Search Results for “antibody” – Page 58 – media

FTC sues to block Amgen’s $28B Horizon buy in alarming sign for biopharma M&A

Just as biopharma’s M&A prospects seemed to be improving, the U.S. antitrust watchdog is putting a damper on dealmaking. The U.S. Federal Trade Commission has filed a lawsuit to block Amgen’s proposed $27.8 billion acquisition of Horizon Therapeutics, the agency said Tuesday. By a unanimous vote among the three Democrat commissioners, the agency is seeking a temporary restraining order and preliminary injunction to prevent the transaction from closing. In an alarming sign for biopharma M&A scrutiny to come, the FTC argues Amgen could leverage its existing product portfolio to “entrench the monopoly positions” of Horizon meds for thyroid eye disease and chronic gout. The antitrust challenge marks the first time that the FTC has reached beyond specific product overlaps in its reviews and instead focused on companies’ past behaviors around drug pricing. It’s an approach that the agency has threatened to implement since 2021 but has only now reared its ...
- Source: drugdu
- 127
- May 18, 2023
Novel Rutgers COVID vaccine may provide long-lasting protection

Animal studies indicate that a new COVID-19 vaccine developed at Rutgers may provide more durable protection against SARS-CoV-2 and its emerging variants than existing vaccines. “We need a better vaccine, one that provides years of robust protection with fewer booster shots against a variety of SARS-CoV-2 strains. Our data suggest this vaccine candidate might be able to do that,” said Stephen Anderson, associate professor of Molecular Biology and Biochemistry in SAS, resident member of the Rutgers Center for Advanced Biotechnology and Medicine and senior author of the paper in Vaccines. Existing COVID vaccines often provide some protection against serious disease and death. However, these vaccines typically elicit temporary bursts of protective antibodies that rapidly wane, even after booster doses, leaving most individuals vulnerable to potentially dangerous repeat infections. This new vaccine, dubbed MT-001, might provide longer-lasting protection against many COVID-19 varieties. “Thankfully, the current vaccines saved many lives, but they’re ...
- Source: drugdu
- 137
- May 10, 2023
As COVID vaccine sales plummet, BioNTech looks for new growth opportunities

After raking in billions with its Pfizer-partnered vaccine, BioNTech is turning to new ventures as its revenues plummet. BioNTech reported first-quarter revenues of €1.27 billion (1.4 billion), a far cry from 2022’s first-quarter haul of €6.37 billion ($7.03 billion). Despite the downturn, the quarter went “fully to our expectations,” CFO Jens Holstein said on a conference call. Sales-wise, the current quarter should be the weakest of 2023, Holstein said. The company’s COVID-19 vaccine revenue guidance for 2023 stands at €5 billion ($5.4 billion), which is “something we can live with,” the CFO added. Meanwhile, BioNTech believes the United States’ transition to a commercial COVID-19 vaccine market could provide new growth opportunities. But as its pandemic-related business struggles, BioNTech is busy advancing its pipeline as it looks for its next big growth driver. The company’s pipeline includes multiple oncology ventures, including an HER2-targeted antibody-drug conjugate (ADC) that it’s working on with ...
- Source: drugdu
- 133
- May 10, 2023
Manufacturing operations for Eli Lilly, Rentschler reprimanded by FDA

After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the U.S.’ drug regulator is making concerns about the facilities public. In Form 483 filings posted this week, the FDA flagged Lilly’s site in Indianapolis for three manufacturing-related shortfalls and Rentschler’s Baden-Wurttemberg, Germany, site for five deficiencies. At Lilly’s site, the regulator said the company’s aseptic technique for an undisclosed drug’s filling operation was “deficient.” Specifically, operators “handled unprotected sterile components” in a way that “may introduce contaminants onto sterile surfaces” in certain areas, the FDA said. Aside from that observation, the FDA flagged “processing areas” for two filling lines as substandard. Again, the FDA flagged sanitization procedures as not meeting its standards. Inspectors visited Lilly’s Indianapolis site from Oct. 17-21, 2022. In parallel to the Indianapolis site inspection and filing, the FDA in April rejected Eli Lilly’s ulcerative colitis prospect mirikizumab over manufacturing-related shortfalls. It isn’t immediately clear whether the ...
- Source: drugdu
- 189
- May 8, 2023
Algorithm generates 128-fold increase in antibodies

In a recent article published in the journal Nature, researchers used a classical concept in computational linguistics to design a new algorithm, LinearDesign, which optimized the structural stability and codon usage of messenger ribonucleic acid (mRNA) sequences. For instance, using this algorithm, researchers could optimize mRNA sequences encoding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein and use it in mRNA-based coronavirus disease 2019 (COVID-19) vaccines. Background All vaccines based on the relatively new mRNA technology suffer from common limitations, such as mRNA instability and rapid degeneration, which, in turn, lead to poor protein expression and, subsequently, compromised immunogenicity and druggability of all mRNA vaccine products. It also critically hinders the storage, distribution, and efficacy of all mRNA vaccines, including COVID-19 and varicella-zoster virus (VZV) vaccines. Therefore, there is an urgent need for a principled mRNA design algorithm that simultaneously optimizes stability and codon usage of encoding mRNA sequences to ...
- Source: drugdu
- 245
- May 5, 2023
Bristol Myers Squibb and Tubulis partner in deal worth over $1bn

The agreement is aimed at developing differentiated ADCs for solid tumours Bristol Myers Squibb (BMS) and Tubulis have announced an agreement aimed at developing differentiated antibody-drug conjugates (ADCs) for solid tumours. ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy ones. Under the terms of the licensing agreement, the German biotech will receive an upfront payment of $22.75m from BMS and will be eligible for future payments of over $1bn plus royalties. In exchange, BMS will gain exclusive rights to Tubulis’ Tubutecan payloads and P5 conjugation platform for the development of a selected number of highly differentiated ADCs to treat solid tumours. ...
- Source: drugdu
- 149
- May 5, 2023
Medicare will cover Leqembi for all patients if FDA approves drug, CMS chief says

Medicare will cover the new Alzheimer’s treatment Leqembi for all patients eligible under the medication’s label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday. The official, Chiquita Brooks-LaSure testified before Congress Wednesday for the first time since her confirmation as administrator of the Centers for Medicare and Medicaid Services. Brooks-LaSure faced pointed criticism from Democrat and Republican members of the House Subcommittee on Health over Medicare’s controversial coverage policy for new Alzheimer’s treatments. The Food and Drug Administration approved Leqembi, which is a collaboration by Biogen and Eisai antibody treatment, on an expedited basis in January. Twice-monthly intravenous infusions of the drug, generically known as lecanemab, have shown promise in slowing the progression of early Alzheimer’s disease. But Medicare, which primarily provides health coverage to senior citizens, currently will only cover the ...
- Source: drugdu
- 121
- May 1, 2023
Merck results beat expectations despite a big drop in sales of Covid antiviral treatment

Merck on Thursday reported first-quarter revenue and adjusted earnings that topped Wall Street’s expectations, despite a steep drop in sales of its Covid antiviral treatment molnupiravir. Sales of molnupiravir plunged to $392 million during the period, down 88% from the $3.2 billion reported for the first quarter of 2022. Merck said the decrease is primarily the result of lower sales in the U.S., U.K., Japan and Australia. The company reported total revenue of $14.5 billion for the quarter, down 9% from a year earlier. But excluding the Covid drug, Merck said its revenue grew 11%. Here’s what Merck reported compared with Wall Street’s expectations, based on a survey of analysts by Refinitiv: Earnings per share: $1.40 adjusted, vs. $1.32 expected Revenue: $14.49 billion, vs. $13.78 billion expected Merck’s stock closed more than 1% higher Thursday. The shares are up more than 3% for ...
- Source: drugdu
- 127
- May 1, 2023
Hansa Biopharma enters into collaboration with Genethon

Swedish biotech company Hansa Biopharma has entered a research and development collaboration with Genethon. The partnership will assess the efficacy and safety of imlifidase, Hansa Biopharma’s antibody cleaving enzyme, in a clinical trial. Imlifidase will be developed as a pre-treatment for patients with Crigler-Najjar syndrome and pre-existing neutralising antibodies (NAbs) to adeno-associated virus serotype 8 (AAV8), before administering GNT-0003, Genethon’s gene therapy product candidate. The company stated that patients with circulating NAbs will be excluded from the clinical trial of potentially curative gene therapies as well as from access to approved gene therapies. Hansa Biopharma president and CEO Søren Tulstrup said: “Genethon is a pioneer at the cutting-edge of research and development of gene therapies for rare diseases and we are thrilled to be collaborating with them. “This research collaboration further validates Hansa’s commitment in gene therapy and underscores the important role that our antibody-cleaving ...
- Source: drugdu
- 129
- April 30, 2023
Pregnant women show unique immune response to COVID-19

Infection with the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), which is the causal agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, has claimed more than 6.8 million lives worldwide. It remains imperative to understand the immune responses to SARS-CoV-2, particularly in high-risk groups, to formulate better vaccination and treatment strategies. The immune response to COVID-19 during pregnancy Immunological assessment related to COVID-19 has been performed largely in healthy individuals across varied age groups. After contracting SARS-CoV-2 infection, patients typically develop robust and transient immune responses that include an abundance of SARS-CoV-2-specific antibodies, T-cells, B-cells, and long-lasting immune memory. Severe SARS-CoV-2 infection has been characterized by the presence of blood hypercytokinemia and hyperactivation of innate/adaptive immune responses. Limited studies have been performed on the immune response after SARS-CoV-2 infection in pregnant women. Pregnant women are considered to be highly susceptible to COVID-19 due to immunological and physiological changes ...
- Source: drugdu
- 116
- April 17, 2023

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