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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
A new cancer drug combination demonstrated significant improvement in overall survival of late-stage pancreatic cancer patients compared to those receiving standard treatment, according to results of a Phase III clinical trial led by physicians from Scottsdale Healthcare's Virginia G Cancer Center Clinical Trials, a partnership with the Translational Genomics Research Institute (TGen). 20 November 2012
Biotechnology
Adding Swiss drug major Roche's (ROG: SIX) blockbuster cancer drug Avastin (bevacizumab) to the current standard of care for newly-diagnosed aggressive brain cancer - glioblastoma multiforme (GBM) - can significantly extend the time people live without their disease worsening, by 4.4 months (progression free survival of 10.6 months compared to 6.2 months with radiation and chemotherapy plus placebo, HR =0 .64, p<0.0001), reducing the risk of progression by 36%. 20 November 2012
Biotechnology
French drugmaker Ipsen (Euronext: IPN) and partner USA-based privately-held Inspiration Biopharmaceuticals have received fast track designation from the US Food and Drug Administration for OBI-1 in acquired hemophilia A. OBI-1, an intravenous recombinant porcine factor VIII (FVIII), is being evaluated for the treatment of individuals with acquired hemophilia A, who have developed inhibitory antibodies (inhibitors) against their innate FVIII. 20 November 2012
Biotechnology
There was a batch of good news for two pharma companies and a negative opinion for one last Friday coming from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) following its monthly meeting on human use marketing authorization applications. 19 November 2012
Pharmaceutical
Japan's largest drugmaker, Takeda Pharmaceuticals (TYO: 4502), this morning announced the launch UK of Adcetris (brentuximab vedotin), the first new treatment licensed in 30 years for adult patients with relapsed or refractory CD30 positive Hodgkin lymphoma (HL) following an autologous stem cell transplant (ASCT) or at least two previous therapies, when ASCT or multi-agent chemotherapy is not a treatment option, and marking the start of the European roll-out for the drug. 19 November 2012
Generics
Humanitarian health organization Medecins Sans Frontieres (MSF) says it continues to follow progress of the case currently unfolding in India's Supreme Court. The question of what deserves a patent, enshrined in Section 3(d) of the country's patent law, is at the crux of Swiss drug major Novartis' (NOVN: VX) six year legal battle against the Indian government, which has now reached the Supreme Court (The Pharma Letters passim). 18 November 2012
Generics
The Community Oncology Alliance (COA), a US non-profit organization, announced the results of a drug shortage survey of 200 member practices representing 525 physicians across the USA. 98.9% of the respondents reported experiencing a drug shortage in the last year. 15 November 2012
Pharmaceutical
US drugmaker MannKind Corp (Nasdaq: MNKD) has licensed agreement exclusive worldwide rights to privately-held Colby Pharmaceutical to develop and commercialize disease-specific antigen compounds and intra-lymph node delivery technologies from MannKind's novel MKC1106 active immunotherapy programs, which are currently being developed for the treatment of melanoma, prostate, hematological disorders and other human cancers. 15 November 2012
Pharmaceutical
Everolimus, a drug originally developed to prevent the rejection of transplanted organs and is also marketed for the treatment of various cancers, has now been shown to dramatically reduce a particular kind of brain tumor in patients with tuberous sclerosis complex (TSC) -- a genetic disease that causes tumors to grow on vital organs. 14 November 2012
Pharmaceutical
German drug major Bayer (BAYN: DE) has initiated the Phase III COMPASS study of its oral anticoagulant Xarelto (rivaroxaban) for investigating the secondary prevention of major adverse cardiac events including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or peripheral artery disease. The study expects to enroll about 20,000 patients in more than 450 sites across >25 countries worldwide. 14 November 2012
Biotechnology
In what was some good news on the pancreatic cancer scene, the European subsidiary of US biotech firm Celgene Corp (Nasdaq: CELG) says that its Phase III study of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naive patients with advanced pancreatic cancer met its primary endpoint of overall survival. 13 November 2012
Pharmaceutical
French drug major Sanofi (Euronext: SAN) has said that it would halve the price of its colorectal cancer drug Zaltrap (ziv-aflibercept) in the USA, The Cancer Letter reported last week, saying this was due to criticism from oncologists. 12 November 2012
Pharmaceutical
In yet another disappointment for pancreatic cancer patients, Norwegian cancer drug developer Clavis Pharma (OSE: CLAVIS), has suspended development of CP-4126 following failure in pancreatic cancer trial. 12 November 2012
Generics
Following what Indian drugmaker Cipla (BSE: 500087) said was an "overwhelming response" on the price cuts made in May received from the patients and their families and doctors, the company is now announcing another breakthrough price reduction of as much as 63% in three additional anti-cancer drugs - erlotinib (its Erlocip brand) docetaxel (Docetax) and capecitabine (Capegard). 12 November 2012
Pharmaceutical
Privately-held Israeli company Immune Pharmaceuticals and US drug developer EpiCept Corp (Nasdaq: EPCT) yesterday announced that they have entered into a definitive merger agreement. The transaction is anticipated to close during the first quarter of 2013 and is subject to satisfaction of certain customary closing conditions, including the approval of a majority of EpiCept shareholders. 8 November 2012
Pharmaceutical
USA-based Novelos Therapeutics (OTCQX: NVLT), which is developing novel drugs for the treatment and diagnosis of cancer, has announced the closing of a private placement of equity securities to an affiliated entity of Renova Group, a leading Russian private business group, for gross proceeds to Novelos of $2 million. 8 November 2012
Biotechnology
US specialty drugmaker Auxilium Pharmaceuticals' (Nasdaq: AUXL) shares fell 7.2% to $18.60 at close of New York trading yesterday, after the company revealed that drugs behemoth Pfizer (NYSE: PFE) has terminated its collaboration agreement for the development, commercialization and supply of the Dupuytren's contracture treatment Xiapex (collagenase clostridium histolyticum), in the European Union and certain other European and Eurasian countries, effective no later than April 24, 2013. 8 November 2012
Pharmaceutical
Life Science Entrepreneurs, a Spanish company dedicated to the early-stage development of high-risk/very high return ventures, has announced the conclusion of a first investment for an antiplatelet drug candidate code-named NmC. 6 November 2012
Pharmaceutical
The prostate cancer drug market will more than double, increasing from $4.1 billion in 2011 to $9.1 billion in 2021 in the USA, France, Germany, Italy, Spain, the UK and Japan, says health care advisory group Decision Resources. 6 November 2012
Biotechnology
Swiss drug major Novartis' (NOVN: VX) generics subsidiary Sandoz has initiated a Phase III clinical trial in the USA for epoetin alfa, which it markets under the brand name Binocrit in the European Union for oncology and nephrology indications, to support registration in the USA. 5 November 2012
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