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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
, it may signal what’s ahead for medical devices.
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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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Gene therapy restored hearing in children with congenital deafness
Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...
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Astra Zeneca’s asthma drug nears approval for sinus inflammation
Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.
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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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Trump aviserar ny prispress – läkemedelsjättar faller
USA:s president Donald Trump har återigen riktat fokus mot landets läkemedelspriser. Han presenterar nu två separata initiativ för att pressa priserna på diabet...
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Texas stämmer Tylenol-tillverkare – anklagas för att ha dolt påstådd autismkoppling
Texas justitieminister stämmer Johnson & Johnson och dess avknoppning Kenvue för att ha dolt misstänkta risker med smärtstillande läkemedlet Tylenol, kopplade t...
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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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Marie Gårdmark: “What to expect from Trump’s second term?”
One may complain about the complex multinational system in EU, but it gives us some predictability that cannot be easily overturned by different member states p...
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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Roche joins Medicon Village
Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...
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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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Novo Nordisk tells staff to return to office
At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...
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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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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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Trumps ”lösning” på autismgåtan får forskare att skaka på huvudet
Användandet av paracetamol under graviditeten pekas av USA:s president Donald Trump ut som boven bakom autism, medan ett annat läkemedel med folinsyra – ett sla...
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Meet us at Control 2025
Innovations that drive efficiency.
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FDA approves Gilead’s HIV injection: “Historic day”
Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...
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An organ seldom in the spotlight – but utterly vital
The kidneys consist of more than 40 types of cells and have more functions in the body than most people know. Julie Williams leads AstraZeneca’s work in preclin...
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Icelandic pharmaceutical company Alvotech to list on Nasdaq Stockholm
One of Iceland's largest companies, the pharmaceutical firm Alvotech, has announced its intention to list on Nasdaq Stockholm.
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Discover Precision: Join ZEISS at the Control Fair in Stuttgart
May 6-9, 2025 in Stuttgart. Hall 9, Booth 9309.
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US Health Secretary Kennedy dismisses all vaccine experts – assembles new committee
Robert F. Kennedy Jr. has dismissed all 17 members of the CDC’s vaccine advisory panel. A new group of experts will be appointed directly by the Health Secretar...
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Storbritannien öppnar för högre läkemedelspriser – Astra Zeneca sänker i USA
Vita husets hårda linje mot höga läkemedelskostnader får konsekvenser på båda sidor Atlanten. Storbritannien öppnar för dyrare läkemedel i sjukvården för att un...
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