Search Results for “Novartis” – Page 21 – media

Biogen to Cut 1,000 Jobs as Part of $1B Cost Savings Plan

Pictured: Biogen/The Boston Globe via Getty, John Tlumacki With full FDA approval and CMS coverage for Leqembi in hand, Biogen is ramping up its launch efforts for the Alzheimer’s drug and executing a massive cost reduction program. The biotech company announced second-quarter earnings and its new cost-savings plan on Tuesday. The “Fit for Growth” program is expected to generate around $1 billion in operating expense savings by 2025, which includes a headcount reduction of approximately 1,000 jobs, or about 11% of Biogen’s workforce. Around $300 million will be reinvested into product launches and R&D programs for a net savings of $700 million. The staff reduction will be completed by 2025. The company had more than 8,700 employees in 2022, according to Statista. Biogen CFO Michael McDonnell told investors on Tuesday’s earnings call that a “substantial portion” of the $700 million in net operating expense savings are expected to come from cutting ...
- Source: drugdu
- 142
- July 27, 2023
Sandoz Granted Positive CHMP Opinion for Multiple Sclerosis Biosimilar

Sandoz, a Novartis division, has announced that its multiple sclerosis (MS) biosimilar has been recommended by the European Medicines Agency’s (EMA) human medicines committee as a single disease-modifying therapy in adults with highly active relapsing-remitting forms of the disease. The “first-of-a-kind” biosimilar natalizumab, developed by Polpharma Biologics, is a version of Tysabri (natalizumab). Biosimilars, according to the EMA, are biological products that are highly similar to a medicine already approved in the EU. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they could potentially lower healthcare costs. Pierre Bourdage, chief commercial officer, Sandoz, said: “Access to affordable, high-quality treatments like disease-modifying therapies – which are a cornerstone in the treatment of MS – remains limited for many people living with this disease.” Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable ...
- Source: drugdu
- 123
- July 26, 2023
ADC Therapeutics Pulls the Plug on Zynlonta Study After Partial FDA Hold

A week after ADC Therapeutics paused its Zynlonta trial to review seven deaths and five other respiratory events in patients who received the drug, the company has scrapped the study altogether following an FDA partial clinical hold. The trial was testing the drug, combined with Roche’s Rituxan, in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Citing the “challenges of defining the addressable segment” of the difficult-to-treat population, ADC believes the benefit-risk profile “does not support” the continuation of the study, the company said in a release. The call came after a meeting with the FDA, in which the agency slapped a partial hold on enrolling new patients in the trial. However, the agency said patients who are already on the drug and seeing clinical benefits can remain enrolled after reconsenting. After those patients are treated, ADC will take steps to wrap up the trial. ...
- Source: drugdu
- 107
- July 25, 2023
Sandoz Invests $90m to Build a Biosimilar Centre in Slovenia

Sandoz has invested $90m to build a biopharma development centre in Ljubljana, Slovenia by 2026. The site will serve to develop biosimilar products and is expected to create 200 new jobs. This follows Novartis’ financial report stating $2.4bn in net sales for Sandoz biosimilars in Q2 2023, along with the proposed 100% separation of Sandoz from Novartis to form an independent company by the end of this year. The fully independent Sandoz will be headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange and American Depositary Receipt (ADR) programme in the US, as per a 1 June press release. To that end, the development centre is the company’s second major investment in Slovenia. In March, the Novartis spin-off announced plans to construct a biologics production plant in Lendava, Slovenia, to support the increasing product demand. According to a press release, Sandoz chief ...
- Source: drugdu
- 110
- July 24, 2023
Immune systems develop specific genes to fight against common bacteria, study finds

Immune systems develop specific genes to combat common bacteria such as those found in food, new research shows. Previous theories have suggested that antimicrobial peptides – a kind of natural antibiotics – have a general role in killing a range of bacteria. However, the new study, published in Science, examined how the immune systems of fruit flies are shaped by the bacteria in their food and environment. The researchers, from the Swiss Federal Institute of Technology and the University of Exeter, found two peptides that each control a single bacterial species commonly encountered by the flies. Dr Mark Hanson (Centre for Ecology and Conservation on Exeter’s Penryn Campus in Cornwall) said, “We know that an animal’s food and environment determine the bacteria it encounters. This in turn shapes its ‘microbiome’ – the collection of microbes that live in and on its body – and our study shows how immune systems ...
- Source: drugdu
- 132
- July 22, 2023
Sandoz doubles down on biosimilars with $90M Slovenia site where it plans to hire 200

Sandoz is doubling down on its commitment to Slovenia in its globe-trotting biosimilar growth quest.The Novartis generics unit is plugging $90 million into a new biosimilar technical development center in Ljubljana, Slovenia, where the company aims to hire 200 new staffers. The new site, which Sandoz says will become “key” to its biosimilar development, will feature end-to-end drug substance and drug product development, the company said in a press release Thursday. This isn’t Sandoz’s first foray into the Balkan country. The announcement follows the company’s recent plan to invest a whopping $400 million in a new manufacturing plant there in Lendava. What’s more, Sandoz has already set up prior complex generic development capabilities in Ljubljana. Nearby, the company is also expanding its biosimilar development firepower in Holzkirchen, Germany. The latest move comes shortly after Sandoz unveiled its Act4Biosimilars action plan in June, under which it’s angling to triple global biosim ...
- Source: drugdu
- 119
- July 22, 2023
Experts Flag Eye Inflammation Reports Tied to Apellis’ Geographic Atrophy Med Syfovre

Apellis Pharmaceuticals’ Syfovre, after achieving the first FDA approval for advanced eye disease geographic atrophy, has been associated with rare but severe side effects, according to the American Society of Retinal Specialists (ASRS).The group issued a letter to doctors Saturday flagging cases of eye inflammation and six reports of occlusive retinal vasculitis in patients who took the drug, BioPharma Dive reported. The condition is a type of inflammation that blocks blood flow to the retina and could potentially cause blindness.ASRS didn’t tie the safety issues to a specific batch of product but noted that the side effects began one to two weeks after a patient’s first Syfovre injection. The organization urged vigilance and close follow-up after administration, according to the news outlet. The news caused Apellis’ stock price to sink nearly 32% to $52.62 by Monday afternoon. The company puts the Syfovre-associated retinal vasculitis rates at 0.01% per ...
- Source: drugdu
- 141
- July 19, 2023
Bicycle Therapeutics Plans $200m Public Offering

NASDAQ-listed Bicycle Therapeutics has announced that $200m worth of shares will be available at a price of $21.25 each. The company, which has offices in the UK and US, expects the underwritten public offering to close around 17 July. On 13 July, more than 12 times the volume of shares were traded on the exchange, compared to the previous day. The underwriters will also have the option to purchase a further $30m of shares in a 30-day period. The company has recently signed two lucrative deals with Novartis and Bayer for the use of its peptide technology to develop radio-conjugates. In March, Novartis paid an upfront sum of $50m, and a possible $1.7bn in milestone payments. Bayer then followed suit in May, with a $45m upfront deal, with a possibility of a further $1.7bn. Both partnerships involve undisclosed oncology targets. The company reported net losses of ...
- Source: drugdu
- 114
- July 18, 2023
Roche’s New Subcutaneous Version Measures up to IV Ocrevus in Multiple Sclerosis

With the multiple sclerosis market growing rapidly—from $18.9 billion in 2020 to a projected $29.8 billion in 2030, according to GlobalData—Roche is primed to take advantage with Ocrevus (ocrelizumab).Now the monoclonal antibody, which racked (PDF) up nearly $7 billion in sales last year, appears on the verge of gaining an added advantage with a more convenient way to be administered. A phase 3 study has shown that a new, subcutaneous version of Ocrevus has proven to be non-inferior to the current infused treatment as measured by the level of drug in the blood, 12 weeks after administration. Specific numbers were not included in Roche’s release but the company said that the trial achieved both its primary and secondary endpoints. The injected version also matched the performance of the infused treatment in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks, Roche said. The injected regimen of Ocrevus is a ...
- Source: drugdu
- 169
- July 15, 2023
FDA Rejects Xspray’s Would-Be Rival to Bristol Myers’ Sprycel on Dosing, Manufacturing Concerns

With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel. Swedish drugmaker Xspray has received an FDA complete response letter on its application for its first product Dasynoc. In issuing the rejection, the FDA requested additional information on the drug’s dosing plus greater clarity around a third-party manufacturing facility. Xspray is seeking an FDA nod for Dasynoc to treat chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). Despite issuing the rejection, Xspray said the FDA signed off on “critical aspects” of the application and did not identify any deficiencies pertaining to the drug’s stability or clinical data, the company said in a release Tuesday. Xspray is positioning its drug as a rival to BMS’ Sprycel, which clinched its first approval in CML back ...
- Source: drugdu
- 204
- July 13, 2023

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