Latest Pharma and Biotech News
Biotechnology
28 November 2024 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.
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Biotechnology
Israel-based biotech Sol-Gel Technologies saw its share price rocket nearly 93% to $17.80 during Monday morning’s trading after the company presented positive data from two Phase III trials. 30 December 2019
Biotechnology
Fulcrum Therapeutics saw its shares rise more than 4% at $17.67 in early trading, after it revealed a lucrative deal with fellow US biotech Acceleron Pharma (Nasdaq: XLRN), which also saw its shares rise almost 2%. 30 December 2019
Biotechnology
US biotech Axsome Therapeutics is set to close 2019 with a share price worth around 40 times more than its value at the start of the year. 30 December 2019
Biotechnology
A new biotech dubbed Sumitovant Biopharma has been founded, following an October 2019 agreement between Japanese drug major Sumitomo Dainippon Pharma and Roivant Sciences. 30 December 2019
Biotechnology
Having been backed in the week before Christmas by a US Food and Drug Administration (FDA) panel by a slender margin of two votes, executives from AstraZeneca and Merck & Co would not have been certain about the approval of Lynparza (olaparib) in a pancreatic cancer indication during their seasonal break. 30 December 2019
Biotechnology
Germany’s Boehringer Ingelheim, a privately-held drugmaker, has become the first company to apply the adopted Marketing Authorization Holder (MAH) system within China’s revised Drug Administration Law (DAL). 30 December 2019
Biotechnology
Netherlands-based Pharming Group today announced it has entered into a definitive agreement with Swedish Orphan Biovitrum (“Sobi”) to reacquire the commercial rights to Pharming’s Ruconest (C1 esterase inhibitor [recombinant]) in all remaining territories, which includes all remaining European Union markets. 30 December 2019
Biotechnology
Zai Lab announced the China National Medical Products Administration (NMPA) had approved the New Drug Application (NDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. 30 December 2019
Biotechnology
Sino-America biotech firm BeiGene says that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies. 30 December 2019
Biotechnology
Japanese drug major Astellas Pharma yesterday announced that it has acquired privately-held US biotech firm Xyphos Biosciences. 27 December 2019
Biotechnology
UCB recently announced positive results from its Phase III active-controlled psoriasis study, BE SURE, in which UCB compared the investigational dual interleukin (IL)-17A/F inhibitor bimekizumab to Humira (adalimumab) in adults with moderate-to-severe psoriasis. 27 December 2019
Biotechnology
US cell and gene therapy company Abeona Therapeutics saw its shares gain 4.2% to $3.75 in after-hours trading Tuesday, after it announced that the European Medicines Agency has granted the designation of Priority Medicines ( PRIME) for its ABO-102, which studies its punctual gene therapy based on adeno-associated virus 9 (AAV9) for the treatment of Sanfilippo syndrome type A (MPS IIIA). 27 December 2019
Biotechnology
US biotech major Gilead Sciences’ Japanese subsidiary and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA). 24 December 2019
Biotechnology
Sarepta has signed a licensing agreement providing Swiss pharma giant Roche with exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), Sarepta’s investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the USA. 23 December 2019
Biotechnology
With yet another earlier-than-expected US regulatory approval, on Friday, the US Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. 23 December 2019
Biotechnology
Danish dermatology specialist LEO Pharma recently announced that its anti-interleukin-13 (IL-13) biologic therapy tralokinumab, which is in development for the treatment of moderate-to-severe atopic dermatitis, met all its primary and secondary endpoints across three pivotal Phase III studies as part of the company’s ECZTRA trial series. 23 December 2019
Biotechnology
The Chinese National Medical Products Administration (NMPA) has approved Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy. 21 December 2019
Biotechnology
Metabolic disease specialist Poxel looked set to close Friday’s trading up more than 9%. 20 December 2019
Biotechnology
In a second licensing deal signed by the Japanese pharma major this week, Takeda Pharmaceuticals has entered into a billion-dollar deal with privately-held Canadian biotech Turnstone Biologics to develop multiple products from its proprietary vaccinia virus platform targeting a broad range of cancer indications. 20 December 2019
Biotechnology
Thriving Danish biotech company Genma has entered a deal with CureVac, a privately-held messenger RNA (mRNA) company. 20 December 2019
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Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Biotechnology
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Biotechnology
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 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
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
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
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
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 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
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
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
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
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
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