Like any reporting beat, biopharma has its slow news days. But its rare to find a whole year when few events of note occur, and 2019 was no exception. Indeed, the last year of the 21st centurys second decade saw its fair share of major mergers and acquisitions, controversies and historical milestones across the medical biotechnology and pharmaceutical industries.

The year kicked off with a mega-merger, when on Jan. 3, New York-based Bristol-Myers Squibb said it would acquire Summit, New Jersey-based Celgene for $74 billion. A wave of mergers and acquisitions across the biopharma industry soon followed. This was a decade after another wave of biopharma consolidation, when 2009 kicked off with Pfizers acquisition of Wyeth, followed by Merck & Co. buying Schering-Plough and Roche buying Genentech. The next large-scale deal happened in June, when Chicago-based AbbVie said it would spend $63 billion to acquire Allergan.

Other than the two aforementioned large deals, however, most M&A activity this year has taken the form of large biotechnology and pharmaceutical companies buying much smaller, but still large-cap players. Earlier this month, Roche concluded its $4.3 billion acquisition of gene therapy maker Spark Therapeutics, originally announced in February. That deal was dogged by a 10-month investigation by U.S. and U.K. regulators into the question of whether the Roche might have a disincentive to develop Sparks Phase III gene therapy candidate for hemophilia A, given that the Swiss drugmaker already makes a drug for the disease. Indianapolis-based Eli Lilly & Co.s $8 billion acquisition of Loxo Oncology days after the BMS-Celgene deal did not face such hurdles, though Loxo handed off its one approved product, the cancer drug Vitrakvi (larotrectinib), to development partner Bayer. Numerous other deals have followed, including Novartis deal to acquire The Medicines Co. for $9.7 billion, Astellas announcement that it would buy Audentes Therapeutics for $3 billion, Mercks move to buy ArQule for $2.7 billion, among others.

While dwarfed by its counterpart in 2009, the current M&A wave has not been without controversy. In September, a group of eight Democratic senators and one independent several of whom are or had been running for president wrote to the Federal Trade Commission urging greater scrutiny over such deals amid concerns about competition and high drug prices. While its uncertain if the FTC was responding to their concerns, the agency said Dec. 17 that it would seek to block genomic sequencing company Illumina from buying a smaller firm, Pacific Biosciences of California, in a previously announced $1.2 billion deal.

Another controversy that arose in 2019 was on the regulatory front. In August, the Food and Drug Administration said it was looking into a disclosure from Novartis subsidiary AveXis that mouse data from a disused assay used in its application for the gene therapy Zolgensma (onasemnogene abeparvovec-xioi) in spinal muscular atrophy which the FDA approved in May had been manipulated. The scandal, which predated Novartis acquisition of AveXis in 2018, led to two of the gene therapy developers executives being fired and created a publicity crisis for the drugmaker.

Yet, while the Zolgensma scandal did not affect the FDAs overall position on the product itself, another FDA decision still raised eyebrows. The approval of Karyopharm Therapeutics Xpovio (selinexor) in highly refractory multiple myeloma patients attracted significant criticism from physicians, who pointed both to what some called a low response rate in the Phase IIa study on which the approval was based and the FDA using Phase III data that were not disclosed to the public. The approval also happened despite the FDAs Oncologic Drugs Advisory Committee voting not to recommend it.

2019 also saw some important milestones on the regulatory front. Nine months after Scott Gottliebs resignation as commissioner of the FDA, the Senate confirmed Dr. Stephen Hahn, a radiation oncologist and chief medical executive at The University of Texas MD Anderson Cancer Center, to take his place. And the agency approved the first ever drug to tackle the root cause of sickle cell disease and its first vaccine against the Ebola virus.

In addition to specific events, many trends that have garnered increasing public and political attention moved to front and center in 2019 as well. The national conversation about drug pricing showed no signs of quieting down, as the Trump administration rolled out various programs designed to tackle high drug prices, and the House fired a shot across the bow with a bill this month that would require the Centers for Medicare and Medicaid Services to negotiate prices for some drugs.

Many of these events will continue to play out in 2020, as a new FDA commissioner takes the helm of the agency and large companies see their acquisitions bear fruit, for good or ill. And the conversation about drug pricing will only get louder amid the 2020 presidential election, which in turn could lead to greater scrutiny over biopharma industry consolidation.

Photo: klenger, Getty Images

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What were the biggest biopharma stories of 2019? - MedCity News