Incubated by OribMed and led by Ariad Pharmaceuticals veterans, Theseus Pharmaceuticals unveiled $100 million in Series B financing to develop the next generation of tyrosine kinase inhibitors, a type of cancer drug. The company expects to enter the clinic by the end of 2021.
Relay Therapeutics has its own technology that applies artificial intelligence and machine learning techniques to drug discovery. Its $85 million acquisition of ZebiAI gives it another technology that applies ML to DNA-encoded libraries and predicts the small molecules with the potential to drug proteins.
Merck is discontinuing work on one Covid-19 drug for treating hospitalized patients after the FDA said it needs more clinical data. Another Merck drug candidate is moving forward only in outpatient testing after independent clinical trial observers concluded the antiviral was unlikely to help those… Read More »Merck’s Covid-19 drug R&D falls short twice in treating hospitalized patients
Thermo Fisher Scientific sells laboratory equipment used in drug research and it also offers manufacturing services for experimental and commercialized drugs. By acquiring PPD, Thermo Fisher says it will gain capabilities in the growing global market of clinical trial services.
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.
Tango Therapeutics’ SPAC merger will infuse the biotech with $353 million to fund clinical trials for its cancer drugs based on synthetic lethality. Tango’s lead program is on track to reach the clinic next year.
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
Cellino Biotech CEO and Co-founder Dr. Nabiha Saklayen talked about the formation of the company and its goal to make stem cell therapies accessible for patients.
No matter if Democrats or Republicans are running the show in Washington, here are three solid bets for pharma companies to plan for in the changing drug-pricing landscape
With two cancer programs already making progress, Repertoire Immune Medicines will use the Series B financing to expand its immune synapse research to autoimmune disorders and infectious disease. CEO John Cox said his startup’s approach could advance immune medicines beyond the scope of currently available… Read More »Biotech startup Repertoire adds $189M to expand array of immune medicines
Peter Meath, Co-Head of Healthcare and Life Sciences for Middle Market Commercial Banking at J.P. Morgan, is bullish that the momentum will continue, particularly with investment trends focused on pain points amplified by the Covid-19 pandemic, from diagnostics development to supply chain management.
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.
Sanofi, which already has messenger RNA R&D alliances with other companies, paid $160 million up front to acquire preclinical startup Tidal Therapeutics. The pharma giant said Tidal’s mRNA approach could lead to an off-the-shelf CAR-T therapy.
The public markets welcomed VectivBio and Reneo Pharmaceuticals, which priced their IPOs late Thursday. Both clinical-stage companies are developing drugs that address rare diseases.
Creating the simplest process for informed consent benefits the potential participant by allowing them the time and resources to understand fully what they are consenting to. Through eConsent processes, research also opens the door to a more diverse population to engage in trials.
RA Capital led Ventus Therapeutics’ Series B financing, which the startup will use to develop its pipeline of medicines for “undruggable” disease targets. CEO Marcelo Bigal said the cash also gives Ventus the flexibility to consider an IPO.
Mobidiag offers multiplex testing, which is the ability to test for multiple pathogens from a single test sample. Hologic said the acquisition will enable the company to enter the acute care test market, which is projected to grow in a post-pandemic world.
A European Medicines Agency review concluded AstraZeneca’s Covid-19 vaccine may be linked to cases of blood clots. The regulator directed the company to conduct more studies to learn more but stopped short of recommending other vaccines as alternatives.
RA Capital led the $100 million Series B round of funding for Icosavax, a startup developing vaccines based on virus-like particles. The biotech is preparing for clinical tests of vaccines for respiratory syncytial virus, human metapneumovirus, and SARS-CoV-2.
Volastra Therapeutics is developing drugs for cancer metastasis, the cause of the vast majority of cancer deaths. The startup has $44 million in funding and an R&D partnership with Microsoft to develop new digital tools to detect and predict metastasis.
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.
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 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.
IQVIA has acquired Quest Diagnostics’ minority stake in Q2 Solutions, a central laboratory services joint venture the two companies formed in 2015. But Quest will remain a preferred provider of lab testing services under an agreement with Q2.
Peter Meath, J.P. Morgan Commercial Banking’s Co-Head of Healthcare and Life Sciences, applies lessons from 2020’s remarkable second half and shares insights on what to expect in 2021.
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
The Achilles Therapeutics IPO comes as several other biotechs make progress developing a type of cancer immunotherapy called a tumor-infiltrating lymphocyte. Clinical-stage Achilles contends its approach could best them all.
Based on the efficacy and safety data for their Covid-19 vaccine in younger teens, Pfizer and BioNTech plan to ask regulators to expand emergency authorization to include this younger group. The expansion could make the mRNA vaccine available to this age group in time for… Read More »Pfizer & BioNTech report Covid-19 vaccine shows 100% efficacy in kids 12 to 15
With the emergence of smart and connected devices and technologies, CROs and life sciences organizations are able to more easily perform decentralized, virtual clinical trials. Now, industry leaders are on a mission to make the practice of administering decentralized clinical trials the norm.
Merck agreed to pay $215 million up front to acquire Alydia Health, a startup that has commercialized a medical device that controls bleeding during childbirth. That product will join the portfolio of Merck spinout company Organon.
Now that trials can happen nearly anywhere, privacy teams and lawyers need to understand how data is collected, stored, managed, disseminated, and ultimately, archived or deleted.
Omega Therapeutics has raised more than $210 million in the past eight months for R&D of medicines that regulate genes. The company’s lead therapeutic candidate addresses a validated but elusive cancer target.
UniQure is making a case for lifting a clinical hold on its hemophilia B gene therapy, reporting Monday results of an independent investigation that appear to clear the experimental treatment as the cause of a patient’s cancer.
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.
Regenerative medicine might someday provide replacement organs for transplant patients. But Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, explained how the technology is already helping in the discovery and testing of drugs.
Design Therapeutics raised $240 million in the biggest biotech IPO this week. One other rare disease drug developer went public along with two oncology biotechs as the IPO momentum continues.
With the increased reliance on digital technologies, pharma companies’ outreach to healthcare providers needs to be thoughtful, efficient, and respectful. An AI-driven, omnichannel strategy makes this possible by giving every member of customer-facing teams visibility across communications.
Founded by scientists behind the technology used in Johnson & Johnson’s Covid-19 vaccine, Leyden Laboratories is developing intranasal medicines intended to stop viruses before they infect the lungs. SARs-CoV-2 is one target, but the startup plans to address many respiratory pathogens.
California Attorney General Xavier Becerra may have won a narrow confirmation to be the Department of Health and Human Services Secretary, but if his past is any indication, his agenda will be bold when it comes to reining in pharma companies, boosting the Affordable Care… Read More »The “biggest thorn in President Trump’s side” is now HHS Secretary. What’s next?
AstraZeneca’s latest efficacy data for its Covid-19 vaccine are down slightly from the 79% it previously reported. The most recent data will form the basis of an application for emergency use authorization, which the company still expects to file with the FDA in coming weeks.
Ho Sung Cho, senior vice president of Biodiscovery Therapeutics at Bristol Myers Squibb, talks about lessons learned from drug discovery, recent success tied to Covid-19, and how the company is leveraging its expertise in protein degradation to develop novel therapies for blood cancers, solid tumors… Read More »In MedCity Pivot podcast, biopharma researcher talks about protein degradation, recent success tied to Covid-19 [Sponsored]
ProQR Therapeutics has encouraging data from an early-stage study evaluating its treatment for vision loss in the rare, inherited disorder Usher syndrome. The biotech now plans to advance its RNA therapy to two pivotal studies later this year.
Federal health authorities say safety observers are concerned AstraZeneca did not release complete information about the efficacy of its Covid-18 vaccine. The company responded by saying its data were from a pre-specified analysis and it will provide the most up to date efficacy data within… Read More »AstraZeneca’s Covid-19 vaccine data may have ‘outdated information,’ NIH cautions
Interluekin-2’s use as an immunotherapy has been limited by its severe side effects. Asher Bio is developing a version of IL-2 that the startup’s Chief Technology Officer Andy Yeung said could be more targeted and safer than other approaches.
With the extension to its Series A financing, XyloCor plans a clinical trial testing its gene therapy as an adjunct to coronary artery bypass graft surgery. A study in refractory angina is already underway.
Scientists at The Ohio State University are developing a cell therapy intended to regrow brain tissue damaged from ischemic stroke. Results from a study in mice were published in the journal Science Advances.
Instil Bio, one of several companies developing tumor-infiltrating lymphocytes, will use its IPO cash to advance its clinical testing plans. Meanwhile, Finch Therapeutics and Gain Therapeutics also priced IPOs to fund clinical trials.
Clinical tests of drugs from Gilead Sciences and Novo Nordisk have yielded encouraging results in nonalcoholic steatohepatitis (NASH), and the partners now want to see if the drug combinations help patients in a larger mid-stage study. The planned Phase 2b study expands on a 2019… Read More »Gilead and Novo Nordisk advance NASH collaboration to larger clinical study
Aktis Oncology is developing cancer radiation treatments intended to more precise and potent compared to other radiotherapies. The startup is now out of stealth with $72 million in Series A financing.
Given our current limited supply, the threat of variant spread, and availability of higher quality antibody test kits, policymakers ought to update their vaccine guidance for those who had Covid and incorporate recent research findings on immunity and vaccine efficacy.
In acquiring the two early-stage Sanofi drugs for sickle cell disease, Global Blood Therapeutics aims to complement Oxbryta, its FDA-approved treatment for the rare blood disorder. Meanwhile, Sanofi can turn its full sickle cell efforts on a gene-editing therapy partnered with Sangamo Therapeutics.
AstraZeneca is turning to digital technology to help patients and clinicians manage the treatment of chronic diseases. Though this technology isn’t tied to any AstraZeneca drug, the company believes such digital tools will become part of the new standard of care.
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.
While Covid-19 temporarily paused our ability to interact face-to-face, it also ushered in an era of global collaboration and the ability for life science teams to make decisions based on an expanded viewpoint.
Roche already sells a Covid-19 diagnostic. In acquiring GenMark Diagnostics for $1.8B, Roche is adding technology that can detect SARS-CoV-2 along with multiple respiratory diseases in a single test from a single patient sample—a capability the Swiss multinational company does not currently offer.
Grifols’s acquisition of GigaGen comes as the startup’s Covid-19 antibody drug is set to start Phase 1 testing. Barcelona-based Grifols says GigaGen’s technology could also help it expand to engineered antibody therapies.
Prometheus Biosciences is taking a precision medicine approach to developing drugs and diagnostics for inflammatory bowel disease. The IPO cash will fund support its pipeline of IBD drug candidates for specific patient subpopulations.
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.
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
While Covid has made many aspects of living with a rare disease more difficult, it has inspired policies and techniques that could help rare disease research progress more smoothly both during and after the pandemic.
Takeda Pharmaceutical and Maverick Therapeutics have been R&D partners since 2017. In buying out its partner, Takeda acquires technology and drug candidates that could offer advantages compared to CAR-T therapies, including the potential to treat solid tumors.
Like much U.S. primetime television, the broadcast of Oprah’s interview of Meghan Markle and Prince Harry carried a lot of pharma advertising. The sheer volume of those ads surprised many British viewers and also highlighted the volume of spending on the U.S. marketing of medicines.
Blue Cross and Blue Shield of Minnesota has filed a class-action lawsuit — on behalf of itself and insurers from 30-plus states — against Martin Shkreli and Vyera Pharmaceuticals. The suit alleges the defendants intentionally monopolized the market for Daraprim to raise the price of… Read More »Insurers sue ‘pharma bro’ Martin Shkreli, company for alleged price gouging
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.
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.
The pandemic has led pharma marketers to embrace digital marketing communications and the benefits of investing in telehealth platforms to engage physicians are numerous and provide a tremendous opportunity.
Antibody therapies from Brii Biosciences and Vir Biotechnology failed to show sufficient efficacy to advance to the next stage of an NIH-sponsored Covid-19 clinical trial. Apellis Pharmaceuticals and Durect also stopped work on experimental Covid treatments.
The acquisition brings Amgen a novel Phase 3-ready drug for gastric cancers. For Five Prime Therapeutics, the deal is a lifeline following a series of clinical and financial setbacks that left much of the biotech’s fortunes resting on its lead antibody drug.
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.
Takeda Pharmaceutical gains full rights to a small molecule that has shown promise treating seizures in several rare forms of epilepsy. Meanwhile, Ovid Therapeutics gains cash to support its pipeline of neurological disease drug candidates.
In an interview, BrightInsight Co-founder and CEO Kal Patel, MD, offered a preview of the report, The Role of Digital Health in Immuno-oncology Therapy Development and Adoption.
Many players in life sciences and other sectors balk at updating their compliance systems because of the cost and resources involved. but addressing possible lapses now can save your company millions of dollars in fines and reputational damage.
Novavax says it’s building up its manufacturing capacity now to be ready to ship Covid-19 vaccine globally as emergency authorizations are granted in coming months. The company expects to seek FDA authorization in the second quarter.
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.
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.
Roivant Sciences is expanding its drug discovery and design capabilities via a stock deal to acquire Silicon Therapeutics. The Boston startup uses physics-based modeling to simulate proteins and the small molecules that bind to them.
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.
Though GlaxoSmithKline’s drug otilimab missed the main goal of a mid-stage Covid-19 study, the company points to better data in a subgroup of older patients. GSK is expanding the study in patients 70 and older in hopes of replicating those results.
Merck’s top immunology drugs face biosimiliar competition. The $1.85 billion acquisition of Pandion Therapeutics gives the pharma giant an opportunity to build up its immunology pipeline with a new approach to treating autoimmune disorders.
Vividion Therapeutics has technology that enables it to develop drugs for “undruggable” disease targets. The Series C financing is a crossover round, an indication a biotech is preparing for an IPO.
The protein-based Covid-19 vaccine from Clover Biopharmaceuticals has distribution and storage advantages compared to messenger RNA vaccines. If the vaccine succeeds in a Phase 2/3 test, China-based Clover will distribute it globally via COVAX.
Base-editing biotech Beam Therapeutics engineered an all-stock buyout of Guide Therapeutics, a startup that finds, in vivo, the lipid nanoparticles that can deliver genetic medicines. Beam said GuideTx’s tech helps it address tissue types throughout the body, not just the liver.
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.
In the past year, Evox Therapeutics has inked alliances with two big pharma companies. The Series C financing now positions the biotech to advance to the clinic with its own exosome-based therapies.
Pfizer and BioNTech say they have data supporting two-week storage of their vaccine at temperatures found in medical-grade freezers. They say FDA approval of an additional temperature option would give vaccination sites more flexibility.
Eli Lilly is paying $125 million up front to team up with Rigel Pharmaceuticals on drugs that block a signaling protein involved in inflammation. With the alliance, Lilly joins Sanofi and Denali Therapeutics in the pursuit of drugs that block this protein.
Humacyte is going public via a SPAC merger that infuses it with $255 million for its regenerative medicine pipeline. The biotech’s technology produces universally implantable tissue that functions like human blood vessels.
Hospital counsel, state advisors, congregate care advocates and university leaders believe that public health ethics must drive the next steps in vaccine distribution and not the constraints of the law.
Join our live webinar with top MedTech sales experts to learn how to succeed in the digital revolution of medical device and healthcare sales.
The amended pact follows a collaboration begun last year when GlaxoSmithKline paid Vir Biotechnology $250 million to team up on potential treatments for Covid-19. The expansion includes an influenza treatment based on Vir’s antibody technology.
Cancer is a known risk of lentiviral-based gene therapies. Though bluebird says its gene therapy is engineered to avoid that risk, the company is suspending two clinical trials pending the outcome of its inquiry.
Ozette applies artificial intelligence to immune monitoring to gain greater insight into a cancer patient’s immune system. Beyond informing treatment decisions, the technology can guide drug and diagnostic development.
Ensoma contends its technology avoids the complexities of other approaches to gene therapy, which could expand genomic medicine’s reach to more patients and more diseases. Takeda Pharmaceutical is collaborating with the startup on up to five gene therapies.
The Biden administration should recognize that including high quality, patient-centered comprehensive medication management (CMM) services as the national standard of care will improve patient outcomes, reduce health care costs and save lives.
Amicus Therapeutics CEO John Crowley said the totality of data support the Pompe disease therapy’s submission to the FDA. That rolling application is on track for completion in the second quarter.
The FDA approval clears Regeneron’s drug, Evkeeza, as a treatment for the rarer of two forms of an inherited disease that causes high cholesterol levels. The company already markets Praluent, which treats the more common form of familial cholesterolemia.
Phase 2 testing of Cyteir’s lead cancer drug candidate later is slated to start later this year. The Series C round of funding includes crossover investors, whose involvement is a sign a biotech is preparing for an IPO.
The decision to discontinue all clinical trials for ziritaxestat is the latest setback in a broad alliance between Gilead Sciences and Galapagos. Last year, the FDA rejected a rheumatoid arthritis drug covered under the partnership.
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.
One year after losing Merck as a partner, KalVista reports mid-stage clinical data for a pill that could offer an alternative to injectable drugs for a rare, potentially life-threatening disease. KalVista plans to meet with the FDA about proceeding to a Phase 3 study.
Verily and Janssen say studying Covid-19 immune responses could yield data that helps clinicians treat the disease. They add that the research could also apply to other illnesses caused by respiratory pathogens.
Nautilus, among the biotechs developing protein analysis tools for drug discovery and diagnostics, already has a partnership with Genentech. As it prepares to go public, Nautilus aims to do for proteomics what Illumina did for genomics.
After some setbacks and delays, the FDA approved Bristol Myers Squibb’s Breyanzi for certain lymphomas. It’s the third CAR T treatment to win the regulatory nod and the first under a new regenerative medicine designation.
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.
Sana Biotechnology is turning new science into novel medicines intended to overcome limitations of current cell therapies. After going from stealth to IPO in two years, it’s now planning to bring multiple programs into clinical testing in 2022.
Medicare Advantage providers need to get ahead of the tide by proactively considering what they can do to suit their enrollees’ new, tech-savvy preferences — now and in the future.
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.
The therapeutic vaccine will be based on Gritstone Oncology’s technology and will use antigens from Gilead Sciences. It’s the latest in a string of partnerships Gilead has signed in its search for an HIV cure.
The startup pitch contest is part of our INVEST conference, April 19-23, which will be hosted online due to the Covid-19 public health crisis. It includes five tracks for startups: biopharma, medical devices, diagnostics, health IT and health services.
Researchers have known for decades that viruses can beat back cancer. But it’s been hard to design a virus that does the trick. A new wave of startups is optimistic they have found the keys.
Viagra’s successful launch gives drug companies a roadmap to building a humanized brand. But it also showed why, even in a pharma-friendly, post-Covid world, humanizing healthcare may be harder than it seems
Loki Therapeutics is advancing research that leverages the immune system’s ability to recall childhood vaccinations and direct it against cancer. The company’s lead therapy candidate could enter phase 1 clinical trials this year.
Covid-19 showed that pharma companies can be nimble and implement changes that prevent processes from weighing down on operations. But which of these operational and strategic changes will stand the test of time and make this year and the future bright for the industry?
Many pharma companies already donate drugs to charity. But the New Jersey-based entrepreneurs have developed a technology platform that makes the process easier to manage and opens up new opportunities.
Merck is discontinuing development of its two Covid-19 vaccine candidates. Instead, it plans to focus on two therapeutic candidates for the disease.
Like food deserts, pharmacy deserts have cropped up across the nation, which could further hamper the much-maligned Covid-19 vaccine rollout.
In its report released last Tuesday, a nonprofit drug pricing research group claims that seven drugs have prices that do not align with any newly discovered increase in clinical benefit, leading to over $1.2 billion in excess drug spending in 2019, alone.
Pharma companies moved fast in 2020 to tackle Covid-19 and to address longstanding issues of racial equity, the CEOS of BD and Sanofi said in a session at the J.P. Morgan Healthcare Conference. The challenge lies in keeping the momentum going in 2021.
Can we try to peel away the layers to see exactly what it is that makes the world’s largest vaccination rollout so daunting and complex? What is it that defines the level of complexity of a situation?
In this article, experts forecast upcoming AI developments that will help shape a new commercial model, making 2021 the year when AI shifts from early exploration to broad adoption.
The scientific adviser who guided U.S. efforts to speed up development of vaccines for Covid-19 is resigning at the behest of the incoming Biden administration.
Metagenomics applied in a rapid clinical setting was unthinkable just a few years ago but now can be deployed by any hospital with local deployment.
Vaccines developed by Aivita Biomedical use a patient’s own blood to attack cancer and Covid-19. But the company also offers a consumer skin-care product that it plans to begin selling more widely.
Host response can be identified by proteomic profiling, which involves analyzing a broad range of select proteins in a series of patient blood samples, with the first collected prior to treatment and the next collected after the first dose of treatment
The latest funding brings total investment in the company to $750 million. The money has gone, in part, toward licensing of promising drug candidates in breast, lung and other cancers.
Ugur Sahin presented a sweeping vision of the company’s goal to become a next-generation immunotherapy company leveraging the messenger RNA platform technology that has won it acclaim and financial returns during the Covid-19 pandemic.
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.
Advocates, industry leaders and legislators have come to a consensus about the scope and urgency of the crisis related to inadequate development of antibiotics. They are calling for legislative fixes to protect public health.
Founded in 2020, Scorpion is agnostic about the potential therapies and targets it will explore with what it describes as its drug-hunting engine. But the company is hoping to unveil its first drug candidate this year.
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.
With a global epidemic of obesity and diabetes and their known relationship to cancer, researchers and oncologists are turning their attention to metabolic hormones as promising new targets for cancer treatment.
The genomic test, known as Oncotype DX, can help predict whether women with certain forms of breast cancer will benefit from chemotherapy — and those who won’t. The latest trial results extend the test’s reach.
Covid-19 stands as a litmus test for pushing the boundaries of standardized research processes. Let’s use this shared focus, urgency, and the new partnerships being forged, to invigorate and accelerate cancer research.
Oncology diagnosis inclusing digital pathology, telehealth and physician access are just some of the areas where AI can have outsize impact in 2021
The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.
Beckman Coulter said it would file for an emergency use authorization for a SARS-CoV-2 antigen test that costs only $4.
By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.
What lessons can future Covid vaccine candidates take from the FDA’s response to Pfizer and Moderna’s study data?
The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person… Read More »Hospitals sue drug companies over discount program
Together, the two companies say can give drugmakers a better view at the cellular level of how a patient’s immune system is responding to a cerain therapy.
Ultimately, we should be excited about AI and its adoption in biopharma, but we should also stay sensible and focus our efforts where they’ll have the greatest impact.
To help clinicians diagnose rare disease more quickly and accurately, many healthcare organizations are embracing technology solutions like natural language processing (NLP) tools that can create augmented intelligence workflows that facilitate the rapid search of unstructured clinical data from multiple data sources.
In medicine, we’re getting real-time experience with what many believed was an inevitable but potentially […]
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 future of precision medicine will come only as quickly as doctors can pick out clinically useful information from the genetic data being gathered on their patients.
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.
Inertia is a barrier as is the traditional split between the clinical and the data-driven spheres of drug development. While smaller firms have an edge in bridging the gap, big pharma will eventually get there, said panelists at the INVEST conference session.
In the last 20 years, access to genetic testing has expanded significant as technology has advanced. But there’s still lots of work to be done to get tests covered and make them more accessible, panelists said at a virtual conference hosted by MedCity News.
Proscia and other digital-pathology firms promise to make pathologists more efficient as they analyze tissue. The need is driven by a steadily declining U.S. population of pathologists.
Interactive, cloud-based video games are designed to tackle pharma’s current challenge: engaging doctors virtually during a pandemic. But the tools are likely to outlive the circumstances in which they were born.
As part of our conferences and to augment panel discussions and presentations, we are launching MedCity News: Spotlight to use video to tell the story of important companies, executives and healthcare initiatives.
To reduce drug prices, we should focus on the complex drug channel arrangements that stand between manufacturers and patients and not as much on price controls.
It is time to make it our collective mission to bring data automation to patient recruiting for clinical trials and not wait for a resolution of the pandemic to manage clinical trial disruption.
Breaking Media’s MedCity News and Above the Law are collaborating to launch Healthcare Docket, a newsletter featuring the latest in litigation, regulation, transactions, and trends for in-house counsel in the healthcare and life sciences industries.
The contracts are complicated and full of risks for drug companies. But there’s also a risk to steering clear of the arrangements — reduced or restricted access to a company’s medication.
Unlike inherited genetic predispositions, accumulated genetic changes are the result of environmental influences, such as smoking, chemicals or ultra-violet radiation. A growing body of research links somatic changes to an increased likelihood of blood cancers and cardiovascular disease, both heart disease and stroke.
Salesforce reimagined a healthcare CRM bringing actionable information into one place to enable improved internal and external collaboration, communication, and smarter, data-based decisions.
All startups are invited to apply for our annual INVEST Pitch Perfect Contest that will take place virtually as part of our annual INVEST conference in April next year.
In this episode of the MedCity Pivot podcast, Daniel Levner, co-founder and chairman of the scientific advisory board at Sight Diagnostics, explains how computer vision is changing blood diagnostics.
The Covid-19 pandemic is altering behavior and fueling demand for remote technologies in clinical trials with Medable, a company in the clinical trial software space, looking to capitalize.
Recent efforts to improve transparency haven’t made much of a difference, one author noted. But earlier reforms made a dent the “most egregious” practices.
Opioid overutilization is a public health crisis, and PBMs with programs aimed at curbing abuse and educating providers can have a positive and substantial impact on clients and their members.
Here’s a preview of some of the panel discussions at INVEST Precision Medicine, including diagnostics, investment trends, and building a bioinnovation hub.
The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce 3 billion doses in 2021 with an emphasis on serving poorer countries.
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 authorization comes as Covid-19 testing demand threatens to swamp U.S. labs. However, it will take time for the Lucira test to become available nationwide.
Radiopharmaceuticals are highly specialized and require equipment, facilities, personnel, licensing and training that is significantly different from traditional pharmaceutical manufacturing.
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.
News of positive results from Pfizer’s Covid-19 vaccine is heartening but historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.
The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.
The nonbinding panel recommendation to reject the drug goes against what FDA scientists presented but they throw up another obstacle for the drug, which is trying to succeed on a front where others have failed.
Tumor boards can help physicians in developing countries get access to U.S. expertise and represent one way to democratize state-of-the-art care for cancer patients throughout the world.
The healthcare and pharmaceutical industries are people-centered by design. So how did tech companies become the default “brands that care”?
The deal will broaden Merck’s oncology portfolio as it picks up an antibody-drug conjugate, a class of biological drugs that target tumor cells even as the pharma giant jettisons other parts of its business
In the coming years, clinicians will be presented with a larger and more capable toolbox to aid in the diagnosis of sepsis, directly overcoming the drawbacks of culture-based diagnostics.
States are trying to strengthen their hand over drug prices in light of stalled federal efforts and their own budget crunches. The wildcard is whether the efforts will survive legal scrutiny.
Investing in new innovative RNA technologies can lead to rapid value creation, and Europe is a fertile ground to hunt for them.
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.
If pharmacists and technicians are properly trained at navigating the idiosyncrasies of managing medication with limited shelf-life, you’ll be in a better position to save on your pharmacy spend.
Even though Covid-19 is distinct from any health crisis the country has previously faced, assessing U.S. public health strategies during past crises can provide insight into what has contributed to a more or less equitable response.
Founded in 2017, Artidis has raised $15.1 million and hopes to enter the U.S. market for cancer diagnosis by 2022. But the startup first has to convince the FDA that its device works.
The deal, offering $2 billion up front and $2 billion in future milestone payments, includes a gene therapy manufacturing facility and a pipeline that includes treatments for Parkinson’s and congestive heart failure.
Massachusetts-based Be Biopharma will use the proceeds to build a team as it seeks to develop B-cell therapies for a variety of diseases.
The Food and Drug Administration approved Gilead’s antiviral drug as the first treatment for Covid-19 but just last week a WHO report showed that the drug appeared to have little to no effect on hospitalized patients.
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.
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
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
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
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.