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Pharmaceutical
Sweden’s Hansa Biopharma says that the European Medicines Agency has accepted the company's Marketing Authorization Application (MAA) for review of Idefirix (imlifidase). 1 March 2019
Pharmaceutical
US tech giant Amazon has reportedly appointed former VP of logistics Nader Kabbani as head of the firm’s pharmacy group PillPack. 1 March 2019
Pharmaceutical
Japanese drugmaker Taisho Pharmaceutical has sought to increase its stake in Vietnam-based Duoc Hau Giang Pharmaceutical JSC beyond the current 35% share. 1 March 2019
Pharmaceutical
Rare diseases company Amryt Pharma has announced an update on its Phase III EASE trial for AP101 as a potential treatment for epidermolysis bullosa (EB). 28 February 2019
Pharmaceutical
There were 31 new prescription drugs registered by Australia’s Therapeutic Goods Administration (TGA) in 2018, compared to 34 in 2017 and 41 in 2016. 28 February 2019
Pharmaceutical
London-listed Hikma Pharmaceuticals has entered into an exclusive license, supply and distribution agreement with Melinta Therapeutics for the latter’s intravenous and oral formulations of Baxdela (delafloxacin) across all its MENA markets. In addition, Hikma has the right of first negotiation for all other products in Melinta’s portfolio and pipeline in the region. 28 February 2019
Pharmaceutical
UK lawmakers are seeking to improve clinical trial transparency, following recommendations from the House of Commons Science and Technology committee. 27 February 2019
Pharmaceutical
Synergy Pharmaceuticals has confirmed that the previously announced agreement with Bausch Health Companies has been designated as the highest and best offer for Synergy's assets, including all rights to irritable bowel syndrome with constipation (IBS-C) drug Trulance (plecanatide), dolcanatide and related intellectual property. 27 February 2019
Pharmaceutical
Ono Pharmaceutical has launched a new combination in its native Japan for the treatment of unreselectable melanoma with a BRAF mutation. 26 February 2019
Pharmaceutical
The US Food and Drug Administration yesterday published a draft guidance for industry titled, “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” 26 February 2019
Pharmaceutical
US-based Taiho Oncology has won US approval for Lonsurf (trifluridine/tipiracil) as a third-line treatment for adults with metastatic gastric or gastroesophageal junction adenocarcinoma. 26 February 2019
Pharmaceutical
Privately-held German firm Boehringer Ingelheim has appointed Mehdi Shahidi as chief medical officer, replacing Thor Voigt, who will retire after 27 years at the firm. 25 February 2019
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER)) on Friday announced that it plans to assess the comparative clinical effectiveness and value of additive cardiovascular disease (CVD) therapies Vascepa (icosapent ethyl), from Amarin Pharma, and Xarelto (rivaroxaban, marketed by Janssen Pharmaceuticals under a partnership with Germany’s Bayer. 25 February 2019
Pharmaceutical
Japan’s Daiichi Sankyo has announced senior-level organizational changes, appointing Junichi Koga as global head of R&D and Ken Keller as president and CEO of the group’s US subsidiary. 22 February 2019
Pharmaceutical
French drug major Sanofi's controversial dengue fever vaccine was dealt another blow as the Philippines permanently banned the treatment that created a health scare in the country, reports The Straits Times and other media. 20 February 2019
Pharmaceutical
Novartis’ US-based generic division Sandoz has launched an authorized generic of Suboxone (buprenorphine/naloxone) in the USA. The therapy is indicated for the treatment of opioid dependence. 20 February 2019
Pharmaceutical
Following a safety review of cough and cold products containing opioids, medicines regulator Health Canada is advising that Canadian children and adolescents (under 18 years of age) should not use cough and cold products containing codeine, hydrocodone and normethadone, as a precautionary measure. 18 February 2019
Pharmaceutical
USA-headquartered Moksha8, a specialty pharmaceutical company focused on licensing and marketing innovative and established therapeutics in Latin America, today announced the closing of a strategic financing agreement for up to $125 million with Canada-based Knight Therapeutics. 18 February 2019
Pharmaceutical
Roche's antiviral Tamiflu (oseltamivir) reduced mortality in severely ill patients with influenza A/H3N2, according to research published in Clinical Infectious Diseases. 14 February 2019
Pharmaceutical
The US Food and Drug Administration has confirmed the capability of two additional European Union member states to carry out good manufacturing practice (GMP) inspections at a level equivalent to the USA. 12 February 2019
Pharmaceutical
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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