PharmaFocus Today – Page 383 – media

Sandoz partners with Samsung Bioepis to license Stelara biosimilar

Sandoz has partnered with Samsung Bioepis to develop and market a Stelara (ustekinumab) biosimilar in the US, Canada, and Europe. Stelara is an interleukin (IL)-12/IL-23 inhibitor monoclonal antibody developed by Janssen Pharmaceutical Companies of Johnson and Johnson (J&J). It was first approved by the US Food and Drug Administration (FDA) for treating moderate to severe plaque psoriasis in adults in 2009. Its approval was later expanded to include Crohn’s disease, active psoriatic arthritis, and ulcerative colitis. With Stelara being a high-grossing drug for J&J, generating $3.2bn in sales in H1 2023, as per the company’s Q2 financial report, multiple companies are developing biosimilars. J&J has already settled three lawsuits with multiple companies, including Amgen, to push the launch of the Stelara biosimilar’s release date to 2025. Samsung Bioepis is expected to present Phase III trial data with the Stelara biosimilar, SB17, by the end of 2023. The Phase I trial ...
- Source: drugdu
- 196
- September 13, 2023
Click Expands to Substance Use Disorder With Indivior Digital Therapeutics Pact

Click Therapeutics, a developer of prescription digital therapeutic products, is adding substance use disorder to its pipeline through a new partnership with addiction medicines maker Indivior. Like other products in the Click pipeline, the new substance use disorder treatment, codenamed CT-102, will be a mobile software app. This app will be designed to work alongside drugs used to treat addiction. The Indivior portfolio includes the opioid addiction products Sublocade and Suboxone. Click said the partnered app will combine evidence-based behavioral therapy with tailored interventions intended to have an effect on the brain. Privately held Click is part of a cohort of companies developing software as treatments for various medical conditions. The company has mapped the entire brain to discover faulty brain circuits that are implicated across a variety of diseases. To treat these diseases, the company designs apps that present users with tasks that have the effect of retraining and ...
- Source: drugdu
- 257
- September 12, 2023
Seagen, Nurix Team to Create New Class of Antibody Conjugates for Cancer

By Tristan Manalac Pictured: Illustration of an antibody molecule/iStock, Dr_Microbe Seagen on Thursday inked a strategic collaboration agreement with San Francisco-based Nurix Therapeutics to develop a potentially new class of therapies—called degrader-antibody conjugates—that selectively kill cancer cells. Under the terms of the agreement, Seagen will make an upfront payment of $60 million and pledge up to $3.4 billion in research, development, regulatory and commercial milestone payments. Nurix will also be entitled to receive mid-single to low-double digit tiered royalties on future sales. The California biotech will also have the option for profit-sharing and co-promotion in the U.S., applicable to two products that emerge from the partnership. Seagen and Nurix will combine their respective expertise and produce degrader-antibody conjugates (DACs), which combine the “tissue and tumor specificity of antibodies with highly potent and catalytic targeted degradation of cancer driver proteins,” Nurix CEO Arthur Sands said in a statement. To achieve this, ...
- Source: drugdu
- 311
- September 12, 2023
AstraZeneca Signs AI-Powered Drug Discovery Pact with Verge

By Tristan Manalac AstraZeneca, through its rare disease division Alexion, has entered into a multi-target agreement with Verge Genomics to discover and develop drugs against novel targets in rare neurodegenerative and neuromuscular diseases, the companies announced Friday. Under the agreement, Alexion will make a $42 million payment in upfront fees, as well as equity and near-term investments. Counting milestones, the four-year collaboration can yield up to $840 million for Verge, plus potential royalties down the line. Alongside the drug discovery pact, AstraZeneca will also take an equity position in Verge. In return, Alexion will gain access to the California biotech’s proprietary full-stack CONVERGE platform, which applies machine learning to human tissue data in order to identify novel disease targets that have a high probability of yielding clinical success. Friday’s partnership will apply the AI-driven approach to several yet-undisclosed rare neurodegenerative and neuromuscular conditions. Alexion will have the option to select ...
- Source: drugdu
- 338
- September 12, 2023
Danco takes mifepristone restrictions lawsuit to the Supreme Court

The legal kerfuffle over the FDA’s 2000 approval of Danco Laboratories’ abortion pill mifepristone, also known as Mifeprex, is heading to the Supreme Court. Friday, Danco asked the Supreme Court to overturn a recent U.S. Court of Appeals for the Fifth Circuit ruling that would severely limit access to the abortion pill mifepristone. “The risks and confusion that result from the Fifth Circuit’s decision are not ones that women, teenage girls, and the public health system should be forced to bear without this Court’s review,” Danco’s lawyers wrote in a legal filing. “Denying review of the Fifth Circuit’s opinion would eviscerate the sovereign authority of states that have chosen to expand and protect access to medication abortion in their jurisdictions,” Danco’s legal team continued, adding that the case is of “indisputable importance.” Mifepristone remains unrestricted until the Supreme Court weighs in on the case. Medication abortion makes up the majority ...
- Source: drugdu
- 180
- September 12, 2023
ICR study finds way to determine efficacy of experimental breast cancer drugs

Researchers at The Institute of Cancer Research (ICR), London, have discovered a way to use a simple, non-invasive MRI scan to determine whether an experimental approach to enhance treatment for breast cancer is effective. New research from the study, funded by Cancer Research UK, could help doctors visualise tumours and speed up the development of targeted therapies for breast cancer. If successful, these drugs could enhance the effectiveness of other drugs administered in combination. Common features of breast cancer include excessive connective tissue, which consists of cells and fibres that provide a scaffold, known as the extracellular matrix (ECM), where tumours can grow. Hyaluronic acid, which works by absorbing water, is naturally present inside the tumour ECM and causes cancer tumours to swell, making it challenging for drugs to penetrate, reach and destroy cancer cells. Researchers are able to use experimental drugs that target and degrade a chemical called hyaluronic ...
- Source: drugdu
- 190
- September 12, 2023
NICE recommends Lilly’s tirzepatide to treat T2D

The UK National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s tirzepatide (Mounjaro) for the treatment of adult patients with inadequately controlled type 2 diabetes. According to NICE’s final draft guidance, the injection is indicated for weekly usage in combination with diet and exercise. Clinical trials show that tirzepatide usage resulted in a substantial decline in both blood sugar levels and body weight, in comparison with insulin therapy, semaglutide or a placebo. Data also showed that tirzepatide aided between 81% and 97% of individuals in attaining improved glucose control, and 54% to 88% also showed a 5% or greater reduction in body weight. These figures were substantially higher than the comparators. The independent NICE committee provided a positive recommendation for tirzepatide after conducting additional assessments and modelling on clinical and cost-efficiency data provided by Lilly. NICE noted that 180,000 individuals with poorly managed type 2 diabetes will ...
- Source: drugdu
- 243
- September 12, 2023
FDA fast tracks Mendus’s acute myeloid leukaemia vaccine vividencel

The US Food and Drug Administration (FDA) has granted fast track designation to Mendus’s cancer vaccine vividencel for the treatment of acute myeloid leukaemia (AML). The FDA’s decision was based on results from the Phase II ADVANCE II trial (NCT03697707), which investigated the vaccine’s use as a maintenance monotherapy in patients with AML in complete remission. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews. In June, the Swedish company, which was previously known as Immunicum, presented comprehensive immunomonitoring data at the European Hematology Association’s 2023 hybrid congress. According to Mendus, the vaccine led to increased levels of activated, cancer-killing T cells and reduced levels of immune-suppressive T cells in the majority of the patients in the Phase II ADVANCE II study. Prior to this, the company published data on the drug’s effects on measurable residual ...
- Source: drugdu
- 290
- September 12, 2023
analysts

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.During second quarter earnings calls, many heavy-hitters—including Johnson & Johnson, Bristol Myers Squibb and Merck—expressed urgency in their quest for deals. With so many buyers in competition, sellers are finding offers that are more attractive. For example, Merck’s $10.8 billion proposal to acquire Prometheus in April came at a 75% premium. In July, Biogen’s $7.3 billion deal for Reata represented a 59% markup. “There’s been such a consistent pick up in momentum in anything above a billion [dollars],” Cody Powers, an M&A expert with ZS Principal, said in an interview. “I think we’re back on the gravy train of where we were a couple of years ago in terms of premiums.” In 2019, the industry ...
- Source: drugdu
- 218
- September 11, 2023
Veracyte and Gustave Roussy announce partnership for cancer therapies

Veracyte has announced a multi-year partnership with Gustave Roussy to support biopharmaceutical companies in expediting the development of new cancer therapies. They will combine their abilities to offer new insights into the biology of metastatic tumours, helping to develop new cancer treatments. The collaboration will utilise Gustave Roussy’s extensive collection of tumour samples and related data, along with Veracyte’s Biopharma Atlas, a machine learning-powered, multi-omic solution aimed at enhancing the effectiveness and efficacy of clinical studies. Gustave Roussy’s department of therapeutic innovation and early clinical trials will deliver metastatic tumour samples and information for several cancer indications. These are derived from research projects, specifically for new immunotherapies. Veracyte intends to combine these resources with its multi-omics testing and machine learning capabilities, resulting in the development of a Veracyte Biopharma Atlas reference database for genomic and immunomic biomarkers. Using the comprehensive understanding of each tumour’s biology, especially its immune context, the ...
- Source: drugdu
- 275
- September 11, 2023

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