An­oth­er ex­ec­u­tive is mi­grat­ing from the ech­e­lons of Big Phar­ma to the cor­ri­dors of small biotech.

In April 2018, Badrul Chowd­hury took his more than two decades of ex­pe­ri­ence at the FDA to As­traZeneca, where he took on the role of se­nior vice pres­i­dent and chief physi­cian-sci­en­tist for res­pi­ra­to­ry, in­flam­ma­tion and au­toim­mu­ni­ty late-stage de­vel­op­ment in bio­phar­ma­ceu­ti­cals R&D.

Af­ter about a year and a half in this role, Chowd­hury is mov­ing to a small Texas biotech called Savara, where he will serve as chief med­ical of­fi­cer.

Its lead drug, Mol­gradex, is be­ing test­ed for a pletho­ra of or­phan lung dis­eases. Months ago the com­pa­ny’s shares $SVRA took a hit af­ter the drug failed to help pa­tients with a rare res­pi­ra­to­ry dis­ease called au­toim­mune pul­monary alve­o­lar pro­teinosis (aPAP) in a piv­otal study.

Rob Neville

“His ap­point­ment comes at a crit­i­cal time as we con­tin­ue dis­cus­sions with the FDA and EMA on the best path for­ward for the Mol­gradex aPAP pro­gram,” said Savara chief Rob Neville in a state­ment.

“With two decades of reg­u­la­to­ry lead­er­ship ex­pe­ri­ence at the FDA’s Pul­monary Di­vi­sion, where he presided over nu­mer­ous ap­provals of med­i­cines for pul­monary and or­phan dis­eases, Dr. Chowd­hury brings a unique per­spec­tive to the Com­pa­ny and we be­lieve he will be in­stru­men­tal in help­ing us achieve our goals.”

Chowd­hury’s move from As­traZeneca may have some­thing to do with some big changes im­ple­ment­ed un­der chief Pas­cal So­ri­ot ear­ly in 2019. A sweep­ing re­struc­tur­ing of its R&D en­gine de­lin­eat­ed the com­pa­ny’s on­col­o­gy ef­fort from every­thing else and erad­i­cat­ed the sub­sidiary struc­ture. The process stripped se­nior ex­ec­u­tives from the top ranks of As­traZeneca’s big bi­o­log­ics sub­sidiary Med­Im­mune, which is where Chowd­hury start­ed out.

Chowd­hury is the lat­est name in the ex­ec­u­tive ex­o­dus from As­traZeneca. David Berman, who was head of I/O re­search at As­traZeneca, has tak­en the top R&D job at Im­muno­core, a biotech that al­so lured Med­Im­mune chief Bahi­ja Jal­lal to take on the CEO role. Berman left As­traZeneca ahead of the re­struc­tur­ing that al­so in­clud­ed the de­par­ture of CMO Sean Bo­hen.

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

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.