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Top related persons:
Regeneron - 1
Top related locs:
Tarrytown , New York U.S
Top related orgs:
Regeneron Pharmaceuticals - 1 U.S . Food - 1 Drug Administration - 1 Roche Holdings - 1

Search resuls for: "Roche Holdings"


6 mentions found


☆ Regeneron shares fall after FDA rejects high-dose eye disease treatment
  + stars: | 2023-06-27 | by ( Annika Kim Constantino | ) www.cnbc.com   time to read: +1 min
A view of the Regeneron Pharmaceuticals headquarters in Tarrytown, New York. Shares of Regeneron fell nearly 9% Tuesday after the U.S. Food and Drug Administration declined to approve a higher-dose version of the company's blockbuster eye disease treatment. Regeneron said the rejection was "solely due to an ongoing review of inspection findings at a third-party filler." That suggests the drug could potentially win approval down the road. But a delay won't help the company fight off threats to its Eylea drug franchise, which is facing competition from Roche Holdings ' eye drug, Vabysmo.
Persons: Regeneron Organizations: Regeneron Pharmaceuticals, U.S . Food, Drug Administration, Roche Holdings Locations: Tarrytown , New York, U.S
☆ Businesses want COP15 nature summit to deliver clarity
  + stars: | 2022-12-07 | by ( Isla Binnie Simon Jessop | Isla Binnie | Simon Jessop | ) www.reuters.com   time to read: +5 min
As the COP15 biodiversity summit kicks off in Montreal, businesses and corporate leaders are pushing for an ambitious agreement with strong policies that will provide guidance to companies seeking to change. They are under increasing pressure to show progress in tackling climate change and reducing harm to the environment. The agency has said some $384 billion will be needed each year for nature projects by 2025. "If we take that mindset to nature, it leads to the investment models that would allow us to invest in nature as infrastructure," he said. "Two years ago, all these governments around the world said 'let's put trillions of dollars into nature.'
☆ FDA Takes Tougher Line on Fast-Tracked Drugs
  + stars: | 2022-12-05 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Food and Drug Administration sometimes clears prescription medicines based on preliminary data but asks makers to conduct follow-up confirmatory studies. The Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK PLC, Roche Holdings AG and other drugmakers to remake plans for their drugs or pull them from the market. Under the accelerated-approval program, the FDA clears the use of prescription medicines faster than it normally would. The agency relies on preliminary data to make the decision, but asks companies to conduct follow-up studies to confirm that the drug works.
☆ Global firms urge governments to require mandatory disclosures on nature
  + stars: | 2022-10-26 | by ( Juliette Portala | Expert Analysis | Reuters Professional | ) www.reuters.com   time to read: +3 min
Some progress has been made, but it's not enough," Rebecca Marmot, chief sustainability officer at consumer goods company Unilever (ULVR.L), said. While regulators have pushed for more rigorous reporting on the companies' environmental impact and efforts to battle climate change, broader impact on nature and biodiversity has not yet been subject to similar scrutiny. The COP15 talks in Montreal will see countries try to agree a new Global Biodiversity Framework to combat the crisis that threatens over one million plant and animal species with extinction. "Assessment and disclosure are an essential first step to generate action, but it will only have an impact if it is made mandatory," the 330 businesses said in their statement. "Without this information, we are flying blind into extinction," Eva Zabey, executive director at global coalition Business for Nature, said.
☆ Biogen and Eisai's latest clinical trial just crossed the finish line. Here's why analysts say the results could disrupt the future of Alzheimer's care.
  + stars: | 2022-09-28 | by ( Yeji Jesse Lee | ) www.businessinsider.com   time to read: +7 min
It's a complicated, debilitating illness and drug companies have struggled for years to come up with viable treatments. On Tuesday September 27, Biogen and Eisai announced that lecanemab slowed the rate of cognitive decline in Alzheimer's patients by 27%. Analysts say that this positive result could lead to it becoming a blockbuster drug for the companies. Other big drug companies such as Roche Holdings and Eli Lilly are pursuing similar treatments, with results expected to come later this year and early next year, respectively. "I think people's confidence in the amyloid hypothesis would go down even further, but ultimately people would wait to see what those other data events show," he said.
☆ Biogen's latest clinical trial is inching towards the finish line. Here's why analysts say the results could disrupt the future of Alzheimer's care.
  + stars: | 2022-09-19 | by ( Yeji Jesse Lee | ) www.businessinsider.com   time to read: +7 min
It's a complicated, debilitating illness and drug companies have struggled for years to come up with viable treatments. Other big drug companies such as Roche Holdings and Eli Lilly are pursuing similar treatments, with results expected to come later this year and early next year, respectively. "I think people's confidence in the amyloid hypothesis would go down even further, but ultimately people would wait to see what those other data events show," he said. Negative results might give a boost to companies that are exploring alternate ways to treat Alzheimer's disease. And though Biogen's drug is furthest along in development, it's far from being the only treatment being tested for Alzheimer's.
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