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The Swiss competition commission (COMCO) has opened an investigation of Novartis over possible unlawful use of a patent to reduce competitive pressure, the Swiss drugmaker confirmed on Thursday, September 15. COMCO conducted an early morning raid on the company on Sept. 13, it said in a statement that did not name Novartis, which subsequently said in its own statement that it was the group under investigation. "The company allegedly attempted to protect its drug for the treatment of skin diseases against competing products by using one of its patents to initiate litigation proceedings," COMCO said in a statement. Novartis said COMCO had started an investigation in collaboration with the European Commission into the assertion of a patent in the broader field of dermatology treatments. "In connection with this investigation, COMCO representatives visited the company headquarters in Basel," it said.

Novartis on Wednesday (February 1) predicted that core operating income would grow in a "mid single digit" percentage range in 2023 following stagnation last year, as the Swiss drugmaker prepares to spin off its Sandoz generics business. Full-year core operating income was broadly flat at $16.7 billion, it said in a statement, coming in slightly below market expectations of $16.8 billion. Adjusted for overall negative currency effects, group sales in 2022 advanced 4 per cent to $50.5 billion as gains from heart failure drug Entresto and multiple sclerosis (MS) drug Kesimpta were partly offset by competition from cheap generic copies of established MS drug Gilenya. Novartis said it was on track to spin off its generics unit Sandoz in the second half of the year as part of its effort to sharpen its focus on its patented prescription medicines. Analysts have welcomed a programme unveiled in 2022 to trim costs and cut 8,000 jobs and plans to focus on fewer therapy areas and drug technologies. But the market has been underwhelmed by prospects for medium-term growth from new drugs.

Amgen Inc sued Novartis AG's Sandoz in a federal court in the United States on Monday (May 1), accusing Sandoz's proposed versions of its multibillion-dollar bone-strengthening drugs Prolia and Xgeva of infringing several patents. Amgen asked the New Jersey court to block Sandoz's biosimilars of the drugs until its patents expire. One of the patents named in the complaint does not expire until 2037. Sandoz declined to comment on the lawsuit on Tuesday. Novartis, which is also named in the complaint, is preparing to spin Sandoz off into a standalone company later this year. Amgen's Prolia is used to treat osteoporosis. Xgeva, with the same active ingredient denosumab, treats bone cancer and prevents fractures in bone-cancer patients.

An oral drug combination by Novartis showed promise in treating a subgroup of patients suffering from a common childhood brain cancer in a trial. In the mid-stage trial, 47 per cent of the patients that were given the two drugs Tafinlar and Mekinist saw their tumours shrink, far above a rate of 11 per cent in a comparative group of participants on standard chemotherapy, the drugmaker said on Monday, June 6. The participants, aged one to 17 years, were suffering from low-grade gliomas (LGG), the most common childhood brain cancer. The trial only included those who were found to have a mutation known as BRAF V600, a genetic contributor in about 15 per cent to 20 per cent of paediatric LGG cases. Among further results of the trial with 110 participants, the median time without disease progression was 20.1 months for those given the Novartis drug combo, compared to 7.4 months on chemotherapy. The new oral treatment candidate also caused less severe side effects than burdensome chemotherapy.

PBR Staff Writer Published 22 April 2014 Swiss pharmaceutical firm Novartis has entered into a definitive agreement to acquire the oncology unit of Britain's GlaxoSmithKline (GSK) for about $14.5bn and up to $1.5bn contingent on a development milestone. As part of the deal, Novartis would have opt-in rights to GSK's current and future oncology R&D pipeline.

The US Food and Drug Administration (FDA) has approved the Novartis drug, Cosentyx, (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults. HS is a chronic, progressive and painful disease which affects one in 100 people worldwide, and has limited treatment options. "Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS," said the Swiss company. The FDA approval was based on robust Phase III data (SUNSHINE and SUNRISE studies) in which Cosentyx showed rapid relief from HS symptoms as early as Week 21.

Novartis has acquired CoStim Pharmaceuticals, an immuno-oncology company developing monoclonal antibody drugs that enable a patient's own immune system to better fight cancer.

PBR Staff Writer Published 21 March 2014 Novartis has launched the Lucentis (ranibizumab) pre-filled syringe (PFS) in Germany and plans to introduce the product in other markets throughout 2014. In October 2013, the company has received approval from the European authorities for Lucentis PFS, which is a new way of administering Lucentis that is specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.

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Novartis has said that Kisqali delivered superior overall survival (OS) in the Monaleesa-3 trial, demonstrating more life for postmenopausal human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer patients.

The drug, alpelisib, which is the 100th cancer drug that has being fast-tracked to patients under the NHS Cancer Drugs Fund (CDF) will be used in combination with the hormone therapy, fulvestrant, to target the gene that causes fast-growing tumours. Up to 3,000 people a year with a certain type of secondary breast cancer will benefit from the treatment. The approach has contributed to people in England having access to nearly one third more cancer drugs compared to the European average. The drug which is manufactured by pharmaceutical company Novartis, is part of a growing number of precision treatments that target a tumour based on mutations in its DNA and that the NHS is rolling out. John Stewart, NHS National Director for Specialised Commissioning said, "In just over five years, more than 80,000 people have benefitted from earlier access to a range of cancer drugs, with people in England having access to nearly one third more cancer drugs compared to the European average, and this latest innovative new treatment will help up to 3,000 more to live a better quality of life.

Swiss generic drugmaker Sandoz said on Thursday that it would pay $265 million (£209m) to settle a pricing antitrust case in the US. Under the agreement, Sandoz is resolving all damages claims without admitting to any wrongdoing in the case brought in the US state of Pennsylvania. "Under the terms of the agreement, Sandoz US will pay $265 million in exchange for a full release of all claims asserted against it in the direct purchaser class action by the settlement class members," the company said in a statement, adding that the payment would be incorporated into 2023 results. Sandoz became an independent company in October 2023, following the spinoff from Novartis. "As a new public company, this settlement underscores the Sandoz commitment to integrity and sound governance, and is an encouraging step toward putting allegations of legacy conduct behind us", it said in its statement.

North America leads the global heart failure drugs market in 2018 followed by Europe. The US dominates the market owing to the presence of a majority of the heart failure drugs manufacturers in the region. However, the fastest growth rate is anticipated to be in the APAC region due to the presence of large heart failure patient population and availability of wide range of drugs. Most of the revenue is generated from the leading players in the market with dominant sales from Novartis AG, GlaxoSmithKline PLC, AstraZeneca PLC, Bayer AG, and Pfizer Inc.

Bas Vorsteveld, who was made vice president and general manager for Great Britain & Ireland (GBI) in November last year, is joined by Monica Michalopoulou as GBI marketing director and Onyeka Anugwom as GBI commercial excellence director GSK Consumer Healthcare. He took over from Jonathan Workman, who held the position from 2018, and has now moved into the role of Business Unit general manager for Northern Europe. Vorsteveld, who has 15 years' industry experience, played at major part in the merger of Novartis and GSK consumer healthcare businesses. Most recently, he held the role of VP & head of commercial excellence EMEA LATAM at GSK Consumer Healthcare, where he spearheaded international sustainability initiatives. Commenting on his new role, Vorsteveld said: "I am incredibly honoured to have been a part of GSK Consumer Healthcare's journey to date and it is our collective ambition to deliver better everyday health with humanity for our customers, with a laser focus on 'self-care'. "The recent pandemic has shown us that healthcare matters more now than ever before for our consumers. We want to redefine the role that self-care plays in people's lives, because it can bring long-term benefits for individuals and society, and is a key component of a sustainable healthcare system.

Pharmaceutical giant AstraZeneca will acquire biotechnology company Neogene Therapeutics for up to $320 million, the London-listed drugmaker said on Tuesday (November 29) as it seeks to build its pipeline of cell-based cancer treatments. Though AstraZeneca's oncology portfolio accounted for more than a third of the company's revenue last year, it does not have an approved cell-based cancer therapy and is behind rivals such as Novartis and Gilead. "Neogene's leading (T-cell receptor) discovery capabilities and extensive manufacturing experience complement the cell therapy capability we have built over the last three years," said Susan Galbraith, AstraZeneca's executive vice president of oncology research. Cell-based treatments are a relatively new approach to treating cancer, most of which involve drawing the body's own immune cells and processing them in the lab to target and kill cancer cells. Neogene's approach goes one step further in that its experimental T-cell receptor therapies seek to target DNA mutations specific to tumours, not only certain proteins on the surface of cancer cells.

The British Generic Manufacturers Association (BGMA) has elected Diane DiGangi Trench to be its new vice-chair. DiGangi Trench takes up the position replacing Xiromed's Peter Ballard and in 12-months' time will assume the association's chair role from Accord's Peter Kelly. With over 25 years of pharmaceutical industry experience, DiGangi Trench has held a number of senior commercial roles including stints with Takeda and Astra Zeneca. She joined Sandoz in 2018 in the US, where she served as Vice-President, Market Access and Patient Services. In 2021, she became the head of Sandoz' UK business and in her two years in role, she has led the organisation through a post-COVID recovery and growth phase to prepare for the proposed spin out of the company from its parent, Novartis, expected later this year. She said: "It's a great honor to take on the role of Vice Chair of the BGMA. The success of the generics and biosimilar industry is essential to the functioning of the NHS. Generic medicines fill four out of five UK prescriptions and biosimilars enable the NHS to expand access to more patients. I am passionate about increasing the sustainability of our industry so we can continue to play our vital part in the health of the nation." Mark Samuels, BGMA chief executive, said: "We are extremely fortunate to be able to call upon the expertise of Diane who has already added significant value through her role on the BGMA board and leadership of a key strategic committee.

Health and Social Care Secretary Sajid Javid and Madelaine McTernan, head of the HRT supply taskforce, continue to take urgent action to resolve the shortage of HRT medicines by meeting the drug manufacturers and representatives from community pharmacies on Thursday (May 5). In the meeting, manufacturers outlined the steps they're taking to boost supply, and pharmacists shared their experiences on the frontline, as well as sharing their thoughts on wider solutions including improved communications. Aspen Pharmacare, Besins-Healthcare, Gedeon Richter, Novartis, Novo Nordisk, Orion, Pfizer, Theramex, Viatris, and representatives from community pharmacies were part of the meeting. As the government confirmed its intention to work with industry to do what is necessary to fix the HRT supply issue, Javis said he wanted to understand the issues facing suppliers and what can be done to address them. "We will leave no stone unturned in our national mission to boost supply of HRT. Along with appointing Madelaine McTernan as head of the HRT supply taskforce to implement lessons learned from the pandemic, and ensuring prescriptions are issued in shorter cycles for now, we are working collectively with the sector to urgently resolve this issue," he commented. The Association of Independent Multiple Pharmacies (AIMp) said the meeting discussed 'why we got into this position' and the way forward.

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