Biogen adds to neuro drug pipeline with acquisition of stroke drug from TMS
Biogen paid $18 million to acquire a drug that TMS Co. of Japan tested in patients with acute ischemic stroke. The acquisition follows the report […]
Biogen paid $18 million to acquire a drug that TMS Co. of Japan tested in patients with acute ischemic stroke. The acquisition follows the report […]
Perceptive Advisors has $515 million for its second fund investing in biotech startups. Portfolio Manager Chris Garabedian says Perceptive Xontogeny Ventures Fund II is looking […]
The coronavirus pandemic is highlighting the potential of public-private partnerships (P3s) to bring together diverse groups to address issues of population growth, rising healthcare costs […]
The FDA has expanded emergency use of the Pfizer/BioNTech Covid-19 vaccine to include children 12 to 15 years of age. Meanwhile, the regulator is planning […]
The messenger RNA vaccine developed by Pfizer and BioNTech has been formally submitted for FDA approval. The application comes amid calls for all vaccine companies […]
Three biotechs IPOs priced this week while one gene therapy developer postponed its plans. The biggest IPO belongs to Talaris Therapeutics, a company developing a […]
Patient-generated healthcare data will catalyze a fundamental shift in the way we measure success in medicine – from looking at a series of clinical outcomes […]
Read about news from life science companies Emulate, Astrocyte Pharmaceuticals and Bone Health Technologies.
Becton Dickinson is known worldwide for its diabetes products. Now the medical technologies giant plans to spin off its diabetes care business as a separate, […]
Dyno Therapeutics’ technology for designing viral vectors that deliver gene therapies has led to partnerships with Novartis, Sarepta Therapeutics, and Roche. With the Series A […]
Eikon Therapeutics joins a growing number of startups researching how proteins move in cells as a basis for drug discovery. Roger Perlmutter joins Eikon as […]
Cell therapy manufacturing is currently a manual, multi-step process that takes weeks. Startup Cellares, which is developing a system that automates the process and makes […]
Neuroelectrics is planning a pivotal test of its wearable medical device, which delivers brain electrical stimulation to treat epilepsy. The startup’s Series A round of […]
Founded by former hedge fund manager Vivek Ramawamy, Roivant Sciences set out to redefine drug development by acquiring overlooked drugs and advancing their development. The […]
Affinia Therapeutics, which has technology that could deliver gene therapies to more tissue types in the body, raised the Series B financing as it looks […]
Capsida Biotherapeutics’ technology can engineer viral vectors that deliver gene therapies to central nervous system cells. With that capability gave the startup was able to […]
Vaccitech and Werewolf Therapeutics joined the public markets, raising a combined $230 million. The vaccine developer and the cancer immunotherapy biotech will apply the IPO […]
The science of using sensor data to define, measure, and create mathematical models of disease can lead to better outcomes—and huge benefits—for everyone in healthcare […]
Adverum Biotechnologies reported that a diabetic macular edema patient treated with the biotech’s experimental gene therapy developed complications, including blindness, in the treated eye. The […]
Boundless Bio’s research has uncovered a previously unknown driver of cancer growth and drug resistance. With $105 million in Series B financing, the biotech is […]
Seasonal allergy sufferers have a plethora of choices for treating the itching and redness affecting their eyes. An experimental Aldeyra Therapeutics drug that takes a […]
Several companies are developing immunotherapies targeting the “don’t eat me” cancer protein CD47. Arch Oncology, which is developing drugs with features that could set them […]
Too many cold chain suppliers are still monitoring deliveries and storage compliance with paper-based documentation by individuals scanning thermometers every two hours. Such systems fall […]
Plant-based drug discovery may be tens of thousands of years old, but in 2021, it feels exciting, rich, and full of potential. Companies are rapidly […]
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 […]
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 […]
Alnylam Pharmaceuticals has filed for FDA approval of vutrisiran, which could become the biotech’s fourth drug that works by RNA interference. Meanwhile the company is […]
As researchers and clinicians understand and embrace the advanced insights genetic and genomic testing can deliver, the industry is poised to dramatically reduce the incidence […]
Covid-19 showed how technology can upend the old ways of clinical trials. Panelists at MedCity’s INVEST conference said it’s highlighting the importance of improving clinical […]
The five life sciences IPOs this week continues the steady march companies are making to the public markets this year. This week’s activity follows a […]
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 […]
Value-based contracts covering the reimbursement of drugs and medical devices are slowly gaining acceptance. A panel at the MedCity News INVEST conference discussed the challenges […]
Vertex Pharmaceuticals is collaborating with Obsidian Therapeutics to develop up to five new gene editing therapies. Obsidian’s technology precisely controls protein expression, a capability the […]
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 […]
Vertex Pharmaceuticals is amending its collaboration with CRISPR Therapeutics, paying $900 million now for chance to grab a bigger share of a gene-editing therapy’s profits […]
Antibody therapies are seen as one way to overcome the variants that continue to fuel the pandemic. With its Series C financing, Adagio Therapeutics, led […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 positive data for the antibody drug from Vir Biotechnology and GlaxoSmithKline give a clearer picture of how and when these treatments could help. Last […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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. […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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, […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 — […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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? […]
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 […]
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 […]
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 latest funding brings total investment in the company to $750 million. The money has gone, in part, toward licensing of promising drug candidates in […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
The genomic test, known as Oncotype DX, can help predict whether women with certain forms of breast cancer will benefit from chemotherapy — and those […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
The company hopes to use the money to bring its T-cell antigen coupler cell therapy technology – currently in preclinical development – into human clinical […]
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 […]
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. […]
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 […]
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 […]
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