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Spanish drugmaker PharmaMar says it has received the Temporary Authorization for the commercialization of Zepzelca (lurbinectedin) by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy without central nervous system (CNS) metastases. 10 March 2023
Pharmaceutical
The trade group for UK-based drugmakers, the Association of the British Pharmaceutical Industry (ABPI), has appointed vice president Susan Rienow to the role of president. 9 March 2023
Pharmaceutical
The US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) investigating a potential new indication to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes. 8 March 2023
Pharmaceutical
Japanese pharma company Alfresa has entered into a licensing deal with K Pharma to develop and commercialize ropinirole in Japan for the treatment of amyotrophic lateral sclerosis (ALS). 3 March 2023
Pharmaceutical
The US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). 2 March 2023
Pharmaceutical
Danish diabetes care giant Novo Nordisk just announced plans to expand its research and development (R&D) presence in the greater Boston, USA, metro area, creating one of its largest R&D hubs outside of Denmark. 2 March 2023
Pharmaceutical
US immunotherapy specialist Dynavax Technologies announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Heplisav B (hepatitis B vaccine (recombinant), adjuvanted). 1 March 2023
Pharmaceutical
The Radiation and Nuclear Countermeasures Program (RNCP) of the National Institute of Allergy and Infectious Diseases, part of the USA’s National Institutes of Health, has selected RedHill Biopharma’s opaganib for the nuclear medical countermeasures product development pipeline. 28 February 2023
Pharmaceutical
New Jersey, USA-based Amarin has inked a deal with CSL Seqirus for the licensing and distribution of Vazkepa (icosapent ethyl). 28 February 2023
Pharmaceutical
Perrigo subsidiary HRA Pharma Rare Diseases has signed a partnership with Celnova Pharma to register and launch products in Argentina, Chile and Peru. 27 February 2023
Pharmaceutical
UK-based Pharmanovia has expanded its neurology portfolio by acquiring certain rights to Sunosi (solriamfetol) from Axsome Therapeutics. 22 February 2023
Pharmaceutical
In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization. Of these, 40 had a new active substance which had never been authorized in the European Union (EU) before. 16 February 2023
Pharmaceutical
British oncology and central nervous system (CNS) specialist Astex Pharmaceuticals has inked a new collaboration deal with Cardiff University’s Medicines Discovery Institute (MDI). 13 February 2023
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. 10 February 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Eylea (aflibercept) as the first pharmacologic treatment for preterm infants with retinopathy of prematurity (ROP), a leading cause of childhood blindness worldwide, says US biotech Regeneron, which out-licensed the drug to German pharma major Bayer. 10 February 2023
Pharmaceutical
Swiss rare disease company Santhera Pharmaceuticals has secured a final reimbursement agreement with the French authorities for its Leber's hereditary optic neuropathy (LHON) therapy Raxone (idebenone). 8 February 2023
Pharmaceutical
The Hellenic Association of Pharmaceutical Companies (SfEE) has announced that representatives of patient associations, the medical, academic and scientific community, and the pharma sector submitted to the Prime Minister and the Minister for Health their joint proposals to pursue the national dialogue on the creation of a modern and effective National Action Plan against Caner. 6 February 2023
Pharmaceutical
Indian drugmaker Sun Pharmaceutical Industries today announced the launch of Sezaby (phenobarbital sodium) in the USA for the treatment of neonatal seizures. 25 January 2023
Pharmaceutical
Spanish drugmaker PharmaMar says that its licensing partner, Adium Pharma, has received full approval for commercialization of Zepzelca (lurbinectedin) by the Federal Commission for the Protection against Sanitary Risks of Mexico (COFEPRIS) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. 24 January 2023
Pharmaceutical
The US Federal Trade Commission has asked a federal judge to hold “Pharma Bro” Martin Shkreli in contempt for failing to provide the FTC with information needed to determine whether he is violating a previous order by the judge that banned him from working in the pharmaceutical industry for life. 23 January 2023
Pharmaceutical
Cytokinetics has sold Sanofi exclusive rights to develop and commercialize aficamten in China. 24 December 2024
Pharmaceutical
USA-based clinical-stage biopharma Traws Pharma saw its shares leap more than 150% to $12.57 as it announced progress in the development of its investigational one-dose influenza (flu) investigational therapy, tivoxavir marboxil for treatment of H5N1 bird flu. 24 December 2024
Pharmaceutical
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
Pharmaceutical
AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024
Pharmaceutical
New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review. 23 December 2024
Pharmaceutical
Spanish plasma-based medicines maker Grifols has announced disappointing top-line data from its Phase III PRECIOSA clinical trial evaluating the potential of long-term albumin treatment with Grifols Albutein on patients with decompensated cirrhosis and ascites, sending its share down 2.4% to 9.27 euros on Friday. 23 December 2024
Pharmaceutical
Denmark has introduced a three-year agreement to regulate price ceilings for hospital medicines, aimed at providing stability for the public healthcare system and pharmaceutical companies. 23 December 2024
Pharmaceutical
French pharma major Sanofi says it has entered into a new chapter of the collaboration with South Korean firm SK bioscience in pneumococcal vaccines, with an expanded agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations. 23 December 2024
Pharmaceutical
US drugmaker Vertex Pharmaceuticals’ shares were unmoved on Friday, despite receiving two new regulatory authorizations. 23 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday approved an expanded indication for Imcivree (setmelanotide), from Boston, USA-based Rhythm Pharmaceuticals, to include children as young as two years old. 23 December 2024
Pharmaceutical
US pharma giant Pfizer on Friday revealed that the US Food and Drug Administration (FDA) has approved its Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. 23 December 2024
Pharmaceutical
Among significant research news last week, UK drug developer PureTech released positive new Phase IIb data on its deupirfenidone in idiopathic pulmonary fibrosis. France’s Sanofi and Israel-based Teva Pharmaceutical Industries announced encouraging new Phase IIb data for their duvakitug in inflammatory bowel disease. Meanwhile, Vertex Pharmaceuticals released Phase II results for its investigational sciatica treatment suzetrigine that failed to impress. Also of note, AbbVie announced strong Phase III results of tavapadon in early Parkinson’s disease. 22 December 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Duvyzat (givinostat) to treat Duchenne muscular dystrophy (DMD). 22 December 2024
Pharmaceutical
San Diego, USA-based Neurocrine Biosciences today announced the launch of its Crenessity (crinecerfont) in the USA. 20 December 2024
Pharmaceutical
Denmark’s Zealand Pharma has been hit with a complete response letter (CRL) from the US regulator for glepaglutide, a long-acting GLP-2 analog. 20 December 2024
Pharmaceutical
Denmark’s Novo Nordisk today announced headline results from REDEFINE 1, a Phase III trial in the global REDEFINE program, which it said were positive, but failed to impress investors, who pushed the firms shares down 19% to 601.30 kroner. 20 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare, genetic form of severe hypertriglyceridemia (sHTG) that can lead to potentially life-threatening acute pancreatitis (AP). 20 December 2024
Pharmaceutical
US pharma giant Merck has announced top-line results from two pivotal Phase III trials of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL). 20 December 2024
Pharmaceutical
US biotech Assembly Biosciences has announced an equity investment of $20.1 million by Gilead Sciences to purchase additional common stock in the company and an amendment to their collaboration to advance the research and development of novel antiviral therapies with $10 million in accelerated funding. 20 December 2024
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