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Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
Pharmaceutical
UK pharma major AstraZeneca today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Biotechnology
Third-quarter 2019 sales for US biotech Celgene came in at $4.52 billion, up 16% year-on-year and beating consensus forecasts of $4.41 billion. 1 November 2019
Biotechnology
Bristol-Myers Squibb was nearly 2% up at midday Thursday after presenting its third-quarter financial results. 31 October 2019
Pharmaceutical
Canada-based Knight Therapeutics has entered into a definitive agreement to acquire a 51.21% interest in Brazil’s Biotoscana Investments, or Grupo Biotoscana (GBT), from a controlling shareholder group that includes Advent International and Essex Woodlands, among others, for 10.96 Brazilian reals per share. 31 October 2019
Biotechnology
German life sciences group Bayer was up more than 2% as Wednesday’s trading day neared its end, after the company presented its third-quarter financial results. 30 October 2019
Pharmaceutical
The share price of Pfizer was up 3% at lunchtime on Tuesday after the world’s biggest pharma company presented its third quarter financial results. 29 October 2019
Biotechnology
Merck KGaA and Pfizer’s entry into the PD-L1 space has secured a European Commission approval in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). 29 October 2019
Pharmaceutical
Independent French drugmaker Servier plans to accelerate its expansion both in the domestic market and abroad within the next several years, that will mainly take place through the expansion of the already existing range and the launch of production of new drugs. 29 October 2019
Biotechnology
US biotech Ziopharm Oncology and The University of Texas MD Anderson Cancer Center have announced a new research and development agreement. 28 October 2019
Biotechnology
Cato Research and SMS-oncology, contract research organizations (CROs) from the USA and The Netherlands respectively, have merged. 28 October 2019
Biotechnology
According to industry analytics firm GlobalData, what is now relatively small in terms of sales, the ovarian cancer drug market is set to grow rapidly over the next 10 years, as a result of important new treatment options, 28 October 2019
Pharmaceutical
Last week’s research news included a boost on Monday for Seattle Genetics, with positive top-line results for its breast cancer candidate tucatinib, and Biogen surprised when it revealed a new analysis of what seemed to be abandoned Alzheimer’s disease drug aducanumab would now be filed with the US Food and Drug Administration. On the deal-making front, Bavarian Nordic acquired the travel vaccine brands from GlaxoSmithKline for up to 955 million euros. There was also good news last Monday for Vertex Pharma, with the FDA approval for its cystic fibrosis drug Trikafta coming five months earlier than a decision was expected. 27 October 2019
Biosimilars
The European Investment Bank (EIB) has agreed to lend 30 million euros ($33.4 million) to Mabion, a Polish biotech company, to finance its growth plans. 24 October 2019
Pharmaceutical
Shares in Anglo-Swedish pharma major AstraZeneca were up 3% by lunchtime on Thursday, taking the company’s stock market gains for the year-to-date beyond 20%. 24 October 2019
Biotechnology
GlaxoSmithKline on Wednesday said it has received approval from the US Food and Drug Administration for an expanded indication for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: 24 October 2019
Biotechnology
Privately-held US biotech Ambrx has announced a second collaboration with NovoCodex Biopharmaceuticals Ltd, a majority-owned company of Chinese group Zhejiang Medicine. 24 October 2019
Biotechnology
In March 2019, after a series of political convolutions worthy of a Choose Your Own Adventure novel, former UK Prime Minister Theresa May finally managed to bring her country, and its complaining industries, to the brink of Brexit. 23 October 2019
Pharmaceutical
Shares of Washington, USA-based drugmaker Seattle Genetics shot up in pre-market trading, after the firm announced positive top-line results from the HER2CLIMB trial. 21 October 2019
Biotechnology
Privately-held UK biotech GammaDelta Therapeutics, a firm focussed on harnessing the unique properties of gamma delta T-cells to develop immunotherapies, has announced the formation of a spin-out company. 16 October 2019
Biotechnology
Swiss pharma giant Roche this morning released financial results for the first nine months of 2019, showing that group sales increased 10%tdo 46.07 billion Swiss francs ($46.16 billion) at constant exchange rates and 9% in Swiss francs, due to new products. 16 October 2019
Biotechnology
Best known as a leading Indian maker of generic medicines, Glenmark Pharmaceuticals has spun out its R&D unit into an independent, fully integrated biotechnology company Ichnos Sciences, to be based in Paramus, New Jersey, USA. 16 October 2019
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