white-rice eaters to brown-rice eaters? Arsenic in rice is a cause for concern, according… Read More »Which Rice Has the Least Amount of Arsenic: Black, Brown, Red, White, or Wild?
Si existe una cita con el destino, está escrita en el calendario del doctor Taison Bell. Al mediodía del martes 15 de diciembre, Bell, especialista en cuidados intensivos del Sistema de Salud de la Universidad de Virginia será uno de los primeros en arremangarse para… Read More »Desafío en hospitales: a qué trabajadores de salud vacunar primero contra COVID
This story also ran on NBC News. It can be republished for free. If there’s such a thing as a date with destiny, it’s marked on Dr. Taison Bell’s calendar. At noon Tuesday, Bell, a critical care physician, is scheduled to be one of the… Read More »Hospitals Scramble to Prioritize Which Workers Are First for COVID Shots
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.
The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use in the U.S. Distribution, however, will remain a challenge.
Arsenic levels were tested in 5,800 rice samples from 25 countries.The arsenic found in five servings of rice a week poses a hundred times the acceptable cancer risk. What did the rice industry have to say about that? When the story first broke in the… Read More »Which Brands and Sources of Rice Have the Least Arsenic?
What You Should Know: – LA-based Scanwell Health announced today that its at-home UTI test kits – featuring the first FDA-cleared urinalysis app that lets people test for a UTI without having to visit a lab or doctor – is now available on Amazon.com. –… Read More »Scanwell Health’s FDA-Cleared, Smartphone-Enabled UTI Test Kit Now Available at Amazon
Freespira Secures $10M for FDA-Cleared Digital Therapeutic to Eliminate Panic Attacks, PTSD Symptoms
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
Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The gist of a briefing document… Read More »FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel
Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck. The FDA has started its review of Nucala (mepolizumab) for the… Read More »Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps
What You Should Know: – Pear Therapeutics today announced that it has successfully closed an $80 million Series D financing led by SoftBank Vision Fund 2. – Pear is the leader in prescription digital therapeutics and the first company to receive FDA authorization for a… Read More »Pear Therapeutics Raises $80M to Advance Prescription Digital Therapeutics
What You Should Know: – Digital health startup Kleva Health launches FDA authorized saliva at-home COVID-19 test kit and raises $1.5 million in seed funding. – Kleva Health’s At-Home COVID-19 Saliva Test Kit will be available for orders on its website, klevahealth.com, and will retail… Read More »Kleva Health Launches FDA Authorized Saliva At-Home COVID-19 Test Kit for $149
A daily half-cup of cooked rice may carry a hundred times the acceptable cancer risk of arsenic. What about seaweed from the coast of Maine? “At one point during the reign of King Cotton, farmers in the south central United States controlled boll weevils with… Read More »Cancer Risk from Arsenic in Rice and Seaweed
Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated. But… Read More »Demand for COVID Vaccines Expected to Get Heated — And Fast
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the… Read More »Insights+ Key Biosimilars Events of November 2020
With multiple COVID-19 vaccines rapidly heading toward approval, optometrists and dentists are pushing for the authority to immunize patients during routine eye exams and dental cleanings. Across the country, these medical professionals say their help will be needed to distribute the vaccines to millions of… Read More »Come for Your Eye Exam, Leave With a Band-Aid on Your Arm
This is the question that a recent paper by Chorniy et al. (2020) attempt to answer. This issue is clearly very relevant as the UK recently has approved the Pfizer/BioNTech vaccine for COVID-19 before the US. Unlike most studies that attempt to examine the relationship… Read More »What is the impact of FDA review time on pharmaceutical R&D investments?
US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. The New York-based firm has requested approval for the combination of its anti-CD20 antibody ublituximab and umralisib, an oral drug… Read More »TG Therapeutics challenges Roche with FDA filing for CLL drug
Recent Executive Hires: CVS Health New President, Cleveland Clinic/Amwell Joint Venture Leadership, Others
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
What You Should Know: – AliveCor announced they received FDA clearance of new algorithms for use with their personal EKG devices, KardiaMobile and KardiaMobile 6L. These additional determinations will be available via a software upgrade for the Kardia devices in 2021. – The additional FDA-cleared… Read More »AliveCor Receives FDA Clearance of Next-Gen EKG Algorithms
Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become available. The cocktail of casirivimab and imdevimab is still being investigated in trials but the FDA has enough data to… Read More »Regeneron’s COVID-19 antibody cocktail gets US emergency licence
Doctors in the US are to get another option to treat COVID-19 after the FDA granted an Emergency Use Authorization (EUA) for Eli Lilly’s baricitinib. Baricitinib is the active ingredient in Lilly’s rheumatoid arthritis drug Olumiant and is the latest example of a drug being… Read More »Lilly’s baricitinib granted US emergency use in COVID-19
The San Francisco-based company aims to complete at least one Phase III study by 2025, and it is weighing an IPO next year to fund more.
The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 90 novel… Read More »Insights+: The US FDA New Drug Approvals in October 2020
The FDA has agreed to expedite development of two rare disease drugs from Sanofi. The most significant of the two announcements is the Priority Review for avalglucosidase alfa, a potential new therapy for Pompe disease. The review period will be shortened from the standard ten… Read More »FDA to expedite development of two Sanofi rare disease drugs
The Food and Drug Administration (FDA) on Tuesday issued an emergency use authorization for the first COVID-19 diagnostic at-home test. The move will not have an immediate impact on in-home care providers, but it could give them one more tool in their pandemic toolbox in… Read More »FDA Signs Off on First At-Home Coronavirus Test
The company is the second this month to report promising results for a Covid-19 vaccine even as the virus rages across the U.S.
What You Should Know: – White house coronavirus task force doubles down on rapid testing strategy to fight the coronavirus as some states say they don’t have the supplies to comply with the federal government’s advice. – This article was originally published by the Center for… Read More »White House Coronavrius Task Force Doubles Down on Rapid Testing Strategy
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
What You Should Know: – Bill & Melinda Gates Foundation awards Caption Health a $4.5M grant to support the development of an AI-guided lung ultrasound system. – The grant from the Bill & Melinda Gates Foundation will be leveraged to create new AI technology that… Read More »Gates Foundation Awards Caption Health $4.95M Grant to Develop AI-Guided Lung Ultrasound System
Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody. The AbCellera-partnered drug, previously known as LY-CoV555 or LY3819253, can be used to treat mild-to-moderate COVID-19 in patients 12 years and older,… Read More »Lilly to ship COVID-19 drug straight away after FDA green light
What You Should Know: – Cardiopulmonary digital health company Eko raises $65M in Series C funding to close the gap between virtual and in-person heart and lung care. – The latest round of funding will enable Eko to expand in-clinic use of its platform of… Read More »Eko Lands $65M to Expand AI-Powered Telehealth Platform for Virtual Pulmonary and Cardiac Exam
The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for the drug is lacking. The much-anticipated advisory committee meeting held on Friday to discuss the marketing application for aducanumab proved… Read More »FDA panel unimpressed with data for Alzheimer’s drug aducanumab
President-elect Joe Biden made COVID-19 a linchpin of his campaign, criticizing President Donald Trump’s leadership on everything from masks and packed campaign rallies to vaccines. That was the easy part. Biden now has the urgent job of filling top health care positions in his administration… Read More »As Faith in Vaccines Falters, Biden Is Under Pressure to Name New FDA Chief Stat
Bristol-Myers Squibb posted a solid set of financial results for the third quarter, but shares slid on investor fears that a payout tied new product approvals was in jeopardy. BMS’ stock fell a little over 2%, but the big casualty was a contingent value right… Read More »Could an FDA inspection scupper CVR deadline for BMS’ liso-cel?
What You Should Know: – The FDA just extended its research collaboration agreement (RCA) with COTA, specifically looking at how COVID-19 is affecting cancer. – With this expanded agreement, COTA and the FDA will use real-world data to explore the impact of COVID-19 and the… Read More »FDA Extends RCA With COTA to Explore COVID’s Effect on Cancer
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
Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data behind the drug is strong enough to support approval. The EMA has just kicked off its review of the anti-amyloid… Read More »Trials and tribulations in Biogen’s Alzheimer’s drug reviews
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
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.
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
Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert Bourla believes hasn’t been given the credit it is due by Wall Street analysts. The US regulator has started a… Read More »FDA sets April verdict for Pfizer’s “underestimated” atopic dermatitis drug
The Los Angeles-based startup received a breakthrough device designation from the FDA for using VR to manage chronic pain. It recently published the results of a 92-person virtual trial testing VR for pain management at home.
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
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