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New FDA Revlimid Approval Extends Celgene's Myeloma Empire

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.

Approvals Policy & Regulation Cancer

Bayer Bets On Oncology Pipeline, Vows To Increase 2017 R&D Budget

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.

Cancer Research and Development Strategies Sales & Earnings

Busy In-Tray Awaits New EFPIA Boss Nathalie Moll

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.

Policy & Regulation Leadership Companies
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Viking Flexes Its Muscles Ahead Of Partnering Talks

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.

Business Strategies Rare Diseases Companies

Rexgenero: Tackling Critical Limb Ischemia With Cell Therapy Approach

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.

Commercial Business Strategies Innovation

Latest From Commercial

Deal Watch: Teva's Sol Barer Leads Buyout Of IO Start-up NexImmune

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.

Commercial Deals

Celltrion's Truxima First Biosimilar MAB In Oncology To Win EU Approval

Celltrion's version of Roche’s MabThera (rituximab), Truxima, has become the first biosimilar anticancer to win marketing authorization in Europe.

Approvals Biosimilars

Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

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.

Business Strategies Research and Development Strategies

NICE Move On Cabometyx Gives BMS Longer To Make Opdivo Case In Second Line RCC

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.

Reimbursement Commercial

Behind The Blockbuster: Investors Sound Off On Biogen's Future With Spinraza

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.

Business Strategies Commercial

WORLD Symposium Notebook: New Data In Lysosomal Diseases And A Push For Earlier Testing

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.

Commercial Clinical Trials

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Rosalind Franklin Institute May Calm Industry’s Brexit Fears

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.

Innovation Policy United Kingdom

Billions At Stake As Generic Approvals Open Up Japan Big Sellers

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.

Generic Drugs Japan

Parsabiv Could Allow Amgen To Maintain Control Of Calcimimetics Market

Amgen's oral calcimimetic Sensipar faces generic competition in 2018, but the new intravenuous Parsabiv has advantages that could make it the more popular alternative.

Reimbursement Approvals

Sweeping FDA Changes Could Have “Disastrous Consequences” For Biotech Investment

Lowering the bar on drug approval standards would create a challenging environment for biotech investors, warned Jonathan Leff, a partner at the health care investment firm Deerfield, during the BIO CEO & Investor Conference.

Pricing Debate Medicare

Research & Development Explore this Topic

Ocular Therapeutix Gets Lead Product Back On Track

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.

Companies Ophthalmic Drug Review

Latest From Research & Development

Argos And Agenus Trials Pile On Fresh Cancer Vaccine Disappointments

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.

Research & Development Clinical Trials

What Progress In The Rare Disease, Osteogenesis Imperfecta?

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.

Rare Diseases Clinical Trials

Melior, Bukwang Seek Diabetes Edge With Novel Insulin Sensitizer

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.

Research & Development Diabetic Care
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