Latest Pharma and Biotech News
Pharmaceutical
23 December 2024 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.
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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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Pharmaceutical
Swiss pharma giant has shared a well-timed updated analysis from the pivotal Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2024. 16 September 2024
Pharmaceutical
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Pharmaceutical
Boehringer Ingelheim today announced that the FIBRONEER-IPF trial met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] (FVC) at week 52 versus placebo. FVC is a measure of lung function. 16 September 2024
Pharmaceutical
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
Pharmaceutical
Pfizer released longer-term follow-up results from the Phase II single-arm PHAROS clinical trial evaluating the efficacy and safety of Braftovi (encorafenib) in combination with Mektovi (binimetinib) for patients with BRAF V600E - mutant metastatic non-small cell lung cancer (NSCLC). 16 September 2024
Pharmaceutical
Under pressure from certain shareholders, autoimmune diseases specialist Aurinia Pharmaceuticals on Friday said it has restructured its board of directors. 14 September 2024
Pharmaceutical
As the world’s leading cancer research professionals arrived at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona on Friday, they were given a reminder of some of the remaining challenges that lie ahead in their field. 13 September 2024
Pharmaceutical
Women’s health focussed company Organon China today revealed that it has entered into license and supply agreements with Shanghai Bao Pharmaceutical, acquiring the exclusive commercialization rights to its investigational asset, SJ02, in China Mainland. 13 September 2024
Pharmaceutical
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
Pharmaceutical
US pharma major Eli Lilly has announced a $1 billion expansion of its manufacturing site in Limerick, Ireland, to increase production of biologic active ingredients, including those for its recently approved treatment for early symptomatic Alzheimer's disease. 13 September 2024
Pharmaceutical
Thursday was a wretched day for Fulcrum Therapeutics, a US biopharma company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. 13 September 2024
Pharmaceutical
Gilead Sciences’ shares closed up 2.7% at $83.16 yesterday, after it releases positive results of an interim analysis from a second pivotal Phase III clinical trial investigating the use of the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir. 13 September 2024
Pharmaceutical
Germany’s Pentixapharm is planning a public offering of new shares as part of its spin-off from Eckert & Ziegler, a leading specialist in radioisotopes for medical, scientific and industrial applications. 12 September 2024
Pharmaceutical
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
Pharmaceutical
Innovent Biologics has announced positive results from a Phase III trial for mazdutide, a dual agonist targeting GLP-1 and glucagon receptor. 12 September 2024
Pharmaceutical
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
Pharmaceutical
French pharma major Sanofi is delving into the emerging class of cancer drugs known as radiopharmaceuticals, which use radioactive substances to attack tumor cells in a targeted way. 12 September 2024
Pharmaceutical
Bain Capital Life Sciences has announced the closing of its fourth fund, securing approximately $3 billion in total commitments. 12 September 2024
Pharmaceutical
EQT Life Sciences revealed that it has led a 93 million-euro ($102.5 million) oversubscribed Series A fundraise in PanTera, a Belgian radioisotope producer. 12 September 2024
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