‘Digitally native’ pharma Valo Health and Khosla scrap merger plan ahead of vote
Flagship Pioneering’s Valo Health and Khosla Ventures Acquisition Co. abandoned their SPAC merger on the eve of a scheduled shareholder vote on whether to approve […]
Flagship Pioneering’s Valo Health and Khosla Ventures Acquisition Co. abandoned their SPAC merger on the eve of a scheduled shareholder vote on whether to approve […]
Recognized as Method of the Year by Nature in 2020, spatial transcriptomics employs advanced imaging methods with novel chemistry techniques that stand to dramatically expand […]
Acelyrin has in-licensed izokipeb, an antibody drug developed by Affibody that could offer advantages compared to currently available monoclonal antibodies. The drug addresses the same […]
Polycythemia vera, a rare blood cancer characterized by the overproduction of red blood cells, now has its first FDA-approved drug treatment. The agency awarded the […]
While much progress has been made, many patients have molecular drivers of disease that are not detected, interpreted and acted upon with precision therapies, leaving […]
Beacon Biosignals technology analyzes EEGs to find insights brain activity. The company will use its new Series A financing to build alliances with more biopharmaceutical […]
Johnson & Johnson announced it plans to separate its consumer health products into a separate company, leaving the remaining business to focus on the more […]
Vaxxinity, a clinical-stage biotech with vaccine technology that gets the body to produce therapeutic or protective antibodies, raised $88 million from an IPO that priced […]
Organon’s proposed acquisition of Forendo Pharma is the company’s third the company since spinning out of Merck in the summer. Clinical-stage Forendo is developing a […]
Vaccine biotech Inventprise has developed technology that offers broader protection than currently available products. Its lead program, a pneumococcal vaccine candidate, is being readied for […]
Arbor Biotechnologies raised new cash to keep up the pace in the chase for new genetic medicines. The MIT spinout applies artificial intelligence and machine […]
Biohaven Pharmaceuticals has seen strong U.S. market uptake for its oral migraine drug, Nurtec. With regulatory decisions looming around the world, the company has landed […]
Alltrna, a biotech startup founded by Flagship Pioneering, is developing a new type of medicines based on a form of RNA called transfer RNA, or […]
Sanofi is committing up to $60 million to Gyroscope Therapeutics, a clinical-stage biotech whose lead program could become the first gene therapy for a particular […]
The team behind the World Without Disease Accelerator, part of Janssen Research & Development, one of the Janssen Pharmaceutical companies of Johnson & Johnson, is […]
Apple Tree Partners’ latest cancer biotech company, Marengo Therapeutics, is using antibodies to selectively activate T cells to fight cancer. Led by former Merck KGaA […]
Evotec is an old player in the life sciences, but in offering new shares on the Nasdaq, the Germany-based company plans to bolster its new […]
Lawmakers have acted to strengthen insurance reimbursement for biomarker testing in California, Illinois and Louisiana. Patient advocates and testing companies hope more will act in […]
PlateletBio trails Sanofi among others in pursuit of a new therapy for a rare blood clotting disorder that has few treatments. But the biotech startup […]
Novartis’s equity stake in Roche, shares acquired 20 years ago in a strategy to build up to a potential mega-merger, will be sold back to […]
Harvard University spinout GRO Biosciences has technology offering the potential for protein therapies that are safer and more effective than currently available biologic drugs. The […]
Amylyx Pharmaceuticals has submitted its amyotrophic lateral sclerosis (ALS) drug for FDA review based on positive Phase 2 data after discussions with the agency over […]
Gilead Sciences and BeiGene, which started research alliances with Shoreline Biosciences earlier this year, are among the investors in the biotech’s latest financing. The preclinical-stage […]
Covid-19 protocols may make re-opening or starting clinical trials seem like a daunting responsibility. Consider these four factors for a successful return to research.
Microsoft seeks to change the way pharma industry companies use technology to navigate human resource challenges and restore confidence in drug development supply chains.
Clinicians must be aware that coordination of care is one of the key factors to combat opioid epidemic and stop overuse of more powerful and […]
Breaking Media Inc. has announced Ken Montgomery as Publisher for MedCity News, the leading online news source for innovation in the healthcare industry.
New semiquantitative tests offer a more granular understanding of our protective immunity, not only identifying Covid-19 antibodies but providing direct, individualized measures of neutralizing antibody levels.
By all accounts, Ro is a successful direct-to-consumer telehealth and pharmacy services startup. At the recently-concluded HLTH conference, Ro’s chief medical officer speculated on how […]
Strados Labs has developed a wearable device that senses lung sounds in patients with asthma, COPD, and other respiratory disorders. The startup, which has FDA […]
Cancer drug developer Xilio Therapeutics and Ventyx Biosciences, a company with drug candidates in cancer and autoimmune diseases, are the latest life science companies to […]
ReCode Therapeutics closed an $80 million Series B round of financing that included Pfizer and Sanofi as investors. The startup’s technology uses lipid nanoparticles to […]
The FDA amended emergency use authorization of the Moderna and Johnson & Johnson Covid-19 vaccines, permitting booster shots. But the agency went further and said […]
Boehringer Ingelheim has shown biosimilar manufacturers the way to win interchangeability with the world’s highest-grossing drug — but the company’s Cyltezo won’t come out until […]
ShouTi Pharmaceuticals, a startup that brings computational techniques to drug discovery, has raised $100 million in Series B financing. The clinical-stage biotech designs small molecules […]
Entasis Therapeutics, the former anti-infectives unit of AstraZeneca, has positive Phase 3 data for its lead program, an antibiotic that could address drug-resistant strains of […]
An Oyster Point Pharma drug for dry eye disease has won FDA approval, the first treatment for the condition that comes as a nasal spray. […]
Biogen amyotrophic lateral sclerosis drug, tofersen, failed a Phase 3 clinical trial, but the drug showed improvement according to secondary and exploratory goals of the […]
A panel of data and biopharma experts at the annual HLTH conference in Boston tried to answer questions about where AI can be best used […]
A new startup initiative in Israel aims to create and invest in startups that use artificial intelligence to address challenges in drug discovery and development. […]
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after […]
Technology can assist sponsors in setting up trials and activating clinical trial sites quickly. But tech will only play a small role within the larger […]
Biomanufacturing technologies company Resilience is partnering with Harvard in a deal that could see innovations from the university’s labs commercialized under new businesses. Resilience has […]
Biotech startup Tentarix Biotherapeutics has come out of stealth with $50 million and technology that develops biologic drugs endowed with multiple functions. The company aims […]
Rectify Pharmaceuticals is taking an approach to disease that led to a successful franchise of Vertex Pharmaceutical lung drugs and expanding it to more diseases […]
By automating patient engagement, these organizations can reduce the burden on both resources and personnel in fighting this pandemic while improving efficiency in the administration […]
Bionano Genomics is acquiring genomics software firm BioDiscovery in a $90 million cash and stock deal. While both companies provide genomics analysis solutions, Bionano said […]
The progress of gene therapies continues to be stymied by safety risks associated with the viruses used to deliver them. Takeda Pharmaceutical is partnering with […]
Large majorities regardless of party identification and age found the following argument convincing: “Those in favor say negotiation is needed because Americans pay higher prices […]
Pyxis Oncology’s IPO raised $168 million as the biotech steers toward the clinic with drug candidates and technology licensed from Pfizer. Theseus Pharma, IsoPlexis, and […]
It is imperative for health systems to form data sharing partnerships that allow for the analysis of de-identified clinical data, while effectively and comprehensively protecting […]
ChemoCentryx has spent decades developing oral alternatives to injectable and infused biologic drugs that treat chronic autoimmune conditions. The research finally paid off with FDA […]
Good communication and engagement practices are critical to participant engagement and retention.
All of Allogene Therapeutics’ clinical trials are now under an FDA clinical hold. The halt was handed down after one patient in the company’s most […]
Bristol Myers Squibb drug deucravacitinib missed the main and secondary goals of a Phase 2 study in ulcerative colitis. Despite the clinical trial failure, the […]
Neumora Therapeutics unveiled $500 million in capital and a research partnership with Amgen. The startup analyzes neurological data to inform its drug research and development; […]
Vedanta Biosciences is developing its microbiome therapy with support from the Biomedical Advanced Research and Development Authority. Under terms of that contract, the positive Phase […]
Biotech startup Exo Therapeutics aims to overcome the challenges of drugging proteins by targeting exosites, locations that modulate enzyme activity. The company has four small […]
Given the suboptimal outcomes with existing therapies to manage chronic kidney disease patients on dialysis, there is a substantial unmet need that additional treatment options […]
Clinical-stage Xencor is receiving $100 million up front and a $25 million equity investment, while Johnson & Johnson’s Janssen Biotech subsidiary gets global rights to […]
Exscientia’s IPO and private placement raised $464 million to support its artificial intelligence-based approach to discovering and developing new drugs. In addition to partnerships with […]
Modern technology can now be used to extract critical information from contracts through the use of an AI-enabled Contact Lifecycle Management (CLM) system, an intelligent […]
Investing in patient engagement strategies that facilitate enrollment and keep people on board, on track, and on drug could be the answer developers have been […]
Diagnostics startup GRIP Molecular is developing an at-home test for Covid-19 and other respiratory infections. The technology builds on advances from several fields, including the […]
TrialSpark, a startup whose software manages various aspects of clinical trials, is becoming a drug developer. Led by CEO and cofounder Benjamine Liu, the company […]
Merck is looking for products that diversify its portfolio beyond reliance on cancer drug Keytruda, and it sees a potential blockbuster cardiovascular drug from Acceleron […]
The dirty secret that many life sciences and medical device companies don’t want people to know is that, to date, quality management has primarily been […]
Mirum Pharmaceuticals drug Livmarli is now approved to treat pruritus caused by Alagille syndrome, a rare liver disease that can worsen to the point of […]
Amicus Therapeutics is spinning its gene therapy pipeline into a separate entity that will go public via a SPAC merger. Executives say the transaction puts […]
Which capital funding options fit your healthcare or life science business?
The success of biopharma and medtech are not mutually exclusive. In some ways, medtech is […]
Cross-border biotech Anji Pharma closed $70 million in Series B funding to advance a drug pipeline that includes metabolic and cancer drugs. The biotech’s business […]
Eisai is seeking accelerated FDA approval of lecanemab, an Alzheimer’s disease drug that is part of a research alliance with Biogen. The drug is following […]
Bringing in market access and collaboration earlier in the process, viewing reimbursement as the last leg of the drug developmental journey, and collaborating across key […]
Delix Therapeutics is developing drugs that offer the therapeutic benefits of psychedelic drugs, but without the hallucinations and other side effects that accompany these compounds. […]
Biohaven’s bet on an AstraZeneca drug for multiple system atrophy does not pan out, failing a pivotal study in the rare, neurodegenerative disorder. But a […]
Life sciences companies are using “digital twins” for everything from drug discovery to manufacturing. A panel of experts at MedCity News’ INVEST Digital Health conference […]
Biotech startup GenEdit is developing polymer nanoparticle technology to deliver genetic medicines, an approach intended to avoid the limitations of viral vectors. Already partnered with […]
The FDA has authorized dosing of booster shots of Pfizer and BioNTech’s Covid-19 vaccine. Consistent with the recommendations of an FDA advisory committee, the agency’s […]
Algorithms are everywhere and so are the biases behind them. As algorithms find greater use in healthcare, a panel at MedCity News’ INVEST Digital Health […]
The Seagen and Genmab antibody drug conjugate (ADC), named Tivdak, is approved to treat cases of cervical cancer that have returned or spread following treatment […]
The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic […]
A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in […]
Bioprocessing technologies company Repligen is acquiring Avitide, and its biologics purifying technology, in a $150 million cash and stock deal. Repligen said Avitide will help […]
An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots […]
Rune Labs developed software that aggregates brain data, providing insights for clinical care and clinical research. Health systems are starting to adopt the technology, and […]
Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With […]
Dice Therapeutics raised $204 million from its IPO to support development of oral drugs that could compete against biologic drugs that are injected or infused. […]
Vanqua Bio aims to treat rare form of Parkinson’s disease by boosting activity of an enzyme that is deficient in patients who have a particular […]
Walking Fish Therapeutics is developing cell therapies from B cells, a type of immune cell that produces prodigious amounts of proteins. Cancer, autoimmune disease, and […]
AbbVie will take the lead on commercializing Regenxbio’s gene therapy in wet AMD and diabetic retinopathy. It’s AbbVie’s second major gene therapy deal this year, […]
Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing […]
The FDA issued a warning letter to Kaleido Biosciences alleging the company tested its experimental microbiome product in Covid-19 patients without submitting a formal clinical […]
Biotech startup iECURE is based on work from the University of Pennsylvania scientist, who has been researching ways to use in vivo gene editing as […]
Mammoth Biosciences is applying CRISPR technology to both diagnostics and therapeutics. With the new financing, CEO Trevor Martin said that the company is looking ahead […]
A-Alpha Bio’s technology analyzes millions of protein-protein interactions simultaneously, a capability that speeds up drug discovery research. Biotech industry partners are already using the technology […]
Roche is partnering with Adaptimmune Therapeutics to develop allogeneic cell therapies based on Adaptimmune’s technology. In addition to these “off-the-shelf” products, the partners will also […]
A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study […]
Unleashed from restrictive norms for recruiting and interacting with patients, researchers are finding ways to bring more people into trials by simply making enrollment and […]
Modulus Therapeutics recently emerged from stealth with technology from various disciplines and seed funding that the startup is using to develop better cell therapies. Natural […]
The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It […]
A Novartis drug intended to prevent organ rejection has failed to beat out the standard of care therapy in a Phase 2 study in kidney […]
Tools like eConsent provides organizations with an efficient and streamlined way to garner consent from study participants. Removing this barrier can help improve engagement and […]
A Roche drug that failed as a treatment for neurological disorders is now the lead program for Disc Medicines. CEO John Quisel said Roche’s clinical […]
Four patients dosed with an experimental Assembly Biosciences hepatitis B treatment developed high levels of liver enzymes, a sign of drug-induced liver toxicity. The biotech […]
The FDA’s review of a post-marketing study for Pfizer blockbuster anti-inflammatory drug Xeljanz found a higher risk of cardiovascular problems and cancer, and the agency […]
Five months after raising $55 million to back a new technology and a promising lead cancer immunotherapy, Asher Biotherapeutics has reeled in $108 million more. […]
Johnson & Johnson reported results from a mid-stage study in southern Africa showing just 25% efficacy for its HIV vaccine. J&J developed the HIV vaccine […]
Novartis was unsuccessful developing bimagrumab as a treatment for a rare muscle disorder, but additional tests showed encouraging results in fat reduction. Startup Versanis Bio […]
After more than a year’s worth of interviewing external experts, the Pivot podcast is turning its gaze inward to demystify — as much as possible […]
One of science’s great puzzles is being solved by artificial intelligence and the answers shared freely on the internet. How can life sciences companies make […]
Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the […]
Full FDA approval of Pfizer and BioNTech’s Covid-19 vaccine was the biggest news in a busy week for coronavirus vaccines, drugs, and diagnostics. Here’s a […]
The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common […]
As a result of the partnership, clinicians using Epic will be able to order Foundation Medicine’s genomic profiling tests directly from the EHR and view […]
Atavistik Bio is one of several companies discovering and developing drugs that work by allostery, binding to less obvious sites of a target protein. Acting […]
The royalty agreement with HealthCare Royalty Partners will support ADC Therapeutics’ plans to commercialize its newly approved cancer drug and develop the next one in […]
Eli Lilly is entering the field of protein-degrading drugs through a partnership with Lycia Therapeutics, a startup whose technology goes further than the first wave […]
Each Organ-Chip is a transparent, flexible microenvironment that contains two parallel chambers that can be configured to grow human cells from an organ of interest, […]
Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the […]
Called Novasenta, the company is focused on the tumor microenvironment and will leverage its machine-learning platform to pinpoint targets for drug development. It aims to […]
The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to […]
Though Gilead Sciences leads the group of companies developing immunotherapies that target the cancer protein CD47, Pfizer contends that molecules it is getting through the […]
Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart […]
CG Oncology CEO Arthur Kuan talked about the biotech company’s experimental bladder cancer treatment in Phase 3 development and collaboration with Merck, among the company’s […]
Vigil Neuroscience led the way with a $90 million round of funding, one of four biotech companies to close Series B financing rounds in the […]
An AstraZeneca antibody drug for Covid-19 has clinical data showing the drug reduced the risk of infection by 77%. With the results, the pharmaceutical giant […]
Alexion Pharmaceuticals drug Ultomiris is already approved to treat a rare blood disorder, but the company hoped the antibody’s approach could also work in amyotrophic […]
MedCity News has launched the Knowledge Hub to help you get targeted healthcare leads and scale your business, at no upfront cost to you.
In closing its Grail acquisition before U.S. and European regulators sign off, Illumina is taking a chance the deal will pass regulatory muster. It’s a […]
In announcing plans to offer Covid-19 booster shots, federal health officials cited declining vaccine efficacy shown by real-world studies. But the World Health Organization said […]
Verily’s recent moves have signaled the company’s interest in supporting decentralized clinical trials and real-world studies. Now the life sciences subsidiary of Alphabet is bolstering […]
Gritstone bio is developing Covid-19 vaccines that use self-amplifying messenger RNA, which is intended to further boost the immune response compared to mRNA alone. The […]
Startup HiberCell has acquired Genuity Science, a marriage that brings together two companies that apply AI and machine learning to drug research. HiberCell says Genuity […]
For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen […]
FDA approval of the Merck drug, belzutifan, covers treatment of tumors caused by von Hippel-Lindau disease, an inherited disorder associated with several types of cancer. […]
It’s essential for physicians to consider the circumstances of their patient’s life while communicating the treatment plan and engage them with dialogue that addresses any […]
Technological innovations have enabled the adoption of decentralized and hybrid clinical trial models (DCTs) at […]
The pandemic made collaboration necessary between stakeholders that otherwise tend to be at odds with each other. But as partnerships grow, providers, payers and pharma […]
A study of women’s participation in cardiovascular clinical trials revealed that only 38% of participants were women. But if women comprise 50 percent of the […]
When is a skinny label skinny enough to protect a generic drug from claims of patent infringement? The answer remains up to interpretation after an […]
An increasingly compelling benefit of digital transformation, across numerous industries, is the ability to construct a digital twin—that is, a full in silico replica of […]
As commercial outsourcing becomes more sophisticated, it allows for greater innovation as small and ambitious biotech companies are given the strategic power to bring to […]
The short answer is that cancer vaccines represent no silver bullet but, in combination with other immunotherapy and drug cocktails, can prove potent.
U.S. government support can advance health breakthroughs and make a significant difference. I encourage you to support the creation of ARPA-H and to take specific […]
The artificial intelligence-based technology of Iterative Scopes brings computer vision analysis to endoscopic images. The startup’s technology was initially developed to assist gastroenterologists in finding […]
An AstraZeneca lupus drug has been awarded FDA approval for treating the most common form of the autoimmune disorder. The regulatory decision gives AstraZeneca a […]
Ipsen is shoring up its neuroscience pipeline via a deal that gives it the option to license drugs that Exicure is developing for Huntington’s disease […]
Of the 20 companies that went public in the last week of July, 11 of them represent some aspect of the life sciences. The tally […]
Icosavax’s research developing a vaccine for a virus that can lead to deadly respiratory infections in the very young and the very old has found […]
Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational […]
Sarah Boyce knows she is a rare breed – a female biotech CEO. In this episode, Boyce talks about the novel therapy she is trying […]
Eli Lilly is beginning a research alliance discovering and developing small molecules that stimulate immune responses against cancer. If drugs from the partnership reach the […]
The engineered viruses used to deliver gene therapies can spark complications and they can’t be re-dosed. Ring Therapeutics says viruses that evolved with humans can […]
Amgen is paying $900 million up front to acquire Teneobio, a biotech with technology for discovering and developing antibody drugs. Though Amgen already has its […]
The hedge fund SS&C Technologies Holdings will be the majority stakeholder, while the two payers will each hold a minority interest in the PBM, dubbed […]
AC Immune is bolstering the Parkinson’s disease portion of its drug pipeline with a deal to acquire a therapeutic vaccine that Affiris is developing for […]
Blending computational biology and AI-based methods, the goal is to identify new targets, pair these with effective chemistry, and define biomarkers to optimally position novel […]
Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary […]
An Incyte drug developed as a treatment for a rare type of anal cancer has fallen short of FDA approval. The regulator said it needs […]
Adverum Biotechnologies still doesn’t know if its experimental gene therapy caused eye problems reported in April in one patient in its diabetic macular edema study. […]
Caribou Biosciences’ CRISPR approach to cell therapy sparked strong investor interest, enabling the clinical-stage biotech to upsize its IPO and raise $304 million in the […]
Arvinas’ early clinical data for its targeted protein degradation drug for breast cancer drew partnering interest from several companies. Pfizer beat them all with a […]
Legislators threaten to ban settlements where branded companies “pay” generics makers to “delay” market entry, while drugmakers say the current framework balances competition and innovation. […]
Seres Therapeutics’ ambitions to treat ulcerative colitis with a microbiome drug were dealt a setback as its experimental therapy failed in Phase 2 testing. The […]
DNA sequencing company Pacific Biosciences has reached a $600 million agreement to acquire Omniome, a startup with complementary sequencing technology. The cash and stock deal […]
Many believe that the biosimilar industry can address the issue of spiraling drug costs, but first it has to make it through a thicket of […]
Opportunities exist in many areas of the industry, and patients are hungrier than ever for more engaging and humane experiences. For D2C brands that are […]
DTx helps reduce mental health stigma that is a barrier for underrepresented populations to receiving mental health care and if developed with intention and within […]
An amyotrophic lateral sclerosis drug from Amylyx Pharmaceuticals is being prepared for Phase 3 clinical testing on track to begin later this quarter. To support […]
Cancer drug developer Frontier Medicines already has a research partnership with AbbVie. Now the preclinical-stage biotech has raised $88.5 million for its own pipeline, including […]
An efficient way to create patient-focused educational materials is putting together a strategic group focused on consumers, which includes a medical expert, allied health professionals […]
A Cytokinetics drug in development for treating a rare heart disorder has promising Phase 2 data suggesting it could compete against a Bristol Myers Squibb […]
Research organizations can participate in ethical data sharing today by considering participants’ privacy and security and balancing the need to protect their commercial interests with […]
Vaxneuvance, a Merck pneumococcal vaccine, is now approved by the FDA. The intramuscular shot protects against 15 pneumococcal strains—five fewer than the 20 covered by […]
Cancer drug developer Erasca, whose mission is to “erase cancer,” has raised $300 million from its IPO. The clinical-stage biotech addresses a single elusive cancer […]
The FDA has yet to approve a therapy for memory loss. Nia Therapeutics is developing a medical device that stimulates the brain to bring it […]
Wugen, a biotech developing “off-the-shelf” natural killer and CAR T cell therapies, has raised $172 million in Series B financing. The company’s lead program has […]
Startup PAQ Therapeutics is developing drugs work like Pac Man, gobbling up components of a cell associated with disease. The biotech has closed $30 million […]
By paying $125 million up front for rights to multiple sclerosis drug candidate orelabrutinib, Biogen secures a place among those companies trying to treat the […]
The FDA is cautioning that the Johnson & Johnson Covid-19 vaccine may cause a rare immune response affecting the nerves. A causal link has not […]
ProfoundBio is developing a type of targeted cancer therapy called antibody drug conjugates. As the biotech looks ahead to clinical trials, it has raised more […]
Novo Nordisk is paying $100 million up front to acquire an experimental Prothena drug being developed to treat heart problems stemming from a misfolded protein. […]
The FDA has approved Bayer’s Kerendia to treat chronic kidney disease in patients with type 2 diabetes. The drug is the first in its class, […]
A hemophilia A patient in a Sigilon Therapeutics clinical trial developed a well-known complication to treatments for the blood disorder. The potential problem for Sigilon […]
Xilis is developing technology that creates a living model of a patient’s tumor, then applies artificial intelligence to determine the best drug or drug combinations […]
The drug label for Biogen Alzheimer’s disease drug Aduhelm has been revised to clarify that its use is for patients with mild forms of the […]
Eli Lilly is partnering with startup Verge Genomics in a move intended to add ALS drugs to its neuroscience pipeline. To date, Verge’s artificial intelligence […]
A NeRRE Therapeutics drug that failed a clinical trial for refractory or unexplained chronic cough is getting a second shot as a potential treatment for […]
Where chatbots really excel is in rapidly delivering reliable content in response to the recipient’s actual needs, questions, or concerns. That allows AI tools to […]
Two months after Eli Lilly began an alliance with MiNA Therapeutics, a startup developing a new type of RNA therapy, the pharmaceutical giant is making […]
Biden has proposed a $9 billion increase in funding for the National Institutes of Health (NIH), of which $6.5 billion will be earmarked for a […]
Intellihealth has developed software puts patients on a personalized program to lose weight. The startup was named by judges as the winner in the health […]
Four years after a private equity acquisition took Parexel private, the contract research organization is being acquired by two private equity firms for $8.5 billion. […]
Acumen Pharmaceuticals’ IPO raised $160 million to fund clinical development of its Alzheimer’s disease drug candidate. Though that drug goes after the same target as […]
Despite mounting court and legislative scrutiny of pharmacy and prescription benefit manager practices, Amazon has chosen to throw its hat into the discount pharmacy ring. […]
We need to embrace principles from the tech industry and incorporate lessons learned from the pandemic to address the challenges of R&D productivity in pharma.
Fresh off its first FDA approval, Apellis Pharmaceuticals is teaming up with Beam Therapeutics, a partnership that will use Beam’s base-editing technology to develop new […]
It’s imperative that we remember that humans are animals. By ignoring this key association, we’re limiting the advancement of science, including the identification of breakthrough […]
Pardes Biosciences advanced from concept to drug candidate in less than nine months. The preclinical biotech is developing an oral antiviral for Covid-19 and other […]
Sanofi, already a global leader in vaccine production, has formed a new division that will focus exclusively on developing messenger RNA vaccines. The pharmaceutical giant […]
Orphazyme’s corporate restructuring comes less than two weeks after the FDA rejected arimoclomal, a drug developed to treat the rare Niemann-Pick disease type C. The […]
Intellia Therapeutics has early clinical trial data showing that its CRISPR-based therapy for a rare disease can edit genes inside the body safely and effectively. […]
The FDA has granted emergency use authorization to a Roche antibody as a treatment for hyperinflammation in patients hospitalized with severe Covid-19. The drug, Actemra, […]
This pandemic has shown that collaboration, biosimulation and decentralized trials, and active preparedness programs lead to fast, effective drug development when we really need it. […]
Systems Oncology has used its its artificial intelligence to discover small molecules in development under partnerships with large pharma companies. The R&D of the company, […]
Lyell Immunopharma and Verve Therapeutics are still preclinical, but they’re bring novel genetic approaches to the treatment of cancer and cardiovascular disease. Now the two […]
A Covid-19 vaccine candidate based on messenger RNA technology from CureVac is showing 47% efficacy according to an interim analysis of a pivotal study. The […]
The pharmaceutical industry should be leading the development and implementation of decentralized clinical trials (DCTs) given their expertise in clinical research.
A Sage Therapeutics depression drug that failed a pivotal study in 2019 has positive preliminary results from a new Phase 3 clinical trial, but the […]
there is an urgent need to support the development of diverse and differentiated, multi-mechanistic and potentially complementary therapies, that are effective against Covid-19, are unaffected […]
As an industry, we should be proud of all that we have accomplished in making precision medicine a reality, whether it has been through advances […]
The American Society of Clinical Oncology’ annual meeting featured news highlights from the Merck, Novartis, and other drug giants. Meanwhile, some small biotechs rode the […]
New technologies that enable precision medicine approaches to treating disease are reaching more patients. But panelists speaking at MedCity News’ INVEST Precision Medicine Conference added […]
Senda Biosciences is developing drugs based on an understanding of intersystems biology—the way that humans interact with bacteria and plants. The startup, founded by Flagship […]
Six years after initially filing suit against CVS, insured customers of the pharmacy giant who charge that it misrepresented the “usual and customary” prices of […]
Valo Health is going public in a SPAC merger. Less than nine months removed from its formal launch, Valo is now revealing more about its […]
A Biogen Alzheimer’s drug that clears amyloid plaque from the brain has been granted accelerated approved by the FDA. The drug, which will be marketed […]
Cancer drug developer Merus has encouraging early results indicating its drug can address several different types of tumors characterized by NRG1, a rare gene fusion. […]
Stablix Therapeutics is developing technology that uses small molecules to stabilize a protein, keeping it from going to a cell’s built-in disposal system. The startup […]
Emergency authorization of Regeneron Pharmaceuticals’ Covid-19 antibody drug now includes an injectable version, which is a more convenient option for patients. The drug developer plans […]
Novartis reported Phase 3 study results for a targeted radiation therapy showing that treatment helped patients with advanced prostate cancer live longer. The company will […]
Auris Medical has acquired Trasir Therapeutics, a startup developing technology that expands the delivery of RNA medicines to tissues beyond the liver. Going forward, Auris […]
The FDA has approved Brexafemme, a Scynexis antifungal drug, for treating vaginal yeast infections. The drug is the biotech’s first FDA-approved product and it also […]
Amgen is paying Kyowa Kirin $400 million to share in the development of a drug that could offer a new approach to treating atopic dermatitis, […]
Digital health startups and pharma industry players sometimes don’t speak the same language, and the culture gap has led to failures in the past. A […]
In response to emailed questions, Castor CEO Derk Arts talks about how he formed the clinical trial tech startup to improve the drug development process.
Three life science companies went public in the last full week of May. The biggest IPO belonged to Centessa Pharmaceuticals, a company that raised $330 […]
FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS […]
Data captured in EHR systems provide near real-time information about the nationwide vaccine rollout, help monitor potential safety issues, and foster understanding of the Covid-19 […]
FDA authorization of the Covid-19 antibody drug from Vir Biotechnology and GlaxoSmithKline adds a third antibody drug for treating early cases of the disease that […]
We urge Congress to quickly pass the NOPAIN Act and help fight the opioid epidemic with the same fervor we’ve battled Covid-19.
Can an industry coalition help craft policy to support the use of Real-World Evidence? Five prominent real-world data and analytics companies are betting on it, […]
Engine Biosciences closed a $43 million Series A financing that the startup will apply to its artificial intelligence-based technology for drug discovery. The company analyzes […]
IQVIA is paying nearly $200 million to purchase a Myriad Genetics subsidiary that provides pharmaceutical contract services , a deal that will put the new […]
Moderna released preliminary clinical data showing its Covid-19 vaccine produced efficacy in adolescents that was comparable to what was seen in adults. The company plans […]
An NGM Biopharmaceuticals drug candidate for the fatty liver disease NASH failed a Phase 2b study less than a year after the company reported positive […]
Johnson & Johnson subsidiary Janssen was awarded approval for Rybrevant, the latest in a string of decisions for targeted therapies for non-small cell lung cancer. […]
CVS has launched a new clinical trials services business that will help drug companies and contract research organizations recruit clinical trial volunteers. The new business […]
Biogen is reaching across the Charles River, striking up a gene therapy manufacturing alliance with synthetic biology firm Ginkgo Bioworks. Ginkgo will use its technology […]
Eli Lilly diabetes drug tirzepatide beat long-acting insulin in the last of a series of global studies designed to support regulatory submissions for the type […]
Bristol Myers Squibb reported Phase 3 data that show its experimental cancer immunotherapy relatlimab, combined with the company’s blockbuster drug Opdivo, was better at stopping […]
BlueRock Therapeutics, a Bayer subsidiary, is teaming up with Opsis Therapeutics and Fujifilm Cellular Dynamics in an R&D pact focused on developing stem cell therapies […]
New investment company eureKARE aims to find promising microbiome and synthetic biology research in Europe and create new companies around that science. EureKARE has three […]
Bristol Myers Squibb already has a cancer program targeting the TIGIT protein, but in acquiring rights to Agenus’s drug, the pharma giant adds a bispecific […]
The FDA approved Apellis Pharmaceuticals drug pegcetacoplan (Empaveli) as a treatment for a rare blood disorder that is currently treated with medicines sold by Alexion […]
Sanofi and GlaxoSmithKline reported positive preliminary Phase 2 data for their Covid-19 vaccine. Though several vaccines have been authorized, the companies say that their vaccine’s […]
A Biogen gene therapy for a rare, inherited eye disorder that leads to blindness has failed a key clinical trial. The preliminary results are the […]
Interline Therapeutics has technology that shows how proteins interact as communities, paving the way for the discovery of new drugs. CEO Zachary Sweeney, a Denali […]
Heron Therapeutics is positioning its drug, Zynrelef, as a way to help patients avoid addictive opioid painkillers following surgery. The extended-release formulation offers analgesic effects […]
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