PharmaFocus Today – Page 328 – media

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
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- 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
- 142
- 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
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- 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
- 143
- 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
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- 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
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- 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
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- 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
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- July 11, 2023
Astellas Gains FDA Priority Review for Gastric Cancer Therapy BLA

The US Food and Drug Administration (FDA) has awarded priority review for Astellas Pharma’s biologics licence application (BLA) for zolbetuximab to treat gastric cancer patients. Zolbetuximab is an investigational monoclonal antibody that acts on Claudin 18.2 (CLDN18.2). It is intended for use as a first-line therapy for HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is locally advanced, unresectable or metastatic, with tumours that are CLDN18.2-positive. Zolbetuximab is the first treatment targeting CLDN18.2 to be offered in the region for such patients. A decision on the approval by the regulatory agency is anticipated on 12 January 2024. The application is based on the Phase III SPOTLIGHT and GLOW clinical trial findings. Zolbetuximab was assessed along with a regimen comprising oxaliplatin, leucovorin and fluorouracil (mFOLFOX6) in the SPOTLIGHT trial. The GLOW trial analysed zolbetuximab in combination with a chemotherapy regimen comprising capecitabine and oxaliplatin (CAPOX). Astellas immuno-oncology development ...
- Source: drugdu
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- July 11, 2023
Novo Nordisk Brings New Round of Lawsuits Against Compounded Versions of Ozempic and Wegovy

As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. Now, five weeks later, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats. Thursday, in federal courts in Florida and Tennessee, the company accused four companies of making compounded versions of its products that are not approved by the FDA. “Testing new drugs and obtaining the regularly acquired regulatory approval to sell them are time-consuming and very costly,” Novo said in its complaints. “Ignoring drug-approval requirements provides defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Worse, it puts patients at risk by exposing them to drugs that have not been shown to be safe or effective.” The defendants are compounding ...
- Source: drugdu
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- July 11, 2023

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