Atopic dermatitis patients now have a new option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the inflammatory skin condition, but the regulatory nod comes with a black box warning on the label that broadly covers the entire class of JAK inhibitors.
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 with chemotherapy. Tivdak is Seagen’s third ADC; for Genmab, the drug will become its first commercialized product.
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 product have approval to treat three eye conditions that lead to vision loss.
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 an older age group. With these preliminary data, the companies said they plan to seek emergency use authorization of the shots.
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 it meet growing demand for gene therapy solutions.
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 in certain high-risk groups, such as the elderly. Panelists want to see more information supporting the need for a booster, as well as data about a heart safety risk the …
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 the startup has now raised $22.8 million to grow that part of the business while also expanding use of the technology in drug development.
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 the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.
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. Also debuting on the public markets were Tyra Biosciences and Procept BioRobotics.
The clinical trial failure of Theravance Biopharma’s most advanced internal program, a drug for a rare blood pressure disorder, is leading to a companywide restructuring. Going forward, the biotech will focus on developing drugs for respiratory disorders.
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 genetic mutation. With $85 million in Series B financing, the biotech startup, which is based on Northwestern University research, aims to reach human testing within two years.
The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy for a rare neuromuscular disorder. Astellas said the cause of death is still under investigation, and the FDA has placed a clinical hold on the study.
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 regenerative medicine are among the targets of the preclinical-stage biotech, which unveiled $50 million in funding.
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, coming months after it committed $90 million to preclinical-stage Capsida Biotherapeutics.
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 of a submission from vaccine developers. U.S. health officials told Reuters they expect the Pfizer/BioNTech vaccine will be the first one ready for an FDA submission.
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 trial application. Kaleido claims the filing was not required because the product is a medical food, but the regulator doesn’t buy that argument.
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 a way to “knock in” healthy versions of a gene to treat rare liver diseases. The company, which will develop therapeutic candidates from Penn, has raised $50 million in Series …
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 toward clinical trials and perhaps partnerships with larger companies.
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 and now with $20 million in Series A funding, the startup plans to build machine-learning capabilities to crunch the data produced by all of those protein interactions.
The cash deal brings to Sanofi the Kadmon Holdings drug Rezurock, which the FDA approved in July as a treatment for chronic graft versus host disease. The French pharmaceutical giant will add Rezurock to a lineup of older products marketed globally for transplant procedures.
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 develop a personalized allogeneic cell therapy designed specifically for a patient’s cancer.
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 showed that some mice developed liver tumors. Patients did not receive the same high dose that was given to the mice, and no one in the clinical trial has developed …
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 participation accessible beyond restraints like geography and availability during “business hours.”
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 killer cells directed against breast cancer is Modulus’s initial focus, but the startup says its approach can apply to multiple types of immune cells and multiple types of cancer.
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 marks the first approval for the Seattle company, which has developed a proprietary nasal delivery technology.
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 transplant patients. Other clinical trial failures announced ahead of the Labor Day weekend include a Forte Biosciences atopic dermatitis drug, as well a cancer therapy from Takeda Pharmaceutical.
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 deeper the pool of potential participants.
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 data showed the small molecule’s promise addressing a rare blood disorder and now the biotech startup has $90 million to advance that drug and another one into Phase 2 testing.
INVEST Digital Health is set for September 20-23, and held in collaboration with Medical Alley. The healthcare conference, held in a virtual format due to Covid-19, brings together innovative investors across the healthcare spectrum, prominent industry players and the most promising digital health startups.
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 has decided to stop further work on that drug and focus instead on developing its other clinical-stage hepatitis B drugs.
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 is requiring additional warnings flagging those risks. The updated warnings extend to AbbVie and Eli Lilly medicines in the same drug class.
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. CEO Craig Gibbs said investors were enticed by encouraging new data suggesting Asher Bio’s lead program is superior to a competitor’s.
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 with the same technology used in its successful Ebola and Covid-19 vaccines.
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 licensed rights to the antibody and plans to use its Series A financing for clinical trials testing the drug in obese patients.
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 — why we write the stories we write.
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 the most of DeepMind’s discoveries while protecting their own?
Tie-ups of candy makers and nutritional product companies into a single firm called Bettera has culminated in a $1 billion acquisition by Catalent. The global contract manufacturing giant plans to leverage Bettera’s ability to produce gummies and chewables as a way to offer its customers new formulation options for nutraceutical products.
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 future of that drug and others might depend more on an FDA review of safety data for medicines in this class of so-called JAK inhibitors.
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 look back at some of the major developments.
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 cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.
Clinical trials are the safest and most trusted route for identifying new breast cancer treatments, and the more research that can be done, the closer we will be to eradicating breast cancer for good.
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 results in the system, providing them with clinical decision support.
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 CEO John Josey said the startup aims to stand apart with its focus on understanding metabolic interactions, a path less trodden by others in allosteric drug discovery.
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 its pipeline. The biotech’s drug Zynlonta is the first of its type approved by the FDA as a treatment for diffuse large cell B-cell lymphoma
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 of such drugs. Lilly paid $35 million to begin the alliance, which spans up to five drugs.
As U.S. plans for Covid-19 booster shots unfold, Johnson & Johnson is angling to join the mix, reporting data that it says support a second shot of its vaccine. But the data the company points to are sparse and it’s not entirely clear they support booster shots.
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, such as the liver, kidney proximal tubule, intestine, lung and brain
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 FDA’s nod green light for its injectable drug, Korsuva.
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 launch its first clinical trial by the end of 2023.
The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to develop the JAK inhibitor for intestinal diseases. Following the Phase 2 failure, Theravance said it will minimize spending on that program.
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 Trillium Therapeutics acquisition have safety and efficacy advantages that could make them the best in this emerging drug class.
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 inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.
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 milestones, in response to emailed questions.
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 past week. The fresh capital comes as each of the companies looks ahead to bringing their respective drugs into the clinic.
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 pulls ahead of other companies developing injectable versions of antibody drugs for Covid-19 prevention.
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 lateral sclerosis. Despite failing in ALS, Alexion, recently acquired by AstraZeneca, brings additional clinical-stage programs for rare diseases.
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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 potentially pricey gambit, as Illumina could face fines for its early action and there are no assurances that regulators will agree that the deal is not anticompetitive.
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 the science is less than clear about booster shots, adding that it’s ethically wrong to give third shots when so many around the world are waiting for their first one.
GlaxoSmithKline drug Jemperli is now FDA approved for treating solid tumors throughout the body as long as they have a particular genetic signature. Expanding the drug’s approval means the drug can treat more patients who have more types of cancer, and it also gives GSK a way to grow revenue in its thin oncology portfolio.
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 its capabilities in this these areas with the acquisition of startup SignalPath.
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 company also says its vaccine candidates may be able to protect against variants of the novel coronavirus.
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 will help the company identify and validate new pathways in how cancer starts and progresses.
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 characterized the regulator’s rejection of the fusion protein as surprising, CEO Tom Cannell also revealed an earlier sign that another clinical trial may be necessary.
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. Merck added the small molecule to its pipeline two years ago as part of a $1.2 billion acquisition.
Covid-19 vaccine booster shots are now authorized for organ transplant patients and others who have weakened immune systems. The FDA based its update on the results of two small studies that tested third shots of the mRNA Covid vaccines from Moderna and Pfizer/BioNTech.
FDA approval of a therapy that pairs drugs from Eisai and Merck allows the combination to become a first-line treatment for renal cell carcinoma. It’s the latest approval for the partners, which have been working together since 2018.
For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form 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 challenges or hesitations that they may have to achieve medication adherence.
Technological innovations have enabled the adoption of decentralized and hybrid clinical trial models (DCTs) at […]
In response to emailed questions, Encellin CEO offered an overview of the company’s device that functions like a pouch to help implanted cells survive in the body.
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 important, controversial decision from the Federal Circuit.
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 a real-life structure, instrument or process.
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 market needed healthcare solutions.
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 actions to let your legislator know its importance.
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 pre-cancerous polyps but CEO and founder Jonathan Ng said it’s also finding additional use helping pharmaceutical companies identify patients for clinical trials.
Sanofi is acquiring Translate Bio, its messenger RNA R&D partner for the past three years, in a $3.2 billion deal. The pharmaceutical and vaccines giant said the acquisition will speed up development of partnered vaccine programs and spark work on new ones in areas such as cancer, immunology, and rare diseases.
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 product that can compete head-to-head with GlaxoSmithKline’s lupus drug, Benlysta.
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 and Angelman syndrome. The programs are based on Exicure’s proprietary technology that produces nucleic acid therapies capable of delivery deep into the brain.
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 of newly public companies made the week the biggest for IPO activity in more than 20 years.
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 an additional application in the pursuit of a vaccine for the novel coronavirus. The biotech’s $182 million IPO gives it the capital to move forward with clinical research on multiple …
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 study, which is one of three post-marketing clinical programs planned to generate more data about the drug
Sarah Boyce knows she is a rare breed – a female biotech CEO. In this episode, Boyce talks about the novel therapy she is trying to develop to tackle a rare genetic muscle condition, while also building a company that is committed to diversity and inclusion.
Ardelyx drug tenapanor was rejected by the FDA as a treatment for a complication experienced by chronic kidney disease patients. The regulatory decision came two weeks after the company received an FDA letter citing deficiencies in the drug application.
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 market, Kumquat could earn up to $2 billion in milestone payments.
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 be better viral vectors and the startup has raised $117 million in new financing to continue its research.
Softbank led the Series C round of funding for Deep Genomics, a startup that applies its artificial intelligence technology to all aspects of discovering and developing new drugs. The Deep Genomics platform has yielded 10 programs; CEO Brendan Frey aims to advance four of them to the clinic in two years, all while tripling the …
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 own antibody platform, the company says Teneobio’s technology and drug assets will complement its own.
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 the disorder. Switzerland-based AC Immune plans to advance its new asset to Phase 2 testing.
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 therapies.
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 withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.
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 to see more clinical data that demonstrating clinical benefit for the antibody drug.
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. But four others have since developed similar problems, and the company will no longer continue to develop the therapy for that indication.
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 biggest life sciences IPO this week. Absci, Sophia Genetics, and Cytek Biosciences also priced IPOs.
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 deal that pays the biotech $1 billion to share in the development and commercialization of this therapy.
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. Who will prevail?
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 company plans a “rigorous scientific analysis” to assess what happened and to determine the next steps for the program.
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 comes about 18 months after antitrust concerns led PacBio and sequencing giant Illumina to terminate their tie-up.
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 challenges.
The FDA has approved Bylvay, an Albireo Pharma drug that treats the severe itching experienced by patients with progressive familial intrahepatic cholestasis (PFIC). Prior to this approval, the only treatment options for the rare liver disorder were surgical.
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 ready to capitalize on the changing market, the sky’s the limit.
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 that research, the biotech has raised $135 million in financing.
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 a drug that could offer advantages over a recently approved Amgen cancer therapy.
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 drug currently under FDA review. Cytokinetics plans to advance its small molecule to Phase 3 testing by the end of this year.
An intranasal Covid-19 vaccine candidate from Meissa Vaccines could offer advantages compared to injectable ones. The company is still in early clinical development but the company now has data from monkey studies that further build the case for the vaccine.
Digital health thought leader Mark Tarby, BrightInsight vice president of regulatory and quality management systems, shared his take on what the EU MDR means for connected devices, Software as a Medical Device (SaMD), and the go-to market strategies for the companies behind them.
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 a Pfizer pneumococcal vaccine that the FDA approved in June.
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 target; it has multiple programs taking multiple approaches, two of them in human testing and the rest on track to join them.
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 already reached human testing and the new capital will be used to continue that research and advance other pipeline programs to the clinic.
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 in financing to continue its research, with a neurodegenerative disorder as its lead disease target.
Substance use support delivered virtually is accessible, cost-effective, and allows anyone struggling with substance use disorder to incorporate life-changing cognitive-behavioral tools into their daily habits.
Eli Lilly has Protomer Technologies, a preclinical startup developing next-generation insulin that senses blood glucose levels and adjusts its activity accordingly. The technology could eliminate the need for multiple insulin injections throughout the day.
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 disease by targeting a particular enzyme highly expressed in the central nervous system. But Biogen still has some catching up to do.
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 been established and the side effect, when observed, is rare, but the vaccine information has been updated to reflect the potential risk.
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 than $55 million in Series A funding.
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 deal is part of a broader strategy to expand into drugs for cardiovascular disease.
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, giving the pharma giant an alternative way to compete against medicines already marketed by AstraZeneca and Bayer.
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 is that its cell therapy is designed to avoid triggering such immune responses.
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 to treat the cancer. Clinical trials are planned to test this precision medicine approach and the biotech startup has raised $70 million to fund its research.
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 neurodegenerative disorder. The change aligns the prescribing information with the patient population studied in clinical trials.
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 technology has produced programs internal programs in ALS, Parkinson’s, and frontotemporal dementia.
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 chronic cough in patients with idiopathic pulmonary fibrosis, a rare lung disorder. The biotech raised £20M to proceed with Phase 2 testing.
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 serve as a bridge between vaccine manufacturers, regulators, public health officials, healthcare providers on the one hand and patients on the other.
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 a $15 million equity investment in its partner. MiNA is developing a new class of medicines called small activating RNA therapies.
Provention Bio needs to show the FDA that the drug substance produced from its contract manufacturer is comparable to the Eli Lilly-made drug substance that was evaluated in clinical trials. A larger study testing the prospective type 1 diabetes therapy teplizumab is ongoing and could provide the information the agency needs.
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 new funding institute to be called ARPA-H (Advanced Research Projects Agency – Health).
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 IT track during the recent MedCity News INVEST Precision Medicine conference.
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. It’s the latest in a series of acquisitions to hit the CRO sector this year.
GlaxoSmithKline is paying Alector $700 million up front to share in the development of the biotech’s two lead drugs, which offer potentially broad application in treating neurological disorders. Alector’s approach addresses the role immune cell dysfunction plays in neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease.
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 Biogen’s recently approved Aduhelm, Acumen says its antibody has potential dosing and safety advantages.
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. Could Amazon “disrupt” prescription drug delivery?
The INVEST Precision Medicine conference cast a spotlight on the role of children’s hospitals, biopharma companies, diagnostic companies and startups in biopharma innovation. The video recordings of the conference sessions are now available to view.
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 therapies for complement system disorders. Apellis has committed to pay Beam $75 million to kick off the alliance.
Led by former Viela Bio CEO Bing Yao, ArriVent Biopharma secures rights to drugs from emerging biotech hubs, then develops them for Western markets. The biotech’s first asset is a cancer drug licensed from Shanghai-based Allist Pharmaceuticals.
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 treatments for life threatening diseases, such as Alzheimer’s, heart disease, cancer and more.
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 coronavirus infections and it is going public in a SPAC merger that will infuse it with $276 million.
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 is committing to spend €400 million annually on this new center’s mRNA R&D.
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 company said it is now focused on securing regulatory approval in Europe and finding a path forward for the small molecule with the FDA.
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 trial is ongoing, but the preliminary results suggest that Intellia’s approach could offer a cure.
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, is an anti-inflammatory medication already approved for treating rheumatoid arthritis.
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, the biopharma startup winner in the Pitch Perfect contest at the recent MedCity News INVEST Conference, includes a new type of RNA drug.
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 companies can claim two of the biggest biotech IPOs of 2021 so far.
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 German company blames the poor showing to new viral variants circulating in the study population.
The pharmaceutical industry should be leading the development and implementation of decentralized clinical trials (DCTs) given their expertise in clinical research.
Mallinckrodt Pharmaceuticals received FDA approval for its engineered skin product, StrataGraft, a treatment for serious thermal burns. The product is the latest to be reviewed under a new designation for regenerative medicines.
CAMP4 Therapeutics is developing a new kind of RNA therapy that treats disease by upregulating gene expression. The startup has raised $45 million as CEO Josh Mandel-Brehm steers toward clinical trials expected to begin next year in liver and brain diseases.
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 data also showed the therapy’s effects waned over time. Questions about zuranolone’s durability are relevant to Biogen, which committed $1.5 billion to Sage in large part due to the drug’s …
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 by the threat of viral mutation and, more critically than ever, are easy to make, distribute and take by the patient.
GlaxoSmithKline is paying iTeos Therapeutics $625 million up front to share in the development of an antibody that targets the TIGIT protein, a hot target in cancer immunotherapy R&D. The deal comes less than a month after rival Bristol Myers Squibb inked its own deal securing rights to a TIGIT-targeting Agenus drug.
Novavax reported that its Covid-19 vaccine was 100% effective at protecting against moderate and severe disease and 90.4% effective overall. The vaccine is seen as an important alternative to messenger RNA vaccines because of its storage and distribution advantages.
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 in screening, drug development, diagnostics, or delivery. However, our work has just begun.
In recent years, a number of niche vendors have entered the market, promising significant savings for payers if they “carve-out” specialty pharmacy services from integrated pharmacy benefits management (PBM). While the savings they claim to provide sound undeniably attractive, they are often greatly exaggerated.
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 coattails of their larger counterparts and others forged their own paths with promising early results for new cancer drug targets.
Panelists at MedCity INVEST Precision Medicine said startups can gain valuable expertise and experience through the process of seeking out non-dilutive funding.
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 that advances in technology are happening faster than the ability of hospitals and health systems to keep pace.
General distrust in healthcare and research is understandable, but we have the power to address this problem.
Read news highlights from HeathMine, Bind Benefits, Kurome Therapeutics, and Elligo Health Research.
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 Pioneering, has added $55 million to advance its three lead programs to clinical testing next year.
Cell and gene therapy companies already faced challenges in finding efficient ways to manufacture these new treatments. Then, the pandemic made these vulnerabilities even more clear.
The clinical trial arena is changing rapidly, driven largely by the acceleration of telehealth usage and the potential provided by new data solutions. Panelists at MedCity INVEST Precision Medicine agreed that clinical trials will never be conducted in the same way again.
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 drugs are finally getting their day in court.
Register for INVEST Precision Medicine to check out the life science track of the Pitch Perfect startup contest and hear compelling panel discussions on software supporting biopharma R&D, and the supply chain challenges of scaling production and delivering personalized therapies.
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 artificial intelligence platform technology, which it plans to use to make the firm the first “digitally native” pharmaceutical company.
The FDA has approved Prevnar 20, a Pfizer vaccine that protects against 20 pneumococcal strains—seven more than the company’s blockbuster Prevnar 13. But others are on Pfizer’s heels with vaccine candidates that aim to match or even beat the Pfizer pneumococcal vaccines.
Register for the INVEST Precision Medicine conference, which kicks off today. Over the next three days industry experts will talk about precision medicine developments across pediatrics, bioinformatics, startups and more.
Biogen is still discussing with the FDA the clinical trial design to confirm the benefit offered by its newly approved Alzheimer’s disease drug, Aduhelm. According to a timeline set by the regulator, that clinical trial is not expected to be complete until 2029.
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 as Aduhelm, is the first new FDA-approved Alzheimer’s treatment since 2003.
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. The company believes the data could support a regulatory filing for the bispecific antibody drug.
The conference, set for June 9-11, will explore different aspects of precision medicine, including the software being used to support drug and therapeutic development.
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 now has $63 million in funding to further invest in the technology and advance its first molecules toward the clinic.
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 to seek full FDA approval of its antibody cocktail later this summer.
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 present data from this pivotal study during the annual meeting of the American Society of Clinical Oncology.
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 will sell or spin off its programs in hearing disorders and allergies and focus exclusively on RNA therapies.
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 represents the first new antifungal drug class in 20 years.
Register for INVEST Precision Medicine for free and check out the life science track of the startup pitch contest Pitch Perfect. The presenting companies focus on neurostimulation to treat memory loss, improving clinical outcomes for women’s health, wireless drug delivery, opioid risk prediction and more.
MorphoSys is acquiring Constellation Pharmaceuticals and its late-stage myelofibrosis drug in a deal that values the epigenetics biotech at $1.7 billion. Germany-based MorphoSys will finance the acquisition with cash from a separate $2 billion deal with drug royalty acquirer Royalty Pharma.
To know how Chiquita Brooks-LaSure will lead the Centers for Medicare and Medicaid Services, we sat down with Matthew Hittle, a former senior adviser to Seema Verma, who led the agency under the former president.
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, a form of eczema. The deal comes months after Japan-based Kyowa Kirin reported positive preliminary Phase 2 data for its antibody.
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 new accelerator focused on helping digital health companies engage better with pharma hopes to flip the script.
Alkermes antipsychotic drug Lybalvi now has FDA approval. Though the field of neuropsychiatric drugs is crowded with generic medications, Alkermes believes Lybalvi, designed to mitigate the weight gain side effect common with mood disorder drugs, could have an advantage.
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 million to support its unconventional but not unprecedented approach to drug R&D.
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 G12C mutation. Mutated KRAS proteins had long been regarded “undruggable” targets.
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 virus, treatments and associated outcomes in real-world care settings.
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 are at risk of progressing to hospitalization. The companies say they plan to launch the drug, named sotrovimab, “in coming weeks.”
Myovant hormonal drug Myfembree has won FDA approval as a treatment for uterine fibroid bleeding. The regulatory decision clears the way for the pill to compete against a similar AbbVie drug, but with dosing and pricing advantages.
The conference will include conversations with healthcare industry experts from The Steve & Cindy Rasmussen Institute for Genomic Medicine, Nationwide Children’s Hospital, Vineti, Ori Biotech, CVS Caremark, Caris Life Sciences, HHS, University City Science Center, and more.
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, launching the RWE Alliance.
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 genetic interactions, “deciphering biology” to find new cancer drugs.
The FDA placed a clinical hold on a Larimar Therapeutics program for Friedreich’s ataxia after monkeys died in tests of the fusion protein. In addition to halting further tests of the drug, the clinical hold also ends the biotech’s plan to raise $95 million that would have funded clinical research.
IQVIA is paying nearly $200 million to purchase a Myriad Genetics subsidiary that provides pharmaceutical contract services , a deal that will put the new acquisition in the company’s Q2 Solutions unit, The deal follows IQVIA’s April announcement that it had secured full ownership of Q2, which had been a joint venture with Quest Diagnostics.
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 to submit applications to regulators in early June seeking expansion of emergency authorization of the vaccine to include this younger age group.
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 results from an earlier mid-stage study. The biotech will now focus on programs in eye diseases and cancer that are partnered with Merck.
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. Rybrevant is the first approved targeted therapy addressing a subset of patients whose disease is characterized by a particular mutation to cancer protein EGFR.
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 unit builds on work the pharmacy giant did last year, identifying and recruiting recruit people for clinical trials testing Covid-vaccines and medicines.
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 to accelerate and make more efficient the process of manufacturing the AAV viral vectors used in gene therapies.
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 2 diabetes drug, a potential successor to blockbuster drug Trulicity. The Indianapolis-based drug giant said it expects to file for approval by the end of 2021.
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 melanoma from progressing. BMS will present the data at the upcoming annual meeting of the American Society of Clinical Oncology.
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 for eye diseases. BlueRock is paying its new partners $30 million up front to kick off the alliance.
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 startups in its portfolio, and it now has $60 million in Series A financing to build more.
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 antibody that preclinical research suggests has the potential to be the best in this drug class. BMS agreed to pay $200 million up front for global rights.
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 Pharmaceuticals, a biotech being acquired by AstraZeneca. But Apellis’s drug beat Alexion drug Soliris in a head-to-head test, and the smaller company aims to steal market share from its larger …
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 foundation in existing influenza vaccines offers advantages, and potentially gives their candidate a place in the market as a booster shot.
Vera Therapeutics raised $47.9 million from its IPO to continue clinical development of its lead asset, a potential treatment for the kidney disease IgA nephropathy. But the company is joining a crowded field of companies aiming to develop a drug for the rare disorder.
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 latest blow to the company’s efforts to expand its scope to gene therapies.
Read about new developments from Vivor, Kiio, Blue Therapeutics, and Seven Bridges.
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 Therapeutics veteran, said the startup will use the $92 million in funding to advance programs in cancer and inflammatory diseases.
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 over 72 hours—when postsurgical pain is most severe and more likely to require pain management medication.
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 of preliminary mid-stage data showing the drug led to no cases of a potentially fatal complication associated with currently available stroke therapies.
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 to make Series A investments in early-stage companies with assets that can show a path to clinical testing.
Ginkgo Bioworks, a company whose cell engineering work can be found in products ranging from food ingredients to vaccines, is going public in a SPAC deal that values it at $15 billion. The merger will infuse it with $2.5 billion in capital to invest in its platform technology.
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 an advisory committee meeting to discuss use of Covid vaccines in pediatric patients broadly.
Incubated by Flagship Pioneering, biotech firm Laronde is developing endless RNA, or eRNA, a new class of medicines that goes beyond messenger RNA-based therapies. Flagship is backing the startup $50 million in Series A financing.
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 to waive patent protections on these products so that others will be able to manufacture them.
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 cell therapy for organ transplant patients that could mean the end of lifelong immunosuppressive drugs that prevent rejection.
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, publicly traded company, leaving BD to focus on its other core segments.
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 financing, the startup plans to expand its technology to address more tissue types, and potentially add more partners.
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 its CEO just four months after he retired as Merck’s top research executive.
Startups in the Biopharma field present their products to a panel of judges.
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 manufacturing scalable, will use the Series B financing to accelerate its work.
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 funding was led by Morningside Ventures.
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 merger deal that will take it public reveals how much new technology changed the company’s vision and its strategy.
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 ahead to clinical testing. The biotech is the latest company to close a substantial round of funding for gene therapy technology.
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 raise $50 million in Series A financing and a multi-drug research alliance AbbVie.
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 proceeds toward clinical development of their respective pipelines.
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 and life sciences.
The list of FDA-approved antibody drug conjugates (ADC) is growing, and two more biotech startups have emerged from stealth with new cash and new approaches to this type of cancer drug. Adcendo and Adcentrx raised a combined $112 from their Series A financings.
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 company has unmasked the study and is trying to identify potential risks to other patients.
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 on a path to bring to the clinic small molecules that address this target, called extrachromosomal DNA.
Amplyx Pharmaceuticals brings Pfizer a clinical-stage antifungal candidate with a novel mechanism of action. The pharmaceutical giant is trying to build its antifungal product lineup, which is currently led by a drug that has lost patent protection.
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 new approach to blocking inflammation triggered by allergens has met the goals of a pivotal study and the biotech now plans to discuss the data with the FDA.
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 apart from the field, now has $105 million for multiple clinical trials.
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 short of 21st-Century requirements for biologic medicine.
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 building scalable databases with hundreds of thousands of unique chemicals and their links to biological signatures.
The finalists across health IT, biopharma, medical devices, diagnostics, and health services tracks were judged on criteria that included: completeness of overall plan, business idea, market opportunity, revenue model, and founder(s) experience.
A uniQure gene therapy for hemophilia B that has been under a clinical hold for four months can now resume testing. The hold was lifted after uniQure answered the FDA’s questions about whether the gene therapy caused the liver cancer diagnosed in one patient who received the therapy.
Healthcare companies had another record-breaking quarter, according to CBInsights. They raised a total of $31.6 billion in the first quarter, including big investments in telehealth and health IT.
With FDA approval of Zynlonta, ADC Therapeutics can offer patients who have diffuse large B-cell lymphoma an option if CAR-T therapy doesn’t work. Additional clinical trials are underway that could expand use of the antibody drug conjugate to more cancer patients.
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 responding to a federal subpoena seeking documents related to the company’s marketing and promotion of its first RNAi drug, Onpattro.
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 and mortality associated with cancers.
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 trial diversity so that tests of new therapies and vaccines reflect the population of patients that they will treat in the real world.
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 first quarter that Renaissance Capital calculates was the busiest for newly public companies since 2000. Healthcare IPOs continued to dominate the stock offerings.
The FDA approved GlaxoSmithKlie drug dostarlimab (Jemperli) for endometrial cancer that carries a particular genetic signature. The immunotherapy now joins Merck’s Keytruda as the checkpoint inhibitors approved for treating endometrial cancer.
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 and opportunities for these contracts, which aim to improve patient outcomes and control the cost of care.
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 partners plan to apply to several undisclosed serious diseases.