Last year the FDA inspected the AbbVie North Chicago manufacturing site during which time they discovered that the company failed to do a proper investigation on five death complaints received relating to Humira and Venclexta treatments. Though the drug maker reported the deaths, it didn’t collate the historical data of the lots in question. It was later discovered that the lots were tied to another 8 to 10 deaths.
Ascletis Pharma has become the first company to seek to list (PDF) in Hong Kong under the exchange’s new, more relaxed rules on biotech IPOs. The antiviral disease specialist will use the cash to win approvals for hepatitis C drugs licensed from Roche and Presidio Pharmaceuticals.
Eli Lilly and Incyte’s second attempt to get U.S. approval of rheumatoid arthritis drug baricitinib could be scuppered again by lingering FDA concerns about safety. A briefing document published ahead of the April 23 advisory committee meeting on baricitinib suggests that Lilly and Incyte’s lightning-fast amendment and refile of the dossier hasn’t added enough data to persuade the FDA to change its stance on the risk of blood clots with the JAK inhibitor.
The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
Takeda is considering making a bold move for Shire, after announcing, as per UK regulations, that it may make an approach for the company.
Takeda's inflammatory bowel disease treatment Entyvio has already been delivering blockbuster-plus sales, and the Japanese drugmaker sees fertile territory for more growth in the Asia-Pacific region.
The commercial life for Novartis’ Arzerra outside the U.S. is coming to an end.
It's not just specialty drugmakers raising prices in recent days. Big Pharma has pushed through a spate of increases, and while all of them are sub-10%—the cap some companies have adopted—some of them will cost payers and consumers plenty.
Boehringer Ingelheim has won its first biosimilar approval in Europe with authorisation of Cyltezo for a range of chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
The National Institutes of Health(NIH) and 11 leading biopharmaceutical companies have launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot.
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