Data integrity is a paramount concern for pharmaceutical manufacturers, particularly as they navigate the complexities of modern production with legacy equipment.
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.
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).
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.
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...
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 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.
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
Once monthly treatment with Novo Nordisk’s antibody treatment reduced annual treated bleeds to zero in 95% previously untreated people with hemophilia A.
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.
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.
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.
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.
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.
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.
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 companies...
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, 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 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...
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.
Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a £1 million investment.
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.
A partnership combining an integrated drug creation platform with a company specializing in dermatological expertise will deliver life-changing medicines to patients.
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.
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 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, 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.
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.
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.
Novartis subsidiary, Sandoz, has secured a postive option from an EMA commitee in relation to its high concentration and citrate-free adalimumab biosimilar
In the US, 2022 heralded the next chapter for biosimilars, including US FDA approval of in new therapeutic areas, additional interchangeable designations, and litigation relating to biosimilars of more recent biologics.
Last year was a slow one in terms of dealmaking in the life sciences sector but the final quarter saw a major uptick, finds the EY annual M&A Firepower report.
Celltrion, one of Korea’s largest biopharma companies, will be Rani’s exclusive supplier of ustekinumab biosimilar, CT-P43, for its oral RT-111 RaniPill program.
A study has demonstrated the effectiveness and safety of adalimumab biosimilars Hulio and Hyrimoz in the therapy of patients with inflammatory bowel disease (IBD).
Teva Pharmaceutical Industries has given a bullish assessment of its chances of claiming a big slice of the Humira biosimilar market, arguing it has “the best product profile of all companies coming to the market in 2023.”
The US Food and Drug Administration (FDA) has approved Coherus BioSciences’ Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis (ranibizumab injection) for all five indications.
Construction of Samsung Biologics’ Plant 4 is on schedule with operations set to start in October, the company confirmed in its Q2 results this morning.
