Almost a year ago, AstraZeneca’s triple-drug combination for chronic obstructive pulmonary disease was shot down with an FDA complete response letter. But on Friday, it finally received the green light.

The UK pharma giant has received approval for its Breztri Aerosphere, formerly dubbed PT010, culminating the drug’s bumpy regulatory journey in a win. Now, AstraZeneca can challenge the leader in the area — GlaxoSmithKline’s Trelegy — without obstacle.

The question of where and by whom drugs’ active ingredients are manufactured was a fairly niche issue back in February, when new Sanofi CEO Paul Hudson first said he would spin off the French giant’s active pharmaceutical ingredient (API) business into its own public company as part of his strategic rethink of the long-laboring drugmaker.

He likely did not imagine that it would soon become a national security question for many countries as a pandemic threatened global supply lines and a vaccine arms race underscored the advantage those with in-country pharmaceutical manufacturing capacity had. Or that French President Emmanuel Macron would stand in a teal facemask at their own French facilities and tell broadcasters about the need to keep production in France.

Amicus received a healthy heaping of good news last month when analysts threw cold water on Sanofi’s late-onset Pompe disease ERT, after a Phase III study essentially cleared the way for Amicus’ competing candidate to be the standard-bearer. Now, Amicus is preparing for a new “path to profitability” with an expected windfall.

The New Jersey-based biopharma announced today it is refinancing debt to the tune of a $400 million loan from Hayfin Capital Management. Amicus will utilize the credit, which is expected to be funded in full on or about August 4, to refinance existing debt and for other development purposes.

Many in the pharma world are hoping — better yet, expecting — JAK inhibitors to provide one of the next big boons for the industry. Few have invested as heavily in this area as Pfizer, which boasts a portfolio including Xeljanz and at least five mid-to-late stage candidates in the pipeline.

But a top Wall Street analyst is pumping the brakes on just how much good fortune is in store for the Big Pharma.

By the time the FDA finally granted an accelerated OK for Immunomedics’ Trodelvy, we already got a very strong hint that their confirmatory Phase III study in metastatic triple-negative breast cancer was a success.

That’s because the independent data safety monitoring committee recommended that the trial be stopped early. But just what pointed them to the conclusion was still unclear.

“We do not know the totality of their decision other than it’s pretty evident that the primary endpoint was met; otherwise they could not request to halt the study,” Behzad Aghazadeh, the executive chairman, told Endpoints News at the time.

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.