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12 February 2025 An Expert View from Nick Petschek, EMEA managing director at global change management firm Kotter International.
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US pharma giant Pfizer has announced positive results from the Phase III TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). 13 February 2025
Biotechnology
The European Commission (EC) has approved Andembry (garadacimab), the first and only once-monthly treatment targeting factor XIIa to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. 13 February 2025
Pharmaceutical
Boston, USA-based Newleos Therapeutics, a neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development, has announced its emergence and the closing of an oversubscribed $93.5 million Series A financing. 13 February 2025
Pharmaceutical
French pharma major Sanofi’s saw its shares edge up 1% by early afternoon, despite announcing a disappointment for a vaccine it Is developing that will results in a significant impairment charge. 13 February 2025
Pharmaceutical
The pharmaceutical industry has reminded the Spanish government of the commitments that it has made to the country during a meeting with Prime Minister Pedro Sánchez. 13 February 2025
Pharmaceutical
The US Food and Drug Administration (FDA) approved expanding the prescribing information for Japanese drugmaker Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 13 February 2025
Biotechnology
South Korea's DAAN Biotherapeutics has entered an exclusive deal with LigaChem Biosciences to develop a novel tumor-targeting antibody. 13 February 2025
Pharmaceutical
Antengene has announced that its multiple myeloma treatment, Xpovio (selinexor), will be included in Taiwan’s National Health Insurance (NHI) reimbursement scheme. 13 February 2025
Biotechnology
The European Commission (EC) has approved catumaxomab, making it the only approved drug therapy for malignant ascites (MA) for patients living with this debilitating condition across Europe. 13 February 2025
Generics
Global private equity firms Blackstone, Brookfield Corporation and Warburg Pincus are in talks to acquire a majority stake in Hyderabad, India-based Gland Pharma from China's Shanghai Fosun Pharmaceutical in a deal expected to be valued at nearly $3 billion, according to media reports quoting three people with knowledge of the development said. 13 February 2025
Pharmaceutical
The Food and Drug Administration (FDA) has approved a New Drug Application (NDA) from Swiss pharma giant Roche’s Genentech subsidiary for an Evrysdi (risdiplam) tablet for people living with spinal muscular atrophy (SMA). 13 February 2025
Biotechnology
In its annual results statement, Galapagos chief financial officer Thad Huston said the firm is moving ahead with a planned split into two publicly-traded companies. 13 February 2025
Pharmaceutical
Santhera Pharmaceuticals, a Swiss specialty pharma focused on rare diseases, has announced an agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement for Agamreee (vamorolone) to treat Duchenne muscular dystrophy (DMD). 13 February 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin) in yet another indication, US pharma giant Pfizer announced late yesterday. 13 February 2025
Pharmaceutical
Danish biopharma giant Novo Nordisk is breaking new ground with its GLP-1 agonist semaglutide, as a small mid-stage study shows its potential in treating alcohol-use disorder (AUD). 13 February 2025
Pharmaceutical
France-based ophthalmics company PulseSight Therapeutics today announced the first close of its Series A financing with existing investor Pureos BioVentures committing new funds to support the Phase I study of PST-611 and enable preparation for a Phase IIa clinical trial. 13 February 2025
Pharmaceutical
Australian radiopharma company Telix Pharmaceuticals has gained approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its prostate cancer imaging agent, Illuccix (gallium-68 gozetotide). 13 February 2025
Biotechnology
IN8bio has announced encouraging new clinical data from its ongoing Phase I trial of INB-100, an allogeneic gamma-delta T cell therapy being tested in patients with acute myeloid leukemia (AML). 12 February 2025
Biotechnology
Shares in AnaptysBio, a San Diego-based biotech focused on delivering innovative immunology therapeutics, was trading 19% higher lunchtime Wednesday. 12 February 2025
Pharmaceutical
The USA-based Institute for Clinical and Economic Review (ICER), England’s National Institute for Health and Care Excellence (NICE), and Canada’s Drug Agency (CDA-AMC) have formed the Health Economics Methods Advisory (HEMA) initiative. The goal of HEMA is to critically and independently research some of the most pressing topics in global health economics and health technology assessment (HTA) methods. 12 February 2025
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Biotechnology
USA-based immunology company RAPT Therapeutics has entered into an exclusive license agreement with Shanghai Jemincare Pharmaceutical for JYB1904 (RAPT designation RPT904), a clinical-stage, half-life extended anti-immunoglobulin E (IgE) monoclonal antibody. 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
Biotechnology
Japanese drugmaker Shionogi has announced that it will acquire full ownership of its joint ventures with subsidiaries of Ping An Insurance. 23 December 2024
Biotechnology
Texan biopharma firm XBiotech has announced a suspension of its clinical program in rheumatology, after its Phase II trial for rheumatoid arthritis failed to meet the primary endpoint. 23 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
Generics
The US Court of Appeals for the Federal Circuit on Friday affirmed a lower district court order against Israeli pharmaceutical maker Teva Pharmaceutical Industries requiring its US subsidiary to delist several asthma inhaler patents from the Food and Drug Administration’s (FDA) Orange Book. 23 December 2024
Biotechnology
Nine months out from landing an additional $35 million in seed funding, Relation has more news – a big pharma collaboration. The group has announced a $45 million upfront deal, including a $15 million equity investment with UK pharma group GSK. 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
Biotechnology
Denmark’s Novo Nordisk said late Friday that the US Food and Drug Administration (FDA) has approved Alhemo (concizumab-mtci) injection. 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
Biotechnology
AI-driven biotech BenevolentAI has announced sweeping changes aimed at refocusing its operations and extending its financial runway into 2027. 20 December 2024
Pharmaceutical
San Diego, USA-based Neurocrine Biosciences today announced the launch of its Crenessity (crinecerfont) in the USA. 20 December 2024
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