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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Pharmaceutical
If January offered excitement, promise and hope for a busy year of pharma M&A ahead, then February has more than tempered those expectations. 2 March 2023
Biotechnology
The developers of the newly-approved hemophilia A therapy Altuviiio (efanesoctocog alfa) have announced positive results from the Phase III XTEND-Kids trial. 2 March 2023
Generics
In 2022, generic drugs remained a significant public health priority for the US Food and Drug Administration (FDA), the agency announced yesterday, along with publishing its 2022 Office of Generic Drugs (OGD) Annual Report. 2 March 2023
Biotechnology
The influential Institute for Clinical and Economic Review (ICER), a Boston, USA-based pricing watchdog, has released a report into the cost-effectiveness of Leqembi (lecanemab). 1 March 2023
Biotechnology
Immuno-oncology (I-O) company Marengo Therapeutics has announced the appointment of Kevin Chin as chief medical officer. 1 March 2023
Pharmaceutical
The political news this week in the UK is full of Prime Minister Rishi Sunak’s deal with the European, commented Ropes & Gray private equity counsel David Dowling. 1 March 2023
Pharmaceutical
Texan biopharma Reata Pharmaceuticals opened trading more than 180% higher on Wednesday. 1 March 2023
Biotechnology
Shares of US biotech Cidara Therapeutics rose almost 20% to $1.81 in early trading as the company announced promising efficacy and safety data from a planned interim analysis of the ongoing Phase IIa trial evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain, as of a February 13, 2023 data cut-off. 1 March 2023
Pharmaceutical
Eager to boost the development of orphan drugs to treat rare diseases in India, the government is looking to offer incentives to drug companies in terms of faster approvals and extended periods of exclusivity. 1 March 2023
Biotechnology
Antibody-drug conjugate (ADC) company ImmunoGen is to license its technology to Vertex Pharmaceuticals. 1 March 2023
Pharmaceutical
The European Commission has granted marketing authorization for Nubeqa (darolutamide) alongside androgen deprivation therapy in combination with docetaxel, to treat metastatic hormone-sensitive prostate cancer (mHSPC). 1 March 2023
Biotechnology
Shanghai Junshi Biosciences had more positive news, this time on its monoclonal antibody (MAb) candidate ongericimab, adding to the successful trials results for its toripalimab in breast cancer last week. 1 March 2023
Biotechnology
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday voted that available data is adequate to support the safety and effectiveness of the respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF, from US pharma giant Pfizer. 1 March 2023
Biotechnology
Two late-stage trials testing Merck & Co’s class-leading immunotherapy Keytruda (pembrolizumab) have been discontinued. 1 March 2023
Biotechnology
In a second financing within one year, China-based Oricell Therapeutics has announced the close of a $45 million Series B1 investment round. This adds to the $125 million Series B fund that was raised in July 2022. 1 March 2023
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) has attempted to show that there is a better way than the existing Voluntary Pricing and Access Scheme (VPAS). 1 March 2023
Generics
US generic drug-focussed drugmaker Viatris has announced that, as it prepares to enter Phase 2 of its previously revealed strategic plan in 2024, the appointment of pharma veteran Scott Smith to lead the execution of that plan as Viatris' new chief executive (CEO), effective April 1, 2023. 28 February 2023
Pharmaceutical
Werner Baumann, chairman of the board of management at the German life sciences major Bayer, presented his final set of annual financial results on Tuesday. 28 February 2023
Biotechnology
US precision medicines company Frontier Medicines today announced the addition of Christo Shalish to the leadership team as senior vice president (SVP) and head of business development. 28 February 2023
Biotechnology
Sino-American biotech BeiGene yesterday reported financial results, showing that revenues for the fourth quarter and full year 2022 was $380.1 million, missing consensus estimates of $345 million by 2%, and $1.4 billion, respectively, compared to $214.0 million and $1.2 billion in the prior-year periods. 28 February 2023
All news
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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