Search Results for “acquisition” – Page 18 – media

Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths

Dive Brief Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday. Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type. Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company. Dive Insight Heartmate devices take over the pumping function of the left ventricle, the ...
- Source: drugdu
- 114
- April 17, 2024
FDA approves new administration routes for Xcopri

South Korea-based SK Life Sciences has received US Food and Drug Administration (FDA) approval for two new forms of administration of its epilepsy drug Xcopri (cenobamate), as an oral suspension mixed with water for mouth administration or via a nasogastric tube. Discovered and developed by SK Biopharmaceuticals, Xcopri is an anti-epileptic drug indicated for partial-onset seizures in adults. The therapy reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents, leading to a decreased occurrence of seizures. The oral form of the treatment is taken once daily. The FDA-approved label revision is based on findings from an open-label study comparing the bioequivalence of three ways of administering the medication: swallowing a whole tablet, taking a crushed tablet in water by mouth, and using a nasogastric tube to administer a crushed tablet in water. The approval addresses the needs of patients living with epilepsy, who are unable to swallow Xcopri tablets whole, ...
- Source: drugdu
- 105
- April 16, 2024
Johnson & Johnson Set to Acquire Shockwave Medical, Aiming to Strengthen Company’s MedTech Division

Don Tracy, Associate Editor The deal, which is worth approximately $13.1 billion, is part of J&J MedTech’s goal to expand into high-growth markets. Johnson & Johnson (J&J) announced that it has agreed to terms on acquiring Shockwave Medical, an intravascular lithotripsy (IVL) technology company focused on coronary artery disease (CAD) and peripheral artery disease. According to J&J, the deal is a part of its strategy to enhance the profile of its MedTech division, with an emphasis on the area of cardiovascular intervention. Shockwave Medical’s IVL technology is described as a minimally invasive treatment for calcified artery diseases that can also lead to reduced blood flow, pain, or heart attacks. Under terms of the deal, J&J is expected to acquire all outstanding shares of the company for $335.00 per share in cash.1 “Shockwave offers a truly differentiated opportunity to further enhance our leadership position in medtech, expand into additional high-growth segments, ...
- Source: drugdu
- 84
- April 8, 2024
Labcorp’s $237M Tuck-In Deal Brings Lab Testing Assets From BioReference Health

Labcorp is buying the clinical diagnostics and reproductive women’s health businesses of BioReference Health, excluding those assets in New York and New Jersey. Labcorp has returned to being fully focused on lab testing after last year’s spinoff of Fortrea, its former clinical trial services business. By FRANK VINLUANLabcorp’s testing capabilities are getting a little broader with the $237.5 million acquisition of certain laboratory assets from BioReference Health, a subsidiary of Opko Health. The BioReference assets going to Labcorp span clinical diagnostics and reproductive women’s health across the U.S. and account for about $100 million in annual revenue. The deal announced Thursday excludes those assets in New York and New Jersey, where BioReference will continue to maintain its full operations. BioReference will also continue to offer oncology and urology diagnostic services nationwide. Burlington, North Carolina-based Labcorp was founded as a laboratory testing company in 1969. In 2015, it entered drug development ...
- Source: drugdu
- 129
- April 2, 2024
J&J reportedly eyeing Shockwave Medical for takeover

Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of medical device company Shockwave Medical, as first reported by the Wall Street Journal (WSJ) on 26 March. The WSJ cited people familiar with the matter who claimed that a finalised deal could be around the corner pending successful acquisition talks. However, the report also noted that another suitor could emerge to merge with Santa Clara, a California-based medical device manufacturer. WSJ did not mention the valuation of the potential acquisition. This is not the first time Shockwave has been involved in acquisition rumours, as Bloomberg reported that Boston Scientific was eyeing Shockwave for a takeover in April 2023. Since the publication of the WSJ report, Shockwave’s stock price has increased by 3.8%. Shockwave has a market cap of $12.3bn. As per a 15 February press release, Shockwave has commenced the ...
- Source: drugdu
- 113
- April 2, 2024
Novo Nordisk to acquire Cardior Pharmaceuticals to strengthen pipeline in cardiovascular disease

The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure Novo Nordisk and Cardior Pharmaceuticals has announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. Martin Holst Lange, executive vice president for Development at Novo Nordisk said, “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development. We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to ...
- Source: drugdu
- 94
- April 2, 2024
Veeda Clinical Research acquires Heads, a European CRO

Veeda Clinical Research has acquired Heads, a privately held European CRO, which specialises in conducting clinical trials in oncology. Established in 2010, Heads has operational presence in 25 multiple strategically important locations across Europe, North America and Asia Pacific region. Veeda expands its reach to major geographies and adds capabilities of late-sta. ge clinical trial execution with strong focus on oncology with this acqusition The acquisition provides Heads a strong operational platform and an opportunity to expand its expertise and capabilities to the Indian and South-East Asian markets. With this acquisition, Veeda’s global pharma and biotech clients can now avail early to late-phase CRO services across Europe, US, and Asia Pacific. During the integration phase, Heads will continue to offer uninterrupted support to client programs. https://www.vspharma.in/veeda-clinical-research-acquires-heads-a-european-cro/
- Source: drugdu
- 85
- March 30, 2024
ICRA

ICRA expects the revenues of its sample set of 25 Indian pharma companies (which account for ~60 per cent of the overall Indian pharma industry) to grow by 8-10 per cent in FY2025, post a YoY increase of 13-14 per cent in FY2024. Following the high base of FY2024, the revenue growth momentum from the US and Europe markets is expected to moderate to 8-10 per cent and 7-9 per cent, respectively, from the YoY expansion of 18-20 per cent and 16-18 per cent, respectively, estimated for FY2024. The domestic market is expected to see stable growth at 6-8 per cent, while the emerging markets may log in an 8-10 per cent rise in FY2025, against 16-18 per cent in FY2024. The revenue growth of the sample set companies in the US market in FY2024 has been supported by increased new product launches, product shortages in select therapeutic segments, and ...
- Source: drugdu
- 137
- March 30, 2024
Novo Nordisk Acquires Cardior Pharmaceuticals for $1.112B in Effort to Bolster Cardiovascular Disease Pipeline

Don Tracy, Associate Editor Deal includes the novel treatment CDR132L, which is currently in Phase II clinical trials for heart failure. Novo Nordisk announced that it has acquired Cardior Pharmaceuticals in hopes of improving its pipeline in cardiovascular disease management. The acquisition includes Cardior’s top drug candidate, CDR132L, which is currently in Phase II of clinical development for treating heart failure. Under terms of the agreement, Cardor has the potential to earn up to $1.112 billion, including an upfront payment and the opportunity for more payments pending the completion of certain development and commercial milestones.1 “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programs across all phases of clinical development,” said Martin Holst Lange, EVP, development, Novo Nordisk, in a press release. “We have been impressed by the scientific work carried out by the ...
- Source: drugdu
- 119
- March 29, 2024
Merck Drug for Heart and Lung Disorder Wins a First-in-Class FDA Approval

Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma. By FRANK VINLUANPulmonary arterial hypertension, a disease that leads to worsening lung and heart problems that eventually become life-threatening, is treated with drugs that alleviate symptoms. FDA approval of a new Merck drug marks the first for a therapy addressing an underlying cause of the disease. The Tuesday approval of the Merck drug covers the treatment of adults whose pulmonary arterial hypertension (PAH) is at intermediate or high risk of progression. The drug, known in development as sotatercept, will be marketed under the brand name Winrevair. Hypertension—high blood pressure—is common. PAH is a rare form of hypertension that specifically affects the arteries carrying blood from the right side of the heart and into the lungs. ...
- Source: drugdu
- 92
- March 28, 2024

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