Prescribed Reading: AACR, Gottlieb and recalls
A weekly guide to the goings-on in the biopharma industry.
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
- PhRMA strikes back with a new ad campaign.
- BIO reviews progress of the JOBS Act.
- Mallinckrodt leaves PhRMA.
Data was the big talk this week as the American Association of Cancer Research (AACR) meeting pushed through last weekend into mid-week, showcasing early research and long-term survival data for some of the most closely watched cancer therapies.
Even though Bristol-Myers Squibb’s flagship checkpoint inhibitor Opdivo (nivolumab) failed in a late-stage study of patients with glioblastoma, the PD-1 inhibitor showed durable long-term survival data in a separate study of patients with advanced melanoma, and others with non-small cell lung cancer. Despite approvals in both cancers already, the long-term data gives a clearer picture of the durability of the treatment.
Meanwhile, eyes turned to other mechanisms of action that could be a good complement to the closely watched checkpoint inhibitors. Newlink Genetics reported data from a mid-stage study that tested its IDO inhibitor with Merck & Co.’s Keytruda (pembrolizumab), showing a 52% response rate in advanced melanoma.
There was also data presented on competing checkpoint inhibitors – Pfizer’s Bavencio (avelumab) and Roche’s Tecentriq (atezolizumab).
Mergers & analysis
On top of the data reported at AACR this week, biotech Incyte Corp. hedged its bets by expanding collaborations with both Merck & Co. and Bristol-Myers for combinations of their respective checkpoint inhibitors with Incyte’s IDOL1 inhibitor. The biotech is taking no chances and doesn’t want to risk a failure due to partnering with the wrong PD-1 inhibitor. It’s a strategic decision that only stands to benefit Incyte, but could mean trouble for a big pharma if one of the checkpoint inhibitors doesn’t perform.
While that was one of the only deals to speak of this week, all eyes turned from AACR to Scott Gottlieb’s Senate hearing on the Hill. After a day of solid answers, Gottlieb could be a pleasing candidate for all parties to head the Food and Drug Administration.
President Trump’s pick to oversee the regulatory agency danced a line between maintaining regulations and making the FDA more nimble. How vowed to uphold the “gold standard” for establishing safety and effectiveness. Yet, he showed that he can take a realistic view, squashing any hopes for anti-vaccers by acknowledging that there is no scientific evidence to support a link between vaccines and autism, and also noting that the opioid crisis has to be a top priority.
Regulators issued warnings this week for two widely used products, prompting U.S. recalls for both Mylan’s epinephrine autoinjector EpiPen and GlaxoSmithKline’s Ventolin (albuterol) inhalers.
Mylan expanded its recall from several countries outside the U.S. after there was a problem at its manufacturing partner, Pfizer subsidiary Meridian Medical Technologies. More than a dozen batches of the emergency allergy medication had a defective part that could prevent it from delivering medication correctly. This recall comes as just the latest hit to company that only seems to be getting bad PR lately.
Meanwhile GSK is pulling the inhalers from hospitals, pharmacies and wholesalers. The company is still trying to get to the root of the problem, but the recall comes after an increased number of reports of damaged packaging.
Bad news has a way of happening in waves; Acorda got caught up in the tide this week. The company was forced to cut 20% of its staff after a court invalidated some of the key patents for its multiple sclerosis walking drug Ampyra (dalfampridine), which makes up nearly 95% of its revenues. The cut of 100-120 employees will save the company $21 million annually. The news wasn’t received well, prompting at least one journalist to question why CEO Ron Cohen is still set to receive millions in compensation. It’s an unusual stance to take – most big pharma execs, which make significantly more than Cohen, don’t get called out when they make huge staffing cuts.
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