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Featured companies in Regulatory

PCI Pharma Services

PCI Pharma Services: Your bridge between life-changing therapies and patients.

Abzena

Abzena is the leading end-to-end bioconjugate and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or...

Asymchem

Since inception in 1999, Asymchem has been positioned and structured to act as a true partner for pharmaceutical and biotech companies by offering integrated solutions across...

Copley Scientific

Leading manufacturer and supplier of pharmaceutical testing equipment

Almac Group

The Almac Group is an established contract development and manufacturing organisation which provides an extensive range of integrated services to the pharmaceutical and biotech...

IMed Consultancy Limited

IMed Consultancy’s team of highly skilled and experienced medical regulatory professionals offers an outstanding yet accessible global regulatory service. We are committed...

Broughton

Helping you deliver life-enhancing products to market through analytical testing excellence integrated with best-in-class scientific consultancy and regulatory compliance

Ecolab Life Sciences

Ecolab Life Sciences is the market leader in the supply of premier contamination control solutions for life science cleanrooms worldwide.

Innopharma Technology

Headquartered in Dublin, Ireland, we design and develop Industry 5.0 manufacturing solutions that simplify process intelligence by delivering data in real-time. Our solutions...

Hermes Pharma GmbH

HERMES PHARMA is the leading expert in developing and manufacturing user-friendly oral dosage forms. As a CDMO, we offer customized services along the entire pharmaceutical...

EECO2

EECO2 is a leading global provider of researched, tested and proven efficiency solutions for the pharmaceutical, biotech and other high-tech industries

Trending Articles

  1. How the EU's AI Act of 2024 will impact businesses using the technology The legally binding rules on AI use aim to enhance the reliability and safety of the technology's implementation globally
  2. SeaBeLife's SBL01 acute liver failure drug candidate receives ODD from the EMA The small molecule acts as a necrosis and ferroptosis inhibitor, allowing for the protection and restoration of liver cells in those with acute liver failure
  3. The right validation model: practical considerations and applications It is widely accepted that validation in the life sciences industry follows a lifecycle model (1,2). What is not always clear is the specific model — or models — to follow...
  4. Novo Nordisk's Wegovy gains positive opinion from the EMA for cardiovascular event risk reduction The GLP-1 medication has proven effective at reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease
  5. Nitrosamines: Information for Marketing Authorisation Holders Nitrosamine impurities have been in the regulatory spotlight since they were discovered in several blood pressure medicines leading to product recalls across the EU and the US

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Regulatory The legally binding rules on AI use aim to enhance the reliability and safety of the technology's implementation globally

How the EU's AI Act of 2024 will impact businesses using the technology

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Regulatory The small molecule acts as a necrosis and ferroptosis inhibitor, allowing for the protection and restoration of liver cells in those with acute liver failure

SeaBeLife's SBL01 acute liver failure drug candidate receives ODD from the EMA

Read more
Regulatory The drug — in combination with the standard of care regimen — was able to exhibit sustained disease control over the 24 week trial period

Johnson & Johnson submits nipocalimab application to the FDA following positive Phase III results

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Regulatory The therapeutic combination will now be named as the first-line, standard of care treatment for metastatic or advanced bladder cancer

Padcev plus Keytruda approved for advanced urothelial cancer by the EC

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Manufacturing The ICMRA's pilot scheme aims to accelerate the regulatory approval process for pharmaceutical companies

PCI Pharma becomes first CDMO to complete an ICRMA site inspection

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Regulatory The subcutaneous C5 inhibitor stops the patients from having to attend the clinic to receive IV infusions for PNH management

Roche receives approval for PiaSky to treat patients with PNH in Europe

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Regulatory The T-cell therapy can significantly improve outcomes for patients who are refractory to BTK inhibitors, which are a common first line treatment for MCL

CAR-T immunotherapy Carteyva approved in China for patients with R/R MCL

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Regulatory The drug significantly improved six minute walk distances, while also reducing risk of death or symptom worsening in the Phase III STELLAR trial

Merck gains EC approval for Winrevair to treat patients with pulmonary arterial hypertension

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Regulatory This year's version of the KP.2-targeting vaccine will endeavour to curb local COVID-19 outbreaks

Moderna's updated COVID-19 vaccine gets the green light from the FDA

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Regulatory The drug will not be available on the NHS owing to significant and potentially life-threatening side effects, as well as the cost of the medicine and its limited efficacy

Alzheimer's drug lecanemab deemed unsuitable for the UK NHS by health regulator

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Regulatory The combination therapy was seen to reduce risk of disease progression or death by 30% compared to the current standard of care, osimertinib

Johnson & Johnson's Rybrevant-Lazcluze combo receives FDA approval for EGFR-mutated lung cancer

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Regulatory The NMPA approval stems from the results of the MIRACLE Phase III trial, which found a 74% reduction in the annualised asthma exacerbation rate

AstraZeneca's Fasenra for severe eosinophilic asthma approved in China

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Regulatory The CD19-directed chimeric antigen receptor T-cell therapy is being considered for approval in adults with relapsed/refractory follicular lymphoma

Bristol Myers Squibb’s CAR T-cell therapy Breyanzi receives application validation from the EMA

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Regulatory The therapeutic significantly improved PFS and OS in patients with limited-stage small cell lung cancer in the Phase III ADRIATIC trial

AstraZeneca's Imfinzi granted priority review and BTD by the US FDA for SCLC

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Regulatory The long-lasting parathyroid hormone prodrug will be available to patients in the first quarter of 2025

Ascendis Pharma's Yorvipath gets the green light from the FDA for hypoparathyroidism

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Regulatory The HER2-targeting ADC has received conditional approval owing to the results of the DESTINY-Gastric06 Phase II trial

AstraZeneca & Daiichi Sankyo's Enhertu bags another approval for gastric cancer applications

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