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FDA clears narrow use of Lynparza in early prostate cancer, continuing ‘shift’ on PARP drugs

Dive Brief: The Food and Drug Administration on Wednesday approved AstraZeneca and Merck & Co.’s Lynparza for use in certain people newly diagnosed with advanced prostate …

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Sanofi drug, acquired from a startup, shows early potential in MS

Sanofi on Wednesday said an experimental multiple sclerosis drug succeeded in a mid-stage trial, giving the company the confidence to bring the medicine into pivotal …

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Medicare keeps limits on Alzheimer’s drug coverage, but loosens policy

Dive Brief: Medicare on Thursday affirmed plans to limit coverage for certain Alzheimer’s disease drugs, but signaled it’s taking steps to ensure broader access should …

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Moderna reports ‘encouraging’ early data for one of its rare disease medicines

Moderna said Friday that one of its rare disease drug programs showed promise in its first clinical trials, according to an early look at the …

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Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

The race to develop the next blockbuster anti-inflammatory disease drug is heating up. In recent months, Merck & Co. and Pfizer have both made moves …

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Supreme Court sides with Sanofi, Regeneron in patent fight with Amgen

The Supreme Court on Thursday ruled against Amgen in its decade-long battle with Sanofi and Regeneron, affirming a lower court’s decision that Amgen’s rivals did …

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Future of Intercept’s NASH drug in doubt after FDA panel rejection

Advisers to the Food and Drug Administration on Friday recommended against approving an experimental drug for a common fatty liver disease called NASH, increasing the …

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SGS PACE is a seamless combination of world-leading development, bioanalysis and clinical research through one point of contact

We are proud to launch SGS PACE. Bringing the vision of your drug to life, SGS PACE is a unique, streamlined pathway to accelerate molecules …

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FDA panel narrowly backs approval of Sarepta’s Duchenne gene therapy

A group of Food and Drug Administration advisers narrowly supported approving what could be the first gene therapy for Duchenne muscular dystrophy in a meeting …

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Amylyx’s ALS drug again surpasses Wall Street expectations

Amylyx Pharmaceuticals has again impressed Wall Street, disclosing Thursday a new earnings report in which product revenue was significantly higher than many analyst forecasts. The …

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Cancer vaccine from BioNTech, Roche shows potential in small study

An experimental vaccine developed by German drug developer BioNTech showed early promise in a small study of people with pancreatic cancer, suggesting that personalized immunotherapy …

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Gilead acquires San Diego startup for early-stage cancer, immune drugs

Dive Brief: Gilead Sciences on Tuesday said it has acquired the privately held biotechnology company XinThera for an undisclosed sum, gaining access to a slate …

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ELRIG UK Appoints Nick Clare to Board as Vendor Strategy Work Group Lead

The European Laboratory Research & Innovation Group (ELRIG) UK today announced the appointment of Nick Clare to the ELRIG board. He will chair and lead …

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PCI Pharma Services Announces New Sterile Fill-Finish Capabilities Now Available in Melbourne and San Diego

New equipment added to San Diego and Melbourne facilities will help with clinical scale and global capacity shortages PCI Pharma Services (PCI), a leading global …

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J&J study data show dramatic benefit to multiple myeloma cell therapy

The cancer cell therapy Carvykti dramatically outperformed standard drugs in a late-stage clinical trial testing its use in earlier treatment of the blood cancer multiple …

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Biotech layoffs gather pace as industry downturn persists

At least five dozen biotechnology companies have laid off employees so far this year in a sector-wide contraction that has reached large and small drugmakers …

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Apellis’ immune system drug hits a setback in ALS

In the latest setback for ALS research, Apellis Pharmaceuticals, a Massachusetts-based drug company, has discontinued a portion of a key clinical trial testing one of …

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Sensitive HPLC refractive Index detector

Biotech Fluidics announce REFRACTiMASTER® – a new HPLC refractive index (RI) detector suitable for detecting compounds with little or no UV activity including simple sugars, …

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Moderna, Merck data support claim of cancer vaccine’s promise

An experimental vaccine may help stop tumors from recurring in people with a common form of skin cancer, detailed results from a mid-stage study run …

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Biotech layoffs gather pace as industry downturn persists

At least five dozen biotechnology companies have laid off employees so far this year in a sector-wide contraction that has reached large and small drugmakers …

Continue Reading →