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Reuters

After Novartis reportedly backed out of late-stage talks to acquire Cytokinetics earlier this year, the company appears to still be on the M&A prowl.Novartis is in advanced talks to acquire German cancer drug maker MorphoSys, Reuters reports, citing two people familiar with the matter. The anonymous sources stayed mum on details about the bid and a potential acquisition price, according to the news service. Also involved in the MorphoSys M&A talks is Incyte, according to Reuters.As a “matter of policy,” Novartis does not comment on “market rumors/speculations,” a company spokesperson said over email. Incyte and MorphoSys did not immediately respond to Fierce Pharma’s requests for comment. Both known bidders have preexisting ties to the company, with Novartis taking over a MorphoSys preclinical cancer program in 2022 and Incyte partnering on MorphoSys’ sole commercial product, the lymphoma med Monjuvi.Monjuvi garnered $92 million in U.S. sales last year, and MorphoSys expects 2024 sales of between $80 million and $95 million. The Novartis ...
- Source: drugdu
- 101
- February 9, 2024
Novartis CEO’s 2023 pay rises 21% as Roche’s helmsman nets $11M in his first year

After leading Novartis and Roche through pivotal years in 2023, the CEOs of the Swiss drug giants each netted multimillion-dollar compensation packages. Novartis handed its CEO Vas Narasimhan 13.3 million Swiss francs ($15.3 million) in total compensation for 2023, according to the company’s annual report (PDF). At grant value, the pay is 21% more than what he earned the year before.By comparison, Roche paid (PDF) its helmsman, Thomas Schinecker, a total of 9.6 million Swiss francs ($11 million). The former Roche Diagnostics chief took over from current Chairman Severin Schwan to become the group’s CEO last year. At Roche, the CEO transition—and the loss of its pharma division leader Bill Anderson to Bayer—marked the dawn of a new era. As for Novartis, the company recently became a pure-play innovative medicines company after spinning off the generic maker Sandoz in October.In his sixth year as Novartis’ CEO, Narasimhan saw his base salary climb 2% year over year to 1.82 million Swiss francs. The largest ...
- Source: drugdu
- 101
- February 9, 2024
FDA and EMA team up to expedite complex generic drug development

In a move to enhance patient access to complex generic drugs, the FDA’s Office of Generic Drugs (OGD) and the EMA have joined forces in a new pilot programme. This initiative, an extension of the original parallel scientific advice (PSA) programme, homes in on complex generics, also known as ‘hybrid medicines’ as per EMA terminology.Launched in 2005, the original programme offers a means for sponsors of new medicines to seek guidance from regulatory agencies in both the US and EU, regarding scientific matters related to product development. The new voluntary programme aims to facilitate concurrent discussions between generic drug manufacturers and regulatory bodies, with the ultimate goal of improving patient access to harder-to-develop generic drugs. To participate in the PSA programme, applicants must submit requests to the EMA and FDA. Examples of suitable candidates for this programme include proposals for single bioequivalence studies, approaches with common comparators, and the use ...
- Source: drugdu
- 114
- February 8, 2024
Pfizer Teams With American Cancer Society to Reduce Cancer Care Disparities

Pfizer announced a partnership with the American Cancer Society aimed at reducing disparities in cancer treatment. As part of the initiative, Pfizer is providing $15 million in funding. This money will go towards improving the health outcomes of cancer patients from underrepresented communities in the United States. This will include working to improve access to cancer screenings, clinical trial opportunities, and patient care. In a press release, Pfizer’s chief oncology officer and executive vice president Chris Boshoff said, “Cancer doesn’t discriminate–and neither should cancer care. Everyone should have the same opportunity to access the latest advances in care, regardless of their background or where they live. We’re proud to partner with the American Cancer Society on a broad, community-focused initiative to reach people living with cancer where they are, with urgency, and connect them to resources to receive the care they deserve.” The partnership will work under the banner of ...
- Source: drugdu
- 74
- February 8, 2024
Telix to acquire QSAM Biosciences for $123.1m

Australia-based global biopharmaceutical company Telix Pharmaceuticals has agreed to acquire US-based QSAM Biosciences for $123.1m.The deal comes after the companies signed a conditional non-binding term sheet for the prospective acquisition.Telix will also acquire QSAM’s lead investigational drug, Samarium-153-DOTMP (153Sm-DOTMP), a new kit-based bone-seeking targeted radiopharmaceutical candidate. The acquisition terms include an upfront payment of $33.1m (A$50.8m), payable as 4,369,914 ordinary shares of Telix.The deal also comprises contingent value rights that could see additional payments of $90m on meeting clinical and commercial milestones. These payments may be made in cash and/or shares.QSAM focuses on the development of therapeutic radiopharmaceuticals for primary and metastatic bone cancer. Its 153Sm-DOTMP for bone cancer has applications in pain management and therapy for bone metastases and osteosarcoma, including for paediatric patients.It complements Telix’s focus on oncology therapies and has shown promising safety, efficacy and commercial potential in early trials. The drug also has an improved safety ...
- Source: drugdu
- 96
- February 8, 2024
Point-Of-Care Tool Diagnoses Genetic Mutations within Hours

Blood disorders like sickle cell anemia arise from genetic mutations. Typically, newborns are screened for sickle cell disease at birth, with any irregularities reported within 96 hours. However, a follow-up blood test is necessary to confirm the diagnosis, and obtaining these results can take between two to four weeks. Often, seeking genetic analysis through specialized private laboratories can be both time-consuming and expensive. Now, a new tool can detect the presence of genetic mutations within hours instead of weeks. Researchers at the University of Calgary (Alberta, Canada) have created a system named One-pot DTECT. This innovation is designed for simplicity and ease of use, enabling any laboratory in the world to quickly set up its own kit for same-day genetic mutation analysis at a minimal cost per sample. One-pot DTECT comprises multiple enzymes and distinct DNA fragments that work together to identify and detect genetic signatures. The compact kit includes ...
- Source: drugdu
- 80
- February 8, 2024
【EXPERT Q&A】What are the steps in the FDA’s drug approval process?

Drugdu.com expert’s response: The drug approval process by the FDA is quite standardized and rigorous. Here’s a detailed breakdown of the entire process: Preclinical Studies: This is the first step in the drug approval process, involving pharmacological and toxicological studies to assess the drug’s safety and efficacy. These studies are usually conducted in laboratories or animal models. Submission of an Investigational New Drug Application (IND): Once preclinical studies indicate that the drug might be safe, pharmaceutical companies submit an Investigational New Drug application (IND). The IND includes preclinical study data, manufacturing information, and clinical trial protocols. Clinical Trials: This is the core part of the drug approval process and mainly consists of three phases. Phase I primarily tests the drug’s safety and dosage in humans; Phase II focuses on the drug’s efficacy and side effects; Phase III further confirms efficacy, monitors side effects, and compares the drug with existing treatments. ...
- Source: drugdu
- 147
- February 8, 2024
BMS reports 2% revenue loss in 2023 after Revlimid generics hurt sales

BMS has reported its results for the 2023 financial year (FY), revealing a 2% decrease in revenues of $45bn from $46.2bn reported in 2022. The company saw a decrease in sales of Revlimid (lenalidomide) following the entry of generic versions after its patent loss in 2022. Revlimid generated $6bn in 2023, compared to $12.9bn in 2021 before the loss. BMS’ blockbuster cancer drug Opdivo generated $9bn in 2023, a 9% increase from 2022. The human IgG4 anti-PD-1 monoclonal antibody saw a label expansion, as well as increased demand from patients with gastric, bladder, non-small cell lung cancer (NSCLC) and melanoma. BMS’ top-seller is anti-stroke drug Eliquis (apixaban), generating $12.2bn in 2023, however, Eliquis loses its patent in 2026, with GlobalData predicting that sales will drop to $3bn by 2029.In a strategic move to counteract anticipated revenue declines from upcoming patent expirations on certain BMS drugs in the next few years, ...
- Source: drugdu
- 91
- February 8, 2024
Valneva sells Ixchiq priority voucher for $103m to fuel R&D

Valneva has sold its US Food and Drug Administration (FDA) priority review voucher for €95m ($103m) to an undisclosed party. The French company received the priority review voucher when its chikungunya vaccine, Ixchiq, got FDA approval in November 2023.Valneva plans to use the funds from the voucher sale to advance its research and development (R&D) efforts, as per a 5 February press release. The voucher sale price is in line with the company’s previous projections of gaining €90m-€110m with such a sale. One of the projects that the company plans to use its proceeds for is the Lyme disease vaccine, VLA15. Valneva is co-developing the vaccine in partnership with Pfizer. VLA15 is an experimental multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia. The vaccine is being evaluated in a placebo-controlled Phase III trial (NCT05477524). The trial suffered a delay when both companies paused patient ...
- Source: drugdu
- 91
- February 7, 2024
Contentious Medicare price negotiations underway as US drug prices rise

The US’ HHS has sent the first offers to participating drug companies eligible for negotiation under the Medicare price negotiation programme as required by the Inflation Reduction Act (IRA). The Centers for Medicare and Medicaid Services is managing these talks, with a 30-day window given to involved drug companies to indicate acceptance of the suggested prices or present an alternative offer. Once both Medicare and the drug company agree on a price, the revised prices will become effective within Medicare in 2026.The IRA allows Medicare to directly negotiate to reduce prescription prices for certain drugs and requires certain companies to pay rebates back to Medicare if the drug prices exceed the rate of inflation. The first ten drugs selected to be negotiated in the programme include those marketed by pharma giants AstraZeneca and Merck & Co’s anti-diabetic drugs, Farxiga (dapagliflozin), and Januvia (sitagliptin), respectively. In the announcement accompanying the offers, CMS administrator Chiquita ...
- Source: drugdu
- 88
- February 7, 2024

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