Drug Topics
SEPTEMBER 26, 2024
Senators sought to uncover why prices of Novo Nordisk’sGLP-1 receptor agonist semaglutide are significantly higher in the US compared with countries in Europe.
STAT
SEPTEMBER 26, 2024
Pfizer’s decision Wednesday to pull its sickle cell pill off the market because of safety concerns shocked advocates and doctors, leaving many searching for answers and scrambling for ways to notify their patients about a drug that has long divided the community. The move underscored the severity of the risks recently seen in studies of the drug, Oxbryta , in which researchers have reported a number of deaths among patients who were receiving it.
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pharmaphorum
SEPTEMBER 26, 2024
Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.
STAT
SEPTEMBER 26, 2024
This month, Apple launched a feature for the Apple Watch that alerts users if it determines they may have sleep apnea, potentially leading to treatment for a dangerous health condition that often goes undiagnosed. Some see this as a good thing: Untreated sleep apnea, a condition where breathing is repeatedly disrupted during sleep, can result in persistent daytime tiredness and in the worst cases, cardiovascular diseases that hasten death.
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
Drug Topics
SEPTEMBER 26, 2024
Researchers aimed to address how community pharmacies target vulnerable groups regarding the promotion of vaccinations.
STAT
SEPTEMBER 26, 2024
For decades, doctors caring for people with schizophrenia have relied on mood-regulating drugs that target the brain chemical dopamine. On Thursday, the Food and Drug Administration approved for the first time a new type of medicine that may change the way the psychiatric disorder is treated. The drug, called Cobenfy, will be sold by Bristol Myers Squibb.
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
STAT
SEPTEMBER 26, 2024
Biden administration officials have abandoned their own proposal to require drug companies to disclose the prices and research costs of drugs that are driving up spending in state Medicaid programs. Pharmaceutical companies and lobbying groups heavily pressured the Centers for Medicare and Medicaid Services to abandon the little-noticed idea to create “drug price verification surveys” — they indirectly threatened to sue if the government moved forward with it.
The Checkup by Singlecare
SEPTEMBER 26, 2024
Synthroid (a brand name for the generic drug levothyroxine) is a prescription medication used to treat hypothyroidism, a condition in which the body does not produce enough thyroid hormone. Levothyroxine is an artificial thyroid hormone meant to replace what your thyroid gland would make on its own if it were functioning normally. If you took levothyroxine pre-pregnancy, good news—you can continue to take the medication safely starting in the first trimester of pregnancy and beyond.
STAT
SEPTEMBER 26, 2024
ARCH Venture Partners has raised $3 billion for a new fund — one of the largest in the biotech industry, and one the VC firm will use to continue its contrarian investment strategy. The last few years have tested many venture firms: biotech stocks dropped, valuations shifted, and the flow of fresh capital forced many startups out of business before signs of a recovery emerged.
pharmaphorum
SEPTEMBER 26, 2024
Flagship Pioneering's latest biotech launch, Mirai Bio, aims to help genetic medicine developers find the best way to get their drugs to patients.The new Cambridge, Massachusetts-based company – which was set up in 2021 but makes its official launch today with $50 million in funding from Flagship – applies artificial intelligence to solve the various obstacles that can block the progress of new medicines.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
STAT
SEPTEMBER 26, 2024
Epic Systems is no stranger to the courtroom. The nation’s largest vendor of electronic health records has fought, and won, legal fights with rivals large and small for many decades. But a new antitrust lawsuit filed this week by Particle Health , an upstart health data company, presents an especially direct threat to Epic’s dominance in the multi-billion dollar market surrounding patient data, legal and health policy experts told STAT.
Drug Topics
SEPTEMBER 26, 2024
For National Recovery Month, Drug Topics sat down with Jake Nichols, PharmD, MBA, to discuss what kinds of resources there are for pharmacists dealing with a substance use disorder.
STAT
SEPTEMBER 26, 2024
Facing charges from the Securities and Exchange Commission for misleading claims related to a controversial Alzheimer’s drug candidate, Cassava Sciences and two of the company’s former executives have agreed to pay fines, the company announced Thursday. The news comes on the same day that the SEC filed charges against Cassava, former CEO Remi Barbier, and former senior vice president of neuroscience Lindsay Burns.
Drug Topics
SEPTEMBER 26, 2024
Study findings raise concern about increased pain and disability, poorer pain self-management, and impaired quality of life during adolescence that can continue into young adulthood.
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STAT
SEPTEMBER 26, 2024
SILVER SPRING, Md. — Food additives rarely face FDA scrutiny once they’re on the market, even those with mounting evidence of safety concerns. At a meeting held by the Food and Drug Administration on Wednesday, regulators said they plan to change that. The public meeting on the FDA’s campus drew dozens of food safety advocates, industry representatives, concerned citizens, and state and federal lawmakers.
pharmaphorum
SEPTEMBER 26, 2024
BioAge Labs has completed its upsized initial public offering (IPO), raising $198 million after increasing the number of shares on offer by 40%. The expansion of the listing reflects the massive investor appetite for companies with assets in the clinic for obesity and takes the on-paper value of the Richmond, California-based company above $600 million.
STAT
SEPTEMBER 26, 2024
WASHINGTON — Pushing back on complaints from Congress this year that her agency’s response to disease outbreaks was sluggish, Dawn O’Connell forcefully defended the Administration for Strategic Preparedness and Response at a STAT event in D.C. Congress has “extraordinary confidence in our ability to deliver,” she said Thursday, pointing to recent budget increases for ASPR in House and Senate markups of the 2025 Labor and HHS appropriations bill.
pharmaphorum
SEPTEMBER 26, 2024
AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments. The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.
STAT
SEPTEMBER 26, 2024
On Wednesday, Congress passed a temporary spending bill that keeps the government funded beyond Sept. 30. Yet, even in light of lawmakers averting a shutdown, there is another end-of-moth deadline looming they’ve largely ignored: expiration of foundational aging and disability legislation called the Older Americans Act (OAA). The OAA supports the delivery of home and community-based social and services that improve the lives, dignity, safety and wellbeing of older adults.
Drug Topics
SEPTEMBER 26, 2024
Check out this list of our top 10 stories from September 2024.
STAT
SEPTEMBER 26, 2024
Within a few days of one another, two teams of accountants released separate estimates on the value of nonprofit hospitals’ tax exemptions. Their wildly different findings underscore the degree to which who’s counting and what they count matters. The first, a JAMA study published today , pegged that number at $37.4 billion. It factored in the value of forgone federal and state income taxes, sales tax, property tax, federal unemployment tax, charitable contributions from donor
Pharmacy Times
SEPTEMBER 26, 2024
The decision is based on positive results from the phase 3 LAURA trial.
STAT
SEPTEMBER 26, 2024
Why are Genentech’s cancer researchers concerned about the direction of the company? What led Pfizer to pull its sickle cell drug off global markets? And what cake did Adam make for all his podcast colleagues except Elaine? We talk about all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.
Fierce Pharma
SEPTEMBER 26, 2024
After collecting a handful of oncology approvals since its first leukemia nod in 2013, Roche’s Biogen-partnered Rituxan successor, Gazyva, is chasing new horizons in active lupus nephritis. | In a phase 3 study called REGENCY, a statistically higher proportion of lupus nephritis patients treated with biannual intravenous Gazyva doses and standard autoimmune disease therapy achieved complete renal responses at 76 weeks compared to those treated with standard therapy alone, Genentech reported Thur
STAT
SEPTEMBER 26, 2024
Rise and shine, everyone, another busy day is on the way. However, this is shaping up as a lovely day as well, despite forecasts suggesting a smattering of rain a few hours from now. For the moment, the skies are tranquil, the birds are chirping, and the official mascots are hunting for noshes on the Pharmalot campus. This calls for celebration with a cup of stimulation, and we are reaching for pecan pie — sweets for the sweet.
pharmaphorum
SEPTEMBER 26, 2024
IntraBio claims FDA approval for its Aqneursa therapy for Niemann-Pick type C, the second new drug for the disease in four days
STAT
SEPTEMBER 26, 2024
This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. I love a good regulatory debate. Biohaven Pharmaceuticals has given us a new one to chew over. On Monday, the company said it planned to submit a marketing application to the Food and Drug Administration before the end of the year, seeking approval for an experimental drug called troriluzole to delay progr
Fierce Pharma
SEPTEMBER 26, 2024
The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors.
STAT
SEPTEMBER 26, 2024
Patients who received higher doses of buprenorphine, a common medication used to alleviate opioid withdrawal and cravings, were less likely to be hospitalized and less likely to discontinue treatment, according to a new study. The findings run counter to federal guidelines about buprenorphine dosing. Currently, the Food and Drug Administration recommends a target dose of 16 mg.
pharmaphorum
SEPTEMBER 26, 2024
MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac
STAT
SEPTEMBER 26, 2024
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. AAM picks up laid-off BIO exec Redox reactions – when an atom loses an electron that is picked up by another atom– are common to some basic functions of life, including photosynthesis, respiration, combustion.
Drug Topics
SEPTEMBER 26, 2024
In the TEMPO-1 trial, both tavapadon doses effectively reduced motor symptoms in patients with early-stage Parkinson's disease.
STAT
SEPTEMBER 26, 2024
This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. The deep financial restructuring announced by Bluebird Bio this week offered another reminder that groundbreaking genetic medicines capable of transforming the lives of people with inherited disease are not now — and may never become — a sustainable business.
Drug Topics
SEPTEMBER 26, 2024
Genentech said it’s sharing the data with global health authorities to make the therapy available to patients as soon as possible.
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