Biopharma is a complex, rapidly evolving and highly regulated industry — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations driving the industry this week.
In case you missed it
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Mergers & analysis
The GOP's promised tax rewrite has finally come to pass. And biopharma companies are expected to start making deals now that the uncertainty has lifted.
Deals are already starting to roll in; Roche AG announced Friday morning it is picking up Ignyta Inc. for $1.7 billion, adding to its oncology pipeline.
Elsewhere, Biogen Inc. extended its agreement with Ionis Pharmaceuticals Inc. to develop another drug for spinal muscular atrophy (SMA) after the success of Spinraza (nusinersen). The deals also come at a time when competitors are starting to move forward in the space.
GlaxoSmithKline plc spinout Autifony Therapeutics Limited has landed a partnership with Boehringer Ingelheim, giving the German pharma an exclusive option to Autifony programs for serious central nervous system disorders in a deal worth €627.5 million (around $742.1 million).
In a move to expand its competitive edge, bluebird bio Inc. has tapped MilliporeSignma to manufacture viral vectors for its gene therapy. Manufacturing is one of the major challenges of the hot space, and bluebird is hoping that the agreements it has set up will help it compete with larger companies in the space.
Clinically relevant
Alzheimer's disease has been a tricky area for pharma to crack. The space has had more late-stage clinical trial blow ups than virtually any other therapeutic area, pushing many pharmas to abandon the area. Yet, should any company succeed in finding a disease-modifying therapy, the payoff would be huge.
Much focus recently has been on Biogen's aducanumab. And a clinical trial failure from one of its earlier Alzheimer's candidates has focus moving more squarely on that compound.
Elsewhere, AbbVie Inc. reported strong Phase 3 results for one of its blockbuster hopefuls in rheumatoid arthritis. Upadacitinib is expected to be a strong follow-up to the pharma's juggernaut Humira (adalimumab). But a patient death in the study took a little bit of the shine off the positive results. AbbVie said that the patient had risk factors for hemorrhagic stroke.
Highly regulated
It has been a record-breaking week for the Food and Drug Administration. The agency has officially beat its approval record for New Molecular Entities (NMEs), which it previously set in 2015 (this doesn't count the historic gene therapy approvals and CAR-T drugs approved as biologics). The FDA approved a 46th NME on Thursday, handing La Jolla Pharmaceutical Company an OK for its blood pressure drug Giapreza (angiotensin II).
Also this week, the FDA approved Spark Therapeutic's hereditary blindness gene therapy Luxturna ahead of its Jan. 12 user fee action date.
Merck & Co. and Pfizer Inc. also garnered an FDA greenlight for their SGLT-2 inhibitor. The type 2 diabetes treatment is an especially late entry to an already crowded market. The drug is meant to extend the lifecycle of Merck's best-selling drug Januvia (sitagliptin), which still brings in more than $4 billion annually, but has started to decline this year.
Aerie Pharmaceuticals Inc. also got an approval from the FDA for its glaucoma drug. Once again, the agency approved the drug well ahead of its Feb. 28 user fee action date.