Three pharmacy trends that will define 2022
The pharmaceutical industry made more headlines in 2021 than in any other year in recent memory. And 2022 is set to be a monumental year as well.
Category: biopharma nl
The pharmaceutical industry made more headlines in 2021 than in any other year in recent memory. And 2022 is set to be a monumental year as well.
TenSixteen Bio has emerged from stealth aiming to develop drugs for diseases caused by genetic mutations accumulated as we age. The startup has been incubating within Foresite Labs and it now has $40 million to finance its research into this new realm of biology.
The current landscape heading into 2022 will keep pharmacy benefits under the microscope. Plan sponsors will evaluate their PBM’s pricing model to determine if their contract will deliver predictable costs, more opportunities for increased savings and improved care for their members.
Palliative care must be the standard of care for all who have been diagnosed with progressive, advanced, and terminal illnesses. Never should we hear the phrase, “I’m sorry, there’s nothing more I can do,” when physicians encounter the failure of a curative course of therapy.
Barry Ticho explains the novel drug that the company is developing to tackle Dravet Syndrome as well as how the company’s stock price decline isn’t reflective of the true value of the therapy the company is hoping to commercialize.
Basic organic chemicals used for the preparation of new medications cost over 54.8% more than they did 12 months ago. Further, with schools and daycare facilities either going fully remote and/or closed, many parents and caregivers had to stay at home, eliminating their availability for study participation.
Physicians may soon have a solution that could be ideal for preventing surgical site infections with a combined multi-layered system that provides the surgical site with controlled and continuous delivery of antibiotics.
BenchSci’s technology uses artificial intelligence to make drug R&D faster and more efficient. Big pharmaceutical companies and clinical-stage biotechs are current users of the software, and BenchSci said it will use its new funding to expand the technology.
The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health from competing against a newly approved human growth hormone drug from Ascendis Health that is also designed for once-weekly dosing.
The FDA placed the partial hold on the study last November following a patient death suspected to be linked to a known complication of leukemia therapies. Kura Oncology said it has reached agreement with the FDA on a mitigation strategy for that complication.
Eleusis is developing a formulation of the psychedelic compound psilocybin that overcomes limitations of pill versions of the drug. Depression is Eleusis’s lead disease target but the biotech notes that its research has shown the potential to bring psychedelic drugs beyond psychiatry.
Despite the targeted approach of some cancer treatments, tumors can find ways to escape, leading patients to relapse. ImmPACT Bio will apply its Series B financing toward the development of cell therapies designed to prevent tumor escape.
Digital health company Verana Health has raised $150 million. The company said it will use the new capital to expand its technology, which is used by physicians and pharmaceutical companies.
AstraZeneca’s partnership with Scorpion Therapeutics will focus on transcription factors that are known to play a role in cancer but have been difficult to target with small molecule drugs. Depending on the progress of the research, Scorpion could receive up to $1.5 billion in option fees and milestone payments.
BeyondSpring Pharmaceuticals’ corporate reorganization comes about six weeks after the FDA rejected the biotech’s drug for a complication experienced by cancer patients. The company still plans to develop the drug for that application and others, but it added that layoffs are needed to reduce expenses.
The National Pancreas Foundation and Seqster are partnering to create a dynamic digital database for patients with pancreatic diseases that compiles patients’ data from genomic DNA test, EHR, and wearable/remote monitoring device to speed up research for pancreatic disease treatments and provide more cohesive treatment for patients.
A month after Freenome closed $300 million in financing, Roche has invested another $290 million in the diagnostics developer. The cash infusion comes as Freenome continues a pivotal test in colorectal cancer while it also readies for clinical trials in other types of cancer.
As the annual J.P. Morgan HealthCare Conference kicked off Monday, two pharma giants unveiled deals that expand give them access to in-vivo gene editing technologies. Pfizer is teaming up with Beam Therapeutics to develop new base-editing therapies while Bayer hopes to develop new medicines with the in-vivo CRISPR editing tools of Mammoth Biosciences.
The field of biotechs pursuing new interleukin-2 cancer immunotherapies is filled with companies engineering different versions of that signaling protein. Avenge Bio CEO Mike Heffernan said his startup stands apart with a cell therapy that produces human IL-2 that could offer advantages compared to engineered versions of that protein.
It’s the first week of the new year, and the life sciences sector continued the IPO momentum of 2021 as Wall Street welcomed three new biotech companies. Here’s a look at the IPOs of Amylyx Pharmaceuticals, CinCor, and Vigil Neuroscience, which raised a combined $482 million to support work on drugs addressing neurodegenerative and cardiovascular […]
Sanofi’s new alliance with artificial intelligence biotech Exscientia spans up to 15 small molecule drugs in cancer and immunology. If drugs from the partnership reach the market, Exscientia could earn as much as $5.2 billion in milestone payments.
A Sanofi strategy shift is leading to the end of a gene-editing alliance with Sangamo Therapeutics. Though the partnership has produced encouraging early clinical data with a sickle cell therapy highly personalized to the patient, Sanofi now plans to focus on universal approaches to genomic medicines.
Oncolytic viruses have the power to make the tumor more visible to the immune system and mark the area of attack. It is this anti-tumor immune activation that has the potential to induce long-term responses in patients.
Avrobio is stopping enrollment in a clinical trial for its Fabry disease program after new results showed variability in how the gene therapy was taken up by patients. No safety problems were reported, but the biotech said it now plans to focus its other gene therapy candidates for rare metabolic disorders.
Health analytics firm Aetion has acquired Replica Analytics, a company that specializes in synthetic data. Aetion said Replica will enable it to analyze previously inaccessible data while maintaining privacy and integrity of the original source data.
“Most Q&As are happening on Twitter. If you’re not doing social listening you’re losing fresh insights into things like disease states.” That was just one of the observations in a new report on how pharma and other life science companies are working with healthcare providers and adapting to improve the patient experience.
The FDA has expanded emergency authorization of Covid-19 boosters to include children 12 to 15 vaccinated with the Pfizer and BioNTech messenger RNA shot. The decision is based on a study that found boosting reduced deaths by 90%, but that Israeli analysis only evaluated these shots in people 50 and older.
Ovid Therapeutics is acquiring global rights to AstraZeneca molecules that address a novel target to treat epilepsy. The AstraZeneca deal comes 10 months after Takeda Pharmaceutical paid $196 million up front to acquire Ovid’s rights to a Phase 3 ready molecule for two rare forms of epilepsy.
As in previous years, cancer products topped the list of new FDA-approved therapies in 2021. But the list of drug approvals is notable for other trends, including developments in rare diseases and regenerative medicine.
The biggest biotech IPO of 2021 belongs to a cell therapy developer that has yet to reach the clinic. Cell therapy and artificial intelligence were hot categories of newly public companies, but even though IPOs reached record levels this year that streak is not expected to continue in 2022.
Pardes Biosciences’ experimental oral antiviral for treating and preventing Covid-19 infection addresses the same target as Pfizer’s authorized pill Paxlovid, but with a potential dosing advantage. The Pardes pill is in Phase 1 testing, and the biotech joined the public markets this week after completing a SPAC merger that infuses the company with $274 million.
With FDA approval for its atopic dermatitis drug Adbry, LEO Pharma will reach the U.S market ahead of an Eli Lilly atopic dermatitis drug that addresses the same target. LEO will also able to offer patients an alternative to the blockbuster Sanofi/Regeneron Pharmaceuticals drug Dupixent.
BridgeBio reported its drug acoramidis missed the main goal of a pivotal study in patients with transthyretin amyloidosis affecting the heart—the same type of patients helped by a currently approved blockbuster Pfizer drug. BridgeBio attributed the trial failure to a surprisingly strong placebo response, and it will continue the study, hoping for better outcomes on […]
Merck antiviral drug molnupiravir received emergency authorization, joining Pfizer’s Paxlovid as the only authorized oral antiviral drugs for treating Covid-19. Though the Merck and Pfizer antivirals appear to work against the omicron variant, FDA officials stressed that these drugs are authorized only for certain patients and they are not a substitute for vaccination.
Novartis drug Leqvio now has the FDA’s green light, making it the first RNA interference medicine approved for lowering cholesterol. The regulatory decision sets the stage for competition against cholesterol medicines from Amgen and Regeneron that also address liver protein PCSK9.
The FDA has halted tests of a Pfizer gene therapy for Duchenne muscular dystrophy. The clinical hold is one of several placed on gene therapy tests in the past year due to safety concerns.
In acquiring Amunix, Sanofi becomes the latest big pharmaceutical company to strike a deal to gain access to technology that improves the safety and efficacy of T cell engager cancer therapies. Sanofi agreed to pay $1 billion up front to buy preclinical Amunix.
Novartis is partnering with BeiGene on the development of a drug that addresses TIGIT, a hot cancer immunotherapy target. The Swiss pharma giant is committing $300 million up front, and up to $700 million more upon exercising its option on BeiGene’s antibody drug.
What follows is guidance for healthcare workers, hospital administrators, journalists, nonprofit leaders, government officials, industry leaders, and others who want to invite engage a patient safety advocate to share their story at an event, or to collaborate on a research or awareness project.
The price of Biogen Alzheimer’s disease drug Aduhelm will be cut in half at the start of 2022, a move that comes as a Medicare recommendation on coverage is expected early next year. Meanwhile, Biogen is preparing corporate measures projected to save $500 million annually, cost-cutting made necessary in part due to slow market uptake […]
The change in terminology from “compliance” to “adherence” is based on unfounded and untenable foundations. It conflates cause and effect, and a shift in language and mindsets can help reframe and better tackle the core problem: patient failure to take medications as prescribed.
Myasthenia gravis patients now have a new FDA-approved biological treatment. Argenx drug Vyvgart provides a treatment alternative for patients who have the rare autoimmune disorder and also marks the first approved product in a new class of medicines.
Ipsen is paying €120 million up front to acquire global rights to elafibranor, a Genfit drug that fell short as a treatment for NASH, but is currently in Phase 3 testing in another liver disease, primary biliary cholangitis. Meanwhile, Genfit is adding an early-stage drug candidate to its own pipeline via a separate transaction.
We cannot simply accept that testing new drugs will continue to be a slow and expensive process. AI has the potential to disrupt the current approach to clinical trials — from patient recruitment to adherence monitoring and data collection – and it is time to seize these opportunities.
Three life science companies unveiled Series B rounds of funding Thursday, early Christmas gifts that top $219 million combined. Along with Verge Genomics, the other companies that raised new capital are Tasso and Brainomix.
Six months after Biogen was awarded regulatory approval for its Alzheimer’s disease drug Aduhelm, the company the company is laying out a timeline for the post-marketing study to confirm whether the drug works. The projected four-year study will enroll more than 1,300 patients and will include a placebo control arm.
Antibody drug conjugates deliver a targeted strike to tumors, but the toxic payloads of these therapies can still reach healthy tissue. Mythic Therapeutics’ FateControl technology ensures that more of an ADC’s drug payload reaches the tumor, and CEO Alex Nichols is steering the startup out of stealth with $103 million and a lead program in lung […]
CSL Limited makes many of its therapies from donated plasma, which posed a challenge as pandemic lockdowns led to a steep drop in plasma collections. In acquiring Vifor Pharma, CSL not only diversifies, it also expands its presence in the fast-growing nephrology market.
Bristol Myers Squibb is paying $150 million up front for global rights to an Immatics biologic drug designed to recruit a patient’s T cells to go after cancer cells. It’s the latest deal in the field of cancer drug developers aiming for off-the-shelf treatments intended to be easier and less expensive to manufacture, distribute, and […]
Genetic tests are becoming available for a wider range of applications. During a CB Insights panel discussion, Phil Febbo of Illumina and Alicia Zhou of Color explained what they think needs to happen to make these tests accessible and affordable for more people.
FDA authorization of AstraZeneca drug Evusheld makes it the first antibody therapy for preventing infection before exposure to Covid-19, providing an option for immunocompromised patients who won’t mount a strong immune response to vaccination. The antibodies that comprise the AstraZeneca drug are engineered with technology that makes the therapy long lasting.
PharmStars, an accelerator for companies developing digital solutions for pharmaceutical companies, has graduated its first class of startups. The theme for this initial group was “innovation in clinical trials.”
We now know how important white matter is to our overall brain health and cognitive ability, as well as how declines in white matter structure are correlated with impairments in brain function.
Odyssey Therapeutics is the latest startup formed by serial biotech entrepreneur Gary Glick. Odyssey’s destination is oncology and immunology drugs that address novel disease targets, and the biotech now has $218 million in Series A financing to fuel the journey.
Liberating the genetics, laboratory and pharmacy data that sits deep within healthcare subsystems, while protecting patient information and navigating the global regulatory landscape, is no easy task but would greatly help in the treatment of diseases.
Nabla Bio emerged from the lab of famed Harvard scientists George Church last year, and its antibody discovery technology has already led to five partnerships with pharma and biotech companies. The startup just closed an $11 million seed financing that will support further development of its technology.
Adicet Bio makes its therapies from gamma delta T cells, a rare type of immune cell that the company believes offer advantages compared to other cell therapies. The company now has early Phase 1 data that bring some validation to the approach.
What do radiation and Botox have in common? Two powerful tools that were tamed by medicine in the quest to help patients. We’ve found ways to parlay our scientific curiosity and expertise into significant medical advances that help prolong and also improve quality of life.
Eli Lilly’s authorized antibody drug for treating and preventing Covid-19 infection in adolescents and adults is now authorized for pediatric patients, including newborns. While tests are still assessing whether the drug works against omicron, early data suggest a Vir Biotechnology antibody can address the new variant but Regeneron Pharmaceuticals’ antibody drug might not.
Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois and elsewhere.
Specialty drugs represent a growing share of overall pharmaceutical sales, and Omnicell is acquiring specialty pharmacy technologies company ReCept Pharmacy to enter into this market. Omnicell is paying $100 million cash to buy ReCept.
Novartis is paying UCB $150 million up front to share in the development of two clinical-stage Parkinson’s disease drugs that offer new approaches to treating the disease. Depending on the progress of those drugs, UCB could earn up to $1.5 billion in milestone payments.
BeyondSpring Pharmaceuticals said the FDA wants another clinical trial to demonstrate patient benefit for its drug, a small molecule developed to treat a dangerous and life-threatening complication of chemotherapy. Shares of the biotech plunged more than 60% after the FDA’s complete response letter was announced.
Sanofi’s strategy to develop new messenger RNA vaccines is adding another piece. The pharmaceutical giant struck a deal to acquire Origimm Biotechnology, a startup developing therapeutic vaccines to treat skin diseases and infections.
For too long, we’ve forced kids to make do with services made for adults. The results have been nothing less than tragic, as evidenced by today’s pediatric behavioral health crisis.
Deciphera Pharmaceuticals’ corporate restructuring will slash headcount by 35% and stop work on two drug programs. Going forward, the biotech said it will focus on developing drugs that have the potential to be the first or the best in their therapeutic classes.
Prescribers need a pharmacogenetics knowledge base to determine a safe and effective medication and dosage for their patients, but they also need pharmacogenetics test information to be easily accessible, interpretable and meaningful.
Quell Therapeutics’ $156 million Series B round comes as it prepares to advance to a clinical trial testing its lead regulatory T cell therapy candidate as way to prevent organ rejection in liver transplant patients. The progress comes as the field of Treg cell therapy research becomes increasingly competitive.
Blueprint Medicines is paying $250 million up front to acquire Lengo Therapeutics, developer of targeted cancer therapies. The startup’s lead drug candidate is on track to begin human testing in non-small cell lung cancer, and Blueprint believes the small molecule has advantages over new targeted therapies from Johnson & Johnson and Takeda Pharmaceutical.
When your organization asks for a lowest-net-cost formulary, what you’re really saying is, “I want the deepest contractual discounts aligned with my formulary without disruption.”
The new Covid-19 variant, named Omicron, has mutations that could help it evade antibodies produced by the immune system. Scientists are conducting lab tests to better understand this new variant and pharmaceutical companies are testing how existing vaccines, as well as those in development, measure up the new mutations.
Takeda Pharmaceutical won FDA approval for Livtencity, an antiviral developed to treat cytomegalovirus infection in transplant patients. The agency also approved an Aadi Biosciences drug, making it the first therapy authorized for treating a rare type of soft-tissue cancer.
AbbVie returned the rights to the drugs to Sosei Heptares earlier this year. Now Neurocrine Biosciences has agreed to pay the Japanese drug company $100 million to license the rights to these preclinical and clinical-stage compounds that address muscarinic receptors to potentially treat a range of neurological disorders.
Nephrology products company Vifor Pharma is shelling out about $252 million combined up front to acquire Sanifit Therapeutics and Inositec, developers of drugs for a blood vessel complication affecting some chronic kidney disease patients. Both biotechs are in clinical trials with their respective lead drug candidates.
BioMarin Pharmaceutical’s Voxzogo is the first FDA approved therapy for achondroplasia, an inherited disorder that causes the most common form of dwarfism. With approvals in Europe and the U.S., and more regulatory decisions expected in 2022, the biotech said the drug has blockbuster potential.
The sum represents Sanofi’s equity investment in Owkin, plus a payment to begin a research partnership covering four types of cancer. Meanwhile, Owkin said the Sanofi investment boosts the startup into unicorn status and marks the start of its Series B funding round.
Generate Biomedicines applies artificial intelligence and machine learning to protein analysis, which it uses to program its protein therapies for particular applications. The startup now has $370 million in financing to rapidly scale up operations, with a goal of reaching the clinic within two years.
Bill Martin, the Global Therapeutic Area Head of Neuroscience at The Janssen Pharmaceutical Companies of Johnson & Johnson, shared some of the promising developments in the neuroscience space, such as the rise of neuro-immunology and the industry’s embrace of digital health tools to support drug development in a recent interview.
The acquisition agreement comes exactly two years after the two companies began a wide-ranging alliance focused on developing RNA interference drug for metabolic disorders. The most advanced therapy from that alliance is on track to reach the clinic in 2022.
The first wave of biotechs developing drugs that employ targeted protein degradation target disease-causing proteins inside the cell. Biotech startup Avilar Therapeutics, formed by RA Capital Management and led by CEO Dan Grau, is targeting proteins outside of the cell and it’s out of stealth backed by $60 million.
Chroma Medicine is developing epigenetic therapies that turn genes on or off. The biotech startup has emerged from stealth mode backed by a $125 million Series A round of funding.
Flagship Pioneering’s Valo Health and Khosla Ventures Acquisition Co. abandoned their SPAC merger on the eve of a scheduled shareholder vote on whether to approve the deal. The parties described the decision as mutual, and they cited “market conditions.”
Recognized as Method of the Year by Nature in 2020, spatial transcriptomics employs advanced imaging methods with novel chemistry techniques that stand to dramatically expand our understanding of health and disease.
Acelyrin has in-licensed izokipeb, an antibody drug developed by Affibody that could offer advantages compared to currently available monoclonal antibodies. The drug addresses the same target as blockbuster immunology drugs marketed by Novartis and Eli Lilly.
Polycythemia vera, a rare blood cancer characterized by the overproduction of red blood cells, now has its first FDA-approved drug treatment. The agency awarded the regulatory nod to a PharmaEssentia drug that reduces the levels of those blood cells.
While much progress has been made, many patients have molecular drivers of disease that are not detected, interpreted and acted upon with precision therapies, leaving potential life-changing treatments on the table.
Beacon Biosignals technology analyzes EEGs to find insights brain activity. The company will use its new Series A financing to build alliances with more biopharmaceutical companies looking for insights about how their experimental brain therapies are working.
Johnson & Johnson announced it plans to separate its consumer health products into a separate company, leaving the remaining business to focus on the more research-oriented pharmaceuticals and medical devices business segments. The announcement follows similar moves made by other large pharmaceutical and medical device companies.
Vaxxinity, a clinical-stage biotech with vaccine technology that gets the body to produce therapeutic or protective antibodies, raised $88 million from an IPO that priced below the targeted price range. In addition to its lead Alzheimer’s disease program, Vaxxinity’s pipeline includes product candidates for Parkinson’s disease, migraine, and Covid-19.
Organon’s proposed acquisition of Forendo Pharma is the company’s third the company since spinning out of Merck in the summer. Clinical-stage Forendo is developing a new, potentially more targeted approach to treating endometriosis.
Vaccine biotech Inventprise has developed technology that offers broader protection than currently available products. Its lead program, a pneumococcal vaccine candidate, is being readied for tests in humans and it now has a financial commitment of up to $90 million from the Bill & Melinda Gates Foundation.
Arbor Biotechnologies raised new cash to keep up the pace in the chase for new genetic medicines. The MIT spinout applies artificial intelligence and machine learning to discover CRISPR enzymes applicable for gene-editing therapies; the Series B financing comes as programs in liver and central nervous system disorders move closer to human testing.
Biohaven Pharmaceuticals has seen strong U.S. market uptake for its oral migraine drug, Nurtec. With regulatory decisions looming around the world, the company has landed the marketing muscle of Pfizer, which is paying $500 million up front for the right to market that drug and another clinical-stage compound outside of the U.S.
Alltrna, a biotech startup founded by Flagship Pioneering, is developing a new type of medicines based on a form of RNA called transfer RNA, or tRNA. The company’s scientists say that this approach offers the potential to treat a wide range of diseases, both rare and common.
Sanofi is committing up to $60 million to Gyroscope Therapeutics, a clinical-stage biotech whose lead program could become the first gene therapy for a particular vision loss disorder. The deal also gives the pharma giant right of first refusal on that gene therapy in certain geographies.
The team behind the World Without Disease Accelerator, part of Janssen Research & Development, one of the Janssen Pharmaceutical companies of Johnson & Johnson, is embracing an ambitious paradigm focused on disease prevention, interception and cure.
Apple Tree Partners’ latest cancer biotech company, Marengo Therapeutics, is using antibodies to selectively activate T cells to fight cancer. Led by former Merck KGaA executive Zhen Su, the startup is launching with $80 million in financing, which will support a drug pipeline that includes a lead program expected to reach the clinic in 2022.
Evotec is an old player in the life sciences, but in offering new shares on the Nasdaq, the Germany-based company plans to bolster its new biologics manufacturing capabilities in the U.S and Europe. In other stock market debuts, IO Biotech’s IPO raised $100 million as it prepares a pivotal test of its lead cancer immunotherapy.
Lawmakers have acted to strengthen insurance reimbursement for biomarker testing in California, Illinois and Louisiana. Patient advocates and testing companies hope more will act in the coming year.
PlateletBio trails Sanofi among others in pursuit of a new therapy for a rare blood clotting disorder that has few treatments. But the biotech startup could stand apart from those drugs with its new class of cell therapy, which harnesses the properties of platelets.
Novartis’s equity stake in Roche, shares acquired 20 years ago in a strategy to build up to a potential mega-merger, will be sold back to the company in a $20.7 billion deal. The cash proceeds could fuel Novartis R&D, as well as potential dealmaking.
Harvard University spinout GRO Biosciences has technology offering the potential for protein therapies that are safer and more effective than currently available biologic drugs. The startup’s research is now backed by $25 million, a Series A financing round whose investors include the venture arm of Bayer.
Amylyx Pharmaceuticals has submitted its amyotrophic lateral sclerosis (ALS) drug for FDA review based on positive Phase 2 data after discussions with the agency over the summer. Meanwhile, a Clene Nanomedicine ALS drug failed its Phase 2 study, but the biotech points to encouraging results in a subgroup of patients.
Gilead Sciences and BeiGene, which started research alliances with Shoreline Biosciences earlier this year, are among the investors in the biotech’s latest financing. The preclinical-stage company technology develops cell therapies for cancer by using natural killer cells.
Covid-19 protocols may make re-opening or starting clinical trials seem like a daunting responsibility. Consider these four factors for a successful return to research.
Microsoft seeks to change the way pharma industry companies use technology to navigate human resource challenges and restore confidence in drug development supply chains.
Clinicians must be aware that coordination of care is one of the key factors to combat opioid epidemic and stop overuse of more powerful and dangerous medications.
Breaking Media Inc. has announced Ken Montgomery as Publisher for MedCity News, the leading online news source for innovation in the healthcare industry.
New semiquantitative tests offer a more granular understanding of our protective immunity, not only identifying Covid-19 antibodies but providing direct, individualized measures of neutralizing antibody levels.
By all accounts, Ro is a successful direct-to-consumer telehealth and pharmacy services startup. At the recently-concluded HLTH conference, Ro’s chief medical officer speculated on how it might enter the business-to-business healthcare world.
Strados Labs has developed a wearable device that senses lung sounds in patients with asthma, COPD, and other respiratory disorders. The startup, which has FDA clearance and a growing list of customers, was judged the winner in the Pitch Perfect competition at MedCity News’ recent INVEST Digital Health conference.
Cancer drug developer Xilio Therapeutics and Ventyx Biosciences, a company with drug candidates in cancer and autoimmune diseases, are the latest life science companies to go public. They’ll use proceeds from their respective IPOs to continue clinical development of drugs being positioned as competitors to drugs from big pharmaceutical companies.
ReCode Therapeutics closed an $80 million Series B round of financing that included Pfizer and Sanofi as investors. The startup’s technology uses lipid nanoparticles to deliver genetic medicines, and its two lead programs are for rare lung disorders.
The FDA amended emergency use authorization of the Moderna and Johnson & Johnson Covid-19 vaccines, permitting booster shots. But the agency went further and said that a booster shot may be different than the one given for the primary vaccination.
Boehringer Ingelheim has shown biosimilar manufacturers the way to win interchangeability with the world’s highest-grossing drug — but the company’s Cyltezo won’t come out until July 2023. Will future Humira competitors have better luck winning an earlier launch date?
ShouTi Pharmaceuticals, a startup that brings computational techniques to drug discovery, has raised $100 million in Series B financing. The clinical-stage biotech designs small molecules intended to do the work of biologic and peptide drugs.
Entasis Therapeutics, the former anti-infectives unit of AstraZeneca, has positive Phase 3 data for its lead program, an antibiotic that could address drug-resistant strains of Acinetobacter baumannii that contribute to hospital-acquired infections. The biotech plans to seek FDA approval in 2022.
An Oyster Point Pharma drug for dry eye disease has won FDA approval, the first treatment for the condition that comes as a nasal spray. In addition to that drug approval, the FDA on Monday rejected two drugs, one from Omeros and the other from United Therapeutics.
Biogen amyotrophic lateral sclerosis drug, tofersen, failed a Phase 3 clinical trial, but the drug showed improvement according to secondary and exploratory goals of the study. Based on those results, the company said it is talking with regulators to find a path forward for the drug.
A panel of data and biopharma experts at the annual HLTH conference in Boston tried to answer questions about where AI can be best used in the world of drug development.
A new startup initiative in Israel aims to create and invest in startups that use artificial intelligence to address challenges in drug discovery and development. Called AION Labs, this innovation lab stems from an economic development effort from the Israeli government and will have contributions from AstraZeneca, Merck, Pfizer and Teva Pharmaceutical.
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after the panel’s affirmative vote on a Moderna vaccine in a busy week of regulatory developments for Covid-19 vaccines, therapies, and diagnostics.
Technology can assist sponsors in setting up trials and activating clinical trial sites quickly. But tech will only play a small role within the larger movement toward accelerated approval.
Biomanufacturing technologies company Resilience is partnering with Harvard in a deal that could see innovations from the university’s labs commercialized under new businesses. Resilience has committed $30 million in funding to support Harvard biomanufacturing research.
Biotech startup Tentarix Biotherapeutics has come out of stealth with $50 million and technology that develops biologic drugs endowed with multiple functions. The company aims to develop new multispecific biologic drugs for cancer and autoimmune diseases.
Rectify Pharmaceuticals is taking an approach to disease that led to a successful franchise of Vertex Pharmaceutical lung drugs and expanding it to more diseases in more organs in the body. The startup has launched with $100 million in financing.
By automating patient engagement, these organizations can reduce the burden on both resources and personnel in fighting this pandemic while improving efficiency in the administration of booster vaccines.
Bionano Genomics is acquiring genomics software firm BioDiscovery in a $90 million cash and stock deal. While both companies provide genomics analysis solutions, Bionano said combining its technology with BioDiscovery’s software will provide the integrated offering that many labs want.
The progress of gene therapies continues to be stymied by safety risks associated with the viruses used to deliver them. Takeda Pharmaceutical is partnering with Poseida Therapeutics in a bet that the biotech’s non-viral technologies could offer a safer alternative.
Large majorities regardless of party identification and age found the following argument convincing: “Those in favor say negotiation is needed because Americans pay higher prices than people in other countries, many can’t afford their prescriptions, and drug company profits are too high.”
Pyxis Oncology’s IPO raised $168 million as the biotech steers toward the clinic with drug candidates and technology licensed from Pfizer. Theseus Pharma, IsoPlexis, and Cognition Therapeutics also went public; combined the four companies raised nearly half a billion dollars.
It is imperative for health systems to form data sharing partnerships that allow for the analysis of de-identified clinical data, while effectively and comprehensively protecting patient information.
ChemoCentryx has spent decades developing oral alternatives to injectable and infused biologic drugs that treat chronic autoimmune conditions. The research finally paid off with FDA approval of Tavneos, a ChemoCentryx pill for a rare autoimmune disease.
Good communication and engagement practices are critical to participant engagement and retention.
All of Allogene Therapeutics’ clinical trials are now under an FDA clinical hold. The halt was handed down after one patient in the company’s most advanced study developed what the company described as a “chromosomal abnormality.”
Bristol Myers Squibb drug deucravacitinib missed the main and secondary goals of a Phase 2 study in ulcerative colitis. Despite the clinical trial failure, the drug previously posted positive Phase 3 results in plaque psoriasis and BMS still projects the molecule will become a blockbuster seller in multiple autoimmune conditions.
Neumora Therapeutics unveiled $500 million in capital and a research partnership with Amgen. The startup analyzes neurological data to inform its drug research and development; President and Chief Operating Officer Lori Lyons-Williams said researching psychiatric drugs and neurodegenerative drugs within the same company allows brain insights from one area to inform the other.
Vedanta Biosciences is developing its microbiome therapy with support from the Biomedical Advanced Research and Development Authority. Under terms of that contract, the positive Phase 2 results in preventing recurrent C. diff infection trigger a $23.8 million payment.
Biotech startup Exo Therapeutics aims to overcome the challenges of drugging proteins by targeting exosites, locations that modulate enzyme activity. The company has four small molecule drug candidates for cancer and inflammation, and the company plans to use the $78 million in new financing to advance them toward human testing.
Given the suboptimal outcomes with existing therapies to manage chronic kidney disease patients on dialysis, there is a substantial unmet need that additional treatment options could potentially address.
Clinical-stage Xencor is receiving $100 million up front and a $25 million equity investment, while Johnson & Johnson’s Janssen Biotech subsidiary gets global rights to plamotamab, a bispecific antibody. Regeneron Pharmaceuticals and Roche are also developing bispecific antibodies against the same targets, but Xencor’s drug has a feature that could be a competitive advantage.
Exscientia’s IPO and private placement raised $464 million to support its artificial intelligence-based approach to discovering and developing new drugs. In addition to partnerships with pharmaceutical companies, an alliance with the Bill & Melinda Gates Foundation is focused on developing antiviral drugs for future pandemics.
Modern technology can now be used to extract critical information from contracts through the use of an AI-enabled Contact Lifecycle Management (CLM) system, an intelligent tool that performs in-depth analysis of contracts
Investing in patient engagement strategies that facilitate enrollment and keep people on board, on track, and on drug could be the answer developers have been looking for.
Diagnostics startup GRIP Molecular is developing an at-home test for Covid-19 and other respiratory infections. The technology builds on advances from several fields, including the discovery of graphene, a material that offers biocompatibility and conductivity.
TrialSpark, a startup whose software manages various aspects of clinical trials, is becoming a drug developer. Led by CEO and cofounder Benjamine Liu, the company now plans to to acquire or partner on drug candidates, and to invest in biotech companies.
Merck is looking for products that diversify its portfolio beyond reliance on cancer drug Keytruda, and it sees a potential blockbuster cardiovascular drug from Acceleron Pharma as fitting the bill. The pharma giant is paying $11.5 billion to acquire the biotech, and executives say they’re still on the hunt for more deals.
The dirty secret that many life sciences and medical device companies don’t want people to know is that, to date, quality management has primarily been paper-based AND an afterthought in comparison to key strategic initiatives such as product development.
Mirum Pharmaceuticals drug Livmarli is now approved to treat pruritus caused by Alagille syndrome, a rare liver disease that can worsen to the point of requiring a transplant. Mirum licensed the drug from Shire in 2018.
Amicus Therapeutics is spinning its gene therapy pipeline into a separate entity that will go public via a SPAC merger. Executives say the transaction puts Amicus on a path to profitability while simultaneously securing the cash needed to develop the gene therapy assets.
Which capital funding options fit your healthcare or life science business?
The success of biopharma and medtech are not mutually exclusive. In some ways, medtech is […]
Cross-border biotech Anji Pharma closed $70 million in Series B funding to advance a drug pipeline that includes metabolic and cancer drugs. The biotech’s business model of finding promising drugs and forming subsidiaries to develop them is similar to approaches taken by Roivant Sciences and BridgeBio Pharma, among others.
Eisai is seeking accelerated FDA approval of lecanemab, an Alzheimer’s disease drug that is part of a research alliance with Biogen. The drug is following the same path blazed earlier this year with FDA approval of Biogen Alzheimer’s drug Aduhelm.
Bringing in market access and collaboration earlier in the process, viewing reimbursement as the last leg of the drug developmental journey, and collaborating across key functions are practices we can evolve so that as many patients as possible can reap the rewards that are waiting for them.
Delix Therapeutics is developing drugs that offer the therapeutic benefits of psychedelic drugs, but without the hallucinations and other side effects that accompany these compounds. The startup has closed $70 million in Series A financing as it works to bring its lead candidates into the clinic next year.
Biohaven’s bet on an AstraZeneca drug for multiple system atrophy does not pan out, failing a pivotal study in the rare, neurodegenerative disorder. But a separate Phase 3 study evaluating verdiperstat in amyotrophic lateral sclerosis is still moving forward.
Life sciences companies are using “digital twins” for everything from drug discovery to manufacturing. A panel of experts at MedCity News’ INVEST Digital Health conference discussed how this capability to run virtual simulations is changing practices now while also shaping the industry for the years to come.
Biotech startup GenEdit is developing polymer nanoparticle technology to deliver genetic medicines, an approach intended to avoid the limitations of viral vectors. Already partnered with a clinical-stage company, it now has financial support from a big pharma giant that joined a syndicate of investors in a $26 million Series A round.
The FDA has authorized dosing of booster shots of Pfizer and BioNTech’s Covid-19 vaccine. Consistent with the recommendations of an FDA advisory committee, the agency’s amendment to the emergency authorization covers only certain groups at high risk of infection and complications from the virus.
Algorithms are everywhere and so are the biases behind them. As algorithms find greater use in healthcare, a panel at MedCity News’ INVEST Digital Health virtual conference addressed how and why algorithms are biased, how that bias affects clinical care, and some possible solutions to bias.
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.
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.
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.
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.
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?
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.
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.
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.
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.
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 […]
The pandemic made collaboration necessary between stakeholders that otherwise tend to be at odds with each other. But as partnerships grow, providers, payers and pharma companies must ensure they are working toward a clear-cut common goal, according to panelists at HIMSS 21 Digital.
A study of women’s participation in cardiovascular clinical trials revealed that only 38% of participants were women. But if women comprise 50 percent of the population, that should be reflected in clinical trials too.
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.
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.
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.
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.
The hedge fund SS&C Technologies Holdings will be the majority stakeholder, while the two payers will each hold a minority interest in the PBM, dubbed DomaniRx. The joint venture will develop a claims adjudication platform to support its operations.
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.
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.
DTx helps reduce mental health stigma that is a barrier for underrepresented populations to receiving mental health care and if developed with intention and within a culturally-responsive framework, DTx won’t judge or discriminate.