Jazz and Roche’s Zepzelca-Tecentriq wins FDA ES-SCLC approval
A combination therapy of Jazz Pharmaceutical’s Zepzelca (lurbinectedin) and Roche’s Tecentriq (atezolizumab) has gained US Food and Drug Administration (FDA) …
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Trump administration announces MFN drug pricing deal with Pfizer
The Trump administration announced Pfizer has agreed to provide all of its medicines at Most Favored Nation (MFN) pricing in …
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Rocket ditches blood disorder gene therapy in ongoing pipeline pivot
The flight path towards a first approved product for Rocket Pharmaceuticals has been hit with turbulence, after the biotech culled …
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FDA approves mifepristone generic as political abortion war rages on
The US Food and Drug Administration (FDA) has approved Evita Solutions’ generic form of mifepristone, one of the two medications …
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Amgen’s Phase III data supports FDA label expansion of Repatha
Amgen is hopeful that Phase III data will cement the validity of its recently approved widened label for cholesterol-lowering drug …
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Takeda walks away from cell therapy in priority U-turn
Japanese pharma Takeda has pulled the plug on its cell therapy efforts, despite its strong prior focus on the modality. This …
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Five key insights to unlock the secrets behind a successful commercial drug launch
The growing demand for contract packaging services is a testament to the added value CDMOs bring to pharmaceutical companies navigating …
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Advancing lifechanging medicine: gRNA in the spotlight
The promise of gene-editing therapies has passed the realm of scientific possibility to clinical reality. While DNA-altering treatments are considered …
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FDA winds down operations amid government shutdown
The US Food and Drug Administration’s (FDA) has stripped its operations down following the government shutdown on 1 October. This comes …
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Halozyme eyes microparticles in $900m Elektrofi acquisition
Halozyme Therapeutics has agreed to acquire US-based Elektrofi in a deal worth up to $900m, which will see it add …
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Huawei’s three key steps to drive industrial intelligence forward and unleash AI’s full potential
Speaking at HUAWEI CONNECT 2025 in Shanghai, Leo Chen, Senior Vice President and President of Enterprise Sales at Huawei, reminded …
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FDA leaders are “acting political”, says ex-agency chief counsel
It has been a tumultuous few months for the US Food and Drug Administration (FDA), with the unexpected exit and …
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Digital first: in silico models join the bioprocess revolution
Few industries have innovated more prodigiously than biopharma over recent years. But its adoption of digital innovations has lagged. Today, …
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Cutting through the hype: Optimising AI in clinical data
Artificial intelligence (AI) has become one of the most talked-about technologies of our time, but when it comes to complex …
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AbbVie breaks ground on $70m US biologics site amid Trump pressure
Chicago-based big pharma AbbVie has started construction on a $70m expansion of its bioresearch and manufacturing site. The facility, located in …
