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Eli Lil­ly ax­es 163 Der­mi­ra staffers, shut­ters Men­lo Park site as it clos­es in around Dupix­ent ri­val le­brik­izum­ab

Eli Lilly made it clear when it shelled out $1.1 billion for Dermira that lebrikizumab is really what it wanted to buy. One year in, the pharma giant is completing its cleavage of the rest.

Days after unveiling the sale of Qbexza — Dermira’s only approved product, a piece of cloth to block excessive sweating — Lilly revealed plans to close down the biotech’s Menlo Park facility, putting 163 jobs on the chopping block. The San Francisco Business Times first reported on the WARN notice filed in early April.

Up­dat­ed: Al­ny­lam faces DOJ probe over On­pat­tro mar­ket­ing

In the competitive market to sell drugs for the rare disease hereditary ATTR amyloidosis, the Justice Department thinks Alnylam may have crossed a line.

Alnylam disclosed in an SEC filing Monday that on April 9, the DOJ served the company with a subpoena related to how they marketed and promoted Onpattro, their $300 million per year drug for the genetic nerve-afflicting condition. The 3-sentence filing offered virtually no details, except that they are cooperating, preparing a response and have hired “experienced outside legal counsel” to assist.

Janet Woodcock (AP Images)

Janet Wood­cock on if the FDA is get­ting tougher on drug re­views: ‘I don’t think so’

Following a recent string of setbacks for some drug developers, acting FDA commissioner Janet Woodcock said Wednesday that she does not think the FDA is getting more stringent in its reviews of new drugs even as the agency hosts a 3-day advisory committee next week to take a closer look at several accelerated approvals.

“I don’t think so,” Woodcock said when questioned about the tougher stance at a webinar for the Alliance for a Stronger FDA. “I think that what’s happening is that science is moving into fields that typically haven’t seen advances that we’re seeing in other areas, and so I think there is some adjustment that has to be made as people deal with that.”

Fifth Cir­cuit sides with FTC in ma­jor pay-for-de­lay set­tle­ment case

The US Court of Appeals for the Fifth Circuit on Tuesday upheld the Federal Trade Commission’s ruling that generic drugmaker Impax Laboratories should be charged with antitrust violations for accepting payments worth about $100 million to delay the entry of a generic opioid for more than two years.

The court’s opinion upheld the FTC’s anticompetitive findings on the deal between Impax (now owned by Amneal Pharmaceuticals) and Endo Pharmaceuticals, under which Endo committed to not market an authorized generic, which increased Impax’s projected profits by $24.5 million. Endo agreed to pay Impax credits for the shrunken market that Impax would inherit if, as expected, Endo made a successful hop to a reformulated Opana ER.

Janet Woodcock, acting FDA commissioner (AP Images)

FDA dis­pens­es with in-per­son re­quire­ment for abor­tion pill ac­cess dur­ing the pan­dem­ic

Women seeking the abortion pill mifepristone during the pandemic will be able to order it through the mail and will no longer have to go into a clinic in person, acting FDA commissioner Janet Woodcock wrote Monday in response to a series of concerns from the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine.

Mifepristone is a drug that can end a pregnancy that is less than 10 weeks along, and has created a whirlwind of political and legal questions related to this in-person requirement.

Re­gen­eron’s Covid mAb as a pro­phy­lac­tic in­jec­tion: Re­duced risk of symp­to­matic in­fec­tion by 81%

Regeneron’s monoclonal antibody cocktail for Covid-19 continues to impress, this time in a joint trial with NIH that found the normally infused treatment works as a preventive subcutaneous injection.

The trial showed that REGEN-COV (casirivimab with imdevimab) reduced the risk of symptomatic infections by 81% in those who did not have Covid before the trial within 29 days. There were 11 cases in the 753-person mAb arm, versus 59 cases in the 752-person placebo arm.

AACR21: Eli Lil­ly blazes new trail for RET in­hibitor, gin­ning up a re­sponse in 9 sol­id tu­mor types in ear­ly da­ta

Eli Lilly was first to market with its RET fusion-inhibitor Retevmo in May, staking its claim in the rare tumor indication. But Roche wasn’t far on its heels with an approval of its own for RET inhibitor Gavreto, and now Lilly is looking to get the leg up on its closest competitor.

Lilly’s Retevmo posted a 47% objective response rate with responses in nine unique RET fusion-positive tumor types, according to early data from the Phase I/II LIBRETTO-001 unveiled Sunday at the virtual AACR meeting.

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CBO: Con­gres­sion­al ac­tion on drug prices will make R&D spend­ing less at­trac­tive

The greed of pharmaceutical companies has long been one of the reasons Congress has sought to reign in the industry’s high price tags for new drugs.

But a new report from the nonpartisan Congressional Budget Office on Thursday pours cold water on the idea that large pharma companies are pumping all their profits into share buybacks, marketing, and CEO salaries. In fact, the CBO notes that pharma spending on drug R&D ramped up by nearly 50% between 2015 and 2019, and now outpaces what other similar industries, like software and semiconductor companies, spend on R&D.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Bris­tol My­er­s' Op­di­vo notch­es a dou­ble win against chemo in esophageal can­cer, po­ten­tial­ly set­ting up 1st-line nod

Bristol Myers Squibb is one of a group of drugmakers prepping for a tense FDA adcomm later this month to review a host of accelerated approvals. Looking to start the month on the right note, the drugmaker rolled out new data for its PD-(L)1 checkpoint inhibitor Opdivo showing more promise in esophageal cancer.

Opdivo in combination with chemotherapy and a combination of Opdivo and Yervoy beat out chemo alone in extending the lives of first-line esophageal squamous cell carcinoma patients whose tumors are metastatic or can’t be surgically removed, according to interim results released Thursday.

Geoffrey Porges, SVB Leerink

Se­ries of JAK in­hibitor de­lays may sig­nal an up­com­ing FDA ad­comm

Three-month review delays from the FDA have become the norm in recent days for JAK inhibitors, some of which are seeking label expansions.

But the pushback of these action dates for AbbVie’s Rinvoq, Pfizer’s Xeljanz and abrocitinib, and Eli Lilly’s Olumiant may be a sign that the FDA is preparing to hold an advisory committee of outside experts to review the risk/benefit profiles of JAK inhibitors for atopic dermatitis, according to SVB Leerink analyst Geoffrey Porges. This wouldn’t be the first time this year that the FDA wants to review a series of drugs before an adcomm as the agency is holding such a review later this month for cancer drugs that have previously won accelerated approvals.