Celltrion's version of Roche’s MabThera (rituximab), Truxima, has become the first biosimilar anticancer to win marketing authorization in Europe.
Bayer has launched an internal oncology R&D unit to speed up development of its pipeline cancer therapies and ensure the company is first to market with its late-stage treatment candidates, head of pharma Dieter Weinand told Scrip on the sidelines of the pharma's annual results conference.
A mixed bag of safety results for the new opioid Olinvo (oliceridine) in the Phase III APOLLO pain trials disappoints the market, but analysts are encouraged by the totality of the data and optimistic about approval.
Two Canadian companies – Theratechnologies and CytoDyn – exploring the use of monoclonal antibodies in the fight against HIV presented data for their novel late-stage candidates at the recent CROI meeting in Seattle. They are aimed at patients experiencing multi-drug resistance and represent a change in this mature therapy area dominated by small-molecule oral products.
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Instead of helping raise a Series A, the Teva chairman and others acquire the preclinical company, convinced of its synthetic nanotech promise in immuno-oncology. Vifor and ChemoCentryx expand their orphan and renal disease collaboration, while Gilead out-licenses an addiction drug candidate.
Debt-fueled acquisitions helped Teva, Shire and Allergan report well-received fourth-quarter earnings. But sector circumstances have changed since 2016 and the ability to grow by debt-funded acquisition is now severely restricted.
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The mid-stage company is approaching Phase II data read outs for two lead assets. It is looking to partner with larger pharmas, but is also pursuing orphan indications that it could develop independently.
Emerging Company Profile: Rexgenero is developing a cell therapy to treat critical limb ischemia and is in the process of raising €25m to fund the Phase III program on top of €60m the company has raised to date. CEO Joe Dupere spoke with Scrip's Mike Ward at the Biotech Showcase last month.
Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.
A NICE knock-back for Ipsen's Cabometyx in renal cell carcinoma (RCC) means less pressure on BMS's embattled Opdivo, but not for long if Ipsen is willing to compromise on price, warn analysts.
Entering 2017 with freshly approved Spinraza and new CEO Michel Vounatsos, Biogen still faces challenges and uncertainty. A poll of investors highlights expectations for the company.
The WORLD Symposium Feb. 13 to 16 in San Diego offered everything from basic research through late-stage clinical data in lysosomal diseases, including ArmaGen's blood-brain barrier-crossing treatment for Hurler syndrome and updates from ongoing development programs from rare disease specialists, such as Genzyme, Amicus and Protalix.
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Japan has approved a new batch of first-time and other generic drugs that will be reimbursed and launched in June, putting at risk several billion dollars’ worth of combined sales of some major branded products.
Celgene is finally able to market its mainstay multiple myeloma therapy Revlimid for maintenance use after stem cell transplant, after the FDA further expanded its approved indications. The EU is set to follow suit following a CHMP positive opinion last month.
Nathalie Moll is moving on from leading the biotech industry body EuropaBio to be the next director general of EFPIA, the federation that represents the R&D-based pharmaceutical industry in Europe. With issues such as the forthcoming Brexit negotiations, the EU’s inquiry into medicines access and pricing, and the implementation of the new Clinical Trials Regulation on the agenda, Moll will have a lot of weighty dossiers to deal with.
The setting up of the Rosalind Franklin Institute to link up with one of the world’s largest electron microscopy centers in Harwell, Oxford, could bolster company sentiment towards UK R&D investment in a post-Brexit world.
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Argos mum on details surrounding Phase III failure of rocapuldencel-T in kidney cancer, while Agenus distances itself from failed Phase II glioblastoma study of Prophage G-200 as an investigator-sponsored trial with a challenging design.
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The long-acting eye insert Dextenza has been accepted for review by the US FDA, a piece of good news for Ocular Therapeutix that had previously received a complete response letter on manufacturing issues and a mixed bag of late-stage clinical trial results.
Two-year-old biotech Mereo BioPharma Group plc is planning to start a pivotal Phase IIb study in osteogenesis imperfecta patients in the first-half of this year with its anti-sclerostin antibody, BPS-804, and if the results are promising, EU patients could gain early access through the region’s adaptive pathways program.
MLR-1023, a repositioned oral compound being developed for type 2 diabetes by Melior and Bukwang, is set to move into Phase IIb in the US and South Korea, and the firms are looking to its novel mechanism of action, improved tolerability and efficacy to carve a niche in a highly competitive sector.
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