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Pharmaceuticals, health and wellness

Kadmon’s Rezurock scores surprise FDA nod in chronic graft-versus-host-disease

With a surprise FDA approval Friday afternoon, Kadmon Holdings is on its way to becoming a commercial drugmaker.  The FDA cleared Kadmon’s Rezurock to treat chronic graft-versus-host disease, a serious complication of transplant procedures. Formerly known as belumodsil, the drug is a first-in-class ROCK2 inhibitor—and now Kadmon’s first approved drug.  GVHD occurs when donor cells mount an immune response against a patient’s own tissues and organs. While doctors can […]

AbbVie, Lilly atopic dermatitis hopefuls hit with more delays as FDA’s JAK inhibitor holdups carry on

With the FDA’s JAK hesitations wearing on, atopic dermatitis hopefuls from AbbVie and Eli Lilly will have to keep waiting for a chance to see the market. The companies separately said on Friday that the FDA again delayed decisions over their applications for Rinvoq and Olumiant in moderate to severe atopic dermatitis. Neither provided an updated timeline […]

Alexion’s Ultomiris notches myasthenia gravis win amid quest for 3rd Soliris use

In the quest to match its predecessor Soliris, Alexion’s Ultomiris just notched a win in the autoimmune disorder myasthenia gravis.  Alexion is trumpeting data showing Ultomiris met its primary endpoint in its rare disease phase 3 study, which evaluated changes in generalized myasthenia gravis (gMG) symptoms using a standard patient assessment. Armed with the results, which Alexion says could position the drug as […]

AstraZeneca, FibroGen hit another roxadustat setback as FDA panel calls for more safety data

AstraZeneca and its roxadustat partner FibroGen headed into a high-stakes FDA expert meeting this week after receiving tough safety questions about the med from agency staffers. The daylong event Thursday featured bruising feedback, and their application now faces even more uncertainty. In a 13 to 1 vote, FDA committee panelists said that the drug should not be approved […]

Sprout’s female libido drug Addyi back in FDA’s crosshairs years after controversial approval

Sprout Pharmaceuticals’ female libido drug Addyi has traveled a winding path through FDA gatekeepers, multiple M&A deals, marketing restrictions and more. With a possible new safety flag, the controversial medicine could be set for even more scrutiny. In a rundown of potential new safety concerns on approved products, the FDA flagged the Addyi for possible risks of drug hypersensitivity. […]

So far, so not-so-good: Neurologists slow to warm up to Biogen’s Alzheimer drug Aduhelm, study finds

Neurologists are thinking about Biogen’s newly approved Alzheimer’s drug, but so far it’s mostly just that—thoughts. While almost 90% of neurologists are moderately or highly aware of Aduhelm, only 3% have written prescriptions so far, according to Spherix Global Insights latest data. Even more concerning? Only about one fourth (27%) plan to prescribe the drug in […]

Gilead’s Veklury shows ‘no antiviral effects’ against COVID-19 in small WHO study

Veklury has become routine treatment for severe COVID-19 patients in the U.S., spurring significant sales for Gilead Sciences. Experts have often debated data from the drug’s clinical trials, and now a small study adds points to the arguments voiced by skeptics. Both Veklury, also known as remdesivir, and hydroxychloroquine didn’t significantly clear the virus from hospitalized COVID-19 […]

Seagen, Astellas’ Padcev snares full approval and expands into second-line treatment on path to blockbuster land

That didn’t take long: Shortly after Seagen and Astellas Pharma’s Padcev nabbed a priority review for two bladder cancer applications, the FDA has returned with double green lights—and it’s given the OK more than a month ahead of schedule.  First up, Padcev’s conditional nod in third-line metastatic or locally advanced bladder cancer has been converted […]

FDA chief asks for independent investigation into approval of Biogen’s Alzheimer’s drug Aduhelm

The FDA’s reportedly cozy relationship with Biogen ahead of its controversial approval of the drugmaker’s Alzheimer’s disease therapy, Aduhelm, has been at the center of calls for an investigation. Now, even the agency’s own chief has joined in.  The FDA’s interim commissioner, Janet Woodcock, M.D., in a letter dated Friday requested the Office of Inspector […]

After 5-month hiatus, bluebird bio’s Zynteglo bounces back in Europe with all-clear from safety group

With a positive safety ruling in hand, bluebird bio has surmounted another hurdle and will once again forge ahead with the European rollout of its beta-thalassemia gene therapy Zynteglo. After nearly five months off the market, the Massachusetts-based company said on Friday that it would lift its marketing hold for the blood disease treatment in Europe […]

OxyContin maker Purdue wins 15 states’ support in controversial $4B bankruptcy plan

Purdue Pharma, after reaping billions in opioid drug sales, has been battling over its role in the U.S. addiction crisis for years. Now, it’s potentially won an out after several states challenged its multibillion-dollar settlement plan. Fifteen states, including Massachusetts and New York, have blessed OxyContin maker Purdue Pharma’s controversial bankruptcy reorganization plan, a court filing in the U.S. […]

Biohaven set to be ‘a major migraine player’ as Nurtec ODT sales dwarf estimates: analysts

Biohaven Pharmaceuticals was confident its oral migraine med Nurtec ODT could rattle the market as the only FDA-approved option to both prevent and treat recurring headaches. Now, with a few months of sales under its belt, it appears the CGRP player is well on its way.  Biohaven on Wednesday reported Nurtec ODT, also known as rimegepant, raked in […]