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
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Pharmaceutical
Munich, Germany headquartered contract development and manufacturing organization (CDMO) Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. 28 November 2024
Pharmaceutical
The board of Spanish plasma-based medicines producer Grifols has announced the termination of discussions with Brookfield Capital Partners (UK) regarding a potential acquisition of Grifols shares. 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 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
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
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Biotechnology
Russia has been faced with a shortage of Oncaspar (pegaspargase), a drug from French independent pharma major Servier, which is designed for the treatment of leukemia in children. 14 October 2022
Biotechnology
A significant late stage trial win lifted GSK stock by around 1.5% in early morning trading on Friday, with the company hailing the result as “truly exceptional.” 14 October 2022
Biotechnology
Late-stage US biotech Relmada Therapeutics’ shares sank 78% to $7.00 by mid-morning, after it revealed that its RELIANCE III study (REL-1017-303), evaluating REL-1017 in the monotherapy setting for major depressive disorder (MDD), did not achieve its primary endpoint. 13 October 2022
Biotechnology
Australian drug discovery company AdAlta and venture-backed Korean biotech GPCR Therapeutics have announced a collaboration. 13 October 2022
Pharmaceutical
The migraine market has seen the introduction of a large number of highly effective monoclonal antibody (Mab) drugs for the prevention of the condition, leading to expectations for the overall therapy sector to grow from $4.7 billion in 2020 to $12 billion in 2030 across the seven major markets. 13 October 2022
Biotechnology
US biotech Novavax has reported potentially important results on its COVID-19 vaccine NVX-CoV2373. 13 October 2022
Biotechnology
Sino-American biotech BeiGene shot up on Wednesday, after the company's chronic lymphocytic leukemia (CLL) treatment was shown to beat out a blockbuster drug from Johnson & Johnson. 13 October 2022
Biotechnology
Shares of US biotech Moderna leapt almost 12% to $134.96 yesterday, after it announced that pharma giant Merck & Co has opted to develop a personalized cancer vaccine based on messenger RNA technology. 13 October 2022
Biotechnology
Updated results from the Phase I/II STAAR trial are good enough for Sangamo Therapeutics to trigger the expansion phase of the study. 13 October 2022
Biotechnology
The US Food and Drug Administration yesterday said it has amended the emergency use authorizations (EUAs) for two COVID-19 vaccine, bivalent to authorize their use as a single booster dose in younger age groups. 13 October 2022
Biosimilars
An Expert View from Mark Samuels, chief executive, British Biosimilars Association. 12 October 2022
Pharmaceutical
French therapeutic peptides for rare endocrine and metabolic diseases company Amolyt Pharma today announced positive Phase IIa safety and efficacy data from the second cohort of its ongoing clinical trial evaluating its lead candidate, AZP-3601, in patients with hypoparathyroidism. 12 October 2022
Biotechnology
GSK subsidiary Sierra Oncology has returned rights for oncology candidate SRA737 to the CRT Pioneer Fund (CPF), a joint initiative between commercialization and development company Cancer Research Technology and the European Investment Fund. 12 October 2022
Biotechnology
Denmark-based clinical-stage firm Evaxion Biotech, which specializes in the development of AI-driven immunotherapies, announced that its new chief executive Per Norlén joined the company on October 3. 12 October 2022
Biotechnology
US precision oncology start-up Tavros Therapeutics and Vividion Therapeutics, a biopharma company that was snapped by German pharma major Bayer last year, have entered into a collaboration to discover or target four oncology targets across an initial five-year term. 12 October 2022
Biotechnology
Boston-based Albireo Pharma, a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, closed more than 14% higher after Tuesday’s trading. 12 October 2022
Pharmaceutical
Japanese pharma major Astellas today released positive 52-week results from the Phase III SKYLIGHT 4 clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 12 October 2022
Biosimilars
Inflation across Europe has now risen above 10%. As a result, this has increased the manufacturing costs of essential, off patent medicines, which account for 70% of those dispensed in Europe. 12 October 2022
Pharmaceutical
Positive early stage data bode well for DICE Therapeutics' goal of developing a novel oral therapeutic for the treatment of psoriasis. 12 October 2022
Pharmaceutical
The global general anesthesia drugs market is anticipated to reach a valuation of $6.7 billion by 2032, with sales growing at a stagnant CAGR of 3.4% from 2022 to 2032, according to Future Market Insights. 12 October 2022
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