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Approvals

Set Alert for Approvals

US Approval For ViiV’s ‘Last Resort’ HIV Drug Rukobia

The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.

Approvals Infectious Diseases

Triple Joy For European Biotechs As FDA OKs Byfavo

Having secured FDA approval, the UK's Acacia Pharma will market Byfavo, the first new product in the sedation space in decades, which was licensed from Italy's Cosmo and developed by Germany's Paion.

Approvals Strategy

EC Approves Extended Invokana Indication On Renal Outcomes In DKD

Mundipharma has announced the European Commission’s extension of the indications for Invokana to include renal outcomes data from the Phase III CREDENCE study.

Renal Approvals

First Vaccine Approval For Janssen With Two-Dose Ebola Prophylactic

The two-part vaccine becomes the second against Ebola to get approval. Janssen is now collaborating with the World Health Organization on vaccine pre-qualification to get it to people in need.

Approvals EU

Pipeline Watch: Pfizer's Vaccines Start Phase III Studies

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Novartis Xiidra Buy Looks Even Pricier With File Pulled In EU

A year after inking a multi-billion dollar deal to get hold of the Takeda eye drop, Novartis has given up on getting approval for Xiidra in Europe with the EMA unconvinced about the therapy's efficacy.

Ophthalmic Drug Review

Zogenix Risks Fintepla Uptake With Dravet Drug’s High Price

The average list price of $96,000 per year is three times the cost of GW’s competing drug Epidiolex, but Zogenix is betting that the reduction in seizures seen in clinical trials will justify the expense. 

Launches Pricing Strategies

Hansa On a High After CHMP Thumbs-Up For Idefirix

Sweden's Hansa Biopharma has taken an important step closer to becoming a commercial-stage company with the backing of European regulators for Idefirix, although launch plans have been impacted by the COVID-19 crisis.

Drug Review Rare Diseases

Pipeline Watch: Phase III Readouts For Ipatasertib, Avaglucosidase Alfa, Lenzilumab

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Approvals Pipeline Watch
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