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27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Pharmaceutical
Italian drugmaker Recordati today presented its annual financial results for the first nine months of 2022, edging its shares up 1.6% to 38.48 euros. 8 November 2022
Biotechnology
Japan’s Ono Pharmaceutical has exercised its option to an iPS cell-derived chimeric antigen receptor (CAR)-T cell therapy targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors, under its collaboration with Fate Therapeutics. 8 November 2022
Pharmaceutical
Ocuphire Pharma’s leapt nearly 27% to $2.65 in pre-market activity this morning, in reaction to its conclusion of an exclusive license agreement with FamyGen Life Sciences (Famy) for the development and commercialization of Nyxol (phentolamine mesylate) across three indications in USA, Europe, Japan, India, China and other global markets. 8 November 2022
Pharmaceutical
Continued growth in the giant and growing market for heart failure treatments looks assured for British pharma major AstraZeneca, with more positive data for its glucose lowering blockbuster Farxiga (dapagliflozin). 8 November 2022
Pharmaceutical
German life sciences giant Bayer has reported an increase in sales across the group in the third quarter 2022, up 5.7% to 11.3 billion euros ($11.3 billion). 8 November 2022
Generics
Generics major Viatris yesterday said it intends to create an ophthalmology franchise by acquiring two companies, Oyster Point Pharma (Nasdaq: OYST) and Famy Life Sciences. 8 November 2022
Biotechnology
US biotech Mirum Pharmaceuticals saw its shares rise 3% to $23.69 yesterday, when it presented new data from Livmarli (maralixibat) oral solution studies at The Liver Meeting of the American Association for the Study of Liver Diseases. 8 November 2022
Biotechnology
Shares in Nicox tumbled last week as investors digested the mixed results from its Mont Blanc Phase III trial evaluating NCX 470 in open angle glaucoma or ocular hypertension. 7 November 2022
Biotechnology
UK pharma major GSK’s shares were down 4.3% at 1,383.60 pence by early afternoon today, as it announced disappointing Phase III results with its Blenrep (belantamab mafodotin). 7 November 2022
Biotechnology
Shares of Germany-based BioNTech were down 6.8% at $147.48 in pre-market New York trading as it reported third-quarter 2022 financial results, showing that sales and profits were almost half those of the comparable 2021 quarter figures. 7 November 2022
Biotechnology
Shares in Sensorion, a French biotech that specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, were trading 17% higher on Monday afternoon. 7 November 2022
Generics
Sandoz, the soon to be divested generic and biosimilar medicines business of Swiss pharm giant Novartis, today announced an additional investment of 50 million euros ($49.5 million) to support increased European manufacturing capacity for finished dosage form (FDF) penicillins, the leading class of antibiotics worldwide. 7 November 2022
Generics
New York Attorney General Letitia James last Friday marked a major milestone in her fight against the opioid crisis in New York state, when she announced that her office has secured up to $523 million from the US subsidiary and affiliates of Israeli generics giant Teva Pharmaceutical Industries for their role in fueling the opioid crisis. 7 November 2022
Biotechnology
Biopharmaceutical firms in China are focusing on the development of new COVID-19 treatments, designed to tackle new Omicron variants. 7 November 2022
Pharmaceutical
In what should be a wake-up call for the European pharma sector, a new report published today by Charles River Associates for the European Federation of Pharmaceutical Industries and Associations (EFPIA) paints a challenging picture of falling competitiveness in Europe, with the global share of pharmaceutical R&D investment, clinical trials and manufacturing output all decreasing. 7 November 2022
Biotechnology
France’s GenSight Biologics saw its shares close up 8.7% at 3.71 euros on Friday, after it announced it has entered into a 35 million-euro ($34.6 million) credit facility agreement with the European Investment Bank (EIB), supported by the European Fund for Strategic Investment (EFSI). 7 November 2022
Pharmaceutical
Japanese drug major Eisai today announced that it has entered into an agreement to divest its rights for muscle relaxant Myonal (eperisone hydrochloride) and vertigo and equilibrium disturbance treatment Merislon (betahistine mesilate) in Asia to a subsidiary of Switzerland-based DKSH Holding Ltd. 7 November 2022
article
The pace of innovation and digital transformation is increasing in the life science industry, particularly regarding regulatory compliance. As a result of the pandemic, when new age technologies were used to rapidly develop COVID-19 vaccines, treatments and tests, the use of automation and artificial intelligence to also optimize pharmacovigilance (PV) and regulatory compliance operations is on the rise. 6 November 2022
Biotechnology
Featured research news last week included US pharma major Bristol Myers Squibb releasing top-line results from a Phase III study suggesting its Reblozyl can address a wider myelodysplastic syndrome patient group. Actinium Pharmaceuticals reported positive top-line Phase III results for it acute myeloid leukemia (AML) candidate Iomab-B. Also, US pharma giant Pfizer last Tuesday presented strong data for its RSVpreF respiratory syncytial virus (RSV) vaccine program. On the deal-making front, US MRNA technology company Arcturus Therapeutics hit the jackpot last week, inking a potentially hugely lucrative deal with Australian biotech CSL Limited, to access the firm’s late-stage self-amplifying mRNA (sa-mRNA) vaccine platform technology. 6 November 2022
Pharmaceutical
US drug developer Ionis Pharmaceuticals saw its shares close down 8.5% at $40.98 on Friday, after it revealed that its licensing partner, Germany’s Bayer, had pulled out of a deal for the development of fesomersen. 5 November 2022
All news
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Pharmaceutical
Munich, Germany headquartered contract development and manufacturing organization (CDMO) Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. 28 November 2024
Pharmaceutical
The board of Spanish plasma-based medicines producer Grifols has announced the termination of discussions with Brookfield Capital Partners (UK) regarding a potential acquisition of Grifols shares. 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Pharmaceutical
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
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