Shares in Zealand Pharmaceuticals A/S hit an all-time high Monday on news that it will shortly start logging double-digit percentage royalty payments from its partner Sanofi SA, following formal European Union approval of the once-daily glucagon-like peptide 1 (GLP-1) agonist Lyxumia (lixisenatide, AVE0010) in Type II diabetes. "It marks the beginning of a new era. How many European biotechnology companies have commercial products?" Zealand CEO David Solomon told BioWorld International. "This

The drug development graveyard that is Alzheimer's disease has claimed yet another victim. This time it's AC Immune SA's ACI-91, a drug that had offered a new approach to tackling this most intractable of diseases. The Lausanne, Switzerland-based firm is terminating its development, following a placebo-controlled Phase II trial in which the drug was associated with a decrease in cognitive performance and function. AC Immune had kept the identity of ACI-91 under wraps but recently revealed it

LONDON – Successful treatment of cancer depends not on killing tumor cells, but in beating them into submission using the immune system, a team of German researchers reported. They have identified a type of immune cell that can "re-educate" cancer cells, so that they enter prolonged periods of growth arrest. Mice with tumors, which were treated with the immunotherapy, survived for many months in a healthy condition, compared with animals that were treated with a placebo. Finances permitting

Israeli biotech Gamida Cell Ltd. moved lead product StemEx one step closer to becoming potentially the first allogeneic biologic cell product to achieve marketing approval in the U.S. and Europe. The therapy, which uses the company's copper chelator technology, demonstrated overall survival – the primary endpoint – in a Phase II/III study comparing its use in a transplantation regimen to historical controls when treating patients with hematologic malignancies such as leukemia and lymphoma who

Say "emerging markets," and anyone within earshot is likely to think of Brazil, Russia, India and China, the so-called BRIC countries. Africa, not so much. Common ideas about the world's second largest land mass date back a decade or so, when The Economist famously dubbed Africa "the hopeless continent." Pharmaceutical firms, though, have recognized Africa's potential for a few years now, said Sarah Rickwood, director of European Thought Leadership with IMS Health. "People hear the bad news

Shares in Active Biotech AB fell almost 13 percent Monday on news that its immunotherapy Anyara missed the primary endpoint of a Phase II/III trial in advanced renal cell cancer. The trial was by no means a complete failure, however, as a subgroup analysis attained statistical significance in around a quarter of the patients recruited, and the Lund, Sweden-based company has a firm understanding of what happened from a biological perspective. "We're encouraged that we got a robust signal," CEO

LONDON – The new £100 million (US$160 million) Wales Life Sciences Fund (WLSF) is poised to make its first investment after appointing biotech veteran Chris Evans to run the fund and pulling together a supporting cast of nine seasoned industry experts to manage its portfolio. The government in Wales is putting up half the money for WLSF, with the balance to be raised by Arthurian Life Sciences Ltd., the company formed by Evans to bid for the business. Alongside Evans in the chair, the board of

LONDON – A family that has 14 members affected by an aggressive form of malignant melanoma has helped researchers discover a new mutation that is common in melanoma tumors and could lead to new, targeted treatments for that type of cancer. Although researchers initially identified the mutation in the family members, they subsequently found two more mutations affecting the same gene in unrelated people with malignant melanoma. Rajiv Kumar, professor of molecular genetic epidemiology at the

LONDON – Pharma's productivity woes have spawned a new UK company, Avillion LLP, which is offering to plug between $50 million and $100 million into the co-development of Phase III assets. Alongside the cash to fund Phase III studies and take products through approval, Avillion will offer its partners expertise in contract research organization (CRO) management, drug development and regulatory affairs. The London-based company said Monday it has received initial funding from life science

Bone Therapeutics SA raised €7.7 million (US$10.4 million) in new financing as a prelude to a larger round, as it seeks to expand the indication range for its cell therapy product Preob. The funding comprises a €6. 1 million equity investment from its existing shareholders, plus another €1.6 million in grant funding from Belgium's Walloon Region. Gosselies, Belgium-based Bone Therapeutics is currently starting a second Phase III trial of Preob, in patients with non-union bone fractures, that

LONDON – Cytox Ltd. has been rescued from liquidation and raised £3.5 million (US$5.5 million) in new money to reinvigorate efforts to develop a simple, definitive blood test for the early diagnosis of Alzheimer's disease. That would both provide an advance in terms of the care of people with the disease and in enabling drugs to be tested in the earlier stages of the disease when there is a greater likelihood of showing a significant clinical effect. The recent Phase III failures of two

With data due from a pivotal Phase III trial of its lead drug candidate around midyear, Gene Signal International SA raised an undisclosed investment from its longstanding syndicate of private investors to keep its pipeline of antisense and peptide-based drugs moving forward. Although it has maintained a relatively low profile since its formation in 2000, the Lausanne, Switzerland-based biotechnology firm has a topical antisense compound, aganirsen (GS-101), undergoing a pivotal Phase III trial

Algeta ASA, of Oslo, Norway, began studying a therapeutic combining its thorium-227 alpha-pharmaceutical agent with an anti-CD22 monoclonal antibody (epratuzumab) by Immunomedics Inc., of Morris Plains, N.J. The agreement between the two companies requires Immunomedics to provide clinical-grade antibody, and for Algeta to fund all preclinical and clinical development through the end of Phase I. At that time, the companies may negotiate for a license. Algeta will pay a signature fee, a milestone

Newly established Dutch start-up Dezima Pharma BV in-licensed what it considers a best-in-class cholesteryl ester transfer protein (CETP) inhibitor, DEZ-001 (formerly TA-8995), from Osaka, Japan-based Mitsubishi Tanabe Pharma Corp. and is planning to move the cholesterol-lowering drug into a Phase II trial involving more than 400 patients in the coming months. Terms of the deal were not disclosed, but Naarden, the Netherlands-based Dezima is now in sole control of the compound, which it is

With key regulatory and clinical events fast approaching, MolMed SpA is set to add about €5 million (US$6.5 million) to its balance sheet in a capital increase that is fully underwritten in all but name. The Milan, Italy-based biotech has received indications from its largest shareholders, which hold an aggregate of 32 percent of its stock, that they are available to participate fully in the transaction. Moreover, the largest of those, Fininvest SpA, a financial holding company controlled by

LONDON – For 60 years, the DNA double helix has provided an iconic image of how our genetic information is held and how it reproduces. Now scientists at the University of Cambridge in the UK – where Watson and Crick developed their ideas about the genetic code – have provided another pioneering insight into the workings of human genes. It turns out that the DNA of human cells can form not only a double helix but also a quadruple helix. The discovery is particularly exciting because the team

ThromboGenics NV and its partner, the Alcon unit of Novartis AG, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Jetrea (ocriplasmin) as a treatment for vitreous macular traction, paving the way for a European launch in the second quarter. That move would trigger a €90 million (US$120 million) milestone payment to Leuven, Belgium-based ThromboGenics and provide it with even greater financial muscle as it starts to

LONDON – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has had another Glybera moment, turning down the rare disease drug Raxone (idebenone) by a narrow majority, despite the rapporteurs on an expert committee recommending approval of the drug, which treats a hereditary cause of blindness. "We're not disclosing the size of the majority against, but we do know, and I can confirm it's very narrow," Thomas Meier, CEO of Raxone's developer Santhera

LONDON – The latest advance in antibody technology has arrived in the shape of the Crescendo mouse, a transgenic mouse that is engineered to generate fully human single domain VH fragments. As the smallest units of a full-scale antibody that are still able to bind antigens, therapeutics based on those fragments are expected to have superior properties, be straightforward to bolt together into bispecific or multivalent entities and be simple to manufacture in microbial systems. And because the