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.
Today's issue
Refine Search
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
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
All news
Biotechnology
The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy). 11 October 2022
Biotechnology
Results from early stage research into AstraZeneca’s coronavirus vaccine has poured cold water onto hopes that a nasally-administered form of the jab could be developed soon. 11 October 2022
Biotechnology
Reports hinting that Michelle McMurry-Heath’s days as president and chief executive of the Biotechnology Innovation Organization (BIO) might be numbered have circulated in recent days. 11 October 2022
Biotechnology
Shares of Ginkgo Bioworks were down 3.6% at $2.78 today, despite the company announcing a deal with US pharma giant Merck & Co to engineer a crucial component of up to four enzymes for use as biocatalysts in Merck's active pharmaceutical ingredient (API) manufacturing efforts. 11 October 2022
Biotechnology
Oxford, UK-based start-up Ochre Bio, an innovator in chronic liver disease drug development, yesterday announced the successful close of $30 million in Series A financing. 11 October 2022
Biotechnology
Dutch rare disease specialist Pharming has moved a step closer to marketing authorization for leniolisib in Europe. 11 October 2022
Biotechnology
Neumora Therapeutics, a US clinical-stage biotech focussed on brain diseases through the integration of data science and neuroscience that came out of stealth in July last year with $500 million financing, has added to its cash pile announcing today the close of a $112 million Series B financing. 11 October 2022
Biotechnology
The UK’s BioIndustry Association (BIA), the trade body for innovative life sciences, has welcomed a one-year extension to the European Commission Decision Reliance Procedure (ECDRP). 11 October 2022
Pharmaceutical
German pharma major Bayer had a boost for its Kerendia (finerenone), a non-steroidal mineralocorticoid receptor antagonist, with an important endorsement for the drug’s use. 11 October 2022
Biotechnology
Positive Phase III trial results evaluating the investigational use of Dupixent (dupilumab) in children aged one to 11 years with active eosinophilic esophagitis (EoE) were presented today at United European Gastroenterology (UEG) Week 2022. 11 October 2022
Biotechnology
Singapore-based TauRx Pharmaceuticals, a company that claims to be the global leader in tau-based research in Alzheimer’s disease, recently reported positive progress for the firm's lead investigative oral drug hydromethylthionine mesylate (HMTM). The drug was found to be effective in improving cognition in patients with early Alzheimer’s disease (AD). 11 October 2022
Biotechnology
German drug developer Immatics has announced a major public offering, raising $110 million for its work on T cell immunotherapies. 10 October 2022
Pharmaceutical
The European Commission has informed Israel-based generics behemoth Teva Pharmaceutical Industries of its preliminary view that the company has breached EU antitrust rules by engaging in practices intended to delay competition to its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate). 10 October 2022
Biotechnology
Shares in Merck & Co were more than 4% higher in the first hour of trading on Monday. 10 October 2022
Pharmaceutical
Swedish firm InDex Pharmaceuticals has announced that its board of directors has named Jenny Sundqvist as the company's new chief executive. 10 October 2022
Pharmaceutical
In what could be a paradigm shift in the treatment of congestion due to worsening heart failure, the US Food and Drug Administration (FDA) has approved Furoscix (furosemide injection). 10 October 2022
Pharmaceutical
Privately-held Covis Pharma knows what it is up against from the US Food and Drug Administration (FDA) as the regulator attempts to have the company’s preterm birth (PTB) drug Makena (hydroxyprogesterone caproate) withdrawn from the market. 10 October 2022
Biotechnology
Set against a turbulent economic backdrop, a major fundraise from the life sciences division of Andera Partners shows there is still significant appetite for investment in the biotech sector. 10 October 2022
Pharmaceutical
UK clinical stage drug development company Evgen Pharma saw its shares rocket more than 66% to 4.63 pence this morning, after it revealed the signing of global license for lead asset SFX-01 in neurodevelopmental disorders and schizophrenia to Stalicla. 10 October 2022
Biotechnology
In a sign that special purpose acquisition company (SPAC) deals may be back in favor, Estrella Biopharma and TradeUP Acquisition Corp, a publicly-traded SPAC, have entered into a definitive business combination agreement that will result in Estrella becoming a publicly listed company. 10 October 2022
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze