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Biotechnology
The European Commission has granted a marketing authorization for Alecensa (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). 23 December 2017
Pharmaceutical
Shares of US oncology focussed firm Ignyta leapt more than 70% in pre-market trading today, following news of a takeover bid from Swiss pharma giant Roche. 22 December 2017
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for avelumab in combination with Inlyta (axitinib) for treatment-naïve patients with advanced renal cell carcinoma (RCC). 22 December 2017
Biotechnology
The USA’s TRACON Pharmaceuticals saw its shares gain 6.78% to $3.15 in pre-market trading, after it announced a licensing deal that could generate as much as $143.5 million for the company. 21 December 2017
Biotechnology
The US Food and Drug Administration’s (FDA) approval of an expanded label for Cabometyx (cabozantinib) has kept Exelixis climbing in the stock market throughout Wednesday morning. 20 December 2017
Biotechnology
Pfizer has received US Food and Drug Administration approved of its supplemental New Drug Application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). 20 December 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending Ninlaro (ixazomib) in combination with lenalidomide and dexamethasone (Rd) for the treatment of multiple myeloma patients who have received two or three prior lines of therapy. 20 December 2017
Biotechnology
Biotech startup Clover Biopharmaceuticals has completed a 62.8 million renminbi ($9.5 million) series A financing round aimed at launching two compounds into human clinical trials next year. 19 December 2017
Biosimilars
Jordanian drugmaker Hikma Pharmaceuticals now has exclusive rights to sell a biosimilar of Rituxan/MabThera (rituximab) in the Middle East and North Africa (MENA) after agreeing a deal with South Korean biopharmaceutical firm Celltrion. 19 December 2017
Pharmaceutical
The US Food and Drug Administration has agreed to review a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib) for a new indication. 18 December 2017
Pharmaceutical
Major news last week included new Teva Pharmaceutical Industries’ chief executive Kåre Schultz bringing out the hatchet with a vengeance, with the market reacting positively to the massive restructuring announcement. Elsewhere, the annual American Society of Hematology (ASH) was still bringing out important results, including on: bluebird bio and Celgene’s myeloma candidate bb2121 and AbbVie’s Venclexta/Rituxan combination. Other clinical trials results of note was the latest on Roche’s Tecentriq in lung cancer and Regeneron and Sanofi’s new checkpoint inhibitor cemiplimab. Also attracting comment was Ionis’ $45 million deal with Roche for its Huntington’s disease candidate IONIS-HTTrx. 17 December 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new medicines for approval at its December 2017 meeting, including two orphan medicines, one of which is also an advanced therapy medicinal product (ATMP), and one biosimilar. 16 December 2017
Biotechnology
US biotech Celgene has signed a five-year deal with a subsidiary of Cancer Research UK to discover, develop and commercialize new oncology treatments. 14 December 2017
Biotechnology
Privately-held Canadian firm Cyclenium Pharma has signed a drug discovery agreement with Ono Pharmaceutical, the Japanese firm whose fortune was made by the discovery of the groundbreaking I-O therapy Opdivo (nivolumab). 14 December 2017
Biotechnology
In a reversal of a previous guidance, the UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending ibrutinib (or routine National Health Service (NHS) use to treat mantle cell lymphoma in people who have had only one prior line of therapy. 14 December 2017
Biotechnology
French pharma major Sanofi and US biotech Regeneron have announced data on a checkpoint inhibitor that suggests that they could be the latest player to gain a foothold in this burgeoning oncology space. 13 December 2017
Pharmaceutical
Japanese pharma major Daiichi Sankyo had a busy day, signing up on two oncology research collaborations. 13 December 2017
Biotechnology
The pressure to show progress in blood cancers at this year’s American Society of Hematology (ASH) Annual Meeting has been intense, and Janssen has not missed out with its data on Imbruvica (ibrutinib), and now on Darzalex (daratumumab) in particular. 12 December 2017
Biotechnology
Swiss pharmaceutical giant Roche, which invested 1.5 billion roubles ($25 million) in the localization of the production of its anti-cancer drug Gaziva/Gazyvaro (obinutuzumab) in Russia in order to participate in public procurements, may not implement its plans, reports The Pharma Letter’s local correspondent. 12 December 2017
Biotechnology
In the race to be the frontrunner in the CAR-T therapy field, the two companies currently in the lead position look to be mirroring each other’s progress. 11 December 2017
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
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
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