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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
The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft guidance (18 December 18) on the use of Swiss drug major Roche's blockbuster cancer drug Avastin (bevacizumab), saying it does not recommend the drug when used with paclitaxel and carboplatin for people with advanced disease, as a cost-effective treatment for the National health Service. 18 December 2012
Generics
Japan's largest drugmaker, Takeda Pharmaceutical (TYO: 4502), has entered into a definitive agreement with Caraco Pharmaceutical Laboratories, a wholly-owned subsidiary of India's Sun Pharmaceutical Industries (SUN: BO) for the sale of the non-Colcrys (colchicine, USP) URL Pharma, generic business. 17 December 2012
Pharmaceutical
In a flurry of activity from the US Food and Drug Administration on Friday, the agency - which looks likely to set a record of new drug approvals in the current year, issues positive rulings for three more, one of which was three months ahead of expectations. 17 December 2012
Biotechnology
Last week's deliberations of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), announced on Friday, resulted in good news for Lundbeck (LUN: D), Alexza Pharmaceuticals (Nasdaq: ALXA) and Roche (ROG: SIX), but not for Genzyme and Isis Pharmaceuticals or Vanda(see separate story today). 17 December 2012
Biotechnology
The US Food and Drug Administration accepted for review a New Drug Application from pharma behemoth Pfizer (NYSE: PFE) and partner Ligand Pharmaceuticals (Nasdaq: LGND) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013. 16 December 2012
Generics
Indian drugmaker Macleods plans to invest up to 700 million roubles (around $25 million) in the construction of a plant for the production of antituberculous drugs in Russia's Belgorod region by 2016. 14 December 2012
Pharmaceutical
Prostate cancer is becoming increasingly common due to globally growing numbers of elderly men, and scientists are fighting to create new treatment options for patients with advanced disease, states a new report by health care experts GlobalData. 13 December 2012
Biotechnology
Sales of cancer pain therapies will increase to $5.2 billion in 2021 in leading seven markets (the USA, France, Germany, Italy, Spain, the UK and Japan), according to a new report from Decision Resources. Over the next decade, several premium-priced agents will enter the market, taking significant patient share from low-cost drugs and spurring growth. 13 December 2012
Pharmaceutical
German drug major Bayer (BAYN: DE) has filed for approval of its radiotherapeutic product Alpharadin for prostate cancer in Europe, triggering a 50 million euro ($65 million) milestone payment to the drug's Norwegian originator Algeta (OSE: ALGETA). 13 December 2012
Biotechnology
US biotech firm Gilead Sciences (Nasdaq: GILD) has agreed to acquire Canada's YM BioSciences (TSX: YM) in a deal that adds another drug candidate to its oncology portfolio and causing the Canadian firm's shares to leap 77% to $2.88. 13 December 2012
Biotechnology
During the 54th Annual Meeting of the American Society of Hematology (ASH) now taking place in Atlanta, USA, drug majors Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE announced the results of the Phase III AMPLIFY-EXT trial, which evaluated treatment with Eliquis (apixaban) showing the drug helped prevent blood clots in the legs and lungs and kept them from recurring. 11 December 2012
Biotechnology
Encouraging safety and efficacy data on novel and emerging therapies presented at the 54th Annual Meeting of the American Society of Hematology (ASH), which is taking place in Atlanta, signal an important step forward in the development of treatment strategies for patients with hard-to-treat leukemia, myeloma, and myelofibrosis. 11 December 2012
Biotechnology
There was mixed news coming out of the San Antonio Breast Cancer Symposium (SABCS), which concluded on December 8, with good and bad news from Genzyme and Pfizer (see Pharma Letter December 7), but disappointing findings for others. 10 December 2012
Pharmaceutical
The University of Texas MD Anderson Cancer Center, one of the world's leading cancer research and treatment centers, has signed a research collaboration and license agreement to develop new therapeutic antibodies that promote an immune system attack against cancer with UK pharma giant GlaxoSmithKline (LSE: GSK). 10 December 2012
Pharmaceutical
New Zealand's Pharmaceutical Management Agency PHARMAC has removed the Special Authority funding requirements from seven cancer treatments, and from the diabetes treatment pioglitazone. Special Authorities define the clinical criteria patients must meet to receive some funded medicines. Clinicians must complete a Special Authority application and receive approval before prescribing in order for the patient to receive the funded medicine. 9 December 2012
Pharmaceutical
Independent Swiss biopharma firm Debiopharm Group announced on Friday that, on December 3, Dr. Reddy's Laboratories (NYSE: RDY), India's second largest drugmaker, launched Pamorelin (triptorelin) LA in India for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer. 9 December 2012
Pharmaceutical
German drug major Bayer (BAYN: DE) and partner Regeneron (Nasdaq: REGN) submitted a marketing application to the European Medicines Agency seeking approval of Eylea (aflibercept solution for injection) for macular edema) following central retinal vein occlusion. The submission is based on data from Phase III COPERNICUS and GALILEO studies. 6 December 2012
Pharmaceutical
US drugs behemoth Pfizer (NYSE: PFE) has presented encouraging data from a randomized Phase II clinical trial that showed PD-0332991 (PD-991) in combination with Novartis' Femara (letrozole) significantly extended progression-free survival (PFS) compared with letrozole alone in post-menopausal patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. 6 December 2012
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