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
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- Cancer concerns weigh on CRISPR developers
Mergers & analysis
Small M&A and licensing deals trickled in this week, while big pharma continued to reorganize. The last two years, in particular, have been marked by major pharmaceutical companies streamlining their businesses. Many of the biggest players have sold off products that are at the end of their lifecycle or no longer fit with their strategic direction. Others have waved goodbye to whole divisions in a quest to shed units where they are not leaders.
In that vein, Johnson & Johnson announced the sale of two divisions in as many weeks. First, the multinational conglomerate said it would sell its Advanced Sterilization Products business to medical and industrial products company Fortive for $2.7 billion.
Several days later, J&J said it took a $2.1 billion offer from private investment firm Platinum Equity for its diabetes monitoring unit LifeScan.
Elsewhere, vaccine maker Sanofi Pasteur partnered with Translate Bio to develop mRNA vaccines for infectious diseases, adding to its vast portfolio of preventative and therapeutic vaccines.
And Sage Therapeutics has licensed out most of the Asian rights to its major depressive disorder drug SAGE-217 to Shionogi. The deal gives the biotech more cash for its arsenal, and comes on the heels of the Food and Drug Administration giving the drug an expedited approval pathway.
Clinically relevant
Galmed furthered the NASH bubble this week, nearly doubling its stock price after announcing somewhat mixed results for its non-alcoholic steatohepatitis drug. There are currently no treatments for the liver disease, but the industry has stoked excitement by suggesting the market potential could be huge. Some are calling this just hype, but only time will tell if the industry can get it right when bringing these much-needed drugs to market.
Allergan, meanwhile, announced positive results for its CGRP inhibitor, furthering excitement around the emerging market for new migraine drugs. Atogepant is just one of many treatments for the condition nearing commercialization. While Allergan has shown positive data, it may not be enough to compete with other drugs that are likely to be available to patients earlier. Pricing dynamics are going to play a major part in this.
Elsewhere, the quest for an Alzheimer's disease treatment took several more hits this week, with two more trial failures. Eli Lilly and partner AstraZeneca have decided to stop development of their BACE inhibitor after an independent Data Monitoring Committee surmised that the drug would not be effective — not even in very early patients. And North Carolina-based biotech vTv Therapeutics also noted a failure for its drug.
The latest failures continue to call into question the amyloid hypothesis, a theory that amyloid protein buildups in the brain are a cause of Alzheimer's. Some critics suggest pharma may be chasing its own tail when continuing to pursue this route.
In other bad news, Flex Pharma revealed it was shutting down development of its lead compound in two rare diseases, noting safety issues seen in clinical trials. The decision means the company can no longer afford to move forward on its own and is exploring strategic options. Flex is laying off 60% of its staff, but will keep a small team on hand to continue development of the compound in a smaller indication until all strategic options can be considered.
Highly regulated
As promised, the Food and Drug Administration issued more guidance this week to further clarify its position in certain areas. The agency unveiled guidelines as part of an effort to stem the problem of antimicrobial resistance and antibiotic overuse. A new guidance document said the regulator is working with the Centers for Medicare and Medicaid Services to improve the reimbursement situation for new antibiotics.
Meanwhile, the agency also clarified how manufacturers can communicate with payers to establish value-based payment schemes without giving information that might considered false or misleading or violate other restrictions about off-label marketing.
And in other regulatory actions, generic drugmaker Mylan revealed to investors that it expects to receive a rejection from the FDA for its generic version of GlaxoSmithKline's asthma drug Advair Diskus (fluticasone propionate/salmeterol). The Complete Response Letter will be the second for the product, but Mylan emphasized it believes it can still gain approval this year