The disruption to biopharma and medtech businesses caused by Covid-19, such as product launch and clinical trial delays, has underscored the need for a more digital focused strategy.
When discussing the role of AI in Covid-19, we have to reframe this conversation and look at AI as an important approach that can provide better analysis and ultimately better outcomes for patients, not as replacing the entirety of the drug discovery process or as… Read More »Will Covid-19 be the straw that breaks AI’s back?
The deal with Roche subsidiary Genentech is likely not the last for Genesis Therapeutics, which is based on AI research undertaken at Stanford. Such partnerships are potentially lucrative for drug-discovery startups.
The assurances come amid concerns that the Trump administration would brush aside scientific expertise in its push for a vaccine ahead of the election on Nov. 3.
The company has received FDA approvals for two cancer drugs in less than 12 months and announced partnerships with Merck last month for a Phase II antibody-drug conjugate and a marketed drug.
The companies will partner on development and commercialization of ARO-AAT, Arrowhead’s Phase II RNA-interference drug for alpha-1 antitrypsin-associated liver disease, a rare genetic disorder. An analyst wrote that the deal makes sense given Takeda’s position in the AAT-augmentation therapy market.
The prize went to Jennifer Doudna of the University of California Berkeley and Emmanuelle Charpentier of the Max Planck Institute. Charpentier published her research on the biology behind the technology in 2011 and collaborated with Doudna. The two discovered it was possible to control the… Read More »CRISPR gene-editing discoverers awarded Nobel Prize in chemistry
The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016… Read More »Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data
The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance,… Read More »FDA issues Covid-19 vaccine guidance as White House reportedly relents
The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the Phase I portion of the Phase I/II study, which showed an overall response rate of 35.3%. ……
The companies expect the deal to close in the fourth quarter. MyoKardia’s lead drug candidate is mavacamten, which it is developing for hypertrophic cardiomyopathy and plans to submit to the FDA in the first quarter of next year.
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.
The company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.
The data from a Phase II pilot and an extension study of soticlestat, also known as OV935 or TAK-935, showed short- and long-term reductions of seizure frequency in patients with CDKL5 deficiency disorder and Dup15q syndrome.
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.
Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data
The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.
The company said that those who received the two-antibody cocktail REGN-COV2 showed a lower viral loads and faster alleviation of symptoms than those who received placebo.
The six-year-old Google-backed company was founded by three MIT physicists and hopes to use its technology to make drug discovery faster and less cumbersome by combining physics, AI and cloud computing.
A review published in JAMA found that bills introduced into the House and Senate don’t go nearly as far as existing drug pricing regulations other countries. The researchers listed eight key lessons from six nations.
The company hopes to use the money to bring its T-cell antigen coupler cell therapy technology – currently in preclinical development – into human clinical trials. German drugmaker Bayer’s venture capital arm led the round.
The company announced Wednesday the FDA approval of its liquid biopsy test, the second to win an agency nod in less than a month, saying it would launch the product on Friday. The FDA acquired the first ever liquid biopsy companion diagnostic, Guardant Health’s Guardant360… Read More »Foundation Medicine to launch liquid biopsy companion diagnostic following FDA approval
Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M
The charges, filed in Philadelphia federal court, allege that Teva conspired with four other generic drug companies to fix prices, rig bids and allocate customers. Teva – which the Justice Department and New York’s state government also sued this month for unrelated allegations – said… Read More »Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M
The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and health authorities in the U.S., is enrolling up to 48 healthy volunteers in the U.K. AstraZeneca’s double-antibody approach is similar… Read More »AstraZeneca starts Phase I study of long-acting double-antibody cocktail for Covid-19
Study uses genomic data to trace Covid-19 ‘superspreader’ event linked to February Biogen exec meeting
The study, by researchers at Harvard, MIT, The Broad and other institutions, used genomic analysis of cases linked to the Biogen meeting, linking much of the community transmission in the Boston area to a European genetic variant of SARS-CoV-2 that first appeared at the meeting.
The healthcare analytics company said it had raised the extension funding from three new investors and would use it to accelerate development of its real-world evidence technology.
In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has… Read More »J.P. Morgan on the state of life sciences and strategies to fuel innovation [Sponsored]
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA… Read More »Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend
The biotech company reached a deal with the European Commission to supply an initial 80 million doses, while European Union member states will have the option to purchase 80 million more.
While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science… Read More »FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy
Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19
Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.
The companies also said their Phase II/III study, slated to enroll about 30,000 participants, had already dosed more than 11,000.
The clinical trial had already been placed on hold in connection with the two prior patient deaths, which were linked to the higher dose of 300 trillion viral vectors per kilogram, while no deaths have been reported among those receiving the lower dose of 100… Read More »Astellas’ Audentes Therapeutics discloses third patient death in gene therapy trial
The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.
The drugmaker emphasized the full global rights it would acquire to Momenta’s lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.
In a CRL issued for valoctocogene roxaparvovec, the FDA told BioMarin that differences between its Phase I/II and Phase III studies limited the ability to rely on the earlier trial to support durability of effect, which an analyst said likely referred to a product comparability… Read More »FDA rejects BioMarin’s hemophilia A gene therapy in ‘massive surprise’
While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.
The deal brings Roche’s considerable manufacturing heft to Regeneron’s efforts to develop the two-antibody cocktail, REGN-COV2. Regeneron will distribute the drug in the U.S., while Roche will distribute it ex-U.S.
The update to the partnership includes opt-in rights for Gilead on 15 drug targets, up from five under the original 2018 deal. Gilead will pay $125 million upfront and make a $20 million equity investment in Tango, which focuses on synthetic lethality.
Nearly all of the states, plus five territories and the District of Columbia, are seeking an aggregate of $2.156 trillion from the maker of the opioid painkiller OxyContin, according to documents filed in the U.S. Bankruptcy Court Monday.
Pleiogenix is a biopharma startup developing treatments for liver diseases as well as Covid-19 and non-alcoholic steatohepatitis (NASH). It recently emerged as the winner of the INVEST Pitch Perfect contest for the biopharma track.
The agency approved Enspryng for the disease, which is often misdiagnosed as multiple sclerosis and can cause blindness, muscle weakness and paralysis.
The French drugmaker will take full control of SAR442168, a BTK inhibitor developed for multiple sclerosis that it in-licensed from the California biotech company in 2017.
Earlier this month, Ohio Gov. Mike DeWine received a false-positive result from a rapid antigen test for Covid-19, raising concerns about the tests’ accuracy. The assay’s maker, Quidel, said it is investigating the case.
The company plans to train 250 new racially and ethnically diverse clinical trial investigators and extend the reach of its trials to underserved rural and urban communities.
UnitedHealthcare sent a notice to plan members stating that it would no longer cover Descovy to prevent HIV, while Truvada – after it goes generic next month – will be covered for free. Gilead reported that Descovy for PrEP had offset a second-quarter fall in… Read More »Gilead got a boost from a newly approved PrEP drug. Now, a major insurer is dropping coverage
In a commentary, physicians and pharmacists wrote that percentages of Black, Latino and Native American patients in two Phase III studies of the drug that the company is using for FDA approval were disproportionate to Covid-19’s incidence in those communities.
The company’s software system is designed to streamline the work done by staff at clinical trial sites, such as manually copying information about patient recruitment and enrollment.
The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.
KaNDy’s lead product candidate, NT-814, is a non-hormonal treatment for symptoms of menopause. The drug completed Phase IIb testing and is slated to start Phase III testing next year.
Russian President Vladimir Putin said a vaccine developed at a Moscow research institute that appears to still be in Phase I development among fewer than 100 participants had undergone all necessary tests.
Analysts noted that Evrysdi would be priced significantly lower than Biogen’s Spinraza or Novartis’ Zolgensma. While this will provide a market advantage, it would also yield lower per-patient revenues.
In a phone interview, Guardant Health CEO Helmy Eltoukhy said he expected the approval to encourage coverage by those payers still on the sidelines.
News from innovative healthcare startups from Specifica, Aerovate Therapeutics and more.
Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.
Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen’s stock rose 10%, but analysts had mixed opinions.
Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.
As we look forward to the back half of the year, it’s clear that the desire for companies to commence their IPO process with organizational meetings and bake-offs continues
The drug has consistently failed to show a benefit when tested in randomized, controlled clinical trials. Social science may explain why laypeople and doctors alike continue clinging to it.
The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.
Under the agreement with BARDA and the Department of Defense, the drugmaker would supply 100 million doses of its vaccine, for which it published preclinical data last and is currently running a first-in-human clinical trial.
With this new cash infusion, Sight Diagnostics, which uses machine learning and AI to analyze images of blood samples, has raised a total of $124 million since its inception in 2011.
Hanmi will retain options for the drug, efinopegdutide, in Korea under the deal, in which Merck is paying the Seoul-based company $10 million upfront and up to $860 for development, regulatory and commercialization milestones.
Amplified Sciences emerged as the winner of the diagnostics track for the MedCity INVEST conference’s Pitch Perfect contest with PanCystPro, the test it is developing to address the problems encountered when determining whether pancreatic cysts are cancerous.
Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.
The company is hoping to close its seed funding round in the next six months and aims to be in a position to seek regulatory approval for its lead asset, PLX888, in acute alcoholic hepatitis in 2023.
The FDA approved Monjuvi for second-line diffuse large B-cell lymphoma. Though the drug has the same antigen target as approved CAR-T cell therapies, it is designed for patients unable to tolerate such intensive treatments.
Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.
The companies will provide 100 million doses of their jointly developed vaccine. But with a Phase I/II study planned in September, it is behind in development compared with those of Moderna and Pfizer and BioNTech, which have already started late-stage clinical testing.
Delivering on the promise of precision cancer medicine and why it matters even more during a pandemic
While many of us have avoided exposure to Covid-19 by sheltering in place, patients with […]
The company said in its 2Q earnings that it would halt development of ALXN2040 for C3 glomerulopathy, or C3G, citing the drug’s lack of potency. However, it may develop a second, more potent drug from the Achillion acquisition, ALXN2050, in the same disease.
The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.
The company said that the COVACTA trial of Actemra in Covid-19 pneumonia had failed to meet its primary endpoint. Earlier this month, Regeneron and Sanofi announced that their study of a similar anti-inflammatory drug had also not met its primary endpoint.
The study design is still being finalized, and the company is thus not yet divulging too many details. However, CEO David Daly said it would be significantly larger than the previous DETECT-A, multi-center and would include both men and women.
AI algorithm for detecting prostate cancer shows more than 98% sensitivity, 97% specificity in study
Tel Aviv-based Ibex Medical Analytics published data on what it called the first algorithm to go beyond detection and into areas like tumor grading and sizing.
The companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III study and days after Pfizer and BioNTech signed a nearly $2 billion vaccine supply deal with the federal government.
The companies will share development and commercialization of DS-1062 in solid tumors. They already have a similar deal in place, the $6.9 billion agreement signed last year for another ADC, the HER2-positive breast cancer drug Enhertu.
The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named… Read More »Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial
The study adds to the growing body of evidence that the drug, promoted early in the pandemic by President Trump, is ineffective, despite its getting a briefly renewed lease on life earlier this month thanks to a retrospective analysis.
The agency approved Tecartus, previously developed under the name KTE-X19, as the first CAR-T therapy for mantle cell lymphoma. The company had previously won approval for another CAR-T, Yescarta, in 2017, for diffuse large B-cell lymphoma.
A successful cocktail would also serve us in the long-run to treat the impacts of Covid-19 and keep those who are most vulnerable, the elderly and those with pre-existing conditions, more resilient against serious illness or death.
The company said it was formally terminating the Phase III study of the drug elafibranor in NASH and refocus its development of the drug on another disease, primary biliary cholangitis, as well as a diagnostic for NASH.
The company said the CareStart Covid-19 MDx RT-PCR test is designed to detect RNA from the SARS-CoV-2 virus and produce results within 83 minutes.
The companies will test Biofourmis’ sensor and artificial intelligence system in a clinical trial of more than 120 women with endometriosis.
How can life science companies benefit from hiring a Professional Employer Organization? [Sponsored]
In an interview, TriNet’s Vice President of Life Sciences, Maria Abouseif, talked about the role Professional Employer Organizations play in helping life science companies navigate the COVID-19 public health crisis.
The company plans to enroll 60 patients who have received its drug, Spinraza, following suboptimal response to Novartis’ Zolgensma, which was approved last year. The trial, RESPOND, is anticipated to start enrolling in the first quarter of 2021, pending regulatory approval.
The company said that patients receiving the drug, SNG001, had a 79% lower risk of requiring ventilation or dying compared with those on placebo, sending the company’s stock soaring more than 400%, but it did not clarify what that meant in terms of patient numbers.
The company announced the publication of interim data from the Phase I/II study of a vaccine it is developing with the University of Oxford. The news comes the week after Moderna announced the publication of data for its vaccine.
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.
A joint report by cybersecurity agencies in the U.K. and Canada, endorsed by their U.S. counterparts, states that the hacker group Cozy Bear had been targeting organizations involved with Covid-19 vaccine development efforts.
The company, whose drug-discovery efforts are focused on protein motion and detection of interactions that occur anywhere on a protein rather than only at active sites, filed to go public last month.
Opioid abuse is a widely recognized public health crisis in the United States and the […]
Evaluation of durability is still under evaluation, but the responses to mRNA-1273 show neutralizing antibody titers multiple times higher than those of recovered patients. Additionally, T-cell responses suggest potentially lower risk of enhanced respiratory disease.
The company is developing biosensors, initially for NASH, that could be used in place of liver biopsy and have applicability in development of drugs for the disease.
The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.
Under the deal, Blueprint will additionally be eligible for more than $900M in milestone payments plus royalties for the RET inhibitor pralsetinib. The deal includes exclusive rights for Roche in ex-U.S. markets other than China and shared rights in the U.S.
The companies anticipate releasing more clinical data from the BNT162 messenger RNA vaccine program and potentially starting a 30,000-participant Phase IIb/III study this month.
The study is enrolling 60 healthy volunteers aged 18-45, but the company hopes it will form the basis of trials of the drug as an outpatient treatment for patients who do not require hospitalization. Remdesivir is currently administered via IV.
The FDA’s Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug’s first-in-class potential, the briefing document for the meeting raised concerns about eye toxicity and questions about its risk-benefit profile.
Research on the drug’s molecular target dates back to the 1950s. A spokesperson for Gilead noted that the company anticipates potentially investing more than $1 billion on the drug this year alone.
The company said it is on track to start its 30,000-participant Phase III trial this month and has finished manufacturing enough supplies of the vaccine to do so.
MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron
Bari Kowal, vice president of global clinical operations at Regeneron Pharmaceuticals, gives an update on the clinical trials ongoing to develop drugs to fight Covid-19 and provides insights on how the clinical trials landscape and pharma overall must change in the next episode of MedCity… Read More »MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron
The company is currently running a Phase I study of its lead candidate, the antibody-drug conjugate VLS-101, in patients with lymphomas and leukemias. It has two additional antibody-drug conjugates and a bispecific antibody in preclinical development.
Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.
The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting… Read More »Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.
ViiV’s twice-monthly injected PrEP drug superior in HIV prevention to Gilead daily pill, analysis shows
The company said Tuesday that a final analysis of its Phase IIb/III study of cabotegravir showed greater efficacy in HIV prevention than Gilead’s Truvada. The study, among men and transgender women who have sex with men, was stopped in May following an interim analysis.
The patient, who had been enrolled in the Phase I study at the higher dose level of UCARTCS1A, suffered a cardiac arrest, the causes of which are under investigation, the company said.
The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.
The company is running a Phase I/II study that started in May in Australia and plans to open a Phase III study of its vaccine candidate, NVX-CoV2373, that will enroll up to 30,000 participants starting in the fall.
The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.