Vaccitech and Werewolf Therapeutics joined the public markets, raising a combined $230 million. The vaccine developer and the cancer immunotherapy biotech will apply the IPO proceeds toward clinical development of their respective pipelines.
The science of using sensor data to define, measure, and create mathematical models of disease can lead to better outcomes—and huge benefits—for everyone in healthcare and life sciences.
The list of FDA-approved antibody drug conjugates (ADC) is growing, and two more biotech startups have emerged from stealth with new cash and new approaches to this type of cancer drug. Adcendo and Adcentrx raised a combined $112 from their Series A financings.
Adverum Biotechnologies reported that a diabetic macular edema patient treated with the biotech’s experimental gene therapy developed complications, including blindness, in the treated eye. The company has unmasked the study and is trying to identify potential risks to other patients.
Boundless Bio’s research has uncovered a previously unknown driver of cancer growth and drug resistance. With $105 million in Series B financing, the biotech is on a path to bring to the clinic small molecules that address this target, called extrachromosomal DNA.
Amplyx Pharmaceuticals brings Pfizer a clinical-stage antifungal candidate with a novel mechanism of action. The pharmaceutical giant is trying to build its antifungal product lineup, which is currently led by a drug that has lost patent protection.
Seasonal allergy sufferers have a plethora of choices for treating the itching and redness affecting their eyes. An experimental Aldeyra Therapeutics drug that takes a new approach to blocking inflammation triggered by allergens has met the goals of a pivotal study and the biotech now… Read More »No more tears: Aldeyra’s eye drug data support its allergy treatment alternative
Several companies are developing immunotherapies targeting the “don’t eat me” cancer protein CD47. Arch Oncology, which is developing drugs with features that could set them apart from the field, now has $105 million for multiple clinical trials.
Too many cold chain suppliers are still monitoring deliveries and storage compliance with paper-based documentation by individuals scanning thermometers every two hours. Such systems fall short of 21st-Century requirements for biologic medicine.
Plant-based drug discovery may be tens of thousands of years old, but in 2021, it feels exciting, rich, and full of potential. Companies are rapidly building scalable databases with hundreds of thousands of unique chemicals and their links to biological signatures.
The finalists across health IT, biopharma, medical devices, diagnostics, and health services tracks were judged on criteria that included: completeness of overall plan, business idea, market opportunity, revenue model, and founder(s) experience.
A uniQure gene therapy for hemophilia B that has been under a clinical hold for four months can now resume testing. The hold was lifted after uniQure answered the FDA’s questions about whether the gene therapy caused the liver cancer diagnosed in one patient who… Read More »FDA lifts clinical hold, clearing uniQure to resume hemophilia gene therapy trial
Healthcare companies had another record-breaking quarter, according to CBInsights. They raised a total of $31.6 billion in the first quarter, including big investments in telehealth and health IT.
With FDA approval of Zynlonta, ADC Therapeutics can offer patients who have diffuse large B-cell lymphoma an option if CAR-T therapy doesn’t work. Additional clinical trials are underway that could expand use of the antibody drug conjugate to more cancer patients.
Alnylam Pharmaceuticals has filed for FDA approval of vutrisiran, which could become the biotech’s fourth drug that works by RNA interference. Meanwhile the company is responding to a federal subpoena seeking documents related to the company’s marketing and promotion of its first RNAi drug, Onpattro.
As researchers and clinicians understand and embrace the advanced insights genetic and genomic testing can deliver, the industry is poised to dramatically reduce the incidence and mortality associated with cancers.
Covid-19 showed how technology can upend the old ways of clinical trials. Panelists at MedCity’s INVEST conference said it’s highlighting the importance of improving clinical trial diversity so that tests of new therapies and vaccines reflect the population of patients that they will treat in… Read More »Covid-19 serves as catalyst for effort to diversify clinical trial enrollment
The five life sciences IPOs this week continues the steady march companies are making to the public markets this year. This week’s activity follows a first quarter that Renaissance Capital calculates was the busiest for newly public companies since 2000. Healthcare IPOs continued to dominate… Read More »Biotech and medical device companies raise $913M in a five-IPO week
The FDA approved GlaxoSmithKlie drug dostarlimab (Jemperli) for endometrial cancer that carries a particular genetic signature. The immunotherapy now joins Merck’s Keytruda as the checkpoint inhibitors approved for treating endometrial cancer.
Value-based contracts covering the reimbursement of drugs and medical devices are slowly gaining acceptance. A panel at the MedCity News INVEST conference discussed the challenges and opportunities for these contracts, which aim to improve patient outcomes and control the cost of care.
Vertex Pharmaceuticals is collaborating with Obsidian Therapeutics to develop up to five new gene editing therapies. Obsidian’s technology precisely controls protein expression, a capability the partners plan to apply to several undisclosed serious diseases.
In response to emailed questions, the CEO and CTO talk about the immune intelligence startups’ Human Immunity Map — a growing database of immune interactions that can support the development of multiplex diagnostics, vaccines and therapeutics.
MedCity Spotlight Video: JPMorgan executive provides insight into healthcare investment trends [Sponsored]
Skip Kelly, a managing director at J.P. Morgan provides a broad overview of how the healthcare investment landscape is shaping out in the midst of a historic pandemic.
Biotech startup Janux Therapeutics has a technology that selectively and safely directs T cells to strike cancer cells and an R&D partnership with Merck. Now it has $125 million in Series B financing as it joins the chase to bring these T cell engager drugs… Read More »Stealthy biotech Janux nabs $125M and joins chase to direct T cells to solid tumors
The FDA placed a clinical hold on a KalVista Pharmaceuticals drug being readied for mid-stage studies in a rare, inherited disorder. Meanwhile, the FDA has some questions about the historical data Y-mAbs used as the control in a clinical trial for its antibody cancer drug.
Vertex Pharmaceuticals is amending its collaboration with CRISPR Therapeutics, paying $900 million now for chance to grab a bigger share of a gene-editing therapy’s profits later—if the treatment is approved. Clinical trials evaluating the CRISPR-based therapy are underway in sickle cell disease and beta thalassemia.
McKesson Ventures is one of the most active investors in the biopharma software sector with Komodo Health, Evidation and M2Gen among its portfolio companies.
Antibody therapies are seen as one way to overcome the variants that continue to fuel the pandemic. With its Series C financing, Adagio Therapeutics, led by CEO Tillman Gerngross, will proceed with a pivotal clinical trial of an antibody that has neutralized SARS-CoV-2 variants in… Read More »Adagio adds $336M for pivotal tests of drug with potential to beat Covid variants
Incubated by OribMed and led by Ariad Pharmaceuticals veterans, Theseus Pharmaceuticals unveiled $100 million in Series B financing to develop the next generation of tyrosine kinase inhibitors, a type of cancer drug. The company expects to enter the clinic by the end of 2021.
AI, therapeutics for autoimmune diseases, automation for biomedical research and oncology are among the areas of interest for the finalists in the biopharma track scheduled for day two of the conference.
Relay Therapeutics has its own technology that applies artificial intelligence and machine learning techniques to drug discovery. Its $85 million acquisition of ZebiAI gives it another technology that applies ML to DNA-encoded libraries and predicts the small molecules with the potential to drug proteins.
Serimmune has enrolled more than 2,000 participants in a clinical study designed to understand the human immune response to the virus that causes Covid-19. Also, news from Legacy, Tomorrow Health, and more.
Merck is discontinuing work on one Covid-19 drug for treating hospitalized patients after the FDA said it needs more clinical data. Another Merck drug candidate is moving forward only in outpatient testing after independent clinical trial observers concluded the antiviral was unlikely to help those… Read More »Merck’s Covid-19 drug R&D falls short twice in treating hospitalized patients
Thermo Fisher Scientific sells laboratory equipment used in drug research and it also offers manufacturing services for experimental and commercialized drugs. By acquiring PPD, Thermo Fisher says it will gain capabilities in the growing global market of clinical trial services.
Amylyx’s ALS drug met the goals of a mid-stage study, paving the way for regulatory submissions in Europe and Canada. But the FDA is requiring data from a larger Phase 3 clinical trial and that study is slated to begin later this year.
In order to gain insight into how organizations are thinking about digitizing medical documents and the strategy behind those decisions, we’re conducting a brief survey of the MedCity News audience and will publish a report based on this survey’s findings.
Tango Therapeutics’ SPAC merger will infuse the biotech with $353 million to fund clinical trials for its cancer drugs based on synthetic lethality. Tango’s lead program is on track to reach the clinic next year.
Blood clots found in six people given Johnson & Johnson’s Covid-19 vaccine have led federal health officials to recommend a pause on dosing with that shot. A CDC advisory committee on vaccine practices is meeting Wednesday to review the cases, which so appear similar cases… Read More »FDA & CDC “pause” J&J Covid-19 vaccine to launch inquiry into rare blood clot cases
Cellino Biotech CEO and Co-founder Dr. Nabiha Saklayen talked about the formation of the company and its goal to make stem cell therapies accessible for patients.
No matter if Democrats or Republicans are running the show in Washington, here are three solid bets for pharma companies to plan for in the changing drug-pricing landscape
With two cancer programs already making progress, Repertoire Immune Medicines will use the Series B financing to expand its immune synapse research to autoimmune disorders and infectious disease. CEO John Cox said his startup’s approach could advance immune medicines beyond the scope of currently available… Read More »Biotech startup Repertoire adds $189M to expand array of immune medicines
Covid-19 was a lightning rod for life science deals last year. What investment trends are taking shape in 2021? [Sponsored]
Peter Meath, Co-Head of Healthcare and Life Sciences for Middle Market Commercial Banking at J.P. Morgan, is bullish that the momentum will continue, particularly with investment trends focused on pain points amplified by the Covid-19 pandemic, from diagnostics development to supply chain management.
A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug developer, along with partner Roche, plan to ask regulators to expand the drug’s authorization to include disease prevention.
Sanofi, which already has messenger RNA R&D alliances with other companies, paid $160 million up front to acquire preclinical startup Tidal Therapeutics. The pharma giant said Tidal’s mRNA approach could lead to an off-the-shelf CAR-T therapy.
The public markets welcomed VectivBio and Reneo Pharmaceuticals, which priced their IPOs late Thursday. Both clinical-stage companies are developing drugs that address rare diseases.
RA Capital led Ventus Therapeutics’ Series B financing, which the startup will use to develop its pipeline of medicines for “undruggable” disease targets. CEO Marcelo Bigal said the cash also gives Ventus the flexibility to consider an IPO.
Mobidiag offers multiplex testing, which is the ability to test for multiple pathogens from a single test sample. Hologic said the acquisition will enable the company to enter the acute care test market, which is projected to grow in a post-pandemic world.
A European Medicines Agency review concluded AstraZeneca’s Covid-19 vaccine may be linked to cases of blood clots. The regulator directed the company to conduct more studies to learn more but stopped short of recommending other vaccines as alternatives.
RA Capital led the $100 million Series B round of funding for Icosavax, a startup developing vaccines based on virus-like particles. The biotech is preparing for clinical tests of vaccines for respiratory syncytial virus, human metapneumovirus, and SARS-CoV-2.
The drugmaker struck a collaboration agreement with Mass General to use its platform for heart failure and asthma management. The health system plans to launch two pilots of the digital health platform.
Volastra Therapeutics is developing drugs for cancer metastasis, the cause of the vast majority of cancer deaths. The startup has $44 million in funding and an R&D partnership with Microsoft to develop new digital tools to detect and predict metastasis.
Nadine Peters, chief legal officer of Cota Healthcare, shares her journey to leadership in health data privacy law and policy recommendations for the Biden Administration on achieving health equity through data use and education.
FDA approval of Supernus Pharmaceuticals drug Qelbree gives attention-deficit hyperactivity disorder patients another treatment option that is not classified as a Schedule II substance. It’s a different formulation of a drug that was first approved in Europe decades ago.
The FDA’s rejection of Nuplazid cited clinical trial results in subgroups of patients. Acadia Pharmaceuticals said the FDA’s decision goes against all feedback the company previously received and amounts to an incorrect way of evaluating dementia patients.
A Helius Medical Technologies medical device that stimulates the brain by sending electrical stimulation to the tongue has received FDA clearance for multiple sclerosis patients. The company says its approach could also have applications in other disorders.
The FDA increased the maximum number of doses permitted for each vial of Moderna’s Covid-19 vaccine, a change intended to make more doses available. The regulator also authorized storage changes for the vaccines at vaccination sites.
IQVIA has acquired Quest Diagnostics’ minority stake in Q2 Solutions, a central laboratory services joint venture the two companies formed in 2015. But Quest will remain a preferred provider of lab testing services under an agreement with Q2.
Peter Meath, J.P. Morgan Commercial Banking’s Co-Head of Healthcare and Life Sciences, applies lessons from 2020’s remarkable second half and shares insights on what to expect in 2021.
The FDA decision for Tyvaso as a treatment for pulmonary arterial hypertension in patients who have interstitial lung disease is the second approval for the United Therapeutics drug. The additional indication gives the company another way to grow revenue for the drug, which faces generic… Read More »United Therapeutics notches another FDA approval for lung drug
The Achilles Therapeutics IPO comes as several other biotechs make progress developing a type of cancer immunotherapy called a tumor-infiltrating lymphocyte. Clinical-stage Achilles contends its approach could best them all.
Why start with innovation? Because it’s where the products, tools, solutions, and ideas that will change the status quo are born. Without diversity of thought, experience, and perspective, the end result of innovation only serves those already at the table.
Based on the efficacy and safety data for their Covid-19 vaccine in younger teens, Pfizer and BioNTech plan to ask regulators to expand emergency authorization to include this younger group. The expansion could make the mRNA vaccine available to this age group in time for… Read More »Pfizer & BioNTech report Covid-19 vaccine shows 100% efficacy in kids 12 to 15
With the emergence of smart and connected devices and technologies, CROs and life sciences organizations are able to more easily perform decentralized, virtual clinical trials. Now, industry leaders are on a mission to make the practice of administering decentralized clinical trials the norm.
The Federal Trade Commission is opposing Illumina’s proposed $7.1 billion Grail acquisition, arguing that it will reduce competition for multi-cancer early detection tests. Illumina disagrees with the regulator’s position and will oppose the FTC’s challenge.
Merck agreed to pay $215 million up front to acquire Alydia Health, a startup that has commercialized a medical device that controls bleeding during childbirth. That product will join the portfolio of Merck spinout company Organon.
Now that trials can happen nearly anywhere, privacy teams and lawyers need to understand how data is collected, stored, managed, disseminated, and ultimately, archived or deleted.
Omega Therapeutics has raised more than $210 million in the past eight months for R&D of medicines that regulate genes. The company’s lead therapeutic candidate addresses a validated but elusive cancer target.
UniQure is making a case for lifting a clinical hold on its hemophilia B gene therapy, reporting Monday results of an independent investigation that appear to clear the experimental treatment as the cause of a patient’s cancer.
The FDA has approved a Bristol Myers Squibb cell therapy made by engineering a patient’s immune cells to target a cancer protein called BCMA. The regulatory decision for Abecma in multiple myeloma gives BMS its second approved CAR-T therapy.
Regenerative medicine might someday provide replacement organs for transplant patients. But Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, explained how the technology is already helping in the discovery and testing of drugs.
Design Therapeutics raised $240 million in the biggest biotech IPO this week. One other rare disease drug developer went public along with two oncology biotechs as the IPO momentum continues.
With the increased reliance on digital technologies, pharma companies’ outreach to healthcare providers needs to be thoughtful, efficient, and respectful. An AI-driven, omnichannel strategy makes this possible by giving every member of customer-facing teams visibility across communications.
Bristol Myers Squibb SVP Ho Sung Cho highlights legacy and ongoing research in protein degradation [Sponsored]
Cho discusses Bristol Myers Squibb’s research efforts in the field of protein degradation to advance potential treatments for a broad range of diseases. In a recent MedCity Pivot Podcast, he also shared insights on his approach to drug discovery, perspectives on dealing with failure, and… Read More »Bristol Myers Squibb SVP Ho Sung Cho highlights legacy and ongoing research in protein degradation [Sponsored]
Read new developments on healthcare startups such as Seven Bridges, Scipher Medicine, Applied VR and more.
Founded by scientists behind the technology used in Johnson & Johnson’s Covid-19 vaccine, Leyden Laboratories is developing intranasal medicines intended to stop viruses before they infect the lungs. SARs-CoV-2 is one target, but the startup plans to address many respiratory pathogens.
California Attorney General Xavier Becerra may have won a narrow confirmation to be the Department of Health and Human Services Secretary, but if his past is any indication, his agenda will be bold when it comes to reining in pharma companies, boosting the Affordable Care… Read More »The “biggest thorn in President Trump’s side” is now HHS Secretary. What’s next?
AstraZeneca’s latest efficacy data for its Covid-19 vaccine are down slightly from the 79% it previously reported. The most recent data will form the basis of an application for emergency use authorization, which the company still expects to file with the FDA in coming weeks.
In MedCity Pivot podcast, biopharma researcher talks about protein degradation, recent success tied to Covid-19 [Sponsored]
Ho Sung Cho, senior vice president of Biodiscovery Therapeutics at Bristol Myers Squibb, talks about lessons learned from drug discovery, recent success tied to Covid-19, and how the company is leveraging its expertise in protein degradation to develop novel therapies for blood cancers, solid tumors… Read More »In MedCity Pivot podcast, biopharma researcher talks about protein degradation, recent success tied to Covid-19 [Sponsored]
ProQR Therapeutics has encouraging data from an early-stage study evaluating its treatment for vision loss in the rare, inherited disorder Usher syndrome. The biotech now plans to advance its RNA therapy to two pivotal studies later this year.
GSK has terminated Moncef Slaoui as board chair of Galvani Bioelectronics after an investigation substantiated a sexual harassment claim dating to his tenure at the pharmaceutical giant. The company said the inquiry is continuing.
Federal health authorities say safety observers are concerned AstraZeneca did not release complete information about the efficacy of its Covid-18 vaccine. The company responded by saying its data were from a pre-specified analysis and it will provide the most up to date efficacy data within… Read More »AstraZeneca’s Covid-19 vaccine data may have ‘outdated information,’ NIH cautions
Interluekin-2’s use as an immunotherapy has been limited by its severe side effects. Asher Bio is developing a version of IL-2 that the startup’s Chief Technology Officer Andy Yeung said could be more targeted and safer than other approaches.
With the extension to its Series A financing, XyloCor plans a clinical trial testing its gene therapy as an adjunct to coronary artery bypass graft surgery. A study in refractory angina is already underway.
AstraZeneca reported that its Covid-19 vaccine was 79% effective at preventing severe infection and 100% effective at preventing hospitalization. The company expects to file a submission seeking FDA emergency use authorization in coming weeks.
Scientists at The Ohio State University are developing a cell therapy intended to regrow brain tissue damaged from ischemic stroke. Results from a study in mice were published in the journal Science Advances.
Instil Bio, one of several companies developing tumor-infiltrating lymphocytes, will use its IPO cash to advance its clinical testing plans. Meanwhile, Finch Therapeutics and Gain Therapeutics also priced IPOs to fund clinical trials.
Clinical tests of drugs from Gilead Sciences and Novo Nordisk have yielded encouraging results in nonalcoholic steatohepatitis (NASH), and the partners now want to see if the drug combinations help patients in a larger mid-stage study. The planned Phase 2b study expands on a 2019… Read More »Gilead and Novo Nordisk advance NASH collaboration to larger clinical study
Aktis Oncology is developing cancer radiation treatments intended to more precise and potent compared to other radiotherapies. The startup is now out of stealth with $72 million in Series A financing.
The Series B round of funding for University of Oxford spinout Vaccitech includes the type of financial backers that could support an IPO. While Vaccitech might be best known for its association with AstraZeneca’s Covid-19 vaccine, the startup also has programs for other infectious diseases… Read More »Oxford vaccines spinout Vaccitech raises $168M, laying groundwork for an IPO
Given our current limited supply, the threat of variant spread, and availability of higher quality antibody test kits, policymakers ought to update their vaccine guidance for those who had Covid and incorporate recent research findings on immunity and vaccine efficacy.
In acquiring the two early-stage Sanofi drugs for sickle cell disease, Global Blood Therapeutics aims to complement Oxbryta, its FDA-approved treatment for the rare blood disorder. Meanwhile, Sanofi can turn its full sickle cell efforts on a gene-editing therapy partnered with Sangamo Therapeutics.
AstraZeneca is turning to digital technology to help patients and clinicians manage the treatment of chronic diseases. Though this technology isn’t tied to any AstraZeneca drug, the company believes such digital tools will become part of the new standard of care.
Melinta Therapeutics already sells an antibiotic for serious skin infections. But FDA approval of Kimyrsa gives clinicians another option to offer patients, one with more convenient dosing.
While Covid-19 temporarily paused our ability to interact face-to-face, it also ushered in an era of global collaboration and the ability for life science teams to make decisions based on an expanded viewpoint.
Roche already sells a Covid-19 diagnostic. In acquiring GenMark Diagnostics for $1.8B, Roche is adding technology that can detect SARS-CoV-2 along with multiple respiratory diseases in a single test from a single patient sample—a capability the Swiss multinational company does not currently offer.
Grifols’s acquisition of GigaGen comes as the startup’s Covid-19 antibody drug is set to start Phase 1 testing. Barcelona-based Grifols says GigaGen’s technology could also help it expand to engineered antibody therapies.
Prometheus Biosciences is taking a precision medicine approach to developing drugs and diagnostics for inflammatory bowel disease. The IPO cash will fund support its pipeline of IBD drug candidates for specific patient subpopulations.
In two pivotal studies years apart, Aveo Oncology’s drug tivozanib did not help kidney cancer patients live longer overall compared to the standard of care. The FDA approved still approved it, the latest development in a long saga that includes several regulatory stumbles.
The positive data for the antibody drug from Vir Biotechnology and GlaxoSmithKline give a clearer picture of how and when these treatments could help. Last week, a different pivotal study testing the same drug in hospitalized patients yielded murkier results.
Eli Lilly reported data from a second group in a Phase 3 study testing its combination antibody drug for Covid-19 showing that the treatment reduced the risk of hospitalization and death by 87%. That’s better than the data that supported the emergency authorization that the… Read More »Eli Lilly’s authorized Covid-19 antibody racks up more positive Phase 3 data
While Covid has made many aspects of living with a rare disease more difficult, it has inspired policies and techniques that could help rare disease research progress more smoothly both during and after the pandemic.
Takeda Pharmaceutical and Maverick Therapeutics have been R&D partners since 2017. In buying out its partner, Takeda acquires technology and drug candidates that could offer advantages compared to CAR-T therapies, including the potential to treat solid tumors.
Like much U.S. primetime television, the broadcast of Oprah’s interview of Meghan Markle and Prince Harry carried a lot of pharma advertising. The sheer volume of those ads surprised many British viewers and also highlighted the volume of spending on the U.S. marketing of medicines.
Blue Cross and Blue Shield of Minnesota has filed a class-action lawsuit — on behalf of itself and insurers from 30-plus states — against Martin Shkreli and Vyera Pharmaceuticals. The suit alleges the defendants intentionally monopolized the market for Daraprim to raise the price of… Read More »Insurers sue ‘pharma bro’ Martin Shkreli, company for alleged price gouging
Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on the market. The voluntary withdrawal comes amid an industry-wide FDA review of drugs that were awarded accelerated approval but later… Read More »Roche withdraws Tecentriq for bladder cancer, pullback comes amid FDA review
FDA approval for Yescarta in follicular lymphoma makes it the first approved CAR-T treatment for this type of cancer. It also marks Gilead Sciences’ third approved indication for a CAR-T cell therapy.
Satsuma Pharmaceuticals executives say they now understand why their intranasal migraine treatment failed a pivotal test. But even with a new Phase 3 plan, the company is behind a competitor that could launch its intranasal migraine treatment later this year.
The pandemic has led pharma marketers to embrace digital marketing communications and the benefits of investing in telehealth platforms to engage physicians are numerous and provide a tremendous opportunity.
Antibody therapies from Brii Biosciences and Vir Biotechnology failed to show sufficient efficacy to advance to the next stage of an NIH-sponsored Covid-19 clinical trial. Apellis Pharmaceuticals and Durect also stopped work on experimental Covid treatments.
This week, read new developments at Carrum Health, Seven Bridges, CARISMA Therapeutics, and more.
The acquisition brings Amgen a novel Phase 3-ready drug for gastric cancers. For Five Prime Therapeutics, the deal is a lifeline following a series of clinical and financial setbacks that left much of the biotech’s fortunes resting on its lead antibody drug.
The U.S. Supreme Court heard oral arguments Monday on the constitutionality of the Patent Trial and Appeal Board, an essential piece of the United States patent litigation puzzle and favored tool of generic and biosimilar patent challengers since its formation in 2012.
A Brainstorm Cell Therapeutics therapy for Lou Gehrig’s disease failed a pivotal study, but the company points to better results in a subgroup. The FDA took the unusual step of publicly stating that study’s results do not show the stem cell therapy helps patients.
Takeda Pharmaceutical gains full rights to a small molecule that has shown promise treating seizures in several rare forms of epilepsy. Meanwhile, Ovid Therapeutics gains cash to support its pipeline of neurological disease drug candidates.
President Biden used the Defense Production Act to direct Merck to convert two of its facilities into production sites for Johnson & Johnson’s Covid-19 vaccine. In addition, he said J&J will run its own vaccine production sites 24/7.
Novavax says it’s building up its manufacturing capacity now to be ready to ship Covid-19 vaccine globally as emergency authorizations are granted in coming months. The company expects to seek FDA authorization in the second quarter.
Athenex’s bid to offer an oral version of an intravenous chemotherapy has stalled after the FDA rejected the drug. Among the remedies proposed by the regulator is another Phase 3 study.
The FDA decision makes Nulibry the first drug approved to treat MoCD type A, a rare metabolic disease. It’s also the first FDA-approved product for rare disease drug developer BridgeBio Pharma.
Johnson & Johsnon’s Covid-19 vaccine is now the third one granted FDA emergency authorization. The company expects to deliver enough vials to for vaccinating more than 200 million people in the U.S. by the middle of this year.
The committee voted 22-0 on the question of whether the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh its risks. FDA emergency use authorization would bring the public a third vaccine for the novel coronavirus.
Roivant Sciences is expanding its drug discovery and design capabilities via a stock deal to acquire Silicon Therapeutics. The Boston startup uses physics-based modeling to simulate proteins and the small molecules that bind to them.
The FDA decision gives Sarepta Therapeutics its third approved drug for Duchenne muscular dystrophy. The accelerated approval requires the biotech to conduct additional clinical testing to confirm the drug’s benefit.
Though GlaxoSmithKline’s drug otilimab missed the main goal of a mid-stage Covid-19 study, the company points to better data in a subgroup of older patients. GSK is expanding the study in patients 70 and older in hopes of replicating those results.
Merck’s top immunology drugs face biosimiliar competition. The $1.85 billion acquisition of Pandion Therapeutics gives the pharma giant an opportunity to build up its immunology pipeline with a new approach to treating autoimmune disorders.
Vividion Therapeutics has technology that enables it to develop drugs for “undruggable” disease targets. The Series C financing is a crossover round, an indication a biotech is preparing for an IPO.
The protein-based Covid-19 vaccine from Clover Biopharmaceuticals has distribution and storage advantages compared to messenger RNA vaccines. If the vaccine succeeds in a Phase 2/3 test, China-based Clover will distribute it globally via COVAX.
The life sciences industry will move toward more agile capabilities for regulatory operations and regulators toward an accelerated approval pathway in support of clinical studies, drawing from lessons learned during the pandemic around global collaboration.
Base-editing biotech Beam Therapeutics engineered an all-stock buyout of Guide Therapeutics, a startup that finds, in vivo, the lipid nanoparticles that can deliver genetic medicines. Beam said GuideTx’s tech helps it address tissue types throughout the body, not just the liver.
AstraZeneca is withdrawing U.S. marketing of Imfinzi in bladder cancer after the drug failed a study required as a condition of its 2017 accelerated approval. The drug’s other approvals in lung cancer are not affected.
Pfizer and BioNTech say they have data supporting two-week storage of their vaccine at temperatures found in medical-grade freezers. They say FDA approval of an additional temperature option would give vaccination sites more flexibility.
Eli Lilly is paying $125 million up front to team up with Rigel Pharmaceuticals on drugs that block a signaling protein involved in inflammation. With the alliance, Lilly joins Sanofi and Denali Therapeutics in the pursuit of drugs that block this protein.
Humacyte is going public via a SPAC merger that infuses it with $255 million for its regenerative medicine pipeline. The biotech’s technology produces universally implantable tissue that functions like human blood vessels.
Hospital counsel, state advisors, congregate care advocates and university leaders believe that public health ethics must drive the next steps in vaccine distribution and not the constraints of the law.
The amended pact follows a collaboration begun last year when GlaxoSmithKline paid Vir Biotechnology $250 million to team up on potential treatments for Covid-19. The expansion includes an influenza treatment based on Vir’s antibody technology.
Cancer is a known risk of lentiviral-based gene therapies. Though bluebird says its gene therapy is engineered to avoid that risk, the company is suspending two clinical trials pending the outcome of its inquiry.
Ozette applies artificial intelligence to immune monitoring to gain greater insight into a cancer patient’s immune system. Beyond informing treatment decisions, the technology can guide drug and diagnostic development.
Ensoma contends its technology avoids the complexities of other approaches to gene therapy, which could expand genomic medicine’s reach to more patients and more diseases. Takeda Pharmaceutical is collaborating with the startup on up to five gene therapies.
The Biden administration should recognize that including high quality, patient-centered comprehensive medication management (CMM) services as the national standard of care will improve patient outcomes, reduce health care costs and save lives.
Amicus Therapeutics CEO John Crowley said the totality of data support the Pompe disease therapy’s submission to the FDA. That rolling application is on track for completion in the second quarter.
The FDA approval clears Regeneron’s drug, Evkeeza, as a treatment for the rarer of two forms of an inherited disease that causes high cholesterol levels. The company already markets Praluent, which treats the more common form of familial cholesterolemia.
Phase 2 testing of Cyteir’s lead cancer drug candidate later is slated to start later this year. The Series C round of funding includes crossover investors, whose involvement is a sign a biotech is preparing for an IPO.
The decision to discontinue all clinical trials for ziritaxestat is the latest setback in a broad alliance between Gilead Sciences and Galapagos. Last year, the FDA rejected a rheumatoid arthritis drug covered under the partnership.
The EUA for Eli Lilly brings to patients a second antibody cocktail, following the FDA’s fall authorization of an antibody combination from Regeneron Pharmaceuticals. Lilly is working with Amgen to ramp up manufacturing of its newly authorized therapy.
One year after losing Merck as a partner, KalVista reports mid-stage clinical data for a pill that could offer an alternative to injectable drugs for a rare, potentially life-threatening disease. KalVista plans to meet with the FDA about proceeding to a Phase 3 study.
Verily and Janssen say studying Covid-19 immune responses could yield data that helps clinicians treat the disease. They add that the research could also apply to other illnesses caused by respiratory pathogens.
Nautilus, among the biotechs developing protein analysis tools for drug discovery and diagnostics, already has a partnership with Genentech. As it prepares to go public, Nautilus aims to do for proteomics what Illumina did for genomics.
After some setbacks and delays, the FDA approved Bristol Myers Squibb’s Breyanzi for certain lymphomas. It’s the third CAR T treatment to win the regulatory nod and the first under a new regenerative medicine designation.
Johnson & Johnson’s Covid-19 vaccine offers storage and distribution advantages compared to mRNA vaccines, and is the only single-shot vaccine to reach late-stage testing. The next stop is a Feb. 26 FDA advisory panel meeting.
For the last few years, digital transformation has been the mantra for healthcare-related organizations of […]
Sana Biotechnology is turning new science into novel medicines intended to overcome limitations of current cell therapies. After going from stealth to IPO in two years, it’s now planning to bring multiple programs into clinical testing in 2022.
EMD Serono’s Tepmetko is one of a number of targeted cancer therapies that have passed FDA muster in the past year. The decision sets up the German company’s pill for head-to-head competition with a Novartis drug targeting the same genetic signature.
The Neurocrine decision follows a clinical hold placed on the Parkinson’s program in December. It’s Voyager’s second loss of an R&D partner in the past year; AbbVie previously ended an alliance aiming to develop gene therapies for Parkinson’s and Alzheimer’s.
The therapeutic vaccine will be based on Gritstone Oncology’s technology and will use antigens from Gilead Sciences. It’s the latest in a string of partnerships Gilead has signed in its search for an HIV cure.
The startup pitch contest is part of our INVEST conference, April 19-23, which will be hosted online due to the Covid-19 public health crisis. It includes five tracks for startups: biopharma, medical devices, diagnostics, health IT and health services.
Researchers have known for decades that viruses can beat back cancer. But it’s been hard to design a virus that does the trick. A new wave of startups is optimistic they have found the keys.
Viagra’s successful launch gives drug companies a roadmap to building a humanized brand. But it also showed why, even in a pharma-friendly, post-Covid world, humanizing healthcare may be harder than it seems
Loki Therapeutics is advancing research that leverages the immune system’s ability to recall childhood vaccinations and direct it against cancer. The company’s lead therapy candidate could enter phase 1 clinical trials this year.
Covid-19 showed that pharma companies can be nimble and implement changes that prevent processes from weighing down on operations. But which of these operational and strategic changes will stand the test of time and make this year and the future bright for the industry?
Many pharma companies already donate drugs to charity. But the New Jersey-based entrepreneurs have developed a technology platform that makes the process easier to manage and opens up new opportunities.
The INVEST Pitch Perfect contest is part of our INVEST conference April 19-23, which will be hosted online due to Covid-19, and includes five tracks for startups: biopharma, medical devices, diagnostics, health IT and health services. Read more on how to apply.
Merck is discontinuing development of its two Covid-19 vaccine candidates. Instead, it plans to focus on two therapeutic candidates for the disease.
Dr. Fauci stressed that whether humanity can root out the novel coronavirus depends on whether a robust global vaccine campaign can be launched such that cheaper and easily deliverable vaccines can be distributed en masse.
Vera Therapeutics licensed the drug candidate after analysis of earlier trials revealed its promise. Boosted by $80 million in Series C funding, the company hopes to launch a phase 2B trial this year.
As my personal experience with my grandparents proved, engaging with your local pharmacist can reduce the burden placed on a patient’s family and the primary caregiver, while making the transition to at-home care manageable.
Like food deserts, pharmacy deserts have cropped up across the nation, which could further hamper the much-maligned Covid-19 vaccine rollout.
Despite lower sales, lack of profits and heavy R&D spending, biotech companies that went public between 1997 and 2016 reached similar market caps as non-biotech companies, according to an academic study.
The tilt was less pronounced in pharma and biotech, which attracted a record level of investment despite the Covid-19 pandemic according to a quarterly report on VC investment activity.
The partnership will further enhance the depth, breadth and value of services for Prescient’s pharmaceutical and biotech clients. LONDON, January 21, 2021: Prescient Healthcare Group (Prescient), a global product strategy advisory firm serving the pharmaceutical and biotech industries, announced today that Bridgepoint Development Capital, part… Read More »Prescient Healthcare Group to Partner with Bridgepoint Development Capital
In its report released last Tuesday, a nonprofit drug pricing research group claims that seven drugs have prices that do not align with any newly discovered increase in clinical benefit, leading to over $1.2 billion in excess drug spending in 2019, alone.
Pharma companies moved fast in 2020 to tackle Covid-19 and to address longstanding issues of racial equity, the CEOS of BD and Sanofi said in a session at the J.P. Morgan Healthcare Conference. The challenge lies in keeping the momentum going in 2021.
In this article, experts forecast upcoming AI developments that will help shape a new commercial model, making 2021 the year when AI shifts from early exploration to broad adoption.
Vaccines developed by Aivita Biomedical use a patient’s own blood to attack cancer and Covid-19. But the company also offers a consumer skin-care product that it plans to begin selling more widely.
The CEOs of Pfizer, Moderna, McKesson and CVS Health explained that the distribution effort has gone well but the administration of the vaccine has now to catch up. They expect it to happen soon.
The latest funding brings total investment in the company to $750 million. The money has gone, in part, toward licensing of promising drug candidates in breast, lung and other cancers.
Biogen plans to launch a virtual study with Apple this year to identify early signs of mild cognitive impairment. The study is expected to launch in the second half of 2021.
Ugur Sahin presented a sweeping vision of the company’s goal to become a next-generation immunotherapy company leveraging the messenger RNA platform technology that has won it acclaim and financial returns during the Covid-19 pandemic.
The new tests can open a window into the duration of immunity and to the antibody levels needed to sustain it. But first, a universal standard is needed to ensure results are comparable between tests.
Advocates, industry leaders and legislators have come to a consensus about the scope and urgency of the crisis related to inadequate development of antibiotics. They are calling for legislative fixes to protect public health.
Founded in 2020, Scorpion is agnostic about the potential therapies and targets it will explore with what it describes as its drug-hunting engine. But the company is hoping to unveil its first drug candidate this year.
With a global epidemic of obesity and diabetes and their known relationship to cancer, researchers and oncologists are turning their attention to metabolic hormones as promising new targets for cancer treatment.
The panel, What It Takes To Build A Successful, Regional BioInnovation Hub (sponsored by Independence Blue Cross) focuses on Philadelphia — one of many cities seeking to support the continued growth of cell and gene therapy and connected health industries.
A video from the conference spotlights startup pitches and Q&A with judges in the Life Science track of the Pitch Perfect contest.
Covid-19 stands as a litmus test for pushing the boundaries of standardized research processes. Let’s use this shared focus, urgency, and the new partnerships being forged, to invigorate and accelerate cancer research.
The Justice Department has sued Walmart for fanning the flames of the opioid crisis through its network of pharmacies, claiming that the retailer knowingly filled thousands of illegitimate opioid prescriptions. But Walmart says the lawsuit is “misguided.”
Moderna is using a Roche antibody test in clinical trials of its Covid-19 vaccine. The test can measure the antibodies created through vaccination, offering a window into how long protection lasts.
Oncology diagnosis inclusing digital pathology, telehealth and physician access are just some of the areas where AI can have outsize impact in 2021
Judges picked TrialSpark as the winner on the life sciences track of the pitch competition at MedCity’s virtual precision medicine conference. While the company is focused on improving clinical trials for others, it hopes eventually to bring drugs of its own to market.
Judges picked Amplified Sciences as the winner of the health IT track at MedCity INVEST Precision Medicine. The startup is working to combat adverse drug reactions by making pharmacogenomic testing easier to access and interpret.
Alphabet and other investors poured $700 million in funding into Verily last week. The company, which is Alphabet’s life sciences subsidiary, plans to pour some of the funds into supporting Covid-19 vaccine studies and programs for businesses.
Here is our attempt to capture this bewildering and memorable year by highlighting the phenomena and personalities who made it so.
The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.
Precision measurement in 2021: Why accuracy is key to the vaccine ‘cold chain’ and disrupting the spread of Covid-19
By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.
What lessons can future Covid vaccine candidates take from the FDA’s response to Pfizer and Moderna’s study data?
The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person… Read More »Hospitals sue drug companies over discount program
Together, the two companies say can give drugmakers a better view at the cellular level of how a patient’s immune system is responding to a cerain therapy.
What You Should Know: – Abbott Receives CE Mark for its COVID-19 IgG Quantitative Antibody Blood Test that specifically detects levels of IgG antibodies that attach to the virus’ spike protein, which can be helpful to evaluate a person’s immune response to vaccines. – Abbott… Read More »Abbott Receives CE Mark for its COVID-19 IgG Quantitative Antibody Blood Test
There judges selected two winners — one in the Health IT track, another in the Life Science track.
Ultimately, we should be excited about AI and its adoption in biopharma, but we should also stay sensible and focus our efforts where they’ll have the greatest impact.
Healthcare consumers are increasingly aware of specific therapies in development or on the market that can help treat the diseases they or their loved ones may be suffering from — and this growing awareness is changing the precision medicine arena.
To help clinicians diagnose rare disease more quickly and accurately, many healthcare organizations are embracing technology solutions like natural language processing (NLP) tools that can create augmented intelligence workflows that facilitate the rapid search of unstructured clinical data from multiple data sources.
In medicine, we’re getting real-time experience with what many believed was an inevitable but potentially […]
The vaccine was developed in record time, a big scientific accomplishment, even though the agency’s move follows an unusual level of pressure from President Trump’s White House, renewing concerns that politics drove the vaccine process even as the first doses are shipped.
The future of precision medicine will come only as quickly as doctors can pick out clinically useful information from the genetic data being gathered on their patients.
The final day of the conference, Friday, December 11, includes a panel on precision medicine investment trends, a look at clinical trial design innovation and the life sciences track of our Pitch Perfect startup contest. Register now!
The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use in the U.S. Distribution, however, will remain a challenge.
Inertia is a barrier as is the traditional split between the clinical and the data-driven spheres of drug development. While smaller firms have an edge in bridging the gap, big pharma will eventually get there, said panelists at the INVEST conference session.
As precision medicine gains steam, the question arises: how can reimbursement models evolve to support these often costly therapies and ensure patient access is not blocked? Drugmakers and payers are working together to find some answers.
Among the areas of interest for companies presenting at Pitch Perfect at INVEST Precision Medicine are clinical stroke detection, making medical research more inclusive, using technology to accelerate the pace of clinical trials, developing more patient friendly drug delivery systems for reconstitutable drugs, and more.
Proscia and other digital-pathology firms promise to make pathologists more efficient as they analyze tissue. The need is driven by a steadily declining U.S. population of pathologists.
Interactive, cloud-based video games are designed to tackle pharma’s current challenge: engaging doctors virtually during a pandemic. But the tools are likely to outlive the circumstances in which they were born.
As part of our conferences and to augment panel discussions and presentations, we are launching MedCity News: Spotlight to use video to tell the story of important companies, executives and healthcare initiatives.
To reduce drug prices, we should focus on the complex drug channel arrangements that stand between manufacturers and patients and not as much on price controls.
It is time to make it our collective mission to bring data automation to patient recruiting for clinical trials and not wait for a resolution of the pandemic to manage clinical trial disruption.
Breaking Media’s MedCity News and Above the Law are collaborating to launch Healthcare Docket, a newsletter featuring the latest in litigation, regulation, transactions, and trends for in-house counsel in the healthcare and life sciences industries.
The contracts are complicated and full of risks for drug companies. But there’s also a risk to steering clear of the arrangements — reduced or restricted access to a company’s medication.
CVS Health’s infusion business will participate in a pilot to administer a recently authorized monoclonal antibody treatment to prevent patients from getting seriously ill with Covid-19. But data about the treatment, bamlanivimab, is mixed, and supply is limited.
Founded in 2014, MaaT Pharma is pushing two therapies through clinical trials that are designed improve survival for patients with blood cancers and other diseases. Despite high-profile hiccups, the field of microbiome therapy remains attractive to investors.
Salesforce reimagined a healthcare CRM bringing actionable information into one place to enable improved internal and external collaboration, communication, and smarter, data-based decisions.
A discussion on the different models healthcare stakeholders are developing to cover the cost of costly therapies will be just one of the compelling conversations at the virtual conference from December 9-11. Register today!
Recent efforts to improve transparency haven’t made much of a difference, one author noted. But earlier reforms made a dent the “most egregious” practices.
Opioid overutilization is a public health crisis, and PBMs with programs aimed at curbing abuse and educating providers can have a positive and substantial impact on clients and their members.
Here’s a preview of some of the panel discussions at INVEST Precision Medicine, including diagnostics, investment trends, and building a bioinnovation hub.
The San Diego-based biopharma firm has several oncology therapies in development and has partnered in the past with the likes of Astellas, BeiGene and Bristol-Myers Squibb.
The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce 3 billion doses in 2021 with an emphasis on serving poorer countries.
The San Francisco-based company aims to complete at least one Phase III study by 2025, and it is weighing an IPO next year to fund more.
Dr. Aleksandr Yampolskiy, CEO of SecurityScorecard, The globalization of the pharmaceutical industry has forced pharma companies to outsource, increasing their reliance on third-party vendors and suppliers. As this supply chain grows in complexity, companies find themselves grappling with a growing amount of cyber risk. A… Read More »7 Best Practices for Third-Party Risk Management in the Pharmaceutical Industry
The authorization comes as Covid-19 testing demand threatens to swamp U.S. labs. However, it will take time for the Lucira test to become available nationwide.
Radiopharmaceuticals are highly specialized and require equipment, facilities, personnel, licensing and training that is significantly different from traditional pharmaceutical manufacturing.
The company is the second this month to report promising results for a Covid-19 vaccine even as the virus rages across the U.S.
News of positive results from Pfizer’s Covid-19 vaccine is heartening but historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.
The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.
The nonbinding panel recommendation to reject the drug goes against what FDA scientists presented but they throw up another obstacle for the drug, which is trying to succeed on a front where others have failed.
Tumor boards can help physicians in developing countries get access to U.S. expertise and represent one way to democratize state-of-the-art care for cancer patients throughout the world.
The healthcare and pharmaceutical industries are people-centered by design. So how did tech companies become the default “brands that care”?
The deal will broaden Merck’s oncology portfolio as it picks up an antibody-drug conjugate, a class of biological drugs that target tumor cells even as the pharma giant jettisons other parts of its business
Following years of research and investment, liquid biopsies are steadily accumulating FDA approvals. The tests are being used in molecular profiling of solid tumors and as companion diagnostics for targeted cancer therapies.
In the coming years, clinicians will be presented with a larger and more capable toolbox to aid in the diagnosis of sepsis, directly overcoming the drawbacks of culture-based diagnostics.
The pharmaceutical company will use Seqster’s system to speed up onboarding for clinical trials and to improve patient engagement.
States are trying to strengthen their hand over drug prices in light of stalled federal efforts and their own budget crunches. The wildcard is whether the efforts will survive legal scrutiny.
The summit gathers directors through the C-suite from across life science and healthcare sectors to discuss new developments in precision medicine, investment trends, and how health IT, diagnostics and biopharma technology are being used to improve outcomes.
Investing in new innovative RNA technologies can lead to rapid value creation, and Europe is a fertile ground to hunt for them.
Scrutiny of drug prices will continue whether Trump or Biden wins. But pharma can take steps to address critics and cut costs before they reach a crisis point, according to a panel of industry experts.
If pharmacists and technicians are properly trained at navigating the idiosyncrasies of managing medication with limited shelf-life, you’ll be in a better position to save on your pharmacy spend.
Why prioritizing health equity in the Covid-19 vaccine distribution is not just right, but necessary
Even though Covid-19 is distinct from any health crisis the country has previously faced, assessing U.S. public health strategies during past crises can provide insight into what has contributed to a more or less equitable response.
Founded in 2017, Artidis has raised $15.1 million and hopes to enter the U.S. market for cancer diagnosis by 2022. But the startup first has to convince the FDA that its device works.
The deal, offering $2 billion up front and $2 billion in future milestone payments, includes a gene therapy manufacturing facility and a pipeline that includes treatments for Parkinson’s and congestive heart failure.
Massachusetts-based Be Biopharma will use the proceeds to build a team as it seeks to develop B-cell therapies for a variety of diseases.
Landmark FDA approval of antiviral drug as 1st COVID-19 treatment comes amid conflicting efficacy data
The Food and Drug Administration approved Gilead’s antiviral drug as the first treatment for Covid-19 but just last week a WHO report showed that the drug appeared to have little to no effect on hospitalized patients.
In addition to monetary damages and the guilty pleas, the government is seeking to transform the maker of OxyContin into a public benefit company that would fund efforts to curb opioid abuse and give away drugs to prevent overdose deaths.
The disruption to biopharma and medtech businesses caused by Covid-19, such as product launch and clinical trial delays, has underscored the need for a more digital focused strategy.