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30 December 2024 For many in the life sciences, the year gone by has been marked by volatility across a range of metrics, as political and economic disruptions threaten to upend the standard operating model.
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The market for artificial intelligence (AI) in cancer care is projected to grow from $2.2 billion in 2024 to $6.3 billion by 2029, reflecting a growth rate of 23.1%, according to a recent study by BCC Research. 31 December 2024
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), from US pharma giant Merck & Co. 31 December 2024
Pharmaceutical
US CNS specialist Axsome Therapeutics yesterday announced the completion of its Phase III clinical program evaluating AXS-05 (dextromethorphan-bupropion). 31 December 2024
Pharmaceutical
It has been a year since the launch of Zepbound (tirzepatide) for obesity, and US pharma major Eli Lilly’s competition with Denmark’s Novo Nordisk continues. 31 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) is reopening the comment period for the Federal Register notice (FRN), “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments” due to high interest from industry. 31 December 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning urging the public to avoid purchasing weight-loss medicines without a prescription. 30 December 2024
Pharmaceutical
For many in the life sciences, the year gone by has been marked by volatility across a range of metrics, as political and economic disruptions threaten to upend the standard operating model. 30 December 2024
Pharmaceutical
China’s National Medical Products Administration (NMPA) has recently approved Zorifer (zorifertinib), an oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) specifically for the treatment of non-small cell lung cancer (NSCLC) with CNS metastases. 30 December 2024
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) in patients with agammaglobulinemia or hypogammaglobulinemia disorders, from domestic drug giant Takeda Pharma 27 December 2024
Pharmaceutical
Japanese drugmaker Kaken Pharmaceutical has entered into a license agreement with US healthcare giant Johnson & Johnson for the global development, manufacturing and commercialization of a STAT6 program that Kaken is developing. 27 December 2024
Pharmaceutical
Akums, India’s largest contract development and manufacturing organization (CDMO), has signed a strategic agreement with an undisclosed global pharmaceutical company. 27 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs). 27 December 2024
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
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Pharmaceutical
Russian drugmaker Nanolek plans to accelerate its expansion this year by expanding its range and increase of output, paying a particular focus to vaccines, The Pharma Letter’s local correspondent reports. 5 June 2024
Pharmaceutical
Lykos Therapeutics’ hopes of being the first to market with a hallucinogenic medicine suffered a major blow Tuesday during a meeting of the US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC). 5 June 2024
Pharmaceutical
Ireland-headquartered fish oil-based heart drug specialist Amarin Corporation announced that it has appointed Aaron Berg, currently Amarin’s executive vice president and president of the US business, as president and chief executive (CEO). 5 June 2024
Pharmaceutical
San Diego, USA-based biopharma company Viking Therapeutics has announced favorable 52-week results from its Phase IIb VOYAGE study of VK2809. 5 June 2024
Pharmaceutical
Japanese pharma major Takeda has presented positive results from its Phase IIb trial of TAK-861 at the SLEEP 2024 annual meeting. 4 June 2024
Pharmaceutical
Japanese pharma major Shionogi says it is responding to the urgent global need for additional antimicrobial research and development by establishing its first discovery laboratory in San Diego, California, USA. 4 June 2024
Pharmaceutical
UK drugmaker GSK closed 9% lower after Monday’s trading in London on news of a negative court ruling. 4 June 2024
Pharmaceutical
The attention-deficit/hyperactivity disorder (ADHD) market across the seven major markets (7MM) is forecast to decline at a negative compound annual growth rate (CAGR) of 0.9% from $11.9 billion in 2022 to $10.9 billion in 2032. 4 June 2024
Pharmaceutical
Bladder cancer specialist UroGen Pharma has appointed David Lin as chief commercial officer. 4 June 2024
Pharmaceutical
Privately-held company GAIA has had more than a front-row seat to observe the arrival of digital therapeutics and applications of AI in pharma over the past quarter century. 4 June 2024
Pharmaceutical
USA-based tumor drug resistance specialist Deciphera Pharmaceuticals today announced results from the company’s MOTION pivotal Phase III study of vimseltinib in patients with Tenosynovial Giant Cell Tumor TGCT) in an oral presentation at ASCO. 3 June 2024
Pharmaceutical
Privately-held neurology company Tris Pharma has received approval from the US Food and Drug Administration for Onyda XR (clonidine hydrochloride). 3 June 2024
Pharmaceutical
CSL Seqirus is set to complete the fill and finish process for pre-pandemic vaccine to support the US government’s outbreak and preparedness response. 3 June 2024
Pharmaceutical
Eli Lilly has released updated data from its Phase I/II clinical trial evaluating olomorasib. 3 June 2024
Pharmaceutical
At the 2024 annual meeting of the American Society of Clinical Oncology (ASCO), Bristol Myers Squibb has announced promising results from the Phase III KRYSTAL-12 study. 3 June 2024
Interview
With a steady flow of oncology results emerging from the ongoing ASCO meeting, a company such as Pierre Fabre, which does not have major data to present, might not usually claim the spotlight. 3 June 2024
Pharmaceutical
US cancer-focussed firm Karyopharm Therapeutics presented updated exploratory subgroup analyses from the Phase III SIENDO study in patients with advanced or recurrent TP53 wild-type endometrial cancer at the American Society of Clinical Oncology (ASCO). 2 June 2024
Pharmaceutical
Last week, the US Court of Appeals for the District of Columbia (DC) ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program, noted Sophia Gaulkin and Alan Kirschenbaum of law firm Hyman Phelps & McNamara. 1 June 2024
Pharmaceutical
Privately-held UK clinical-stage firm Soterios Pharma has announced positive multi-dose Phase II trial evaluating STS-01 as a treatment for mild/moderate alopecia areata (AA). 31 May 2024
Pharmaceutical
Biogen has announced European approval for Qalsody (tofersen), for certain amyotrophic lateral sclerosis (ALS) patients, under exceptional circumstances. 31 May 2024
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