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
Among regulatory developments last week, the UK’s AstraZeneca received approval from the US food and Drug Administration (FDA) for its checkpoint inhibitor Imfinzi plus Imjudo for the treatment of lung cancer. Adding to the litany of failures in the search for an effective Alzheimer’s treatment, Swiss giant Roche last Monday released new clinical trial data on its candidate gantenerumab which did not meet the primary endpoint of the study. On the deal-making front, US companies POINT Biopharma and Lantheus Holdings entered into a licensing agreement for PNT2002 and PNT2003, two novel radiopharmaceuticals for cancer. US biotech Arcutis Biotherapies last Wednesday released positive Phase III results for its investigational atopic dermatitis drug roflumilast. 20 November 2022
Biotechnology
US biopharma Iveric Bio received a boost on Friday after its lead treatment candidate won Breakthrough Therapy designation from the US regulator, sending its shares up more than 25% to $21.65. 19 November 2022
Biotechnology
US biotech Iovance Biotherapeutics said on Friday that, although its ongoing rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) for lifileucel is expected to be completed in the first quarter of 2023, the FDA recently raised new questions that might prolong the approval process, but not by much. 19 November 2022
Biotechnology
Amyloidosis-focused biopharma Attralus and Ossianix, an antibody engineering company developing a single domain antibody platform (VNARs) to deliver molecules across the blood-brain barrier (BBB), have agreed a deal. 18 November 2022
Generics
A seven-member panel has been formed by India's Ministry of Health and Family Welfare to prepare the country's first-ever national drug database, which will be used to monitor the quality of drugs in circulation, reports The Pharma Letter’s local correspondent. 18 November 2022
Biotechnology
French drugmaker Sanofi has added a European approval to those in the USA and Japan for Enjaymo (sutimlimab) to treat hemolytic anemia in adults with cold agglutinin disease (CAD). 18 November 2022
Biotechnology
Shares of US biotech Inovio were down almost 7% at $2.30, after the company disclosed it was halting development of two vaccine programs because of disappointing clinical trial results. 18 November 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Exkivity (mobocertinib) for treating EGFR Exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy within a Final Appraisal Document (FAD). 18 November 2022
Biotechnology
While excitement about the potential of CRISPR/Cas9 gene editing remains high, a setback for a leading company using this technique shows it is no golden ticket to success. 18 November 2022
Pharmaceutical
Today, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) – the expert committee that evaluates the value of medicines in in the country – published advice recommending Australia’s discount rate could be lowered between 3.5% - 4% to bring the country closer to other recommended international standards. This is down from the current 5%. 18 November 2022
Biotechnology
The US Food and Drug Administration late yesterday approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who currently have stage 2 type 1 diabetes. 18 November 2022
Biosimilars
The US Food and Drug Administration has approved the second interchangeable biosimilar insulin product to Lantus (insulin glargine), Eli Lilly’s Rezvoglar (insulin glargine-aglr). 17 November 2022
Biotechnology
The European Commission today granted marketing authorization for Sino-American biotech BeiGene’s Brukinsa (zanubrutinib) for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. 17 November 2022
Biotechnology
Japanese drug major Takeda today revealed that the Phase III PhALLCON trial of Iclusig (ponatinib) for adult patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) met its primary efficacy endpoint in the frontline setting. 17 November 2022
Biotechnology
Shares in Californian company CytomX Therapeutics opened 23% higher on Thursday. 17 November 2022
Pharmaceutical
The critical need to develop new antibiotics has been underlined by the Association of the British Pharmaceutical Industry (ABPI). 17 November 2022
Biotechnology
French specialty vaccine company Valneva today announced the appointment of Dipal Patel as chief commercial officer (CCO) and management board member. 17 November 2022
Biotechnology
Australia’s Therapeutic Goods Administration (TGA) has granted a provisional determination to US pharma giant Pfizer’s bivalent COVID-19 vaccine candidate: tozinameran and famtozinameran (Comirnaty bivalent Omicron BA.4/BA.5 COVID-19 vaccine). 17 November 2022
Pharmaceutical
The unexpected news of a positive Food and Drug Administration advisory committee vote yesterday sent US cardiorenal-focussed drugmaker Ardelyx’ shares surging 84.4% to $2.25 in pre-market trading this morning. 17 November 2022
Biotechnology
Research from industry analyst GlobalData has identified challenges in the development of new CAR-T cell therapies for chronic lymphocytic leukemia (CLL). 17 November 2022
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