The European Commission has granted Orphan Medicinal Product designation for zatolmilast an investigational treatment for Fragile X syndrome (FXS), a leading cause of inherited intellectual disability and autism.
Biogen Inc. has taken a step closer to bringing its ‘groundbreaking treatment’ to patients with a rare, genetic, life-shortening, debilitating, and neurodegenerative disorder.
A treatment option to reduce the number and intensity of hot flashes and night sweats associated with menopause has been approved by the European Commission (EC).
Calliditas Therapeutics AB announced on Friday (October 5) that the European Medicines Agency (EMA) has issued a positive opinion on the company’s drug, setanaxib in Alport Syndrome (AS).
Notocord, an Instem company, will provide data acquisition and analysis services to a research and innovation program to improve risk prediction of cardiovascular adverse events.
The European Commission approves Pfizer’s Vizimpro monotherapy for the first-line treatment of non-small cell lung cancer, as the market is projected to grow to $26.8bn by 2025.
Takeda’s aim to acquire Shire for $62bn received a boost after regulators vote positively to approve the transaction following the divestment of Shire’s IBD drug.
The European Commission has publish a draft revision of its GMP guidelines on the production of sterile drugs with tweaks to recommendations on clean rooms, sealing technologies and single-use systems.
Generics industry group Medicines for Europe says proposed supplementary protection certificate (SPC) waiver will help European API manufacturers compete.
Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.
The Council of the EU has unveiled a plan to analyse the competitive landscape for pharmaceuticals in Europe in a bid to improve patients' access to medicines.
Organisations that identify API manufacturers whose manufacturing activities spread antimicrobial resistance will be considered alongisde other NGOs for a new European Commission award.
IPEC Europe has reminded drugmakers they have less than a year to risk assess all excipients used in their products under recently introduced EU rules.
Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.
Replacing animal studies in drug development is impossible according to the European Commission, which has rejected a petition calling for a ban signed by 1.2m people.
In order to close Novartis’ $16bn purchase of GlaxoSmithKline’s portfolio of cancer treatments, the FTC (Federal Trade Commission) is requiring Novartis to divest all assets related to its potential BRAF and MEK inhibitor drugs to settle anticompetitive...
US package delivery giant UPS has announced it will buy Polish healthcare logistics firm Poltraf SP zoo from private equity fund Ortie Capital Investment.
DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.
The EU commission plans to strip DG Sanco of responsibility for the running the European Medicines Agency (EMA) and hand it to the directorate in charge of enterprise and industry.
Concerns recently introduced import laws would cause EU-wide API shortages now appear unfounded, but European industry groups say the buffering effects of stockpiling mean it is still too early to be sure supplies will not be affected.
Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
The European CRO Federation is calling to widen the scope of a proposed delegated act related to pharmacovigilance legislation to include scenarios when observational PAES (post-authorisation efficacy studies) will be required.
US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification.
‘Long awaited’ draft guidelines on excipient risk assessments proposed by the European Commission (EC) have been welcomed by industry group IPEC Europe.
The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.
United Parcel Service (UPS) has abandoned its bid to buy Holland-based logistics firm TNT Express after the European Commission said it would block the deal.
Proposed EMA pharmacovigilance fees are too high and place a disproportionate burden on generics firms according to the European Generic Medicines Association (EGA).
The European Commission (EC) has made changes to its GMP guidelines in order to align them more closely with the pharmaceutical quality system described in ICH Q10.
The EC says proposals to replace the Clinical Trials Directive with simplified rules will make Europe more attractive for trials, but what do CROs think? Share your opinions in this exclusive Outsourcing-pharma.com poll.
The EU Commission could soon revise its guidance for information allowed on packaging of prescription-only medicines, after European Parliament urged it to update its original policy.
Amcor’s takeover of Alcan has been cleared by the European Commission after the Australian company agreed to sell off two pharmaceutical and food packaging plants in Spain.
Amcor has unveiled its proposed management shake up in preparation for the $2.025bn takeover of Alcan – three days before the European Commission is due to deliver its verdict on the deal.
Officials carried out another set of surprise inspections at pharma companies yesterday, in the latest stage of the European Commission's clampdown on anti-competitive practices.
Efforts to sure-up pharma track and trace rules and combat counterfeiting are a significant opportunity for specialist labelling firms, but the pace of change is proving to be a frustration, according to Domino Printing Sciences MD, Nigel Bond.
