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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Pharmaceutical
Germany’s Evotec has said its chief operating officer Craig Johnstone will leave the business at the end of the year. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biosimilars
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
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
Biotechnology
France-based Advanced Accelerator Applications (AAA), a privately-owned player in molecular nuclear medicine (MNM), has announced the initiation of an international Phase III clinical trial evaluating the effect of Lutathera, an investigational peptide, in patients with inoperable progressive midgut carcinoid. 20 September 2012
Pharmaceutical
US companies Baxter International (NYSE: BAX) and privately-held biotech Onconova Therapeutics have entered into a European licensing agreement for rigosertib, a novel targeted anti-cancer compound currently in Phase III development for the treatment of a group of rare hematologic cancers, ie, myelodysplastic syndromes (MDS) and in a Phase II/III study for pancreatic cancer. 20 September 2012
Pharmaceutical
In anticipation of the launch of Alpharadin (radium-223 chloride), for the treatment of cancer patients with bone metastases, Norwegian cancer drug developer Algeta ASA (OSE: ALGETA), yesterday officially opened the offices and facilities of Algeta US in Cambridge, Massachusetts. 19 September 2012
Pharmaceutical
The launches of Bristol-Myers Squibb's (NYSE: BMY) immunotherapy Yervoy (ipilimumab) and Roche (ROG: SIX)/Genentech/Chugai/Daiichi Sankyo BRAF inhibitor Zelboraf (vemurafenib) have transformed the treatment of advanced malignant melanoma and, in 2011, these agents accounted for two-thirds of total malignant melanoma sales, according to the latest findings of health care advisory firm Decision Resources. 18 September 2012
Generics
Over the weekend, the Intellectual Property Appellate Board (IPAB) of Chennai, India, has dismissed the plea by German pharmaceutical company Bayer (BAYN: DE), which was seeking a stay on the compulsory license issued by the Indian Patent Controller to Indian generics drugmaker Natco Pharma (524816: BY) to manufacture generic versions of the anti-cancer Nexavar (sorafenib tosylate; The Pharma Letter March 13), Bayer confirmed to TPL yesterday, but stressing that it has not rejected the company's main appeal. 18 September 2012
Biotechnology
US biotech firm Threshold Pharmaceuticals (Nasdaq: THLD) said yesterday that data from a Phase IIb trial of TH-302 in patients with advanced pancreatic cancer will be presented at the European Society for Medical Oncology, Austria, September 28 to October 2, 2012. New finding on overall survival indicate that patients treated with gemcitabine alone had a median overall survival of 6.9 months versus 9.2 months with TH-302 340 mg/m2 + gemcitabine (HR: 0.955, 95% CI: 0.67-1.37, p=0.800) and 8.7 months with TH-302 240 mg/m2 + gemcitabine (HR: 0.960, 95% CI: 0.67-1.38, p=0.827). 18 September 2012
Pharmaceutical
Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) has reached agreement on returning development and marketing rights for cancer drug Busulfex (busulfan) to Otsuka Pharmaceuticals (TYO: 4578), for use as a part of conditioning regimen prior to hematopoietic progenitor cell transplantation. As a result, Kyowa Hakko Kirin will receive 2 billion yen ($25.3 million). 17 September 2012
Biotechnology
Australian biotech firm Bionomics (ASX: BNO) has expanded its presence in the USA with the acquisition of San Diego, USA-based private biotechnology company Eclipse Therapeutics in a scrip-based $10 million deal. With consideration of around 23.9 million shares at $0.4176 per share, Eclipse shareholders, that include Biogen Idec (Nasdaq: BIIB), will own about 6.5% of Bionomics' issued capital. 17 September 2012
Pharmaceutical
USA-based Medivation (Nasdaq: MDVN) and Japanese partner Astellas Pharma (TSE: 4503) yesterday announced the US launch of their prostate cancer drug Xtandi (enzalutamide), which was approved last month by the Food and Drug Administration for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel (The Pharma Letter September 3). 14 September 2012
Pharmaceutical
Oncodesign, a Dijon, France-based drug discovery company and oncology pharmacology service provider, has entered into a strategic research collaboration with French drug major Sanofi (Euronext: SAN) to apply exclusively Oncodesign's Nanocyclix technology to several Sanofi kinase target programs. 14 September 2012
Pharmaceutical
Germany's Bayer (BAYN: DE) say that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted priority review to subsidiary Bayer Yakuhin's New Drug Application for regorafenib filed at the end of July for the treatment of patients with unresectable, advanced/recurrent colorectal cancer (CRC). The MHLW grants priority review to medicines on the basis of their clinical usefulness and severity of the disease. 13 September 2012
Biotechnology
The overall global market for translational regenerative medicine will reach a value of $1.4 billion in 2012. That revenue forecast and others appear in Translational Regenerative Medicine Market Prospects 2012-2022, published by Visiongain, a business information provider based in the UK. 12 September 2012
Biotechnology
Following the European approval of the drug this spring (The Pharma Letter May 14), US biotech firm Cell Therapeutics (Nasdaq and MTA: CTIC) has initiated the commercial launch of Pixuvri (pixantrone) in the European Union, with entry into Sweden, Denmark and Finland in September, to be followed by Austria and Norway in early October 2012 and Germany, the UK and the Netherlands in November 2012. 12 September 2012
Pharmaceutical
Shares of US drug developer Geron Corp (Nasdaq: GERN) plunged 50% to $1.44 in pre-market trading yesterday, as the company revealed it is discontinuing its randomized Phase II trial of imetelstat in metastatic HER2-negative breast cancer because median progression-free survival (PFS) in the imetelstat arm was shorter than in the comparator arm. 11 September 2012
Pharmaceutical
Swiss drug major Roche (ROG SIX) says it is "extremely disappointed" that the Scottish Medicines Consortium (SMC) has decided not to make Zelboraf (vemurafenib) available for the treatment of BRAF mutation positive unresectable or metastatic melanoma. However, there was better news for Swiss rival Novartis (NOVN: VX0, with the SMC approving use of the company's multiple sclerosis drug Gilenya (fingolimod). 11 September 2012
Biotechnology
Shares of US biotech firm Peregrine Pharmaceuticals (Nasdaq: PPHM) rocketed 56.4% to $4.80 last Friday, after the company presented positive interim results from its 121 patient randomized, double-blind, placebo-controlled Phase IIb trial in patients with refractory non-small cell lung cancer (NSCLC) with drug candidate bavituximab. 10 September 2012
Generics
SFJ Pharmaceuticals Group, a global drug development group of companies which provides a unique co-development partnering model (SFJ), has entered into a collaborative ement with Pfizer (NSE: PFE) to conduct a Phase III clinical trial of the pharma behemoth's investigational pan-HER (pan-human epidermal growth factor receptor) inhibitor, dacomitinib (PF-00299804). 10 September 2012
Generics
Anglo-Swedish drug major AstraZeneca (LSE: AZN) has told its development partner Palatin Technologies (NYSE PTN) that it has decided to discontinue further development of AZD2820, one of a number of collaboration compounds in various stages of development for the treatment of obesity. 10 September 2012
Biotechnology
The protracted development of antibiotic ceftobiprole has left Swiss biotech firm Basilea Pharmaceutica (SIX: BSLN) under a cloud of investor disillusionment, say analysts at Edison Investment Research. 10 September 2012
Pharmaceutical
There was disappointing news for US drug major Eli Lilly (NYSE: LLY) yesterday ,as the company announced that the Phase III POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with non-squamous non-small cell lung cancer (NSCLC) who were randomized to receive a combination of its already marketed Alimta (pemetrexed for injection) with bevacizumab (Roche's Avastin) and carboplatin induction followed by Alimta plus bevacizumab maintenance - the Alimta arm - compared to the combination of paclitaxel with bevacizumab and carboplatin followed by bevacizumab maintenance - the paclitaxel arm. 7 September 2012
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