Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations driving the industry this week.
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Mergers & analysis
This week saw little deal activity ahead of two of the industry's biggest conferences: the American Society of Clinical Oncology annual show and the BIO International Convention. But Allergan CEO Brent Saunders surprised investors, mentioning to an analyst conference the company will look to exit women's health and infectious diseases. After a rollercoaster year for the specialty pharma, Allergan is looking to bring in some cash by selling off the assets.
Maybe Allergan should rethink its previous decision to stay out of oncology. A recent report from Evaluate Pharma shows that oncology drugs are the top selling therapeutics on the orphan drug market. Currently, global sales of orphan drugs totaled $125 billion in 2017 and will grow to $262 billion by 2024 — cancer drugs are expected to account for 50% of that.
Elsewhere, the European Union is trying to help bolster market competition — a move the U.S. Food and Drug Administration has been making as well. The EU has decided to refine its intellectual property laws to allow European companies to manufacture generic and biosimilar forms of supplementary protection certificate-protected drugs during the term of the certificate, provided it is for export to non-protected non-EU markets.
Madrigal Pharmaceuticals hit it out of the park this week, with shares jumping more than 120% after the biotech announced Phase 2 results for its non-alcoholic steatohepatitis (NASH) drug MGL-3196. The drug had statistically significant more patients showing resolution of NASH according to a liver biopsy than those on placebo. Investors have high expectations for this market, but with no drugs yet over the finish line, it will be a wait-and-see game to determine if the pharma industry can roll these drugs out right.
Elsewhere, AstraZeneca reported the second failure for its respiratory biologic Fasenra in chronic obstructive pulmonary disease. The drug is already approved for asthma and the British pharma was hoping to expand the market with a COPD indication. But with two late-stage failures under its belt, AstraZeneca has elected not to file.
Danish drugmaker Novo Nordisk chalked up a win this week, with its oral version of semaglutide showing superiority to Eli Lilly's Jardiance on the measure of blood glucose. Yet, there wasn't a statistically significant difference in the amount of weight patients lost.
The Food and Drug Administration handed an approval to TherapeuticsMD for its treatment of pain in the vagina during sexual activity for women after menopause. The OK comes a little over a year after the agency gave the company a Complete Response Letter and said it would need more data. TherapeuticsMD managed to garner approval with the promise of a post-approval observational study, as well as a boxed warning. Some are calling this a turnaround from the FDA, but the current outcome was one that some analysts had anticipated at the time of the original rejection.
The agency also slapped Vertex Pharmaceuticals and its partner CRISPR Therapeutics with a clinical hold on their Investigational New Drug application for their cystic fibrosis gene therapy. The companies will have questions to answer if they want to proceed into human clinical testing. The hold didn't hurt Vertex all that much, but it spooked CRISPR investors as they anticipate some of the first CRISPR/Cas 9 gene editing products entering the clinic.