Now that the EMA has elbowed Novartis’ application for Xiidra off the table, the reverberations are being felt at Takeda.

The pharma giant noted early Monday that it will recognize a loss of $200 million for the current quarter after the news hit late last week that the European regulator had decided that the eye drug they sold to Novartis for $3.4 billion in cash and $1.9 billion in milestones hadn’t made its case on efficacy. The drug has been marketed in the US now for 4 years, and Takeda picked it up in the $62 billion Shire buyout and then promptly sold it off to Novartis.

Axsome Therapeutics’ surprise win in a late-stage Alzheimer’s study, unveiled just two months ago, has registered with regulators. The New York-based biotech has notched a breakthrough therapy designation for AXS-05 for the indication, its second after major depressive disorder.

So what’s the big deal here? The drug is an oral agent “with multimodal activity” consisting of two components: dextromethorphan, an NMDA receptor antagonist, and bupropion — whose main purpose is to slow down the metabolism of the former.

For years, it was a two-company race to develop the first treatment for peanut allergy. Then in January, Aimmune won approval for its peanut powder pill and now it looks like their competitor and the erstwhile frontrunner is struggling to stay alive.

DBV Technologies said today that it has not heard from the FDA since the agency said they were concerned about how effective DBV’s experimental peanut patch would be and, as a result, plan to lay off a “significant” number of employees. These cuts will be part of a “global and comprehensive restructuring plan” that will begin immediately and attempt to keep the company solvent past Q1 2021.

When Regeneron won its first OK for their PD-1 Libtayo as a treatment for recurrent or metastatic cutaneous squamous cell carcinoma, the second most common form of skin cancer, company president George Yancopoulos crowed about their ability to grab a major niche market left wide open by the 2 big powerhouses in the field, Merck and Bristol Myers.

Today, though, Regeneron and their partners at Sanofi no longer enjoy a monopoly in that particular field. Merck grabbed an OK for their top-selling PD-1 Keytruda in the same group of patients. But don’t expect Regeneron — still struggling to boost sales — to let go of their best-in-class claims.

Innate Pharma has smoothed over a bump on a Phase II for lacutamab, resuming enrollment in the US as the FDA lifts its partial hold.

The hold, which was issued in January, came after the French biotech stopped treating new patients following discussions with regulators in Europe. Its manufacturing subcontractor, Rentschler Fill Solutions, had abruptly filed for bankruptcy and withdrawn a certificate of conformity on the lacutamab batches they produced.

FDA commissioner Stephen Hahn on Tuesday testified before the House Energy and Commerce Committee on his agency’s response to the coronavirus disease (Covid-19) pandemic.

User fee goals, policy review

Despite an “incredible surge in volume” of applications and constraints on the agency’s ability to conduct inspections, Hahn said that the FDA “has maintained the same pace of meeting its goals on applications for medical products for the last six months that is has maintained in recent years.”