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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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Swedish biotech company Inify Laboratories has raised approximately 135 million kroner ($12.3 million) through a private placement, supporting a planned expansion into the UK. 16 December 2024
Pharmaceutical
Japan’s largest drugmaker, Takeda Pharmaceuticals, announced it is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU). 16 December 2024
Pharmaceutical
The schizophrenia market across the seven major markets is poised to grow at a compound annual growth rate (CAGR) of 7.4% from $8.4 billion in 2021 to $17.0 billion in 2031, driven by the anticipated introduction of 11 late-stage pipeline products during the forecast period. 16 December 2024
Pharmaceutical
Denmark-based diabetes and obesity giant Novo Nordisk says it plans to invest 8.5 billion Danish kroner ($1.2 billion) to establish a completely new production facility in Odense, Denmark. 16 December 2024
Pharmaceutical
UK-based PureTech Health has announced positive results from ELEVATE IPF, a Phase IIb trial of deupirfenidone (LYT-100) at two dose levels, three times a day (TID) over 26 weeks in patients with idiopathic pulmonary fibrosis (IPF). 16 December 2024
Pharmaceutical
UK-based NeoPhore Limited, a small molecule neoantigen immuno-oncology company, today announced the appointment of Michael Shih as chief executive (CEO) and to the board of directors, effective immediately. 16 December 2024
Pharmaceutical
The pharmaceutical and life sciences industry is gearing up for what analysts at PwC predict will be a highly active year for mergers and acquisitions in 2025, following a mixed performance in 2024. 13 December 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended another batch medicines for approval at its December 2024 meeting, bringing the total number of medicines recommended for approval in 2024 to 114. 13 December 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has published its annual report examining price increases for top-selling drugs in the USA, pointing to $815 million in prices hikes which it says are not clinically supported. 13 December 2024
Pharmaceutical
US biotech Corcept Therapeutics has reported positive results from the Phase IV CATALYST study of Korlym (mifepristone) in people with hypercortisolism and difficult-to-control type 2 diabetes. 13 December 2024
Pharmaceutical
Italy-based CNS specialist Newron Pharmaceuticals has entered into a license agreement with EA Pharma, part of Japan’s Eisai to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, in Japan and other designated territories. 13 December 2024
Pharmaceutical
US antivirals major Gilead Sciences announced that Dr Dietmar Berger will join the company on January 2, 2025, as chief medical officer (CMO) and will become a member of Gilead’s senior leadership team. Dr Berger succeeds Dr Merdad Parsey. 13 December 2024
Pharmaceutical
Spanish plasma-based medicines producer Grifols has announced the execution of an agreement for a private placement of 1.3 billion euros ($1.4 billion) of 7.125% senior secured notes due May 2030 at par. 13 December 2024
Pharmaceutical
Canada-headquartered Bausch + Lomb Corporation, a leading global eye health company, on Thursday confirmed reports that it is exploring a potential sale, acting in response to a request from the Canadian Investment Regulatory Organization (CIRO). 13 December 2024
Pharmaceutical
Based on its review of post-market clinical trial data, the US Food and Drug Administration (FDA) identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver. 13 December 2024
Pharmaceutical
UK-based Tenpoint Therapeutics and Seattle’s Visus Therapeutics have announced the completion of their merger to create an entirely new chapter in ophthalmic therapeutic medicines aimed at rejuvenating the aging eye. 12 December 2024
Pharmaceutical
A plan to buy back a whopping $15 billion worth of shares comes in at three times the previous largest scheme in Eli Lilly’s history. 12 December 2024
Pharmaceutical
Danish allergy immunotherapy specialist ALK Abello announced that its European regulatory filing for Acarizax (house dust mite sublingual allergy immunotherapy tablet) in young children aged five to 11 has been approved by the health authorities in 21 European Union (EU countries via a type II variation procedure. 12 December 2024
Pharmaceutical
US clinical-stage drug developer Keros Therapeutics’ shares plummeted more than 73% to $18.20 in pre-market activity on revealing a setback for a lead investigational candidate. 12 December 2024
Pharmaceutical
UK-based Essential Pharma has announced the completion of a 900 million euros ($945 million) financing. 12 December 2024
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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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