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
The Australian Therapeutic Goods Administration (TGA) said today that it has commenced evaluation of an application from the local subsidiary of US mRNA vaccines specialist Moderna to transition its Spikevax (COVID-19 Vaccine, mRNA), to full registration for the immuniz0ation of individuals six years and over, and as a booster dose for individuals aged 12 years and older. 20 January 2023
Biotechnology
Chinese biotech company BeiGene has announced that the US Food and Drug Administration (FDA) has approved Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 20 January 2023
Biotechnology
Positive Phase III results for Shanghai’s Junshi Biosciences will lift the company’s prospects in the competitive market for lung cancer therapies. 20 January 2023
Biotechnology
Patient groups have expressed disappointment that USA-based drugmaker Eli Lilly has not been granted an Accelerated Approval for its Alzheimer’s disease candidate, donanemab. 20 January 2023
Biotechnology
Cambridge, USA-based genome editing company Editas Medicine has entered into a definitive agreement with US biotech Shoreline Biosciences (Shoreline) to license Editas Medicine’s proprietary SLEEK (SeLection by Essential-gene Exon Knock-in) and AsCas12a gene editing technologies and acquire Editas Medicine’s pre-clinical gene edited induced pluripotent stem cell (iPSC) derived natural killer cell (iNK) programs and related manufacturing technologies. 20 January 2023
Biotechnology
On Thursday, the US Food and Drug Administration (FDA) granted accelerated approval for Seagen’s Tukysa (tucatinib) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. 20 January 2023
Biotechnology
After a difficult year for investment, look for the biotech industry to engage in creative dealmaking in the market, leading to faster innovation in the lab, Protagonist Therapeutics CEO Dinesh Patel writes in Bio.News. 20 January 2023
Pharmaceutical
Leading Indian drugmaker Sun Pharmaceutical Industries today announced a definitive agreement under which Sun Pharma will acquire all outstanding shares of US firm Concert Pharmaceuticals, with the news pushing the latter's shares up more than 20% to $8.30. 19 January 2023
Pharmaceutical
Massachusetts, USA-based psychoactive medicine specialist Sensorium Therapeutics has appointed Jeffrey Brown as chief scientific officer. 19 January 2023
Biotechnology
Following on from European Commission (EC) approvals in November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Brukinsa (zanubrutinib) in Great Britain. 19 January 2023
Biotechnology
The UK health technology assessor, the National Institute for Health and Care Excellence (NICE) has issued a Final Evaluation Document recommending Translarna (ataluren) for reimbursement and use across the National Health Service (NHS) in England and Wales in the treatment of Duchenne muscular dystrophy (DMD). 19 January 2023
Biotechnology
RNAi specialist Alnylam Therapeutics’ Amvuttra (vutrisiran) has been recommended for use on the National Health Service (NHS) in England as an option for treating hereditary transthyretin-related (ATTRv) amyloidosis. 19 January 2023
Biotechnology
The pivotal Phase III IMbrave050 study, which investigated PD-L1 inhibitor Tecentriq (atezolizumab) plus anti-VEGF antibody Avastin (bevacizumab) in people with early-stage hepatocellular carcinoma or HCC at high risk of recurrence following surgery, met primary endpoint of recurrence-free survival at the prespecified interim analysis, according to Swiss pharma giant Roche. 19 January 2023
Pharmaceutical
An investigational HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition compared to placebo, an independent data and safety monitoring board (DSMB) has determined. No safety issues with the regimen were identified, but it is another blow for hopes of a vaccine against the virus. 19 January 2023
Biotechnology
Sino-American biotech BeiGene saw its shares rise 3.5% to 160.51 renminbi, after it announced that the National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include four new indications for its PD-1 inhibitor tislelizumab. 19 January 2023
Biotechnology
Neurodegenerative diseases specialist APRINOIA Therapeutics has announced a merger with Ross Acquisition Corp II, a special purpose acquisition company (SPAC) founded by former US Secretary of Commerce Wilbur Ross. 18 January 2023
Biotechnology
Negotiations with the China National Healthcare Security Administration (NHSA) have borne fruit for Hutchmed and its product Orpathys (savolitinib). 18 January 2023
Biotechnology
EVOQ Therapeutics and fellow USA-based Amgen today announced they are advancing their ongoing license and collaboration agreement for the discovery and development of novel therapeutics including the receipt of a milestone payment and expansion of the scope of collaboration to include a total of three indications in autoimmune disorders. 18 January 2023
Biotechnology
SFJ Pharmaceuticals is claiming victory in its legal dispute with cardiopulmonary diseases focussed US firm PhaseBio Pharmaceuticals regarding a blood thinner reversal agent, announcing the closing of the sale and transfer of assets related to bentracimab from PhaseBio to SFJ. 18 January 2023
Pharmaceutical
There is no shortage of criticism currently being directed at the UK government from the public sector, especially where healthcare is concerned ... 18 January 2023
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