Latest Pharma and Biotech News
Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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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
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
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
All news
Biosimilars
Similis Bio, the JSR Life Sciences business unit focused on biosimilar development, has announced plans to enter into a partnership with Novel351k. 16 February 2023
Biotechnology
Swedish biotech Aqilion has announced a deal with Germany’s Merck KGaA. 16 February 2023
Biotechnology
Privately-held Direct Biologics has named Amy Lightner its chief medical officer. 16 February 2023
Biotechnology
US biotech Capricor Therapeutics has entered into a partnership with mid-sized Japanese drugmaker Nippon Shinyaku, for the exclusive commercialization and distribution in Japan of Capricor’s lead asset, CAP-1002, for the treatment of Duchenne muscular dystrophy (DMD), a rare neuromuscular disease with limited treatment options. 16 February 2023
Biotechnology
US biotech Seagen was trading 12% higher early in Thursday’s trading after its latest financial results beat estimates. 16 February 2023
Biotechnology
French biotech firms Erytech Pharma and Pherecydes Pharma today announced they intend to merge their operations and relocate all teams to Erytech’s premises in Lyon, France, where they would benefit from presence in a major European hub for infectious diseases. 16 February 2023
Biotechnology
Dutch rare disease specialist Pharming has suffered a setback in the European approval process for its leniolisib, a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. 16 February 2023
Biotechnology
Japanese drugmaker Shionogi recently won approval for Xocova (ensitrelvir) for SARS-CoV-2 infection in Japan. 16 February 2023
Pharmaceutical
Spanish producer of blood plasma-based products Grifols has joined the ranks of pharma and biotech companies cutting their budgets and workforces, in a move that was welcomed by investors, with the firm’s shares rising 9% Wednesday and a further 8.6% to 14.76 euros this morning. 16 February 2023
Biotechnology
Privately-held Italian biotech Enthera Pharmaceuticals today announces the appointment of Filippo Canducci as chief medical officer. 16 February 2023
Biotechnology
US biotech Arrowhead Pharmaceuticals yesterday revealed receiving a written notice from US healthcare giant Johnson & Johnson’s Janssen unit that it has terminated its rights to JNJ-75220795, now called ARO-PNPLA3, under the October 2018 research collaboration and option agreement, as part of J&J’s strategic R&D portfolio review. 16 February 2023
Generics
Indian drugmaker Glenmark Pharmaceuticals (BSE: 532296) and US pharma giant Merck & Co (NYSE: MRK) are facing an antitrust lawsuit over allegations that the duo illegally settled a patent dispute in order to delay the launch of generic versions of the blockbuster cholesterol reducer Zetia (ezetimibe). 16 February 2023
Pharmaceutical
Italian central nervous system (CNS) specialist Newron Pharmaceuticals saw its shares leap more than 17% to 5.12 Swiss francs this morning, after it announced what it called ‘very exciting’ results for its antipsychotic candidate evenamide. 16 February 2023
Pharmaceutical
Denmark’s Bavarian Nordic, which has won a number of significant contracts for its smallpox vaccine Imvanex that has also shown efficacy against monkeypox, an infectious disease that has been spreading strongly, is now taking advantage of its windfall to expand its travel vaccines portfolio. 15 February 2023
Biotechnology
Sesen Bio and Carisma Therapeutics have further changed their previously amended merger agreement following investor pushback. 15 February 2023
Biotechnology
February 15, 2023
US biotech major Biogen today reported financials for 2022, showing that fourth quarter revenues were $2,544 million, a decline of 7% but beating consensus forecasts of $2.45 billion. 15 February 2023
Biotechnology
Hematologic diseases specialist Disc Medicine has announced a $62.5 million financing. 15 February 2023
Pharmaceutical
The Secretary of the US Department of Health and Human Services (HHS) has selected three new models for testing by the Centers for Medicare & Medicaid Services’ (CMS) Innovation Center to help lower the high cost of medicines in the USA. 15 February 2023
Generics
Indian generics major Zydus Lifesciences has received tentative approval from the US Food and Drug Administration (FDA) to market canagliflozin tablets, 100mg and 300mg. 15 February 2023
Biotechnology
With its recently granted expanded approval by the US Food and Drug Administration (FDA) for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) - for patients with HR-positive/HER2-negative metastatic breast cancer who have received hormonal therapy and at least two additional therapies – the drug is expected to become a standard of care for these breast cancer patients, who have had limited treatment options. 15 February 2023
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