Bristol Myers Squibb has data showing that its multiple myeloma treatment Abecma beat the standard of care, preliminary Phase 3 results that could support moving the FDA-approved CAR T-cell therapy into an earlier line of treatment—ahead of a rival cell therapy. In other BMS cell therapy news, the pharma giant started an R&D alliance focused …
Value-based pricing could have shown us with more certainty the real level of effectiveness of Aduhelm. Maybe it is worth paying something for; and value-based contracts are the only way to figure that out.
Vector BioPharma has launched from the biotech startup incubator of Versant Ventures, which is backing the company with a $30 million Series A financing. Vector is developing virus-like particles with the capability to deliver large payloads of genetic medicines to a wide range of tissues.
Merck is paying $25 million to kick off a research partnership with Cerevance, a startup that analyzes donor brain tissue to find novel targets for new neurological disorder drugs. While Cerevance’s lead program is a Parkinson’s disease drug, Merck is wants to see if the startup’s technology can help it discover and develop new Alzheimer’s …
GSK is partnering with Mersana Therapeutics on the development of an antibody-drug conjugate that is approaching Phase 1 testing. Unlike other ADCs that deliver a toxic drug payload, the Mersana drug is designed to activate the innate immune system to fight tumor cells.
Pfizer’s own R&D efforts in sickle cell disease have fallen short, so the pharmaceutical giant is turning to M&A to gain a presence in the blood disorder. The acquisition of Global Blood therapeutics brings the commercialized drug Oxbryta plus a pipeline of other therapeutic candidates.
Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.
Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.
Over the past 15 years, more than 60% of asset growth among the top 30 biopharma companies came from acquisitions. Such inorganic growth is no longer viable, argues Pervaise Khan, Accenture’s UK Life Sciences Lead. The pace of innovation in biopharma has rocketed over the last two years, with vaccines, new antivirals, and therapies delivered …
Amgen’s drug portfolio boasts several biologic drugs that are blockbuster sellers. In acquiring ChemoCentryx for $3.7 billion, the pharmaceutical giant gains a company entirely focused on developing small molecule alternatives to biologic medicines.
Pfizer is stopping work on a drug for a rare heart disease after an interim look at Phase 3 data indicated that the study was unlikely to succeed. The small molecule came to Pfizer’s drug pipeline as part of the $11.4 billion acquisition of Array Biopharma in 2019.
Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help the much larger group of patients suffering heart problems from the rare protein disease. An FDA submission is planned, which would pit the Alnylam drug in competition with a blockbuster …
Ipsen has been an active dealmaker lately, and it just struck another one that takes the pharmaceutical company into a new area of drug research. The Paris-based company is collaborating with Marengo Therapeutics on the development of two drugs that selectively activate T cells to fight cancer.
Taking inspiration from the success of drug cocktails that halt viral infections, startup IDRx aims to develop cancer drug combinations that stop tumor escape. The company, founded by serial entrepreneur Alexis Borisy, has set gastrointestinal stromal tumor (GIST) as its first disease target.
The FDA approved Arcutis Biotherapeutics drug Zoryve, a topical treatment for plaque psoriasis. With the decision, the company will proceed with a pricing strategy it believes will speed up insurance coverage and patient adoption of the new treatment for the chronic inflammatory skin disorder.
Beam Therapeutics’ application to begin human testing of a cell therapy made with base-editing technology is now under an FDA clinical hold. In other clinical hold news, the FDA lifted a hold on a Celyad Oncology cell therapy clinical trial that was halted in March.
Vicinitas Therapeutics is developing small molecule drugs that stabilize key proteins, preventing them from going to a cell’s built-in disposal system. The startup, which stems from a research partnership between Novartis and the University of California, Berkeley, has raised $65 million in Series A funding.
The U.S. government has signed a supply agreement securing 66 million doses of Moderna’s Covid-19 vaccine booster shots, which are designed to address the omicron subvariants driving new cases of infection. The agreement follows a similar supply agreement reached with Pfizer and BioNTech.
Pregnant women and others able to give birth are severely underrepresented in clinical research globally. But real-world data – when relevant, reliable, and fit for the purpose of answering a given research question – can be used to generate evidence on how health interventions perform in those who are pregnant.
Kidney disease patients need access to innovative therapies to expand treatment choices and improve quality of life. The FDA should closely examine whether it is applying the appropriate benefit/risk assessment for new drugs intended for this population.
Researchers at the University of Texas MD Anderson Cancer Center published a new study revealing that cancer cells make their own unique form of collagen to help them grown and proliferate. This means drug developers may have a new, highly specific target for oncology therapeutics.
The conference highlights the convergence of digital health and drug development. Among the panel discussions are a focus on the state of AI in drug discovery and the future of digital medicines. A startup pitch contest spotlights companies seeking to improve clinical trials. Register for free today!
Persephone Biosciences, a preclinical biotech focused on microbiome-based medicines, raised $15 million in seed funding on Tuesday. The company will use the money to advance its trial for oncology therapeutics, as well as to continue developing its preventive medicine for infants.
It is time to shift the conversation, incentives, and policy solutions to help people improve their health and get off of medications—not just make them cheaper.
With promises of more efficient and reliable diagnoses, future breakthroughs in personalized medicine and targeted therapeutics, and an expedited R&D lifecycle, industry leaders must be prepared to invest in quantum technologies to deliver better outcomes for their organizations and patients.
Novartis is partnering with algorithms startup Anumana to develop a new artificial intelligence-based solution for cardiovascular diseases. The goal is to find ways to detect heart conditions years before symptoms develop in order to enable earlier intervention.
Technological advances are moving drug discovery work to computers, but experimental medicines still must be tested in animals. Startup Manifold Bio is developing technology that enables the testing of hundreds of molecules in a single mouse, bringing drug hunters valuable in vivo data much earlier in the drug discovery process.
The FDA has deferred a regulatory decision on an esophageal cancer drug from partners BeiGene and Novartis, citing the need to complete inspections of the China-based facilities where the drug is made. The agency said Covid-19 travel restrictions have prevented it from conducting those inspections.
Whether they are acting as a therapeutic or preventive treatment, monoclonal antibodies can allow us to help contain the virus, where we might see the light at the end of the tunnel.
Without the parent company, there’s concern Teva won’t be able to pay billions in reward to NY state.
Merck is partnering with Orion on the clinical development and potential commercialization of a new drug for advanced prostate cancer. Though Merck already has a piece of the prostate cancer drug market, Orion’s drug would offer a new approach for treating cancers that have become resistant to currently available hormone therapies.
Since we know the fundamental causes of the opioid epidemic, why are we still here? It all centers around stigma.
PharmStars, a digital health accelerator, graduated its latest cohort of startups, each of them developing a solution addressing some aspect of neurological disease. The accelerator is accepting applications for the next group of startups for the fall program. The theme is innovations in real-world evidence.
New company Areteia Therapeutics launched with up to $350 million in financing and an asthma drug candidate from Knopp Biosciences. That drug, dexpramipexole, previously failed a pivotal test in amyotrophic lateral sclerosis but more recent clinical testing found that the way the small molecule works has applications in eosinophilic asthma, a severe form of the …
Gene therapy is making a world where cancer and AIDS can be cured, and a person can alter their genetic makeup, changing the direction of their own and their offspring’s evolution in the process. However, the effects of gene therapy are long-lasting, and may impact both your and the health of your future children. What …
An Ionis Pharmaceuticals drug has positive Phase 2 results in immunoglobulin A nephropathy, leading Roche to exercise its option to license the rights to the molecule. The pharmaceutical giant gets a contender in the chase to win the first regulatory approval of a therapy for this rare kidney disease.
Vertex Pharmaceuticals already has a cell therapy candidate for type 1 diabetes but the company says acquiring rival ViaCyte will provide it with complementary assets and technologies. The two companies already share a partner in common: both have therapeutic candidates that use the gene-editing capabilities of CRISPR Therapeutics.
The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers for an antiviral and Novavax’s European marketing authorization has been expanded to an additional age group.
AbbVie paid Alector $205 million up front five years ago to begin an R&D partnership on two drugs intended to bring an immunotherapy approach to the treatment of Alzheimer’s disease. One of the drugs has reached Phase 2 testing but the pharmaceutical giant has terminated the alliance on a program in Phase 1.
Kernal Biologics has technology that enables the delivery of messenger RNA therapies to a wider range of destinations in the body. The Series A financing comes as the startup works to advance its lead immuno-oncology program toward its first clinical test.
Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.
Read about executive hires across healthcare and life sciences.
Because the virus keeps mutating and will be around for a long time, the market for Pfizer’s products won’t go away. In wealthier countries, the public is likely to keep coming back for more, like diners at an all-you-can-eat restaurant, sated but never entirely satisfied.
Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.
Emergn Principal Consultant Mario Moreira shared insights on how pharma companies can use the principles of Value, Flow and Quality to shorten drug development timelines and deliver better patient outcomes through improved ways of working.
Messenger RNA vaccine biotech CureVac is suing BioNTech, alleging that its rival’s Covid-19 vaccine infringes on intellectual property built on more than two decades of research. BioNTech responded that its work is original and the company will defend against the infringement allegations.
AstraZeneca is acquiring TeneoTwo in a $100 million bet on that biotech’s lymphoma drug candidate, which is designed to go after two targets. It’s the latest deal made by a big pharmaceutical company looking to get its hands on a new type of cancer therapy called a T cell engager.
Summer weather is heating up but the market for IPOs remains cold. Bausch + Lomb’s successful return to the public markets in the second quarter proved to be an exception as the slowdown in IPO activity reached levels not seen in years.
Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. The $100 million price tag is in the neighborhood of the going rate for these vouchers, which grant a company a shorter regulatory review timeline for a drug that addresses a rare or neglected disease.
Rising deal premiums and shrinking profit margins are threatening the sustainability of the traditional approach to mergers and acqusitions, according to a report by Accenture. The firm expects growth-minded companies will turn to other pathways.
The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.
What You Should Know: – The traditional approach to fostering biopharma growth is no longer sustainable, according to Accenture research and analysis. The new research reveals perspectives on the life sciences industry based on an extensive analysis of over 300 M&A deals made by the top 30 biopharma companies between 2010–2021. – The analysis reveals multiple factors are eroding the sustainability of an inorganic growth strategy, such as rising costs of M&A, declining ability to pay and new challengers. However, …
New Covid-19 vaccine booster shots are coming and they’ll likely include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering 105 million doses of the Pfizer/BioNTech vaccine for a planned vaccination campaign in the fall.
A recent webinar by Medable discussed steps it’s taking to improve clinical trial design through decentralized clinical trials
In less than one year, ReCode Therapeutics has reeled in $200 million in financing. Big pharmaceutical companies are taking notice of the biotech startup’s technology, which enables lipid nanoparticles to go a wide range of organs and tissues, potentially broadening the reach of genetic medicines.
What You Should Know: – Merck, today announced the launch of the Merck Digital Sciences Studio (MDSS) to enable the generation of innovative technologies for drug discovery and development. – MDSS will support early-stage biomedical startups with direct investment, access to powerful Azure Cloud computing and opportunities to pilot their technologies in collaboration with discovery …
Sanofi won European Commission approval for two therapies that treat rare enzyme deficiencies. Xenpoyzme is the first treatment for acid sphingomyelinase deficiency (ASMD) while Nexviadyme is a successor to a blockbuster Sanofi drug for Pompe disease.
The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.
Ipsen is paying $247 million to acquire Epizyme, a cancer drug developer with one FDA-approved product: follicular lymphoma therapy Tazverik. The drug is a modest seller now, but more cash could be paid out if the small molecule hits sales targets in coming years.
With emerging biotech needing help with a little bit of everything, these preferred partnerships can deliver a type of one-stop shopping leveraging an agency’s best practices, current trends, and data.
For small biotech companies that are always raising money, business development is a critical next step. Joining with a credible partner goes a long way in validating technology and platforms and gives small biotech companies the runway needed to grow.
A Duchenne muscular dystrophy drug candidate from Italfarmaco Group has encouraging preliminary data from a pivotal study. The Milan, Italy-based pharmaceutical company says it now plans to meet with U.S. and European authorities about seeking regulatory approval for the small molecule.
An Intellia Therapeutics therapy that uses CRISPR to perform in vivo genomic edits has clinical data showing that the therapeutic effects continue for a year in patients. The biotech now plans to speak with regulators about the design for a pivotal clinical trial testing this therapy, a potential one-time treatment for a rare inherited disease.
Two private equity firms have reached an $890 million deal to buy Radius Health, a company whose main asset is the commercialized osteoporosis drug Tymlos. In other M&A news, cancer biotech F-star Therapeutics is being acquired in a $161 million deal.
The Pitch Perfect contest at MedCity INVEST PharmaTech, the free virtual conference scheduled for July 26, will spotlight five startups seeking to improve clinical trials.
Novartis is paying Precision Bio $75 million up front to begin a partnership aiming to develop in vivo gene-editing therapies for serious genetic blood disorders, such as sickle cell disease. One of the goals of the alliance is to make genetic medicines more globally accessible.
An Alzheimer’s disease drug from Athira Pharma has failed a Phase 2 clinical trial and the biotech has a surprising theory why. Athira says standard of care drugs Alzheimer’s patients are already taking may diminish the effect of its small molecule and this finding could inform how the company proceeds with an ongoing Phase 3 …
Human Longevity, Inc., a startup founded by genomics pioneer J. Craig Venter, plans to join the public markets via a SPAC merger. If the business combination closes, HLI would receive about $345 million for continued commercialization of its platform that uses genomics, AI, and other technologies for early disease detection and other strategies intended to …
The planned FDA submission follows the report from AstraZeneca and Ionis Pharmaceuticals that their partnered drug, eplontersen, met the main goals of a pivotal study in treating nerve pain caused by hereditary transthyretin-mediated amyloidosis. The data come one week after rival Alnylam Pharmaceuticals won FDA approval for its second drug for this rare disease.
AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation. In other drug decision news, the Rhythm Pharmaceuticals product Imcivree added the rare disease Bardet-Beidl syndrome as a new approved indication.
Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease Control and Prevention signs off on these shots this weekend, these pediatric vaccines could become available for distribution early next week.
Grail, a company focused on early cancer detection, introduced its test that screens for more than 50 kinds of cancer last year. At AWS’ Thursday conference for healthcare and life sciences innovation, the company’s chief security officer explained how the company is evaluating the test in clinical trials and preparing to file for its FDA …
As a VC, if you start thinking about commercialization until after you’ve made the investment, then you’ll need a lot more than just good luck to make these investments generate a good return.
Drug prices are on the minds of patients and politicians. The November election is expected to tip the balance of power in Congress and a panel held during the Biotechnology Innovation Organization’s annual meeting discussed what that change could mean for drug price legislation.
Rapid and effective research is the only way to stave off massive loss of human life over the next 50 years. Fortunately, there are three things we can do right now to give researchers the tools and support they’ll need in the near future.
Biopharmaceutical companies and public health officials have learned a great deal about pandemic response in the last two years. A panel discussion during the annual meeting of the Biotechnology Innovation Organization explored some of the lessons from Covid-19 and how they can prepare us for the next pandemic.
At the MedCity INVEST PharmaTech virtual conference July 26, strategies and alignment between digital and pharma companies will be a major theme of the conference. Register now to join the conversation.
ImCheck Therapeutics aims to broaden the reach of cancer immunotherapy with antibody drugs that activate a rare but powerful type of immune cell called gamma delta T cells. The biotech has unveiled €96 million to advance its pipeline, including a lead candidate in development for both liquid and solid tumors.
The French delegation at BIO on June 13-16 has a compelling story to tell about biopharma and medtech growth and investment in France and the U.S. Here’s a preview of some of the companies that will be at the convention, events they will host and why you should check them out.
Ten biotech companies were able to raise more than $500 million in combined financing in the past week. Here’s a recap of the funding activity, which spanned AI-based drug discovery, cell therapy clinical research, cancer drug development, and more.
Pharma’s evolving role in patient care The digital revolution has already reshaped the commercial engine of biopharma companies. Pharma’s digital initiatives now routinely enable new channels that educate and market to patients, physician engagement that is more efficient and effective, and novel payment mechanisms and distribution models that improve access to therapies. The pandemic accelerated …
Operational efficiency and visibility brought on by digital transformation can help improve how pharmaceutical manufacturers do their critical part in improving equitable access and availability of medicine around the world.
During first three months of 2022, biopharma tech companies raised less money and made fewer dealsthan they did in the last three months of 2021. A volatile stock market is exacerbating the trend.
A small Memorial Sloan Kettering Cancer Center study found that all rectal cancer patients treated with GSK drug Jemperli showed a complete response at six months—there were no detectable signs of the cancer. These early data presented at ASCO suggest that rectal cancer with a particular genetic signature might be treatable with this immunotherapy in …
Follicular lymphoma patients in Europe now have a new treatment option. The European Commission approved Roche drug Lunsomio, a bispecific antibody designed to go after two targets to treat advanced cases of this type of cancer.
The MedCity INVEST PhrmaTech virtual conference, scheduled for Tuesday, July 26, offers free registration and a compelling day of conversations exploring the convergence of the health tech and biopharma sectors.
Breast cancer drugs and cell therapies were prominent in this year’s annual meeting of the American Society of Clinical Oncology. Here’s a recap of some of the news highlights from the biggest cancer conference of the year.
Our Omnichannel Maturity tool is designed for biopharmaceutical, healthcare technology, and wellness companies that are driven to develop integrated and customer-centric omnichannel experiences. This simple 8-question quiz is divided into 4 sections to help you understand your organization’s level of omnichannel maturity. Once you have completed the questionnaire, you will receive tangible recommendations and an …
The CEO of Anagenex believes that the company’s AI engine trained on billions of data points and iterative testing will blow other AI drug discovery startups out of the water.
PMV Pharmaceuticals has its first clinical data showing that its lead therapeutic candidate can hit p53, a tumor-suppressing protein long thought to be undruggable. After reporting the preliminary data during ASCO, PMV said it plans to continue Phase 1 study with the goal of advancing to Phase 2 early next year.
Code Biotherapeutics uses synthetic DNA as the foundation for its genetic medicines, which the startup claims offer several key advantages compared to genetic medicines delivered via engineered viruses. The startup plans to use its new capital to develop lead programs in Duchenne muscular dystrophy and type 1 diabetes.
Here’s a selection of recent executive hires across healthcare and life sciences.
Taking steps to eliminate health disparities among people of color and ensuring diversity throughout the development cycle should be a strategic goal for all. Medical Affairs can be the change agents within their organizations to help with this push.
Pharma companies often take the blame for high prescription costs. But a new, industry-sponsored survey shifts attention to insurance industry practices.
During the annual meeting of the American Society of Clinical Oncology, AstraZeneca and Daiichi Sankyo reported pivotal clinical trial data showing that their partnered cancer drug Enhertu can treat a group of patients previously thought to be out of reach for a targeted therapy. The results suggest use of this FDA-approved drug could significantly expand …
Gilead Sciences has more detail about breast cancer drug Trodelvy, a blockbuster hopeful it acquired two years ago. Additional data from a pivotal study were presented during the annual meeting of the American Society of Clinical Oncology and they still leave many questions unanswered.
Bristol Myers Squibb is splashing out $4.1 billion to acquire Turning Point Therapeutics, a clinical-stage biotech whose lead drug is currently in pivotal testing as a treatment for certain lung cancers. Recently reported preliminary data suggest the small molecule could have advantages over currently available drugs in the same class from rivals Pfizer and Roche.
Regeneron Pharmaceuticals has big plans for cancer immunotherapy Libtayo and it believes it can better execute on them if it has full control of the drug, currently partnered with Sanofi. Regeneron struck a deal to pay Sanofi $900 million, plus another $200 million in milestones, to secure full global rights to the asset.
Roche’s deep oncology pipeline is adding a drug candidate from Repare Therapeutics that works by interfering with a DNA repair mechanism of cancer cells. Repare receives $125 million up front and it retains the right to share in the development and commercialization of the drug, camonsertib.
In the healthcare sector and beyond, the adoption of digital tools and novel analytics has exploded. However, unlike many consumer industries, biopharma, medical technology, and wellness companies have struggled to build meaningful personalized customer experiences. Today, biopharma and med tech executives are faced with numerous channels, novel technologies, and a high volume of data. They struggle …
When consumer healthcare products joint venture Haleon spins out from GSK as an independent company next month, Pfizer will sell its minority stake in the business. Pfizer said that selling its ownership in Haleon is keeping with its focus on developing innovative new medicines and vaccines.
Roche drug Evrysdi, one of three FDA-approved treatments for spinal muscular atrophy, is now approved for treating those younger than age 2. The regulatory decision puts the oral drug on equal footing with SMA drugs from Novartis and Biogen.
Pfizer and Merck have each won FDA approvals in the past year for new pneumococcal vaccines, but GSK aims to top both of them with its $2.1 billion acquisition of Affinivax. That biotech’s Phase 3-ready vaccine candidate addresses more bacterial strains than any pneumococcal vaccines currently available.
The American Society of Clinical Oncology’s annual meeting begins this week, including the presentation of more than 2,800 abstracts. Amgen, Roche, and Sierra Oncology are among the companies with key presentations at this year’s gathering.
Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee meeting scheduled to discuss the use of that vaccine and Moderna’s in kids. In other Covid news this week, the CDC issued a health advisory for Pfizer’s antiviral Paxlovid and …
Since it measures the total amount of circulating DNA (ctDNA) in a patient’s bloodstream using a simple blood draw, ctDNA liquid biopsy tests offers oncologists with an accurate, molecular, real-time cancer detection tool. It also helps to determine cancer staging and can help assess how aggressive the treatment regimen should be.
ProFound Therapeutics emerged from stealth with technology that it claims has discovered tens of thousands of previously undiscovered proteins—many of them promising new drug targets. The Flagship Pioneering-founded startup is backed by $75 million to support its drug R&D along with plans to partner with large pharmaceutical companies.
A clinical hold on an Antios Therapeutics drug has led to the end of a collaboration with Assembly Biosciences less than a year after their alliance began. The partners had hoped pairing their drugs with an approved Gilead Sciences antiviral would produce a combination hepatitis B treatment with the potential for a cure.
Plaque psoriasis drug Vtama is now approved by the FDA, making it the first novel topical treatment for the chronic autoimmune disorder in a generation. Roivant Sciences subsidiary Dermavant Sciences acquired the drug from GlaxoSmithKline in 2018.
At the upcoming INVEST PharmaTech virtual conference scheduled for July 26, the conversations will span myriad topics at the intersection of digital health and drug development. Register today.
Biohaven’s migraine drug research led to an FDA-approved product with strong commercial uptake, but its other neuroscience efforts have yet to achieve the same outcomes. Drug candidate troriluzole has failed a Phase 3 test in neuromuscular disorder spinocerebellar ataxia, the molecule’s third failure in a pivotal study in the past two years.
Entasis Therapeutics is being acquired by Innoviva in a deal that brings an FDA-ready antibiotic developed to address drug-resistant strains of a bacterium that infects critically ill, immunocompromised patients. Innoviva has been steadily building up its stake in Entasis, an AstraZeneca spinout, over the past two years.
Kelonia Therapeutics is developing cell therapies made by the in vivo engineering of a patient’s cells made possible by the targeted delivery of a genetic payload. The startup, newly out of stealth with $50M in funding, claims its approach would offer manufacturing and safety advantages over other cell therapy technologies.
A Rocket Pharmaceuticals gene therapy for the rare immune disorder leukocyte adhesion deficiency-I has met the survival goals of a pivotal study, paving the way for regulatory submissions that the company expects to file in early 2023.
The lead cancer drug candidate of Foghorn Therapeutics is now under a partial clinical hold following a patient death. According to the biotech, the patient may have experienced a side effect that is a known complication of leukemia drugs.
An antiviral that Enanta Pharmaceuticals is developing for respiratory syncytial virus infection failed to beat a placebo in its first Phase 2 test. But the biotech notes that these study participants weren’t very sick and may have recovered on their own, so it’s now pinning its hopes on ongoing studies in higher-risk groups, such as …
A webinar sponsored by Twilio will share predictions for driving personalized care and engagement in healthcare and life sciences in 2022.
Sonata Therapeutics is developing drugs that reprogram cellular microenvironments to send signals intended to have curative effects. Cancer is the initial focus of the biotech, which Flagship Pioneering formed by combining two of its preclinical portfolio companies.
Modality.ai has developed a conversational AI system that replaces in-person interviews that are part of neurological assessments for a range of disorders. The startup was judged co-winner in the pharmatech category during the recent MedCity INVEST conference in Chicago.
Dry age-related macular degeneration currently has no FDA-approved treatments but the research of Clover Therapeutics has yielded two candidates. The biotech startup has made progress in the past two years under CEO Cheng Zhang and it’s now revealing more details about its approach, a new corporate identity, and a Series A financing that puts it …
A webinar sponsored by Medable will explore challenges of drug innovation in the cardiometabolic space and how connected devices could make evidence collection less costly and more efficient to support regulatory evaluation and approvals.
Chimerix is selling global rights to smallpox drug Tembexa, the biotech’s only FDA-approved product, as a way to fund clinical development of a therapy in pivotal testing for a rare type of brain cancer. The deal marks Chimerix’s nearly complete departure from the antiviral work that defined the company for most of its history.
Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, vadadustat, and asked for another clinical trial. Otsuka alleges unspecified breaches of the agreement by Akebia, and ending the alliance early could spare it from spending hundreds of millions of …
The FDA approved Eli Lily drug Mounjaro as a treatment for type 2 diabetes. The decision gives the pharmaceutical giant a new competitor to a blockbuster drug from rival Novo Nordisk, as well as a successor to its blockbuster diabetes drug Trulicity.
The FDA cited manufacturing issues in turning down UCB’s application seeking approval for bimekizumab, an antibody drug developed to treat moderate-to-severe plaque psoriasis. Bimekizumab is already approved and available in other markets around world, but the FDA rejection delays UCB’s antibody drug from competing in the U.S. for now.
Bristol Myer Squibb is getting rights to BBP-398, a contender in the chase for drugs that address difficult-to-target KRAS mutations. Meanwhile, BridgeBio Pharma receives some needed cash as it restructures in the wake of the Phase 3 failure of its lead program late last year.
Nuvig Therapeutics is developing drugs that tap into one of the body’s natural mechanisms for controlling inflammation. Co-founder and CEO Pamela Conley, a veteran of Portola Pharmaceuticals, says Nuvig’s approach could offer efficacy similar to currently available autoimmune drugs but with a better safety profile.
Roche reported that its drug tiragolumab failed to achieve one of two main goals of a Phase 3 study in non-small cell lung cancer. The antibody is designed to block TIGIT, a checkpoint protein that has been a hot target for pharmaceutical companies looking for a way to broaden the reach of cancer immunotherapy.
Pfizer is turning to M&A to get its next blockbuster, buying Biohaven six months after the two companies began a commercialization pact centered on the oral migraine drug Nurtec. The acquisition will lead to the spinout of Biohaven’s other assets into a new, publicly traded company capitalized with $275 million.
Aspen Neurosciences is developing a cell therapy that uses a patient’s own stem cells to develop a personalized treatment for Parkinson’s disease. The approach is slightly different than that of Bayer, whose experimental Parkinson’s cell therapy is made from stem cells sourced from healthy donors.
Cell and gene therapy research has been hot the past few years but the overall market has cooled down in recent months. During the World Medical Innovation Forum in Boston, a panel of venture capitalists discussed capital formation and what biotech firms need to do to win over investors and advance their research.
The model of investing huge amounts of money into one drug to try to recoup it later is problematic at best and unsustainable at worst. Platform technology provides a better, more cost-effective way forward.
The FDA amended emergency authorization of Johnson & Johnson’s Covid-19 vaccine. In other regulatory news this past week, drug approvals include a cancer drug that converted its accelerated regulatory approval to a full regulatory nod, while several companies dealt with rejections or clinical trial setbacks.
PepGen’s technology improves the delivery of a therapy to more tissue types and the clinical-stage biotech plans to use its IPO cash to continue developing its lead program for Duchenne muscular dystrophy. Meanwhile, eye products giant Bausch + Lomb returned to the public markets as a standalone company. Both the PepGen and Bausch + Lomb …
INVEST PharmaTech Pitch Perfect virtual conference July 26 will give startups the opportunity to present their approaches to clinical trial innovation to a team of investor judges. Apply today!
Read about new developments from Healthmine, Capable Health, Imagene AI, PolyCore Therapeutics, Inc and more.
UK-based OMass Therapeutics is leaning on a proprietary form of native mass spectrometry to help develop small-molecule drugs for rare diseases.
Biogen struck a deal that could bring a digital therapeutic to its multiple sclerosis product portfolio. The drugmaker is partnering with startup MedRhythms in the development of a therapy that combines sensors, software, and music to improve walking problems in multiple sclerosis patients.
As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to improve the pharma giant’s first generation of cell therapies while also building a pipeline of next-generation treatments with better features and properties.
CAR T cell therapies for cancer still pose challenges in manufacturing, safety, and the ability to address solid tumors. A panel at the World Medical Innovation Forum discussed efforts to improve CAR T as well as new approaches for the next generation of cell therapies.
Unauthorized immigrants over age 49 who fall below certain income thresholds are now eligible for full coverage by Medi-Cal, California’s version of Medicaid. If Gov. Gavin Newsom gets his way, which seems entirely plausible considering the state’s rosy financial outlook, California could allow all remaining low-income unauthorized immigrants — an estimated 700,000 people — to …
What You Should Know: – Kelonia Therapeutics, a Boston-based biotech company focused on vivo gene delivery, launched with a $50 million in Series A funding to expand the benefit and reach of genetic medicines. – Despite life-changing responses, existing gene therapies are highly complex, costly, and limited by complicated treatment paradigms, tractable therapeutic applications, and …
Takeda Pharmaceutical spinout HilleVax broke the biotech IPO drought with a $200 million stock market debut for clinical development of a norovirus vaccine. Two eye health companies marked the other IPO activity: Belite Bio went public while Bausch + Lomb set financial terms for what could become one of the biggest IPOs of the year.
Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.
Athelo Health’s software is a personal coach that supports women with breast and gynecological cancers. The startup was judged co-winner in the pharmatech category during the recent MedCity INVEST conference in Chicago.
Pfizer now has the regulatory O.K. to resume pivotal tests of its gene therapy for Duchenne muscular dystrophy—but with new limitations and safety measures. The FDA had placed a clinical hold on the study late last year following a patient death.
The European Commission approved Biohaven Pharmaceuticals migraine drug rimegepant. While the regulatory decision marks another milestone for Biohaven, it’s also a win for Pfizer, which holds rights to commercialize the drug outside of the U.S.
Biotech startup Pheast is out of stealth taking a tack similar to that of cancer immunotherapy company Forty Seven, also a spinout from the Stanford University lab of Irving Weissman. While both companies get immune cells to eat tumors, Pheast’s technology has the potential to take the approach to a broader range of cancer types …
The Series D round of funding makes Biofourmis a unicorn valued at $1.3 billion. CEO and founder Kuldeep Singh Rajput said that the new capital will be used to expand his company’s remote-monitoring technologies and continue development of digital therapeutics, both as companions to traditional drugs and as monotherapies.
Founded in 2021, Gandeeva is developing precision imaging solutions with the integration of cryo-electron microscopy (cryo-EM) and artificial intelligence. Its technology can be applied to advance drug discovery and by lowering risks of late-stage clinical failures.
Two natural killer (NK)cell therapy candidates from Nkarta now have preliminary Phase 1 clinical data suggesting these therapies are helping patients in two types of blood cancers. Nkarta therapies based on engineered NK cells could offer both efficacy and safety advantages over the first generations of cell therapies, which are made from a patient’s own …
Experimental Roche drug giredestrant failed to meet the main goal of a Phase 2 study in advanced breast cancer. The disappointing results allow competitors to gain ground in the field of companies developing oral selective estrogen receptor degraders (SERDs), drugs that block a receptor key to driving breast cancer growth.
While Covid-19 has had a significant impact on drug spending, IQVIA projects that its effect will moderate in coming years. IQVIA’s new report on U.S. medicines spending projects that immunology, oncology, and neurology will continue to drive the growth in drug spending.
Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.
AstraZeneca’s Covid-19 antibody drug Evusheld reduced the risk of infection by 83% after six months. These results published in the New England Journal of Medicine are the latest clinical data supporting the durability of Evusheld, which was designed to offer longer-lasting protection.
Octant Bio’s synthetic biology approach to drug discovery is making progress, and the preclinical biotech has raised $80 million in Series B financing to continue the journey. The company added Bristol Myers Squibb as an investor and collaborator in the search for new immunology drugs.
Satellite Bio has emerged from stealth with technology for bioengineering tissue to restore organ function. The regenerative medicine startup, based on research from MIT and Boston University, is backed by $110 million in financing.
Unlearn.AI’s Series B round follows a positive European Medicines Agency draft opinion finding that the company’s artificial intelligence technology can be used in Phase 2 and Phase 3 clinical trials. The startup is now on the hunt for pharmaceutical partners that want to use the technology to speed up their clinical research.
Regeneron Pharmaceuticals is paying $250 million cash to acquire Checkmate Pharmaceuticals, a clinical-stage biotech developing drugs that activate the innate immune system. The biotech’s lead drug candidate is currently in pivotal testing in melanoma.
TG Therapeutics is pausing its cancer drug research and withdrawing the approved cancer drug Ukoniq from the market. The move comes as the FDA places greater scrutiny on Ukoniq’s drug class—concerns that will be discussed during an FDA advisory committee meeting scheduled for April 21.
Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid news, a vaccine developer won marketing authorization in Europe while another one faces a regulatory setback.
Versant Ventures has launched Cimeio Therapeutics, a biotech startup with technology that can shield transplanted stem cells or cell therapies. Shielding these cells enables them to be dosed alongside an immunotherapy—an approach that is not currently done because the therapies don’t discriminate between diseased cells and transplanted ones.
Bristol Myers Squibb and Nektar Therapeutics are ending a cancer drug research alliance after data showed the combination of their respective drugs failed clinical trials in kidney and bladder cancers. The disappointing results come one month after the drug combo failed a pivotal melanoma clinical trial.
Be Biopharma is developing cell therapies by engineering B cells to churn out therapeutic proteins with an initial focus on cancer and rare disease. The company’s Series B financing comes as competitors in the space also make progress with their engineered B cell therapies.
GlaxoSmithKline is further building out its cancer drug portfolio by acquiring Sierra Oncology, a biotech whose FDA-ready myelofibrosis drug has clinical data showing advantages over a blockbuster product marketed by Incyte. The deal comes as GSK prepares a spinoff of its consumer products as part of a broader strategy to hone its focus on specialty …
As artificial intelligence becomes more focused and efficient, and the pharmaceutical and biotech industries consolidate to survive, it’s important to also reflect on what is working in the fight against Covid-19. This will help us to be more prepared for the next global health crisis.
Organ donation has long been a matter of demand outstripping supply, but Aurion Biotech aims to improve the supply part of the equation with a cell therapy. Aurion’s technology turns a single donated cornea into treatments for up to 100 patients and the startup now has $120 million for clinical trials.
A.J. Loiacono was speaking at MedCity INVEST in late March in Chicago when an audience member requested him to address whether it is sustainable to have a system where after insurance a drug costs $150 for consumers whereas with GoodRx the same drug is $6. Loiacono took aim at PBMS but also didn’t spare the …
An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead drug, magrolimab, is part of a class of cancer immunotherapies that address a hot target for the field.
The DNA currently used in genetic medicines research is synthesized by chemical methods. Ansa Biotechnologies employs faster and less expensive enzymes-based technology, and the startup has raised capital to scale up operations as it prepares to launch its service.
Oral delivery of messenger RNA is one of the capabilities of Matinas BioPharma’s technology. BioNTech will explore that feature among others under a new research alliance with Matinas, a clinical-stage biotech that also has an ongoing collaboration with Genentech.
California awarded the Medi-Cal Rx program to a unit of Magellan Health, a company with expertise in pharmacy benefits and mental health. But Magellan was then gobbled up by industry giant Centene.
Kaleido Biosciences, formed by Flagship Pioneering as part of a wave of biotech companies developing microbiome therapies, has laid off its entire workforce and is winding down operations. The shutdown follows a strategic review that failed to turn up any deals to support its clinical-stage pipeline.
Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.
Jazz Pharmaceuticals is licensing rights to a Werewolf Therapeutics cytokine therapy that’s on track to reach clinical testing next year. The deal gives Jazz a drug candidate that expands the company’s scope to immuno-oncology.
Pfizer is already in the mix of companies pursuing vaccines for respiratory syncytial virus. The pharma giant is now broadening its scope with a deal to acquire ReViral Therapeutics, a biotech with two clinical-stage antivirals, each taking a different approach to stopping the potentially deadly pathogen.
MedCity INVEST PharmaTech, a virtual conference scheduled for July 26, will bring together technology disruptors, Big Pharma and biotech leaders, investors and entrepreneurs to discuss how to adopt digital strategies to transform every aspect of the pharma industry.
A Novartis drug that stops abnormal cell growth in breast cancer now has an additional FDA approval treating a group of rare disorders characterized by overgrowth in various types of tissue. The regulatory decision makes the drug, Vijoice, the first approved therapy for these disorders termed “PROS.”
The lead drug candidate of Imara failed two separate mid-stage clinical trials evaluating it in rare, inherited hemoglobin disorders. Imara had been planning to advance the small molecule to yet another Phase 2 study in heart failure, but in light of the twin trial failures, the biotech is now weighing “strategic options.”
Evozyne uses artificial intelligence and machine learning to design novel proteins that can be used in gene therapies. The new agreement with Takeda Pharmaceutical covers the development of proteins that can be used in gene therapies for rare diseases.
Here is a selection of recent executive hires and departures across healthcare and life sciences.
The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The biotech company said the patient experienced a complication that is a known risk of the small molecule drug.
Novartis unveiled a corporate restructuring that is consolidating some operations in cash-saving moves expected to lead to $1 billion in annual savings. The shakeup means the departure of several key executives, including Chief Medical Officer John Tsai, who has held that role since 2018.
Multinational insurance company AXA has launched a new €440 million ($500 million) drive to provide private equity investments in healthcare companies that deepens its interest in the life sciences sector. Until now, AXA Investment Managers has been focused more on the delivery end of health care – health centres and private hospitals, for example – …
Bayer is committing another €1.3 billion to Leaps by Bayer, the company’s investment arm, to support additional investments in companies developing innovative technologies in healthcare and agriculture. In addition to backing companies developing cell and gene therapies, Leaps has also deployed its cash to startups developing artificial intelligence technologies for a range of applications.
API adoption will hinge on efforts from all angles — such as healthcare organizations, IT specialists and regulators – working together to support a standardized API solution and overhaul of systems in much need of transformation.
The second quarter of 2022 kicked off with a new life sciences company joining the public markets, but not via an IPO or merger. Becton Dickinson on Friday completed the spinoff of its diabetes care business, Embecta, which now trades on the Nasdaq.
Check out new developments from Healthmine, Light Solutions Company, Zephyr AI and Sema4.
The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety concerns and asked for another clinical trial to show that the pill’s benefits outweigh its risks.
The partners aim to make decentralized clinical trials more efficient and less expensive through greater use of AI and machine learning.
Neuron23 is developing drugs that treat neurological conditions by penetrating the blood-brain barrier to reach disease targets in the central nervous system. The biotech’s lead program is a Parkinson’s disease drug candidate with features that could distinguish it from rival compounds that are aiming for the same target.
Venture capital investment in healthcare startups is continuing at a steady pace. Is it too much? Is a correction coming? Three investors offered their perspectives during a panel discussion at MedCity News’s INVEST conference in Chicago.
A pharmaceutical giant reported a Phase 3 success for a potential blockbuster drug, while four other companies reported disappointing data from their respective clinical trials. Our recap of data readouts and regulatory news also includes one FDA rejection.
AN2 is developing an antibiotic based on boron chemistry that could offer advantages over carbon-based molecules. The biotech plans to advance its drug candidate, licensed from Pfizer, to a pivotal test in a rare and potentially fatal lung infection caused by mycobacteria.
Fixing the last mile may not be as sexy as sprinting toward the development of the mRNA vaccines or our first anti-viral treatments, but addressing it is the only way we can improve outcomes for people who need this the most.
The direct recording and analysis of voice ensures that a more diverse range of patients is represented in clinical trials. This is crucial for effective therapeutic outcomes.
OmniAb, the antibody division of Ligand Pharmaceuticals, is set to go public through a SPAC merger that will infuse the business with up to $266 million. The deal comes as traditional IPOs have mostly ground to a halt due to uncertain market conditions, but Ligand is making a longer-term bet on growing demand for antibody …
Single-cell analysis biotech Celsius Therapeutics has raised $83 million to advance its pipeline of drugs for autoimmune disorders and cancer. The startup’s lead autoimmune program, a TREM1-blocking antibody for inflammatory bowel disease, is expected to begin human testing in early 2023.
The FDA approved Pluvicto, a Novartis radiopharmaceutical, as a new treatment option for advanced prostate cancer. Novartis added the therapy via its $2.1 billion acquisition of Endocyte four years ago.
LifeMine Therapeutics, a company that analyzes fungal genomes to find molecules that have potential as new medicines, has raised $175 million in financing. Among the investors is GlaxoSmithKline, which is teaming up with the biotech startup in a multi-target drug discovery alliance.
Affini-T Therapeutics is developing new cell therapies for cancer that could overcome limitations of the first generation of cell therapies. The initial genomic cancer targets of the startup are mutations of KRAS and p53, both of which have proven difficult to drug.
A retrospective study published in American Journal of Health-System Pharmacy found that machine learning and advanced analytics technology not only identifies drug diversion – when drugs are stolen from hospitals – but also that the tech can do so 160 days faster than standard methods, and with a 96.3% accuracy rate.
Marinus Pharmaceuticals drug Ztalmy is now FDA approved for treating the seizures in patients who have CDKL5 deficiency, an inherited form of epilepsy. The drug is the first approved treatment for the rare disorder and it’s also Marinus’s first approved product.
AnHeart Therapeutics is developing a pipeline of precision oncology therapeutics. Chief Business Officer and Co-founder Lihua Zheng provided an overview of company’s strategy in response to emailed questions.
Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The drug is approved for advanced melanoma as part of a combination treatment that includes the already approved BMS cancer immunotherapy Opdivo.
Apellis Pharmaceuticals has additional clinical data that show its drug having an effect on geographic atrophy, a rare vision-loss disorder with no FDA-approved treatment. The biotech plans to include the latest results in a new drug application being readied for submission in coming months.
Regulatory setbacks for a new migraine treatment have led Zosano Pharma to restructure, laying off about 31% of its staff. Zosano is one of several biotechs that announced cost-saving measures this week.
Whether seeking to overcome ongoing hesitation of the Covid-19 vaccine or searching for moonshot cancer solutions, whatever the healthcare need demands, seeking results for diverse populations must be a priority.
Illumina Accelerator has invested in 68 companies so far, all of them startups developing genomics technologies. Seven startups comprise the latest cohort selected by the startup engine.
Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna and Pfizer infringe on a patent covering this LNP technology.
Antibody drug conjugates have made scientific and regulatory progress in recent years. Sanofi is partnering with ADC specialist Seagen in a multi-drug alliance that keeps the pharmaceutical giant in the mix of this growing field of cancer therapies.
Scientists developing new RNA drugs need to understand how proteins bind to these molecules. Eclipsebio’s technology provides that analysis and the biotech startup now has a Series A round of funding to scale up its business.
Better Therapeutics reported that its digital therapeutic for type 2 diabetes met the main goal of a pivotal study. An FDA submission is expected in the middle of this year, followed by additional clinical trials testing digital therapeutics developed for other cardiometabolic disorders.
ARCH Venture Partners led the Series C round of financing for Nutcracker Therapeutics, a company developing new RNA drugs. The company’s process for developing and manufacturing RNA therapies borrows from techniques used in the technology sector.
Bristol Myers Squibb bet more than $1.8 billion that Nektar Therapeutics’ drug could be combined with the pharma giant’s Opdivo to expand the reach of that drug to more patients. The drug combination has failed its first Phase 3 in advanced melanoma; separate studies in kidney and bladder cancers are ongoing.
Creyon Bio is the latest company to launch with artificial intelligence technology for drug R&D. The startup claims it’s technology can provide sufficient safety and toxicity to enable a therapy to bypass the animal research currently needed before clinical trials.
Harpoon Therapeutics is discontinuing work on its lead drug in prostate cancer following disappointing data in an early-stage clinical trial. Though Harpoon has other drugs in its pipeline, the decision is a setback to the company’s efforts to develop a new type of cancer immunotherapy.
MorphoSys is cutting the drug discovery and R&D work of Constellation Pharmaceuticals, a company it acquired lats year in a $1.7 billion deal. This consolidation of research operations will result in non-cash impairment charge on Constellation’s goodwill.
Targeting mutations isn’t the only way to treat genetically driven diseases. Scenic Biotech is developing molecules to target genes that suppress disease, and it has raised $31 million to advance its pipeline of potential therapies for cancer and rare diseases.
An experimental hemophilia A therapy from Sanofi and partner Sobi has met the goals of a pivotal study, and the pharmaceutical giant is now planning global regulatory submissions for later this year. The drug could compete against a blockbuster hemophilia A treatment marketed by Roche.
Novartis is paying Voyager Therapeutics $53 million up front to begin a partnership focused on the discovery of capsids for central nervous system disorder gene therapies. Depending on the progress of the research, Voyager could earn up to $1.5 billion in milestone payments.
Diagnostics developer Sherlock Biosciences has advanced its molecular diagnostic capabilities, which can now produce faster results on low-cost devices. The startup will use its Series B round of funding to expand the reach of its technology, potentially placing it directly in the hands of consumers around the world.
Research of Johnson & Johnson’s baby powder included a prison study in which inmates, mostly Black men, were injected with asbestos. The study was intended to assess how asbestos’s effects on the skin compare to talc, the key component of baby powder.
Two biotechs are braving the roiling financial markets to raise money for clinical trials. AN2 Therapeutics is preparing for a pivotal test of its boron-based drug candidate for a rare, chronic lung disease. Okyo Pharma also filed IPO paperwork as it looks to advance to the clinic with its dry eye disease drug.
The FDA placed a partial clinical hold on a Phase 1 study testing experimental Alpine Immune Sciences cancer drug davoceticept in combination with Merck cancer immunotherapy Keytruda. The partial hold does not affect a separate study testing the Alpine drug as a monotherapy.
The FDA approved drugs from Johnson & Johnson and CTI BioPharma in the past week. Complete response letters were issued to Gilead Sciences, Amryt, and Reata Pharmaceuticals.
The idea of helping millions of Americans with diabetes afford a crucial medicine has immense public support and even bipartisan adherents. But then, there is politics — between Democrats and Republicans, of course, but also among Democrats.
Anti-infective drug discovery startup ArrePath has launched with $20 million in seed funding to advance the development of molecules that use a dual mechanism to kill bacteria. The Princeton University spinout says its approach could overcome the drug resistance bacteria are developing to currently available products.
A judge ruled the lawsuit against Eli Lilly for their Medicaid rebate payments will proceed to trial; Ely Lilly is accused of underpaying for Medicaid rebates between 2005 and 2016.
Rondo Therapeutics is developing bispecific antibody drugs capable of treating solid tumors, which have eluded this type of cancer therapy. Led by co-founders and Teneobio veterans Shelley Force Aldred and Nathan Trinklein, the biotech startup has emerged from stealth backed by a $67 million Series A round of funding.
Civica Rx plans to make lower cost versions of three branded insulin products, biosimilars that are expected to reach the market in 2024. In addition to $30 vials, Civica plans to sell pen cartridges at $55 for a box of five.
Artificial intelligence is a powerful tool for rare disease drug discovery. The founders of Vesalius Therapeutics say AI and machine learning can also be applied to common diseases, and the startup has launched with $75 million in committed financing.
AbbVie has acquired Syndesi Therapeutics, an early clinical neuroscience startup developing drugs that have potential applications in a range of cognitive disorders. Syndesi is based on research from Belgian pharmaceutical company UCB.
Sanofi and digital therapeutics company DarioHealth will work together to promote the tech firm’s offerings for the management of chronic diseases. Under the $30 million, multi-year agreement, the partners will also develop new technology tools.
Five companies will present to a group of investor judges. They will be evaluated on criteria such as business idea, market opportunity, and revenue model.
Leveraging a precision prescribing platform with embedded genomic analysis will help physicians improve care and reduce costs by providing valuable information to inform mental health medication choices that can deliver treatment success for their patients from the start.
Approval of the Johnson & Johnson and Legend Biotech cell therapy, Carvykti, marks the second CAR T-cell therapy to clear the regulatory bar for multiple myeloma. The FDA approved Bristol Myers Squibb’s cell therapy Abecma last year.
Biocon Biologics is acquiring the biosimilars business of its longtime partner, Viatris. The deal gives Biocon a biosimilars presence in both emerging and developed markets, while Viatris sheds non-core assets as part of a broader strategic review.
The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in patients who have the rare disease Alport syndrome. The regulatory decision follows an FDA advisory committee vote recommending against approval of the small molecule drug.
The racial reckoning of the past couple of years has inspired many industries to take a look at their histories and practices.
Neuroscience drug developer Biohaven Pharmaceuticals is expanding its pipeline to include epilepsy and spinal muscular atrophy. The drug developer is acquiring Channel Bioscience and licensing global rights to a Phase 3-ready drug from Bristol Myers Squibb.
New startup hC Bioscience is developing therapies based on transfer RNA, molecules that can be leveraged to address disease-causing proteins. The biotech joins several companies that are developing tRNA therapies in this emerging class of genetic medicines.
The SPAC merger that Amicus Therapeutics planned for its gene therapy assets has been called off due to market conditions. The rare disease company is instead keeping those assets but streamlining its portfolio in order to save $400 million—the amount that the gene therapy spinout was in line to receive from the merger deal.
A Kodiak Sciences drug failed to beat a Regeneron Pharmaceuticals product in a key test in the wet form of age-related macular degeneration. The biotech says the failure is due to a subset of undertreated patients, but the results raise the stakes for the drug, its lead product candidate, in other eye diseases.
Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster.
The Lilly Institute for Genetic Medicine is a new facility in Boston that will focus on the R&D of RNA and DNA-based therapies. Eli Lilly is investing about $700 million to establish the site, which will also include lab and office space for biotech startups.
BioNTech is acquiring a preclinical T cell receptor program (TCR) from Medigene, as well as licenses to the biotech’s TCR technologies. The agreement helps BioNTech expand its scope in cancer immunotherapy with a new approach for addressing solid tumors.
Agios Pharmaceuticals has its third FDA-approved product, and the first under its new rare disease strategy. The regulatory decision also marks the first approved treatment for pyruvate kinase deficiency, a rare disease that leads to chronic anemia.
Yumanity’s corporate restructuring means the biotech is now exploring “strategic alternatives” that could include a sale of the company or its assets. The biotech’s lead drug candidate is an experimental Parkinson’s disease drug currently in Phase 1 testing.
Several biotech companies are rising to the challenge of developing small molecules to drug RNA. Remix Therapeutics is joining the chase, but its different approach has drawn the interest of Johnson & Johnson, which has inked an R&D alliance spanning cancer and immunology.