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.
The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.
Recruiting and nurturing talent will be incredibly important in the biosimilar industry as it continues its rapid evolution, according to RSA Talent Equity.
The US Federal Trade Commission (FTC) announced on June 7 that it will examine pharmacy benefit managers’ role at the center of the US pharmaceutical system.
Last week saw the US Food and Drug Administration (FDA) approve the Biologics License Application (BLA) from Amneal Pharmaceuticals Inc for bevacizumab-maly, a biosimilar referencing Avastin, the Roche/Genentech product.
While skills shortages present one of the main challenges to the biopharma industry, North Carolina believes its investments in the life science ecosystem have given it a ‘multiple decade jumpstart’ in building a successful biopharma hub for both manufacturing...
The two co-founders of JHL Biotech, Racho Jordanov and Rose Lin, were sentenced by the US Department of Justice for their roles in conspiring to commit trade secret theft and wire fraud.
A global biomanufacturing training hub will be established in Korea to serve low- and middle-income countries wishing to produce biologicals such as vaccines, insulin, monoclonal antibodies and cancer treatments.
Biogen Inc and Xbrane Biopharma AB have entered into a commercialization and licensing agreement on Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA.
Sandoz has submitted its Biologics License Application (BLA) for a proposed biosimilar trastuzumab developed by EirGenix, Inc to the US Food and Drug Administration (FDA).
This month saw BioCina officially open its new biologics manufacturing facility in Adelaide, Australia, flagging it as the only TGA, EMA, Health Canada and US-FDA approved commercial facility of its kind in the country.
The Biosimilars Forum, in partnership with the Pacific Research Institute (PRI), recently released a report and interactive tool highlighting the significant costs that biosimilars can save US states.
Biosimilar producer, Sandoz, has entered into a commercialization agreement for biosimilar, BAT1706, referencing Avastin (bevacizumab) with Bio-Thera Solutions for the treatment of multiple types of cancers.
PhRMA has called for the US FDA to ensure its capacity planning adjustment (CPA) methodology addresses the “unique needs” of the biosimilar review program.
