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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
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) revealed this morning that it has received approval in 23 European Union member states and Norway for Axanum, a fixed dose combination of 81mg low-dose ASA (acetylsalicylic acid; aspirin) and 20mg esomeprazole. 2 August 2011
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has published a final guidance recommending National Health Service use of two new treatments for multiple myeloma: USA-based Celgene's (Nasdaq: CELG) Thalidomide Celgene (thalidomide) and health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen's Velcade (bortezomib). 27 July 2011
Pharmaceutical
The US Food and Drug Administration should require manufacturers of all glucocorticosteroid drugs, such as prednisone, methylprednisolone and dexamethasone, to revise their labels to warn about a rare, but serious adverse effect that could leave patients with impaired vision, said consumer advocacy group Public Citizen and an eminent neuro-ophthalmologist from the University of Michigan, USA. 26 July 2011
Generics
US generic drugs firm Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market dutasteride and tamsulosin hydrochloride capsules, a generic version of UK pharma giant GlaxoSmithKline's (LSE: GSK) Jalyn, which is are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. 26 July 2011
Generics
India's largest drugmaker, Ranbaxy Laboratories (RANB: BO) which is 64% owned by Japan's Daiichi Sankyo (TYO: 4568), yesterday announced the launch of letrozole tablets 2.5mg in the UK, Romania and France. 26 July 2011
Pharmaceutical
US drug developer BioSante Pharmaceuticals (Nasdaq: BPAX) has licensed exclusive worldwide for its melanoma vaccine to the John P Hussman Foundation, a charitable foundation that supports research to address life-threatening medical conditions and significant disabilities. BioSante received $100,000 on signing the accord and is eligible for up to $39 million in milestone payments, plus royalties on sales. 23 July 2011
Biotechnology
There is plenty of optimism surrounding the US biotechnology industry as firmer pricing and new products have improved sales and earnings trends, notes The Bedford Report. Meanwhile, younger, more speculative firms continue to garner significant attention with potential blockbuster products working their way through the regulatory process. 20 July 2011
Pharmaceutical
In yet another negative opinion for breast cancer use on the UK's National Health Service, UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) today issued draft guidance on Japanese drug major Eisai's (TYO: 4523) Halaven (eribulin) for public consultation, saying that it does not recommend NHS funding of eribulin, a treatment for locally advanced or metastatic breast cancer. 20 July 2011
Generics
The European Commission has granted marketing authorization for US biotech giant Amgen's (Nasdaq: AMGN) Xgeva (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. 18 July 2011
Pharmaceutical
Swiss drug major Roche (ROG: SIX) says it plans to seek approval of its monoclonal antibody pertuzumab from health authorities based on encouraging results in the treatment of breast cancer. 17 July 2011
Generics
US drugmaker Par Pharmaceuticals' (NYSE: PRX) proprietary products division, Strativa Pharmaceuticals, recently faced a setback when MonoSol Rx and APR Applied Pharma Research announced that they will reacquire the US commercial rights to Zuplenz (ondansetron) from Strativa. 17 July 2011
Pharmaceutical
Following a recent positive recommendation from the European Medicine Agency's advisory panel, Bristol-Myers Squibb today announced that the European Commission has approved US drug major Bristol-Myers Squibb's (NYSE: BMY) Yervoy (ipilimumab) for the treatment of adult patients with previously-treated advanced melanoma (The Pharma Letter May 23). 15 July 2011
Pharmaceutical
The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend that the agency grants accelerated approval of Seattle Genetics (Nasdaq: SGEN) Adcetris (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant (ASCT). 15 July 2011
Pharmaceutical
French orphan cancer drug developer BioAlliance Pharma (Euronext Paris: BIO) has announced the validation of its application for a Phase III clinical trial for Livatag (doxorubicin Transdrug) in the treatment of primary liver cancer submitted to the French drug regulation agency, the Afssaps. This will enable the review of the preclinical and clinical dossiers by the experts of the Agency. 15 July 2011
Pharmaceutical
Cancer patients and clinicians in Canadians are set to benefit from the implementation of the pan-Canadian Oncology Drug Review (pCODR), which began accepting submissions this week. 14 July 2011
Pharmaceutical
French drugmaker Ipsen (Euronext: IPN) and the Salk Institute for Biological Studies are renewing the Ipsen Life Sciences Program at the Institute. The mission of the partnership is to advance knowledge in the field of proliferative and degenerative diseases through fundamental and applied biology research. 12 July 2011
Biotechnology
US drug discovery firm Micromet (Nasdaq: MITI) stands to earns as much as 695 million euros ($991 million) under the terms of a collaboration with biotech major Amgen (Nasdaq: AMGN) for the research of BiTE antibodies against three undisclosed solid tumor targets. Amgen will have the right to pursue development and commercialization of BiTE antibodies against up to two of these targets, to be selected by Amgen. The news sent Micromet's shares 5.7% higher to $6.09 while Amgen slipped 1.1% to $57.00 in mid-day trading. 12 July 2011
Biotechnology
The Second Judicial District Court of US state Nevada ruled in favor of PD BioPharma (Nasdaq: PDLI) on two motions filed by Genentech and its parent company, Swiss drug major Roche (ROG: SIX), in PDL's royalty law suit related to a 2003 settlement agreement with Genentech. PDL's stock rose 9.2% to $6.28 on the news yesterday. 12 July 2011
Generics
Fast-growing Jordan-headquartered drugmaker Hikma Pharmaceuticals (LSE: HIK) says that it has acquired a 'significant,' but undiscosed minority interest in China-based Hubei Haosun Pharmaceutical through the subscription of new equity for a cash consideration of $5.0 million. 11 July 2011
Pharmaceutical
Just days after demonstrating positive results in breast cancer, Swiss drug major Novartis (NOVN: VX) announced Phase III trial results that showed more than one-third of patients taking Afinitor (everolimus) tablets experienced a 50% or greater reduction in the size of their subependymal giant cell astrocytomas (SEGAs), non-cancerous brain tumors associated with tuberous sclerosis complex (TSC). This study, the largest prospective clinical trial to date in this patient population, was presented on at the International TSC Research Conference in Washington DC, USA. 11 July 2011
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