Latest Pharma and Biotech News
Pharmaceutical
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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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
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
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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
Biotechnology
The US Food and Drug Administration (FDA) on Friday updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. 5 November 2022
Biotechnology
An Expert View from RJ Tesi, co-founder and chief executive of INmune Bio. 4 November 2022
Biotechnology
The European Commission (EC) has approved Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. 4 November 2022
Pharmaceutical
Further adding to the wealth of support for their blockbuster diabetes drug Jardiance (empagliflozin), German family-owned Boehringer Ingelheim and US partner Eli Lilly today released new data supporting its benefits in chronic kidney disease during the American Society of Nephrology (ASN)’s Kidney Week 2022. 4 November 2022
Biotechnology
mRNA-based vaccine specialist BioNTech and its partner Pfizer have released strong new data for its Omicron-adapted bivalent booster. 4 November 2022
Pharmaceutical
Privately-held German drugmaker Boehringer Ingelheim has appointed a new chief medical officer, Lykke Hinsch Gylvin. 4 November 2022
Pharmaceutical
Japanese drugmaker Kissei Pharmaceutical has entered into a license agreement with Synmosa Biopharma for the development and commercialization rights in Taiwan for the GnRH antagonist linzagolix that was discovered by Kissei. 4 November 2022
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