NICE grants Lynparza expansion for advanced ovarian cancer

Europe – NICE nod for Novartis’ targeted skin cancer combo

Final draft guidelines are recommending the combination for use in patients with stage III BRAF V600 mutation-positive melanoma who have disease that has spread...
US approves AZ’ hairy cell leukaemia drug

USA – US approves AZ’ hairy cell leukaemia drug

The decision allows physicians to prescribe the drug for patients with relapsed or refractory HCL who have received at least two prior systemic therapies,...
China’s NMPA Launches Voluntary Device Master File Process

China – Chinese API Manufacturer Refuses EU Officials’ Inspection

China-based active pharmaceutical ingredient (API) and intermediate manufacturer Jiangsu Yew Pharmaceutical Co. has refused an inspection by Hungarian officials and has been found to...
FDA awards another non-opioid pain drug breakthrough status

USA – FDA awards another non-opioid pain drug breakthrough status

The US regulator yesterday awarded Concentric Analgesics and its pipeline drug CA-008 in post-surgical pain with an FDA Breakthrough Therapy designation (BTD). Concentric specialises in...
Philippe Tcheng élu Président du Leem

France – Philippe Tcheng élu Président du Leem

Administrateur du Leem depuis 10 ans, Philippe Tcheng était jusqu’à ce jour membre du Bureau, trésorier et Président de la Commission des Affaires Scientifiques. Philippe...
EC green-lights MSD’s Keytruda combo for lung cancer

Europe – EC green-lights MSD’s Keytruda combo for lung cancer

Specifically, the decision allows use of the combination in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who have no EGFR or ALK...
Les mauvais brevets limitent l'accès aux médicaments en Europe

Europe – Les mauvais brevets limitent l’accès aux médicaments en Europe

Les brevets pharmaceutiques peuvent être des obstacles à l'accès des patients au traitement dont ils ont besoin pour rester en vie et en bonne...
AstraZeneca, Amgen’s tezepelumab wins ‘breakthrough’ status

USA – AstraZeneca, Amgen’s tezepelumab wins ‘breakthrough’ status

The therapy is being developed for use in patients who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers. The...
FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

USA – FDA approves new dosage strength of buprenorphine and naloxone sublingual film as...

The U.S. Food and Drug Administration today approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid...
WHO develops classification system for protecting efficacy of antibiotics

UK – The Family-run Fake Pill Factory: trio busted following drugs raid

Daniel Hackland, wife Jenna and his brother Matthew Hackland pleaded guilty to 7 counts between them of producing and supplying unlicensed class C drugs,...

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