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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...
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Aqilion's licensing journey: From Merck partnership to new opportunities
Be extremely meticulous with your scientific data, but spend just as much time and effort on business development. That piece of advice comes from Aqilion's CEO...
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Could an overly burdensome QMS be the organization’s own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...
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Billion-Dollar Deal Sends BioArctic Soaring
Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug de...
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Phase III win for Hansa Biopharma: “We Are Thrilled”
Swedish biotech Hansa Biopharma’s transplant drug imlifidase has met the primary efficacy endpoint in a registration-enabling Phase III study in the United States.
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Trump in new push to lower drug prices
U.S. President Donald Trump announced on Sunday that he plans to sign an executive order to lower the cost of prescription drugs to the same levels paid in othe...
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How the Nobel discovery is used in drug development
Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how t...
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New drug to simplify treatment of hemophilia
A new type of treatment for hemophilia, which only needs to be administered every two months, has been approved by the U.S. Food and Drug Administration (FDA).
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FDA’s Top Vaccine Official resigns – Issues sharp criticism of Kennedy
FDA’s Top Vaccine Official is leaving his post while simultaneously criticizing the country’s health secretary for allowing “misinformation and lies” to influen...
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ZEISS introduces the new Smartzoom 100
The future of digital microscopy for efficient optical inspections.
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Many discontinue obesity medication – new study highlights the reasons
A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...
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Anocca raises SEK 440 million ahead of clinical cancer trial
Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.
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Heart Monitoring in Breast Cancer – Essential or Excessive?
Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...
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New moves around Nykode's management – withdrawal of resignations
Norwegian Nykode Therapeutics is reinstating members of the management team who previously announced their resignations.
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The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
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Astra Zeneca pauses multi-million investment in the UK
Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.
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FDA approves new cystic fibrosis therapy
A new treatment for cystic fibrosis has been approved by the U.S. Food and Drug Administration (FDA).
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Allogene discontinues investigational antibody following patient death
U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pi...
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Achieve Effortless, Standardized Automation with the new ZEISS Automation Interface
Simple interfaces for automated loading of CMMs.
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Novo Nordisk appoints Mike Doustdar as new CEO
The Danish pharmaceutical giant Novo Nordisk has appointed Mike Doustdar as its new CEO. At the same time, the company announced it was lowering its forecasts –...
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BMS and venture capital giant form new company
The American pharmaceutical company Bristol Myers Squibb, together with the venture capital firm Bain Capital, is forming a new biotech company. The company wil...
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The top five most expensive drugs in 2025
New advanced therapeutic medicines are reaching the market, but their price tags remain exceptionally high. This year’s ranking of the most expensive drugs in t...
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Novo Nordisk cuts ties with Hims & Hers after Wegovy dispute
Novo Nordisk is ending its collaboration with Hims & Hers Health due to concerns about the company’s sales and marketing practices related to the weight-loss drug Wegovy.
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Tau-targeted Alzheimer's drug gets Fast Track designation in the USA
Biogen's Alzheimer's candidate BIIB080 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
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