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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Pharmaceutical
Context Therapeutics, a women’s oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, and the Menarini Group have announced a clinical trial collaboration and supply agreement for the latter firm’s oral selective estrogen receptor degrader, elacestrant. 2 August 2022
Biotechnology
Oncology-focused Australian drug development company Kazia Therapeutics lost more than 50% of its stock market value on Monday. 2 August 2022
Pharmaceutical
Shares of Sosei Group were up nearly 5% at 1,500 yen today, as it announced a lucrative deal with US pharma major AbbVie. 2 August 2022
Biotechnology
Pre-clinical stage gene therapy company AviadoBio has announced the appointment of David Cooper as chief medical officer (CMO). 2 August 2022
Biotechnology
USA-based clinical-state biopharma firm IDRx, which is dedicated to transforming cancer treatment with purpose-built precision combination therapies, launched today with a $122 million oversubscribed Series A financing. 2 August 2022
Pharmaceutical
A new analysis by the health care analytics and research firm Avalere reveals the US Senate’s partisan drug pricing bill will have a much deeper impact on the biopharmaceutical research industry than previously reported, noted the leading US sector lobby group Pharmaceutical Research and Manufacturers of America (PhRMA), which gave its assessment of the implications. 2 August 2022
Pharmaceutical
German biopharma Vivoryon Therapeutics has announced results for its Alzheimer’s disease (AD) drug candidate varoglutamstat from the ongoing European Phase IIb study VIVIAD. 2 August 2022
Biotechnology
USA-based GreenLight Biosciences, a biotechnology company dedicated to making ribonucleic acid (RNA) products affordable and accessible, saw its shares close up almost 10% at $2.33 yesterday, after it announced the successful completion of the first commercial-scale engineering run for the mRNA production partnership with South Korean contract development and manufacturing organization (CDMO), Samsung Biologics. 2 August 2022
Biotechnology
GluBio Therapeutics, a Sino-American biotech developing novel targeted protein degradation (TPD) drugs, has completed a Series A+ financing of $22 million. 2 August 2022
Pharmaceutical
Scientists at the Russian Granov Scientific Center for Radiology and Surgical Technologies have developed a new drug, which could be recommended for the use against severe forms of cancer, reports The Pharma Letter’s local correspondent. 2 August 2022
Biotechnology
OriCell Therapeutics has announced the completion of Series B financing totaling more than $120 million, which was jointly led by Qiming Venture Partners and Quan Capital. 2 August 2022
Biotechnology
Belgian clinical-stage biotech Celyad Oncology, which is focused on the discovery and development of chimeric antigen receptor T cell (CAR-T) therapies for cancer, yesterday announced that the US Food and Drug Administration (FDA) has lifted the clinical hold on the CYAD-101-002 (KEYNOTE-B79) Phase Ib trial after the company made changes to the eligibility criteria for the trial. 2 August 2022
Biotechnology
Swiss pharma giant Roche today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of its cancer immunotherapy Tecentriq (atezolizumab) met its co-primary endpoints. 2 August 2022
Biotechnology
US healthcare giant Johnson & Johnson’s Janssen subsidiary today announced that the US Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA). 1 August 2022
Generics
Shares in Sun Pharma closed more than 5% higher on Friday. 1 August 2022
Pharmaceutical
Thousands more people in the UK will get potentially life-saving treatment for hepatitis C thanks to a new National Health Service (NHS) screening pilot – driving forward the NHS ambition to eliminate the virus by 2030. 1 August 2022
Pharmaceutical
UK-based Arecor Therapeutics has announced that it is to acquire Tetris Pharma. 1 August 2022
Biotechnology
German independent research institute BioMed X has announced the start of its new research project ‘Extrachromosomal DNA in Cancer’ (EDC) in collaboration with the healthcare business of Germany’s Merck KGaA. 1 August 2022
Pharmaceutical
German glass company Schott has established a stand-alone company for its pharma business to advance its growth strategy. 1 August 2022
Biotechnology
French drugmaker Ipsen and USA-based immuno-oncology start-up Marengo Therapeutics today announced a strategic partnership to advance two of Marengo’s pre-clinical STAR platform-generated candidates into the clinic. 1 August 2022
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Pharmaceutical
The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter's local correspondent. 28 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
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
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