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
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
All news
Pharmaceutical
When new group chief executive Bill Anderson takes over at Bayer in June, he will find a Pharmaceuticals Division that looks very different to the organization that the American might have perceived for much of his 25 years in life sciences. 13 February 2023
Biotechnology
Positive Phase III data for Bristol Myers-Squibb’s Abecma (idecabtagene vicleucel) underscore the potential of the firm’s CAR-T cell therapy in multiple myeloma. 13 February 2023
Pharmaceutical
Mineralys Therapeutics, a previously private company in the portfolio of HBM Healthcare Investments, successfully completed its IPO last Friday. 13 February 2023
Pharmaceutical
It was a black Friday for San Diego, USA-based Aristea Therapeutics, as it announced that, due to safety findings in the ongoing Phase II clinical trials, it has discontinued the development program of its inflammatory disease drug candidate RIST4721 in order to protect patient safety. 13 February 2023
Pharmaceutical
Contract research organization (CRO) Novotech has published a new global report on Phase I trial activity including current metrics on fast growth regions and therapeutic areas. 13 February 2023
Biotechnology
Swedish immuno-oncology company Alligator Bioscience today announces the promotion of Laura von Schantz to the post of chief technology officer (CTO), and her joining the executive management team. 13 February 2023
Biotechnology
At the start of last week, US pharma major Bristol Myers Squibb pulled out of a licensing collaboration with Dragonfly Therapeutics on the development of the latter’s cancer drug candidate DF6002. UK pharma major GSK gained US Food and Drug Administration for its immune-oncology drug Jemperli for the treatment of endometrial cancer and an FDA advisory committee voted in favor of a clinical trial testing the drug in rectal cancer. There were a number of financial results releases, among which Anglo-Swedish drugmaker AstraZeneca posted fourth-quarter and full-year 2022 figures claiming that long-term investment in R&D is paying off. Also, the USA’s AbbVie announced financials on Thursday, with full-year guidance that warned its best-selling drug Humira will now be facing biosimilar competition in the USA. 12 February 2023
Generics
The courts in India have come down heavily against certain domestic pharmaceutical companies who have been accused of allegedly flagrantly violating patent policies, with many launching drugs that are still covered by patents, reports The Pharma Letter’s India correspondent. 11 February 2023
Biotechnology
The US Food and Drug Administration (FDA) has verbally informed US biotech Blueprint Medicines that it has placed a partial clinical hold on the Phase I/II VELA trial of BLU-222 due to visual adverse events (AEs) observed in a limited number of patients, the company announced on Friday, with the news pushing the firm’s shares down 7.9% to $40.80 pre-market. 11 February 2023
Biotechnology
US biotech Hillstream BioPharma, which is developing therapeutic candidates targeting drug resistant and devastating cancers using ferroptosis, saw its shares skyrocket 75% to $2.07 pre-market on Friday, and still closed up 35% at $1.59, after it released new clinical data on its lead candidate HSB-216. 11 February 2023
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca delivered a stunning rebuke to the embattled UK government on Thursday. 10 February 2023
Pharmaceutical
In the USA, the Department of Health and Human Services (HHS) has released its initial guidance for the implementation of a rebate program capping the price of certain medications provided under the Medicare insurance program. 10 February 2023
Biotechnology
US biotech Magenta Therapeutics has announced the outcome of a review of its business, including the status of its programs, resources, and capabilities. 10 February 2023
Pharmaceutical
UK medicines cost watchdog the National Institute for Health and Care Excellence (NICE) has recommended Stivarga (regorafenib), from German pharma major Bayer, as a treatment option for adult patients with metastatic colorectal cancer who have had previous treatment (including fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy) or when these treatments are unsuitable. 10 February 2023
Biotechnology
With its Vabysmo (faricimab) already approved in more than 50 markets including the USA and Europe for the treatment of wet, or neovascular, age-related macular degeneration (AMD), Swiss pharma giant Roche is now touting the benefits of the drug in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). 10 February 2023
Biotechnology
More compelling evidence of the safety and efficacy of delgocitinib has lifted the likelihood that Danish dermatology specialist LEO Pharma will be able to secure approval. 10 February 2023
Biotechnology
Given the spate of non-conversions of accelerated approvals by the US regulator, there was good news yesterday for UK pharma major GSK regarding Jemperli (dostarlimab-gxly), as the company’s ambition is for the drug to become the backbone of its ongoing immuno-oncology-based R&D program. 10 February 2023
Pharmaceutical
Shares of US pharma major AbbVie were up 4% at $150.57, after it announced financial results for the fourth quarter and full-year 2022 results, with profits ahead of expectations but 2023 forecast disappointed. 9 February 2023
Pharmaceutical
Mid-size drugmaker Ipsen looked set to close Thursday’s trading with gains of more than 4% in the stock market. 9 February 2023
Biotechnology
Adding to a string of strong clinical trials reports for its already-marketed drug, Gilead Sciences subsidiary Kite today announced the three-year follow-up results from the pivotal ZUMA-3 study of its CAR T-cell therapy Tecartus (brexucabtagene autoleucel). 9 February 2023
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