EMA accepts Alvotech and Advanz Pharma’s Marketing Authorization Application for biosimilar of J&J’s Simponi
The Simponi biosimilar, AVT05, has shown positive top-line results in patients with moderate to severe rheumatoid arthritis.
Biosimilars
Innovations in mass spectrometry accelerate the shift toward precision medicine
Thermo Fisher’s John Lesica discusses how mass spectrometry technology enables scientific breakthroughs in genomics and proteomics to provide valuable insights for drug discovery and development.
MinervaX and Wacker Biotech partner to scale up GBS vaccine production
MinervaX and Wacker Biotech announced yesterday that they have entered into a manufacturing agreement for MinervaX’s prophylactic vaccine against Group B Streptococcus infections.
EU approves Regeneron’s bispecific antibody following US rejection
Just months after facing a rejection in the US, the bispecific antibody odronextamab (Ordspono) has been approved by the European Commission for the treatment of two types of blood cancer in patients that have failed to respond to previous treatments.
EU and UK approve Microbiome Medicines for advanced melanoma and ulcerative colitis
Microbiotica has received the green light from EU and UK regulatory authorities to start phase 1b studies for its microbiome medicines in advanced melanoma and ulcerative colitis.
Researchers develop temperature-sensitive amyloid fibrils for therapy
In a promising advancement, scientists from the University of North Carolina at Chapel Hill and Emory University have developed a novel drug delivery system using synthetic amyloid beta (Aβ) peptides.
Citius Pharma receives FDA approval for immunotherapy targeting rare blood cancer
The FDA has given the green light to Lymphir, the first immunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) to get approval in over five years.
BeiGene new flagship biologics manufacturing facility opens after $800M investment
BeiGene, a global oncology company, has announced the opening of its flagship US facility, which will expand the company’s biologics manufacturing capabilities and clinical research and development activities.
Eisai 'extremely disappointed' by EMA's decision on Alzheimer's drug
A committee from the European Medicines Agency (EMA) has voted against granting Leqembi (lecanemab) a marketing authorization due to the risk of serious side effects associated with the treatment.
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Alvotech and Stada debut uzpruvo, the first ustekinumab biosimilar in Europe
Alvotech and Stada launch Stelara biosimilar following European approval earlier this year and expiry of exclusivity rights on the original molecule.
Ensuring pharma data integrity: COPA-DATA’s automation solution tackles ALCOA challenges
Data integrity is a paramount concern for pharmaceutical manufacturers, particularly as they navigate the complexities of modern production with legacy equipment.
Global biosimilar market estimated to reach a size of $43.8 billion by the end of 2024
Demand for biosimilars is booming, with no hints of slowing down as the number of biosimilars getting approved keeps growing. Here are all the biosimilars that have received approval in 2024 to date.
FDA approves Samsung Bioepis’ Epsyqli biosimilar for PNH and aHUS treatment
Samsung Bioepis Co., Ltd. announced yesterday (July 23) that the US Food and Drug Administration (FDA) has approved Epsyqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab).
Boehringer Ingelheim and GoodRx undercut Humira by massive 92% with biosimilar
In a bid to make biologic treatments more accessible to patients, Boehringer Ingelheim is harnessing the reach and scale of the prescription savings platform GoodRx to provide its Humira biosimilar adalimumab-adbm at a low price.
Top 5 CDMOs driving advanced therapies to market amid rising demand and challenges
Contract development and manufacturing organizations (CDMOs) perform vital services for the biopharmaceutical industry – a role that is growing as cell and gene therapies gain momentum. Here are five of the top CDMOs bringing advanced therapies toward...
Myricx Bio using £90M series A round taking ADC pipelines through clinical proof of concept
As the industry continues its fascination with antibody-drug conjugates (ADCs), UK startup Myricx Bio heralds European biotech’s biggest Series A round this year.
CureVac signs agreement with GSK for mRNA vaccines amid layoffs in €1.45B restructuring deal
CureVac has signed a new licensing agreement with GSK shortly after announcing the decision to reduce its workforce by 30% and refocus its research and development priorities.
Beacon Therapeutics raises $170M in series B to advance gene therapies for eye disease
The fundraising will accelerate the clinical development of Beacon Therapeutics’ lead gene therapy candidate, which is currently in phase 2/3 trials.
ReciBioPharm’s Edita Botonjic-Sehic, on analytics, AI, and continuous RNA manufacturing
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
EvolutionaryScale raises $142M and launches AI model for protein discovery
The new generative AI model released by EvolutionaryScale will be used by researchers and pharma companies to empower drug discovery.
Purolite's launch of innovative DurA Cycle A50 resin, expanding market impact at BIO 2024
At BIO 2024, Purolite made waves in the biopharmaceutical industry with the launch of their innovative DurA Cycle A50 resin.
Novo Nordisk's Mim8 significantly reduces bleeds in hemophilia A - plans approval submission
Once monthly treatment with Novo Nordisk’s antibody treatment reduced annual treated bleeds to zero in 95% previously untreated people with hemophilia A.
Bright Peak Therapeutics bags $90 million Series C to develop cancer immunotherapies
As investors and big pharma pile on developers of antibody-drug conjugates (ADCs), Bright Peak Therapeutics has attracted $90 million based on the promise of a related type of technology called immunoconjugates.
SMC recommends first injectable bispecific for aggressive blood cancer
AbbVie has announced that the Scottish Medicines Consortium (SMC) has approved Tepkinly (epcoritamab) for adults with diffuse large B-cell lymphoma (DLBCL) who have not responded to or have relapsed after at least two prior treatments.
Three Indian CDMOs ready to seize the BIOSECURE Act opportunity
In the wake of escalating tensions between the United States and China, the Biden Administration is intensifying its strategic focus on biosecurity.
Breaking barriers in bioprocessing: An Interview with Enzene Bioscience's CEO
With a rich background in biochemistry and extensive experience in the pharmaceutical industry, Himanshu Gadgil shares insights into Enzene's journey, its innovative approach to biosimilars.
BIO International 2024 to focus on partnerships amid new BIOSECURE bill
As the BIO International 2024 trade show approaches, industry insiders anticipate a significant focus on partnership discussions, driven by the pressing financial needs of biotech companies rather than the new BIOSECURE act.
Worldwide Clinical Trials' Peter Benton on the outlook for biopharma funding
Peter Benton is president and CEO of Worldwide Clinical Trials, a full-service global CRO. We spoke with him about his insights into recent trends and factors influencing biopharma investment decisions.
Production of tree-saving transformative vaccine adjuvant with in-lab plants
During DCAT this year, CEO Gaston Salinas from Botanical Solution Inc., (BSI), sat down with Liza Laws, the senior editor of OSP and BPR to discuss his company’s pioneering work in revolutionizing vaccine adjuvant production.
Recent pharma industry appointments that should be on your radar - KBI Biopharma, Veranova and more
Bio Pharma Reporter and Outsourcing Pharma is back with our latest instalment of movers and shakers - breaking down all the key pharma industry appointments that you should know about. KBI Biopharma, Veranova and Kindeva Drug Delivery are among the...
Reuters Pharma USA 2024: What are key pharma players hoping to achieve?
This week, the pharma industry will descend on Pennsylvania Convention Center for Reuters Pharma USA, North America’s largest cross-functional pharma gathering.
Rani Therapeutics announces promising phase 1 results for oral Stelara biosimilar
Rani Therapeutics, a clinical-stage biotherapeutics company focused on the oral delivery of biologics, has announced encouraging results from its phase 1 study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43.
AbbVie receives greenlight from NICE for blood cancer treatment
AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has recommended epcoritamab (tepkinly), its treatment for adults with diffuse large B-cell lymphoma (DLBCL), an aggressive and fast-growing blood cancer, whose cancer...
Hired and retired: New appointments in the pharma industry
BioPharma Reporter and Outsourcing Pharma presents its latest round-up of the movers, shakers and key announcements in the pharma industry. From Stand Up To Cancer, Astraveus and KBI Biopharma, we break down the key changes.
Women in Science: An instant passion for science and thriving in a male-dominated industry
Lisa Sellers is the CEO of Vector Laboratories, and she is passionate about staying ahead of the pharma trends.
Symbiosis Pharmaceutical Services granted MHRA license following £1 million investment
Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a £1 million investment.
Piramal Pharma has launched a high-throughput screening facility
Piramal Pharma has launched a high-throughput screening facility at its drug discovery services site in Ahmedabad, India.
Lilly's plans for $2.5 billion site in Germany to expand injectable manufacturing capacity
Eli Lilly has invested in its manufacturing capacity once more and has announced plans to build a $2.5 billion high-tech manufacturing site in Germany.
Almirall and Absci partnership will help deliver life-changing medicines
A partnership combining an integrated drug creation platform with a company specializing in dermatological expertise will deliver life-changing medicines to patients.
Janssen commits as first tenant in Fujifilm Diosynth US facility
Johnson & Johnson’s Janssen Supply Group is to be the first tenant in Fujifilm Diosynth Biotechnologies’ $2 billion cell culture manufacturing facility, which is planned to open in Holly Springs, North Carolina, in 2025.
Cervical cancer could be diagnosed earlier with new DNA biosensor
Researchers from Chung-Ang University, Korea have developed a novel DNA biosensor which could result in early diagnosis of cervical cancer.
Polpharma Biologics gets greenlight for first multiple sclerosis biosimilar in Europe
Polpharma Biologics, an international biotech company developing and manufacturing biosimilars, has announced that the European Commission (EC) has approved Tyruko (natalizumab) as the first and only biosimilar for relapsing forms of multiple sclerosis...
Novartis' Leqvio can provide consistently low cholesterol for six years, trial results show
Novartis announced today (Monday August 28) that new long-term data from its open-label trial extension demonstrated twice-yearly dosing inclisiran with statin therapy provides consistent low-density lipoprotein cholesterol (LDL-C) reduction beyond six...
Polpharma Biologics gets FDA green light for multiple sclerosis treatment
Polpharma Biologics, a biotech company developing and manufacturing biosimilars, has announced that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko.
AbbVie feels biosimilar impact on Humira sales
In first quarter 2023 financials, the company reported a drop in net revenue of close 10%, as the impact of Humira biosimilar entry onto the market begins to bite.
Dyadic licensing deal seeks affordable vaccines and biologics for Africa
Dyadic extends its licensing agreement with Rubic for the use of its C1-cell protein expression platform.
CBM signs agreement for AAV vector manufacturing platform
The CDMO signs an exclusive partnership with the University of Pennsylvania to gain access to its cell manufacturing platform.
Sandoz to build new biologics production plant in Slovenia, facility will support global demand for biosimilars
Sandoz is set to build a new biologics production plant in Lendava, Slovenia.
US market gets first biosimilar to AbbVie’s Humira
Amgen is launching Amjevita, or adalimumab-atto, a biosimilar to AbbVie’s Humira, in the US; it is the first such biosimilar to the blockbuster drug in that market.
Sandoz bags positive EU opinion for higher strength adalimumab biosimilar
Novartis subsidiary, Sandoz, has secured a postive option from an EMA commitee in relation to its high concentration and citrate-free adalimumab biosimilar