Tag: Biotech and Pharma

US FDA grants standard approval of Eisai/Biogen Alzheimer’s drug

The FDA decision marks a new milestone for a fatal disease that has eluded drugmakers’ efforts for decades. Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer’s.

AstraZeneca Stock Sinks as Cancer Drug Results Disappoint Investors

American depositary receipts of AstraZeneca were falling Monday after the drugmaker reported disappointing results from a Phase 3 trial of a lung- cancer drug.

EU announces deal with Pfizer, others to reserve vaccines for future pandemic

The European Commission has contracted Pfizer and several European companies to reserve capacity to make up to 325 million vaccines per year in case of a future global health emergency, it said on Friday.

Eli Lilly experimental obesity drug could beat rivals in total weight loss for patients

Eli Lilly’s experimental drug helped patients lose up to 24% of their weight after almost a year, the highest reduction seen in the obesity treatment space to date, according to new mid-stage clinical trial results released Monday.

Pfizer scraps one weight loss drug in race to develop Ozempic rival

Pfizer Inc said it is scrapping its once-a-day experimental obesity pill because of concerns about liver safety, but will continue developing its other obesity pill, the twice daily treatment danuglipron, as it races to rival the success of other weight loss treatments.

Novo Nordisk says obesity pill leads to 15% weight loss; availability ‘to be determined’

Novo Nordisk on Sunday said a late-stage trial found that a high-dose oral version of its drug semaglutide helped overweight or obese adults lose 15% of their body weight, which is in line with recent results for other experimental obesity pills.

Gilead Gets Positive European Opinion for Additional Indication for Trodelvy

Gilead Sciences has received a positive response from the European Medicines Agency’s Committee for Medicinal Products for Human Use on an additional indication for the use of its antibody-drug conjugate Trodelvy in certain types of pre-treated breast cancer.

GSK Stock Climbs on Zantac Settlement. Drug Maker Avoids a California Trial.

U.S.-listed shares of GSK were rising in premarket trading Friday after the pharmaceutical company said it reached a first legal settlement over claims that heartburn medication Zantac can cause cancer.

Eli Lilly to Buy DICE Therapeutics in $2.4 Billion Autoimmune Disease Push

Eli Lilly has agreed to buy DICE Therapeutics in a $2.4 billion cash deal that reflects Lilly’s ambitions in immunology, a hot market where the company has lagged behind its coompetitors.

Weight loss drug Wegovy slower to launch in new markets – Novo Nordisk

Novo Nordisk’s launch of obesity drug Wegovy in most of Europe will be slower than planned and the drug will likely not be sold in developing nations for a very long time, executives said on Tuesday, as demand booms in the United States.

Roche’s cancer therapy gets US FDA nod, heating up competition with AbbVie

The U.S. Food and Drug Administration (FDA) greenlighted Roche Holding AG’s experimental therapy to treat a type of advanced blood cancer, nearly a month after the approval of a rival therapy from AbbVie Inc.

European Alzheimer’s experts unconvinced by new Eisai, Biogen drug

Alzheimer’s disease experts in Europe weighing potential use of a new drug from Eisai and Biogen say its ability to slow cognitive decline may not outweigh its health risks, or be worth the toll on scarce healthcare resources.

AstraZeneca signs $2 billion agreement with Quell to develop cell therapies

AstraZeneca (AZN.L) said on Friday it had signed an agreement with Quell Therapeutics potentially worth more than $2 billion to develop cell therapies that could cure autoimmune diseases.

Biogen Takes Alzheimer’s Drug to FDA Advisers. The Last Time Was a Disaster.

Biogen and Eisai are headed back to face the Food and Drug Administration’s outside neurology experts, two and a half years after the same panel dealt what proved to be a decisive blow to their Alzheimer’s disease therapy, Aduhelm.

Rocket Pharmaceuticals shares rise on FDA fast-track designation for heart disease treatment

Shares of Rocket Pharmaceuticals gained 2.3% premarket on Thursday after the late-stage biotech company said the U.S. Food and Drug Administration granted fast-track and orphan-drug designations to its gene therapy candidate for treatment of an inherited heart disease.

Weight-loss drug pioneers aim to jump on Wegovy bandwagon

Weight loss drug Wegovy has transformed the obesity market and pharmaceutical companies with existing treatments are hoping the resulting demand will boost demand for their older, less effective but cheaper, drugs.

Germany’s Merck flags decline in operating profit of up to 10% in 2023

Germany’s Merck KGaA on Thursday warned that adjusted operating earnings could decline by as much as 10% this year as the outlook for its specialty chemicals business darkened, offsetting an upswing in drug prescriptions.