Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- Johnson & Johnson's Remicade sales fell
- BioPharma Dive sat down with GE to talk manufacturing
- Novartis getting the third degree over Cosentyx
Mergers & analysis
2018's M&A rollercoaster is continuing with Shire plc at the forefront. The beleaguered rare disease giant is selling off its oncology assets to French pharma Servier S.A.S. in a deal worth $2.4 billion. The selloff comes at a time when the company is being pursued as a takeout target. The Irish drugmaker confirmed that it is being courted by Japanese pharma Takeda Pharmaceutical Co. Ltd., and has rejected the offers three times now. Shire and Takeda revealed Friday morning that a fourth offer has been made, but no decision yet from Shire. We'll keep you posted.
Allergan also briefly jumped into the mix, admitting it was exploring a deal ... and then announcing it was not just a few hours later. Some media reports suggest there are other suitors who are getting in on the talks for the company as well.
Elsewhere in the pharma universe, companies are offloading units that are not core to their strategy. In the last few weeks we've seen GlaxoSmithKline plc pick up Novartis AG's consumer business and offload its gene therapy unit. And this week followed with Merck KGaA selling off its consumer unit to Proctor & Gamble Co. for $4.2 billion, and Sanofi SA announcing it will sell its European generics business to Advent International Corp. for $2.4 billion.
Clinically relevant
The American Association of Cancer Research (AACR) conference doled out a lot of promising early stage data and gave the world one of the first glimpses at how the strategy for combination therapies is working out in cancer research.
Merck & Co. is being lauded as the 'winner' so far in this space due to data from a combo trial of chemo with its blockbuster checkpoint inhibitor Keytruda (pembrolizumab) in non-small cell lung cancer. Yet, combos from both Bristol-Myers Squibb Co. and Roche AG, respectively, are also making waves.
A recent strategy from Bristol-Myers betting on a new biomarker could be another gamechanger in this space. Read here to find out why.
Elsewhere, Celldex Therapeutics Inc. fell on the Phase 2 failure of its breast cancer drug, ImmuPharma plc dropped on the late-stage flop of its lupus drug, and, on the other end of the spectrum, NGM Biopharmaceuticals Inc. showed progress in its mid-stage NASH study.
Highly regulated
The Food and Drug Administration made a major about-face with its decision on Alkermes plc's major depressive disorder drug ALKS-5461 just two weeks after the agency refused to accept its New Drug Application — without any new data. The move was a surprise, but also likely indicative of the administration's new push to bring drugs forward more quickly.
This dramatic turnaround could come back to bite the agency (and Alkermes) later. In a similar move last year, the FDA chose to allow Eli Lilly & Co. to resubmit its NDA for its rheumatoid arthritis drug baricitinib — again without any new clinical data, despite a previous rejection. Now, that same drug is facing an Advisory Committee meeting on Monday and the briefing documents from the FDA were ugly. The documents called into question, multiple times, the safety and efficacy of the 4 mg dose of the drug, and made it clear that there isn't enough evidence to support either for the 2 mg dose. Monday's panel could have far-reaching implications for the JAK inhibitor class.
Another Advisory Committee was much more lenient this week; on Thursday, a panel recommended the approval of the first drug derived from a whole marijuana plant. The class of drugs has long had a stigma attached to it, but the loosening legality around the country related to marijuana could be opening up new avenues for the substance as a drug class.