PharmaFocus Today – Page 311 – media

Acute Kidney Injury Does Not Predict Worsening Kidney Function Trajectory in CKD Patients

A study of hospitalized persons with chronic kidney disease (CKD) fournd that acute kidney injury (AKI) did not predict worsening of kidney function trajectory once difference in pre-hospitalization characteristically were fully accounted for. Instead, the authors suggest that much of determinants of faster kidney disease decline observed after AKI may already be present before AKI. The findings are published in Annals of Internal Medicine. Many now believe that AKI is an independent risk factor for accelerated loss of kidney function. This has led to changes in research focus, practice patterns, and public health targets. However, prior studies associating AKI with more rapid subsequent loss of kidney function had methodological limitations, including inadequate control for differences between patients who had AKI and those who did not. Researchers from the University of California, San Francisco and colleagues in the Chronic Renal Insufficiency Cohort (CRIC study) analyzed data from 3,150 persons ...
- Source: drugdu
- 134
- July 12, 2023
Novartis Plans Appeal to Ward Off Entresto Generics

Swiss-based Novartis announced that the US District Court for the District of Delaware has invalidated the patent covering its cardiac drug Entresto, which expires on 15 July 2025 with the associated paediatric exclusivity. The company said it will now appeal to the US Court of Appeals for the Federal Circuit (CAFC) to further pursue the efforts to validate the combination patent around Entresto. A combination of sacubitril and valsartan, Entresto was first approved by the US Food and Drug Administration (FDA) to treat heart failure with reduced ejection fraction in July 2015. It is also approved to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients. Apart from the patent which was adjudicated by the District Court, additional patents for the combinations of sacubitril and valsartan, including the drug forms and dosages, are listed to expire from November 2026 to May 2036. ...
- Source: drugdu
- 260
- July 12, 2023
Novavax’s COVID-19 Vaccine Granted Full Marketing Authorisation in EU

Novavax has announced that its COVID-19 vaccine, Nuvaxovid, has been granted full marketing authorisation in the EU. The vaccine is now fully authorised for use as a primary series in individuals aged 12 and older for COVID-19 prevention and as a booster dose in adults aged 18 and older, the company said. Novavax’s protein-based vaccine, which was originally granted a conditional marketing authorisation in the EU for these indications, contains the SARS-CoV-2 spike protein and Matrix-M adjuvant to enhance immune response and stimulate high levels of neutralising antibodies. The European Commission’s latest decision follows a recommendation by the European Medicines Agency’s human medicines committee earlier this year and is supported by positive results from the phase 3 PREVENT trial that evaluated the safety, immunogenicity, and efficacy of Nuvaxovid. John Jacobs, president and chief executive officer of Novavax, said: “This marketing authorisation establishes the foundation for all ...
- Source: drugdu
- 200
- July 12, 2023
Novartis Pledges to Appeal After Delaware Court Nixes Patent on Big-Selling Entresto

After a Delaware federal court ruled a Novartis combination patent on big-selling cardiovascular drug Entresto is invalid, the company pledged to continue its efforts to block generics with an appeal. The combination patent, which includes an extension thanks to a pediatric exclusivity award, is set to expire in July of 2025. Other patents on the drug run until 2026, 2027 and 2036. Now, Novartis will head to the U.S. Court of Appeals for the Federal Circuit (CAFC) in an effort to reverse the decision, the company said in a recent statement. The company will “continue to defend” its Entresto patents “vigorously” and warned that any generics that launch before the outcome of the appeal “may be at risk” of litigation. Currently, there are no Entresto copycats with tentative or official FDA approvals, the company noted. Just last week, the company chalked up a win against Mylan when a West Virginia court ruled that the ...
- Source: drugdu
- 134
- July 12, 2023
Samsung Biologics, After Expanding Pfizer Collab, Inks Novartis Production Deal Worth $391M

Just days after sewing up a pair of $897 million deals with Pfizer, Samsung Biologics has added a few hundred million dollars more to its partnership cash pile—this time courtesy of an expanded pact with Novartis. Monday, Samsung Bio said in a regulatory filing that it’s inked a $390.9 million deal to help crank out Novartis drugs. The latest production pact builds on an earlier Samsung-Novartis tie-up worth $81 million in June 2022. Last week, meanwhile, Samsung Bio said Pfizer had added $486 million to two biosimilar production accords the companies made in early 2023. In June, the partners signed a contract for the Korean CDMO to produce biosimilar drugs in the fields of immunology, oncology and inflammation. And in March, the companies linked up on a deal worth $193 million, according to a regulatory filing. Samsung’s Novartis deal comes in below that Pfizer deal from June. Still, the Novartis tie-up now represents ...
- Source: drugdu
- 138
- July 12, 2023
CMS Expands Medicare Coverage for Leqembi After FDA Traditional Approval

Pictured: Sign of U.S. Department of Health & Human Services at its headquarters in Washington/iStock, JHVEPhoto The Centers for Medicare and Medicaid Services will now provide broader coverage for Eisai and Biogen’s Alzheimer’s disease therapy Leqembi (lecanemab), the federal agency announced Thursday. The Medicare coverage expansion comes after Leqembi won the FDA’s traditional approval, making it the first anti-amyloid and disease-altering treatment to do so. Eisai and Biogen were granted accelerated approval for Leqembi in January and soon commenced their bid for full approval with data from the Phase III Clarity-AD study. According to CMS, only patients enrolled in Medicare and with physicians participating in a qualified registry will be eligible for reimbursement—provided their doctors collect their data as real-world evidence for Leqembi and submit it to a registry. Coverage is restricted to those who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with evidence of beta-amyloid deposits in the brain. “With FDA’s decision, CMS will ...
- Source: drugdu
- 131
- July 11, 2023
Novo Nordisk Files Another Round of Lawsuits Over Semaglutide Copycats

Pictured: Novo Nordisk building in California/iStock, hapabapa Thursday, Novo Nordisk filed legal complaints against three pharmacies in Florida and one in Tennessee for allegedly selling products that contain semaglutide, the active compound in the company’s best-selling weight-loss and diabetes drugs Ozempic, Wegovy and Rybelsus, Bloomberg reported. Novo filed three separate lawsuits in Florida federal court, targeting three compounding pharmacies: WellHealth, TruLife Pharmacy and Brooksville Pharmaceuticals. A fourth lawsuit was filed in Tennessee against DCA Pharmacy. The Danish drugmaker is asking the courts to block these pharmacies from marketing their semaglutide-containing products and is seeking unspecified financial damages. This latest round of lawsuits comes two weeks after Novo sent out a barrage of legal complaints against wellness and weight loss clinics, medical spas and other compounding pharmacies, also claiming that these businesses were selling products containing semaglutide. Semaglutide is a peptide that mimics the GLP-1 hormone to active its counterpart receptor. In turn, this induces the pancreas to secrete ...
- Source: drugdu
- 144
- July 11, 2023
PacBio’s Revio Long-read Sequencing System to Help Bioscientia Solve Complex Genetic Cases

PacBio, a leading developer of high-quality, highly accurate sequencing solutions, today announced that Bioscientia is using its Revio long-read sequencing system to expand its genomics research projects and sequence several thousand human genomes per year. Part of Sonic Healthcare Group, Bioscientia is a leading global provider of clinical laboratory testing services for diagnostics based in Germany. The increased accuracy, read length and methylation insights offered by the Revio system will enable Bioscientia to explore certain monogenic disorders, such as deafness, blindness, and developmental delay, and study the underlying causes of rare diseases. “Bioscientia is a world-leading provider of testing services, and we are thrilled that they have chosen Revio to explore the potential clinical use of long-read sequencing,” said Christian Henry, President and Chief Executive Officer of PacBio. “Revio will help enable Bioscientia to deliver more insights to families with fewer tests, lower overall costs, and less time spent ...
- Source: drugdu
- 114
- July 11, 2023
PrecisionLife Licenses OXEGENE Dataset to Develop Personalized Treatments for Endometriosis

PrecisionLife, a leading techbio company driving precision medicine in complex chronic diseases, announced today a data access agreement with the University of Oxford to license the Oxford Endometriosis Gene (OXEGENE) dataset with the aim to develop new personalized treatments for endometriosis patients. Endometriosis is a chronic disease associated with severe pain and infertility. It affects 10% of women globally, but how and why it develops is unknown. On average it takes over 7 years for patients to receive a diagnosis and there are currently no approved diagnostic biomarkers or cures for the disease. The OXEGENE dataset contains anonymized genotype data including disease stage and infertility status, from 1,000 surgically confirmed patients. PrecisionLife’s combinatorial analytics platform is unique in its ability to analyze patient data to better understand the causes of complex chronic disease and achieve mechanistic patient stratification to enable precision medicine where it has not previously been ...
- Source: drugdu
- 154
- July 11, 2023
Sales of Alzheimer’s Drug Leqembi may be Slow Initially But Could Pick up in 2024

Sales of the Alzheimer’s drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S. Wall Street is chewing over the Food and Drug Administration’s Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn’t a cure. Leqembi, from drugmakers Eisai and Biogen, is the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. Medicare on Thursday announced it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, broadening access for those who can’t afford the drug’s hefty $26,500-a-year price tag. But coverage comes with several conditions. Analysts believe certain Medicare requirements and new guidance on Leqembi’s prescription label could potentially weigh on sales of the ...
- Source: drugdu
- 118
- July 11, 2023

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