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A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. The post Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose appeared first on MedCity News.
AstraZenecas EsoBiotec acquisition is the latest in a series of deals struck by the pharma giant to secure a place in the next wave of cell therapies for cancer and immune-mediated diseases. EsoBiotecs allogeneic cell therapies are made by the in vivo reprogramming of a patients immune cells.
Vertex Pharmaceuticals Jounavx is now FDA approved, providing patients a non-opioid option for treating acute pain. The post Vertex Pharmas Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds appeared first on MedCity News.
Expanded FDA approval of Phathom Pharmaceuticals drug Voquezna now includes patients with non-erosive gastroesophageal reflux disease (GERD). The post Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients appeared first on MedCity News.
Wegovy will ship directly to eligible patients through NovoCare, an online pharmacy established by Novo Nordisk. The products price matches a recent price cut for Zepbound offered by Eli Lilly through its own direct-to-patient online platform.
Technology is transforming how clinical trials are run. A panel during MedCity News’ INVEST Digital Health conference discussed the tech trends shaping the design and execution of drug studies.
Emergn Principal Consultant Mario Moreira shared insights on how pharma companies can use the principles of Value, Flow and Quality to shorten drug development timelines and deliver better patient outcomes through improved ways of working.
FDA approval of Ascendis Pharma’s Yorvipath is just in time for patients with hypoparathyroidism as Takeda Pharmaceutical will soon stop making the only drug therapy for the rare disorder. The post Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency appeared first on MedCity News.
Verona Pharma’s COPD drug Ohtuvayre is a single small molecule that blocks two targets to bring patients both bronchodilation and anti-inflammatory effects. The post Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD appeared first on MedCity News.
As GenAI and other technologies advance the speed of development and the precision of drugs, pharma commercial teams need to make sure they are harvesting the right data with the right AI tools in order to ultimately reach the right patients.
Maina Bhaman, a board member of CinCor Pharma reflects on the news from Monday that AstraZeneca is acquiring the Massachusetts startup to bring another option for patients with resistant hypertension.
FDA approval of Sanofi hemophilia A drug Altuviiio provides patients with a therapeutic option that lasts longer than most other products available, including one already marketed by the French pharma giant. Altuviiio also gives Sanofi a way to better compete against blockbuster Roche drug Hemlibra.
It fits in amongst the goal of running nimble and patient-centered studies. But, without legislation, it’s doubtful that pharma companies will give up ownership of participant data out of sheer goodwill. Putting data into the hands of participants is an important step in changing the traditional clinical trial paradigm.
Investors in 2022 appeared confident that the continued transformation of drug research and development protocols and the overall life sciences industry will not only include digital health solutions, but will even depend on them for data collection, analysis, patient engagement, and even their therapeutic properties.
Matthew Walsh, General Manager of Biopharma at ixlayer - the leading cloud-based platform powering an end-to-end, direct-to-patient healthcare solution - sat down with Fierce at Digital Phar | Matthew Walsh, General Manager of Biopharma at Ixlayer – a cloud-based platform specialist empowering operational efficiency, patient access, and improved outcomes (..)
ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News. The novel immunotherapy works by sparking activity from three types of immune cells.
Eli Lilly now offers vials of obesity medication Zepbound directly to self-pay patients at a nearly 50% discount off the drug’s list price. But more than offering patients a lower-cost alternative, this move represents a strategic stance against certain pharmaceutical industry players.
A panel at the MedCity News INVEST conference in Dallas discussed how new tech platforms help speed up the process of recruiting patients and running clinical trials. AI technologies have a role in the life sciences that goes beyond drug discovery.
We cannot change the fact that some patients must take multiple drugs, but we can certainly change how we manage it with careful coordination and communication among healthcare providers, and personalized medicine practices such as pharmacogenomics.
Vesalius Therapeutics’ AI-based technology finds novel targets and intervention points for subgroups of patients within a common disease. A small molecule that Vesalius has been developing for a novel Parkinson’s disease target is now headed to GSK, which has licensed global rights.
Results from the Phase 3 DREAMM-7 study show GSK drug Blenrep is helping multiple myeloma patients live longer compared to treatment with blockbuster Johnson & Johnson drug Darzalex.
Rexulti, a drug for schizophrenia and depression, now has an additional approval for treating agitation in Alzheimer’s disease patients. The FDA decision makes the Otsuka Pharmaceutical and Lundbeck product the first drug approved for this indication.
Positive preliminary results for Eli Lilly’s efsitora alfa continue to build the case for this once-weekly insulin in type 2 diabetes patients. The post Eli Lilly Moves Closer to Bringing Diabetes Patients a Once-Weekly Insulin Alternative appeared first on MedCity News.
AstraZeneca and Daiichi Sankyo are looking at moving their antibody-drug conjugate Enhertu into another new breast cancer patient class. AstraZeneca and Daiichi Sankyo are looking at moving their antibody-drug conjugate Enhertu into another new breast cancer patient class. lawmakers.
The post The Role of Medical Affairs in Bridging Clinical Trial Access for All Patients appeared first on MedCity News. Underrepresentation of racial and ethnic groups and other historically disenfranchised populations in clinical trials continues to be a major challenge. Medical Affairs can help identify solutions.
Delivering on these heightened expectations has fueled the urgency to invest in patient engagement and support. A seismic shift has occurred in the healthcare landscape.
Merith Basey, executive director of Patients For Affordable Drugs, believes the Medicare price negotiation program is here to stay, no matter who is president and no matter how many Big Pharma players file lawsuits. among pretty much everyone who isn’t a pharma company, she said during a session at Engage at HLTH. Her reasoning?
Cincor Pharma drug baxdrostat failed its Phase 2 test, falling short of the goal of reducing blood pressure in patients with uncontrolled hypertension. But results in a subgroup of patients showed double-digit declines, which the company said could inform the design of a Phase 3 clinical trial.
the European Union and other countries amid ongoing efforts to encourage patients who want to share their data. In a recent interview, Jennifer Cubino, COO of BC Platforms, discussed regulatory differences between the U.S.,
While pharmaceutical companies continue to raise list prices year-over-year, we work behind the scenes to fight the trend by driving competition, negotiating with drugmakers and incentivizing the use of less expensive medicines that deliver the same clinical value.
The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products. The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.
The patient who died in the Phase 1 test of Alpine Immune Sciences drug, davoceticept, reportedly suffered the same cardiovascular complication as the first patient. The biotech company is stopping enrollment in two clinical tests of the drug and assessing all patients in the studies.
Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.
The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.
Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.
Theseus Pharmaceuticals discontinued its former lead program in July following the report of dose-limiting toxicities in two patients. Though Theseus has other assets in its pipeline, it has decided to explore strategic alternatives with the goal of “maximizing shareholder value.”
Soleno Therapeutics Vykat XR is now FDA approved for treating hyperphagia, or excessive hunger, in patients with Prader-Willi syndrome. The once-daily pill is the first approved therapy for this rare disease, a leading cause of childhood obesity.
The post Amylyx Aims to Help Patients With a Novel GLP-1 Drug, But Not the Way You Think appeared first on MedCity News. Amylyx plans to advance this GLP-1 antagonist into Phase 3 testing for post-bariatric hypoglycemia, a rare condition in which blood sugar levels drop precipitously.
As the pharmaceutical landscape evolves, small-molecule CDMOs will be essential in balancing supply and demand, driving innovation, and improving patient outcomes. They must continue embracing innovation and strategic agility to survive and thrive in this complex environment.
Patients with rare or complex diseases often struggle to find specialists who meet their specific condition and individual needs. Patients with rare or complex diseases struggle to find specialists who fit their unique needs, delaying crucial care. Digital tools can help.
While attention is focused on the former Lilly asset, also at stake is Acrivon’s technology platform that relies on proteomics rather than genomics for identifying patients appropriate for targeted therapies.
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